Covid19, SARS-CoV Infection
Conditions
Keywords
Coronavirus
Brief summary
This is a randomized, observer-blinded, Phase 1/2 study evaluating the safety and immunogenicity of a quadrivalent HA nanoparticle influenza and SARS-CoV-2 rS nanoparticle combination vaccine with Matrix-M1 adjuvant; this combination is referred to as ICC vaccine.
Detailed description
This is a randomized, observer-blinded, Phase 1/2 study evaluating the safety and immunogenicity of a quadrivalent hemagglutinin (HA) nanoparticle influenza vaccine (qNIV) and severe acute respiratory syndrome coronavirus 2 (SARSCoV2) recombinant spike (rS) nanoparticle combination vaccine with Matrix-M1™ adjuvant; this combination vaccine is referred to as Influenza COVID-19 Combination (ICC) vaccine. The study will enroll approximately 640 healthy (based on history and physical examination) adult male and female participants 50 to 70 years of age, inclusive, targeting participants who are baseline seropositive (either previously infected with SARS-CoV-2 ≥ 8 weeks prior to enrollment, or have been previously immunized against SARS-CoV-2 with a completed regimen of an authorized vaccine at ≥ 8 weeks prior to enrollment). Randomization will be stratified on age ≥ 50 to ≤60 or ≥ 60 to ≤ 70 years to distribute the proportions of each age stratum evenly across vaccine groups.
Interventions
BIOLOGICALICC Vaccine
Intramuscular (deltoid) injections of in-clinic mix of various doses of quadrivalent hemagglutinin nanoparticle influenza vaccine(qNIV2), SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
BIOLOGICALqNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant
Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
BIOLOGICALSARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant
Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
Sponsors
Novavax
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy, medically stable adult males or females ≥ 50 to ≤ 70 years of age at screening. 2. Willing and able to give informed consent prior to study enrollment. 3. Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs. 4. Participants must have been baseline seropositive to SARS-CoV-2 defined as either: • Having completed a primary vaccination series against SARS-CoV-2 with an authorized COVID-19 vaccine with receipt of second/final dose of authorized vaccine ≥ 8 weeks prior to enrollment (first study vaccination). OR • Previously infected with SARS CoV-2 ≥ 8 weeks prior to enrollment (first study vaccination). Note: Baseline SARS-CoV-2 serostatus determination at screening will be based on vaccination documentation (eg, vaccination card or vaccination registry) or participants' report of a previous SARS-CoV-2 infection. 5. Women of childbearing potential (defined as any female participant who is NOT surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea at least 12 consecutive months\]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study. 1. Condoms (male or female) with spermicide (if acceptable in-country) 2. Diaphragm with spermicide 3. Cervical cap with spermicide 4. Intrauterine device 5. Oral or patch contraceptives 6. Norplant®, Depo-Provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy 7. Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle 6. Participants must be healthy and medically stable, as determined by the investigator (based on a review of health status, vital signs \[to include body temperature\], medical history, and targeted physical examination \[to include body weight\]). Participants must have a body mass index (BMI) of 17 to 34 kg/m2, inclusive, at screening. Vital signs must be within medically acceptable ranges prior to the first vaccination. 7. Participants must agree to not participate in any other SARS-CoV-2 or influenza prevention or treatment studies for the duration of the study. Note: For participants who become hospitalized with COVID-19, participation in investigational treatment studies is permitted.
Exclusion criteria
1. Any ongoing, symptomatic acute, or chronic illness requiring medical or surgical care. * Asymptomatic chronic conditions or findings (eg, mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (ie, unlikely to result in symptomatic illness within the time-course of this study), in the opinion of the investigator. * Acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable. * Acute or chronic illnesses reasonably expected to be associated with increased risks in the event of influenza or SARS-CoV-2 infection (eg, cardio-pulmonary diseases, diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are exclusionary, even if stable. 2. Participation in research involving an investigational product (drug/biologic/device) within 90 days before the planned date of the first injection. 3. Use of COVID-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to the planned date of the first injection. 4. History of a serious reaction to prior influenza vaccination or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80; or any known allergies to products contained in the investigational product. 5. Any history of anaphylaxis to any prior vaccine. 6. History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine. 7. Receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 2 months preceding the study vaccination. Note: Routine vaccinations will not be allowed until after study Day 70. 8. Any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination. 9. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccines. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted. 10. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. 11. Active cancer (malignancy) therapy within 3 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator). 12. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the EoS. 13. Known disturbance of coagulation. 14. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first trial vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance. 15. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature \> 38.0°C, on the planned day of vaccine administration). 16. Any condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). 17. Study team member or immediate family member of any study team member (inclusive of Sponsor, Contract Research Organization, and study site personnel involved in the conduct or planning of the study).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Day 0 to Day 63 | Numbers of participants with solicited local and systemic AEs over the 7 days post-injection after first and second doses. |
| Number of Participants Reporting All AE's | Day 0 to Day 70 | Number of participants reporting all AEs, (solicited and unsolicited), over 70 days after the first dose. |
| Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | Day 0 to Day 180 | Number of participants with Medical Attended Adverse Events (MAAE's), Adverse events (AESI's), Including potential immune-mediated medical conditions (PIMMCs), Serious Adverse Events SAEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 0 to Day 182 | Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points. |
| Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 0 to Day 182 | Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points. |
| Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 0 to Day 182 | Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points. |
| Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 0 to Day 182 | Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points. |
| Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 0 to Day 182 | Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points. |
| HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 to Day 182 | GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers) |
| Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 28 to Day 182 | Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points. |
| Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 to Day 182 | Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points. |
| Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 28 to Day 182 | Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points. |
| Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 to Day 182 | Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points. |
| Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 to Day 182 | Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points. |
| Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 to Day 182 | Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points. |
| Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 28 to Day 182 | Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points. |
| Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 to Day 182 | Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points. |
| HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 28 to Day 182 | GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers) |
| Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 28 to Day 182 | Hemagglutination-Inhibition (HAI) Antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points. |
| Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 to Day 182 | Hemagglutination-Inhibition (HAI) Antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points. |
| Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 to Day 182 | Hemagglutination-Inhibition (HAI) Antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points. |
| HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 to Day 182 | HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points. |
| HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 to Day 182 | HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype)strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points. |
| HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 to Day 182 | HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points. |
| HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 to Day 182 | HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points. |
| HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 to Day 182 | HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points. |
| HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 28 to Day 182 | GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers) |
| HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 to Day 182 | GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers) |
| HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 to Day 182 | GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers) |
| HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 to Day 182 | GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers) |
| HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 to Day 182 | GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers) |
| HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 28 to Day 182 | GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers) |
| Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 28 to Day 182 | Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) on Days 56, 70, and other follow-up time points. |
| Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 28 to Day 182 | Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) on Days 56, 70, and other follow-up time points. |
| Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 28 to Day 182 | Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) on Days 56, 70, and other follow-up time points. |
| Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 28 to Day 182 | Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) on Days 56, 70, and other follow-up time points. |
| Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 28 to Day 182 | Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype)on Days 56, 70, and other follow-up time points. |
| Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 28 to Day 182 | Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) on Days 56, 70, and other follow-up time points. |
| Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 28 to Day 182 | Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) on Days 56, 70, and other follow-up time points. |
| Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 28 to Day 182 | Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) on Days 56, 70, and other follow-up time points. |
| MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 0 to Day 182 | MN50 GMTs to the SARS-CoV-2 Wuhan Strain from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points. |
| MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 0 to Day 70 | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points. |
| MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 28 to Day 182 | MN50 GMTs to the SARS-CoV-2 Wuhan Strain from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points. |
| MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 28 to Day 70 | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points. |
| MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 28 to Day 182 | MN50 GMTs to the SARS-CoV-2 Wuhan Strain from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points. |
| MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 28 to Day 182 | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points. |
| MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 28 to Day 182 | MN50 GMTs to the SARS-CoV-2 Wuhan Strain from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points. |
| MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 28 to Day 182 | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points. |
| Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 0 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Brisbane (H1N1 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT. |
| Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 0 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Kansas (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT. |
| Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 0 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Wisconsin (H1N1 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT. |
| Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 0 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Cambodia (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT. |
| Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 0 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Hong Kong (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT. |
| Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 0 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Phuket (Yamagata Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT. |
| Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 0 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Maryland (Victoria Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT. |
| Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 0 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Washington (Victoria Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT. |
| Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Brisbane (H1N1 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR. |
| Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Kansas (H3N2 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR. |
| Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Wisconsin (H1N1 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR. |
| Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Cambodia (H3N2 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR. |
| Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Hong Kong (H3N2 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR. |
| Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza B/Maryland (Victoria Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR. |
| Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza B/Phuket (Yamagata Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR. |
| Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza B/Washington (Victoria Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR. |
| Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR. |
| Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Kansas (H3N2 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR. |
| Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR. |
| Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR. |
| Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR. |
| Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza B/Maryland (Victoria Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR. |
| Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza B/Phuket (Yamagata Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR. |
| Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza B/Washington (Victoria Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR. |
| Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Brisbane (H1N1 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR. |
| Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Kansas (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR. |
| Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Wisconsin (H1N1 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR. |
| Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Cambodia (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR. |
| Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Hong Kong (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR. |
| Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Maryland (Victoria Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR. |
| Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Phuket (Yamagata Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR. |
| Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 0 to Day 182 | Hemagglutination-inhibition (HAI) antibody titers specific for the hemagglutinin (HA) receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points. |
| Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 0 to Day 182 | IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Wuhan Strain spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points. |
| Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 0 to Day 182 | IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Omicron BA.1 spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points. |
| Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 28 to Day 182 | IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Wuhan Strain spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points. |
| Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 28 to Day 182 | IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Omicron BA.1 Variant spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points. |
| Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 28 to Day 182 | IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Wuhan Strain spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points. |
| Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 28 to Day 182 | IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Omicron BA.1 Variant spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points. |
| Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 28 to Day 182 | IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Omicron BA.1 Variant spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points. |
| Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 28 to Day 182 | IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 (Wuhan) spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points. |
| Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 28 to Day 182 | Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Washington(VictoriaSubtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR. |
| Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 0 to Day 182 | Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points. |
| Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 0 to Day 182 | Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points. |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A and Group C - ICC Vaccine Formulation 2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56. | 80 |
| Group B -ICC Vaccine Formulation 2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56. | 40 |
| Group D - ICC Vaccine Formulation 2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56. | 39 |
| Group E - ICC Vaccine Formulation 2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56. | 37 |
| Group F- ICC Vaccine Formulation 2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56. | 41 |
| Group G- ICC Vaccine Formulation 2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56. | 41 |
| Group H and Group N- ICC Vaccine Formulation 2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56. | 81 |
| Group I- ICC Vaccine Formulation 2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56. | 39 |
| Group J -ICC Vaccine Formulation 2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56. | 39 |
| Group K - ICC Vaccine Formulation 2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56. | 40 |
| Group L - ICC Vaccine Formulation 2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56. | 40 |
| Group M -ICC Vaccine Formulation 2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56. | 41 |
| Group O - qNIV With Matrix-M1 Adjuvant 2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70. | 39 |
| Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant 2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56. | 40 |
| Total | 637 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 3 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Group A and Group C - ICC Vaccine Formulation | Group B -ICC Vaccine Formulation | Group D - ICC Vaccine Formulation | Group E - ICC Vaccine Formulation | Group F- ICC Vaccine Formulation | Group G- ICC Vaccine Formulation | Group H and Group N- ICC Vaccine Formulation | Group I- ICC Vaccine Formulation | Group J -ICC Vaccine Formulation | Group K - ICC Vaccine Formulation | Group L - ICC Vaccine Formulation | Group M -ICC Vaccine Formulation | Group O - qNIV With Matrix-M1 Adjuvant | Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 5.7 | 59 years STANDARD_DEVIATION 5.3 | 59 years STANDARD_DEVIATION 5.5 | 58 years STANDARD_DEVIATION 5.5 | 60 years STANDARD_DEVIATION 5.4 | 59 years STANDARD_DEVIATION 6.1 | 59 years STANDARD_DEVIATION 6 | 59 years STANDARD_DEVIATION 6.1 | 59 years STANDARD_DEVIATION 6.5 | 59 years STANDARD_DEVIATION 5.7 | 59 years STANDARD_DEVIATION 5.1 | 58 years STANDARD_DEVIATION 6.3 | 59 years STANDARD_DEVIATION 5.7 | 58 years STANDARD_DEVIATION 5.5 | 59 years STANDARD_DEVIATION 6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 627 Participants | 79 Participants | 39 Participants | 39 Participants | 36 Participants | 39 Participants | 40 Participants | 80 Participants | 39 Participants | 39 Participants | 38 Participants | 40 Participants | 41 Participants | 39 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 615 Participants | 76 Participants | 39 Participants | 37 Participants | 36 Participants | 41 Participants | 39 Participants | 76 Participants | 39 Participants | 39 Participants | 38 Participants | 39 Participants | 39 Participants | 38 Participants | 39 Participants |
| Regimen of Previous COVID Vaccine Mixed or Other | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Regimen of Previous COVID Vaccine Oxford-AstraZeneca | 435 Participants | 50 Participants | 28 Participants | 27 Participants | 29 Participants | 25 Participants | 26 Participants | 52 Participants | 30 Participants | 28 Participants | 24 Participants | 30 Participants | 31 Participants | 26 Participants | 29 Participants |
| Regimen of Previous COVID Vaccine Pfizer-BioNtech | 198 Participants | 30 Participants | 11 Participants | 12 Participants | 8 Participants | 16 Participants | 14 Participants | 29 Participants | 8 Participants | 11 Participants | 16 Participants | 10 Participants | 9 Participants | 13 Participants | 11 Participants |
| Sex: Female, Male Female | 398 Participants | 43 Participants | 28 Participants | 25 Participants | 25 Participants | 26 Participants | 25 Participants | 50 Participants | 19 Participants | 27 Participants | 27 Participants | 22 Participants | 29 Participants | 28 Participants | 24 Participants |
| Sex: Female, Male Male | 239 Participants | 37 Participants | 12 Participants | 14 Participants | 12 Participants | 15 Participants | 16 Participants | 31 Participants | 20 Participants | 12 Participants | 13 Participants | 18 Participants | 12 Participants | 11 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 40 | 0 / 39 | 0 / 37 | 0 / 41 | 0 / 41 | 0 / 81 | 0 / 39 | 0 / 39 | 0 / 40 | 0 / 40 | 0 / 41 | 0 / 39 | 0 / 40 |
| other Total, other adverse events | 8 / 80 | 6 / 40 | 12 / 39 | 13 / 37 | 7 / 41 | 8 / 41 | 19 / 81 | 5 / 39 | 7 / 39 | 2 / 40 | 4 / 40 | 8 / 41 | 6 / 39 | 4 / 40 |
| serious Total, serious adverse events | 2 / 80 | 1 / 40 | 2 / 39 | 0 / 37 | 2 / 41 | 1 / 41 | 3 / 81 | 2 / 39 | 0 / 39 | 0 / 40 | 5 / 40 | 0 / 41 | 1 / 39 | 1 / 40 |
Outcome results
Primary
Number of Participants Reporting All AE's
Number of participants reporting all AEs, (solicited and unsolicited), over 70 days after the first dose.
Time frame: Day 0 to Day 70
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Number of Participants Reporting All AE's | Solicited AEs | 77 Participants |
| Group A and Group C - ICC Vaccine Formulation | Number of Participants Reporting All AE's | Unsolicited AEs | 25 Participants |
| Group B -ICC Vaccine Formulation | Number of Participants Reporting All AE's | Solicited AEs | 33 Participants |
| Group B -ICC Vaccine Formulation | Number of Participants Reporting All AE's | Unsolicited AEs | 15 Participants |
| Group D - ICC Vaccine Formulation | Number of Participants Reporting All AE's | Solicited AEs | 35 Participants |
| Group D - ICC Vaccine Formulation | Number of Participants Reporting All AE's | Unsolicited AEs | 14 Participants |
| Group E - ICC Vaccine Formulation | Number of Participants Reporting All AE's | Solicited AEs | 34 Participants |
| Group E - ICC Vaccine Formulation | Number of Participants Reporting All AE's | Unsolicited AEs | 17 Participants |
| Group F- ICC Vaccine Formulation | Number of Participants Reporting All AE's | Unsolicited AEs | 16 Participants |
| Group F- ICC Vaccine Formulation | Number of Participants Reporting All AE's | Solicited AEs | 39 Participants |
| Group G- ICC Vaccine Formulation | Number of Participants Reporting All AE's | Unsolicited AEs | 20 Participants |
| Group G- ICC Vaccine Formulation | Number of Participants Reporting All AE's | Solicited AEs | 39 Participants |
| Group H and Group N- ICC Vaccine Formulation | Number of Participants Reporting All AE's | Solicited AEs | 70 Participants |
| Group H and Group N- ICC Vaccine Formulation | Number of Participants Reporting All AE's | Unsolicited AEs | 30 Participants |
| Group I- ICC Vaccine Formulation | Number of Participants Reporting All AE's | Solicited AEs | 37 Participants |
| Group I- ICC Vaccine Formulation | Number of Participants Reporting All AE's | Unsolicited AEs | 9 Participants |
| Group J -ICC Vaccine Formulation | Number of Participants Reporting All AE's | Unsolicited AEs | 17 Participants |
| Group J -ICC Vaccine Formulation | Number of Participants Reporting All AE's | Solicited AEs | 31 Participants |
| Group K - ICC Vaccine Formulation | Number of Participants Reporting All AE's | Unsolicited AEs | 19 Participants |
| Group K - ICC Vaccine Formulation | Number of Participants Reporting All AE's | Solicited AEs | 38 Participants |
| Group L - ICC Vaccine Formulation | Number of Participants Reporting All AE's | Unsolicited AEs | 10 Participants |
| Group L - ICC Vaccine Formulation | Number of Participants Reporting All AE's | Solicited AEs | 34 Participants |
| Group M -ICC Vaccine Formulation | Number of Participants Reporting All AE's | Unsolicited AEs | 16 Participants |
| Group M -ICC Vaccine Formulation | Number of Participants Reporting All AE's | Solicited AEs | 39 Participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Number of Participants Reporting All AE's | Solicited AEs | 38 Participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Number of Participants Reporting All AE's | Unsolicited AEs | 18 Participants |
| Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant | Number of Participants Reporting All AE's | Unsolicited AEs | 14 Participants |
| Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant | Number of Participants Reporting All AE's | Solicited AEs | 39 Participants |
Primary
Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs
Number of participants with Medical Attended Adverse Events (MAAE's), Adverse events (AESI's), Including potential immune-mediated medical conditions (PIMMCs), Serious Adverse Events SAEs.
Time frame: Day 0 to Day 180
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | AESIs | 0 Participants |
| Group A and Group C - ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | MAAEs | 14 Participants |
| Group A and Group C - ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | SAEs | 2 Participants |
| Group B -ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | MAAEs | 8 Participants |
| Group B -ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | AESIs | 0 Participants |
| Group B -ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | SAEs | 1 Participants |
| Group D - ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | AESIs | 0 Participants |
| Group D - ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | MAAEs | 7 Participants |
| Group D - ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | SAEs | 2 Participants |
| Group E - ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | SAEs | 0 Participants |
| Group E - ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | AESIs | 0 Participants |
| Group E - ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | MAAEs | 12 Participants |
| Group F- ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | AESIs | 0 Participants |
| Group F- ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | SAEs | 2 Participants |
| Group F- ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | MAAEs | 10 Participants |
| Group G- ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | MAAEs | 11 Participants |
| Group G- ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | SAEs | 1 Participants |
| Group G- ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | AESIs | 0 Participants |
| Group H and Group N- ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | MAAEs | 20 Participants |
| Group H and Group N- ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | SAEs | 3 Participants |
| Group H and Group N- ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | AESIs | 0 Participants |
| Group I- ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | MAAEs | 9 Participants |
| Group I- ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | SAEs | 2 Participants |
| Group I- ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | AESIs | 0 Participants |
| Group J -ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | SAEs | 0 Participants |
| Group J -ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | AESIs | 0 Participants |
| Group J -ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | MAAEs | 14 Participants |
| Group K - ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | SAEs | 0 Participants |
| Group K - ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | AESIs | 0 Participants |
| Group K - ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | MAAEs | 7 Participants |
| Group L - ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | SAEs | 5 Participants |
| Group L - ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | AESIs | 0 Participants |
| Group L - ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | MAAEs | 7 Participants |
| Group M -ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | SAEs | 0 Participants |
| Group M -ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | MAAEs | 7 Participants |
| Group M -ICC Vaccine Formulation | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | AESIs | 0 Participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | MAAEs | 14 Participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | SAEs | 1 Participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | AESIs | 0 Participants |
| Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | SAEs | 1 Participants |
| Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | AESIs | 0 Participants |
| Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant | Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs | MAAEs | 12 Participants |
Primary
Number of Participants With Solicited Local and Systemic Adverse Events (AE's)
Numbers of participants with solicited local and systemic AEs over the 7 days post-injection after first and second doses.
Time frame: Day 0 to Day 63
Population: Safety Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Local AEs | 71 participants |
| Group A and Group C - ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Systemic AEs | 50 participants |
| Group B -ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Local AEs | 32 participants |
| Group B -ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Systemic AEs | 17 participants |
| Group D - ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Local AEs | 32 participants |
| Group D - ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Systemic AEs | 27 participants |
| Group E - ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Local AEs | 28 participants |
| Group E - ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Systemic AEs | 24 participants |
| Group F- ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Systemic AEs | 29 participants |
| Group F- ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Local AEs | 38 participants |
| Group G- ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Systemic AEs | 27 participants |
| Group G- ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Local AEs | 36 participants |
| Group H and Group N- ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Local AEs | 64 participants |
| Group H and Group N- ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Systemic AEs | 59 participants |
| Group I- ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Local AEs | 32 participants |
| Group I- ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Systemic AEs | 29 participants |
| Group J -ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Systemic AEs | 20 participants |
| Group J -ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Local AEs | 28 participants |
| Group K - ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Systemic AEs | 28 participants |
| Group K - ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Local AEs | 34 participants |
| Group L - ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Systemic AEs | 26 participants |
| Group L - ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Local AEs | 34 participants |
| Group M -ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Systemic AEs | 30 participants |
| Group M -ICC Vaccine Formulation | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Local AEs | 39 participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Local AEs | 34 participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Systemic AEs | 27 participants |
| Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Systemic AEs | 30 participants |
| Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant | Number of Participants With Solicited Local and Systemic Adverse Events (AE's) | Local AEs | 35 participants |
Secondary
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR)
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.17 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 1.04 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.09 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.28 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.08 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.22 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.04 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.96 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.77 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.16 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.83 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.03 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.09 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.18 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.83 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.73 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.98 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.17 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.76 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.00 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.80 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.03 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.11 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.03 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.81 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.98 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.83 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.08 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.01 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.07 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.98 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.80 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.85 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.98 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.81 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.89 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.98 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.95 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.07 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.14 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.11 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.00 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.84 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.97 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.88 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.76 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.79 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.75 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.65 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.92 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.77 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.87 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.85 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.68 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.15 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.99 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.94 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.06 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.97 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.04 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.87 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.09 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.83 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.08 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.99 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.02 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.09 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.00 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.78 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.87 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.00 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR) | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.98 Geometric mean titer ratio |
Secondary
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.98 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.13 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.94 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.01 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.25 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.02 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.05 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.42 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.36 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.94 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.96 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.96 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.85 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.03 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.92 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.72 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.98 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.84 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.79 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.85 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.83 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.72 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.76 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.94 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.97 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.05 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.90 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.15 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.96 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.18 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.03 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.82 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.83 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.91 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.06 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.84 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.12 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.20 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.92 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.97 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.93 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.00 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.71 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.06 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.85 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.92 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.77 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.10 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.77 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.75 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.93 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.81 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.06 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.79 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.15 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.40 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 1.02 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.14 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.39 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.04 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.04 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.38 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.95 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 1.08 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.03 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.15 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.01 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.79 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.83 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.83 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.99 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.90 Geometric mean titer ratio |
Secondary
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 27.6 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 10.8 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 30.4 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 23.1 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 14.3 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 17.9 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 30.8 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 15.4 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 17.9 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 22.5 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 19.4 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 25.7 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 23.7 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 8.8 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 8.8 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 5.7 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 11.1 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 13.5 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 5.7 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 13.9 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 26.8 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 15.0 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 12.8 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 25.0 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 5.1 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 10.5 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 20.0 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 22.5 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 13.2 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 12.5 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 15.8 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 28.2 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 9.3 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 28.9 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 20.3 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 13.2 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 10.3 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 12.8 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 18.4 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 5.4 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 10.5 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 15.8 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 8.1 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 15.4 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 13.2 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 41.0 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 23.5 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 35.1 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 11.1 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 36.1 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 5.3 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 26.3 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 13.5 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 27.0 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 30.8 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 17.1 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 15.0 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 5.1 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 19.5 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 12.2 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 7.9 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 23.1 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 21.1 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 30.8 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 10.5 percentage of participants |
Secondary
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.07 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.03 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.96 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.99 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.03 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.05 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.05 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.97 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.94 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.14 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.20 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.18 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.94 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.97 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.82 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.89 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.89 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.73 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.91 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.84 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.73 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.80 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.93 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.87 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.96 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.89 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.91 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.01 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.82 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.05 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.95 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.87 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.92 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.86 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.77 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.92 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.19 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.03 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.95 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.02 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.01 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.93 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.78 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.94 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.84 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.94 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.76 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.78 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.98 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.85 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.93 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.91 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.91 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.86 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.99 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.07 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.97 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.19 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.19 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.99 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.09 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.02 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.18 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.99 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.09 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.02 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.94 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.06 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.88 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.14 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.94 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.86 Geometric mean titer ratio |
Secondary
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype)strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 19.2 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 21.5 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 6.8 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 25.0 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 11.7 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 22.5 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 20.5 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 12.8 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 23.1 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 15.4 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 17.1 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 13.9 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 13.2 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 11.8 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 5.9 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 11.1 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 10.8 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 5.7 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 5.7 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 8.3 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 10.0 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 10.3 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 5.1 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 12.5 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 17.1 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 12.5 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 5.0 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 7.5 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 5.3 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 5.3 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 9.3 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 19.0 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 21.1 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 25.6 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 15.8 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 7.7 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 7.7 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 13.2 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 0 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 5.3 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 10.5 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 17.9 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 18.4 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 10.5 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 0 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 28.2 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 27.8 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 18.9 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 20.6 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 8.3 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 10.5 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 18.9 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 25.6 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 13.5 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 2.6 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 17.1 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 12.2 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 12.5 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 7.7 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 9.8 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 13.2 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 10.5 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 20.5 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 13.2 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 15.4 percentage of participants |
Secondary
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.12 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.76 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.83 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.24 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.88 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.06 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.80 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.11 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.67 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.01 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.72 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.07 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.83 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.05 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.67 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.48 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.64 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.01 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.48 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.69 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.56 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.76 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.87 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.78 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.67 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.80 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.69 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.01 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.09 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.09 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.92 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.52 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.56 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.81 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.83 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.64 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.74 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.87 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.16 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.19 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.12 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.88 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.89 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.80 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.64 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.53 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.78 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.47 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.46 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.96 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.58 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.78 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.73 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.59 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.03 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.95 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.80 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.04 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.81 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.81 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.75 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.92 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.79 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.98 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.73 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.01 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.92 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.14 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.70 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.81 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.99 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.73 Geometric mean titer ratio |
Secondary
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.23 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.20 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.08 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.27 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 1.07 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.14 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.90 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.89 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.96 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.08 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.93 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.87 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.93 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.85 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.83 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.97 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.90 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.96 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.87 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.95 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.99 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.95 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.00 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.84 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.14 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.99 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.10 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.22 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.94 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.17 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.08 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.86 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.89 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.05 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.89 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.84 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.08 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.03 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 1.02 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.95 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.08 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.22 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.98 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.03 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.92 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.82 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.88 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.99 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.82 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.82 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.83 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.81 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.86 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.80 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.05 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.98 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.03 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.09 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.10 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.96 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.92 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.01 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.03 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.96 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.95 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.92 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.95 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.14 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.05 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.98 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.17 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.89 Geometric mean titer ratio |
Secondary
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.96 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.10 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.04 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.03 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.15 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.18 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.90 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.04 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.85 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.01 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.89 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.03 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.90 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.62 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.75 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.72 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.88 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.84 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.85 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.87 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.86 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.98 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.87 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.74 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.74 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.04 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.90 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.97 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.83 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.02 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.70 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.86 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.76 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.88 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.92 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.76 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.15 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.08 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.90 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.95 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.05 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.91 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.90 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.78 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.85 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.67 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.74 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.78 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.70 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.65 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.88 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.79 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.71 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.82 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.90 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.78 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.94 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.87 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.89 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.02 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.95 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.82 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.99 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.78 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.89 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.76 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.92 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.82 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.95 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.78 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.01 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.87 Geometric mean titer ratio |
Secondary
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 16.2 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 22.1 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 12.8 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 11.4 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 15.8 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 10.3 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 17.5 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 12.8 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 12.8 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 7.7 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 2.9 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 5.3 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 11.8 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 0 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 5.9 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 8.6 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 5.4 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 8.6 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 2.8 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 8.3 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 4.9 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 17.9 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 7.7 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 2.5 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 10.0 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 2.6 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 7.5 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 7.9 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 5.0 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 5.0 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 10.1 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 19.7 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 16.0 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 14.1 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 14.5 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 0 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 0 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 2.6 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 2.6 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 0 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 2.6 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 5.1 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 10.5 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 5.4 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 7.9 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 8.3 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 5.4 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 0 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 10.3 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 11.8 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 5.4 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 5.3 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 8.1 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 7.7 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 2.6 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 4.9 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 4.9 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 2.6 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 0 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 7.3 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 13.2 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 15.4 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 10.5 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 20.5 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 13.2 percentage of participants |
Secondary
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.11 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.76 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.86 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.81 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.02 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.95 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.82 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.73 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.58 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.91 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.62 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.86 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.69 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.80 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.57 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.44 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.73 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.53 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.72 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.76 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.54 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.64 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.50 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.82 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.68 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.00 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.00 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.05 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.69 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.85 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.50 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.56 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.60 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.72 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.73 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.80 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.68 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.90 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.86 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.64 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.72 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.90 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.83 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.65 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.56 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.79 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.59 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.73 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.80 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.68 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.66 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.52 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.49 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.56 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.71 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.84 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.60 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.86 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.93 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.65 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.87 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.61 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.84 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.60 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.66 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.79 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.75 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.70 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.89 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.94 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.88 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.75 Geometric mean titer ratio |
Secondary
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 16.7 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 20.3 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 29.9 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 20.3 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 25.0 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 30.8 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 17.9 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 15.4 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 22.5 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 25.6 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 17.1 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 2.6 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 11.8 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 5.6 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 17.6 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 11.4 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 11.1 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 5.6 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 5.4 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 20.0 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 22.0 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 17.9 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 37.5 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 33.3 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 10.0 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 10.0 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 10.0 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 7.5 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 13.2 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 10.5 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 18.7 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 11.4 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 21.1 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 17.9 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 34.2 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 10.3 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 7.9 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 7.7 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 16.2 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 18.4 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 5.4 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 7.9 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 10.3 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 2.6 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 7.9 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 8.1 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 22.2 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 26.5 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 11.1 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 12.8 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 10.5 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 13.5 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 27.0 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 15.4 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 7.9 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 22.0 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 24.4 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 17.5 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 12.8 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 22.0 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 42.1 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 21.1 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 43.6 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 34.2 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 38.5 percentage of participants |
Secondary
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.91 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.99 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.93 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.91 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.86 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.01 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.82 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.87 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.86 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.88 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.88 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.83 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.74 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.75 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.82 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.81 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.72 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.73 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.81 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.85 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.88 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.91 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.80 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.79 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.90 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.78 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.87 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.83 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.85 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.91 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.76 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.77 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.80 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.77 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.73 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.72 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.88 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.90 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.85 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.92 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.86 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.88 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.73 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.78 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.76 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.79 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.76 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.74 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.74 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.79 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.71 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.80 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.79 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.77 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.96 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.93 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.84 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.82 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.83 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.90 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.80 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.85 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.75 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.88 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.80 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.83 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.86 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.83 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.85 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.84 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.86 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.82 Geometric mean titer ratio |
Secondary
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 1.3 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 5.1 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 6.4 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 6.6 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 2.7 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 0 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 0 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 0 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 0 percentage of participants |
| Group B -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 0 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 0 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 0 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 0 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 0 percentage of participants |
| Group D - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 0 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 2.8 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 2.7 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 2.9 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 2.9 percentage of participants |
| Group E - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 2.8 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 2.5 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 2.6 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 2.6 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 7.5 percentage of participants |
| Group F- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 4.9 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 5.0 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 5.0 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 2.5 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 0 percentage of participants |
| Group G- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 0 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 0 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 3.8 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 5.3 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 6.4 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 1.3 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 0 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 2.6 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 0 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 0 percentage of participants |
| Group I- ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 0 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 2.6 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 2.6 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 0 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 2.6 percentage of participants |
| Group J -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 2.7 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 2.6 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 2.8 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 3.8 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 0 percentage of participants |
| Group K - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 0 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 2.6 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 8.1 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 7.7 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 2.7 percentage of participants |
| Group L - ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 2.6 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 4.9 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 0 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 0 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 0 percentage of participants |
| Group M -ICC Vaccine Formulation | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 0 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 7.9 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 5.3 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 15.4 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 13.2 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 15.4 percentage of participants |
Secondary
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre)
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 70 | 1.7 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 28 | 1.7 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 56 | 1.5 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 84 | 1.3 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 182 | 1.0 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 182 | 0.9 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 84 | 1.3 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 70 | 1.9 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 56 | 1.3 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 28 | 1.4 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 182 | 1.0 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 56 | 1.3 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 70 | 1.7 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 84 | 1.4 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 28 | 1.3 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 84 | 1.1 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 70 | 1.6 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 56 | 1.1 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 28 | 1.2 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 182 | 0.8 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 70 | 1.5 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 84 | 1.1 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 182 | 0.8 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 28 | 1.3 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 56 | 1.1 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 70 | 1.5 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 84 | 0.9 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 182 | 0.8 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 28 | 1.3 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 56 | 1.2 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 28 | 1.6 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 84 | 1.3 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 56 | 1.4 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 70 | 1.6 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 182 | 0.9 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 182 | 0.6 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 28 | 1.2 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 84 | 0.8 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 56 | 1.1 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 70 | 1.4 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 28 | 1.1 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 182 | 0.8 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 56 | 1.0 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 70 | 1.3 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 84 | 1.0 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 84 | 1.0 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 28 | 1.5 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 182 | 0.8 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 56 | 1.3 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 70 | 1.5 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 182 | 0.8 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 56 | 1.1 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 28 | 1.3 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 84 | 1.1 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 70 | 1.5 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 70 | 1.6 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 182 | 0.8 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 56 | 1.2 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 84 | 1.1 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 28 | 1.3 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 70 | 1.5 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 84 | 1.1 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 182 | 0.8 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 56 | 1.4 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre) | Day 28 | 1.6 geometric mean fold rise |
Secondary
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR)
Hemagglutination-Inhibition (HAI) Antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 70 | 17.1 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 182 | 10.8 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 56 | 12.8 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 84 | 14.5 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 28 | 15.2 percentage of participants |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 56 | 7.7 percentage of participants |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 70 | 15.4 percentage of participants |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 28 | 10.0 percentage of participants |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 84 | 20.5 percentage of participants |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 182 | 10.3 percentage of participants |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 56 | 8.3 percentage of participants |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 70 | 17.1 percentage of participants |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 182 | 2.9 percentage of participants |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 28 | 5.3 percentage of participants |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 84 | 11.8 percentage of participants |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 70 | 11.1 percentage of participants |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 56 | 0 percentage of participants |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 28 | 2.7 percentage of participants |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 182 | 0 percentage of participants |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 84 | 0 percentage of participants |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 182 | 2.6 percentage of participants |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 56 | 5.0 percentage of participants |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 84 | 7.7 percentage of participants |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 70 | 10.0 percentage of participants |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 28 | 12.2 percentage of participants |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 84 | 2.6 percentage of participants |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 182 | 0 percentage of participants |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 56 | 5.0 percentage of participants |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 70 | 7.5 percentage of participants |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 28 | 5.0 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 70 | 15.8 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 56 | 10.1 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 28 | 14.1 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 84 | 14.5 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 182 | 6.7 percentage of participants |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 56 | 5.1 percentage of participants |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 28 | 5.1 percentage of participants |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 70 | 10.5 percentage of participants |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 84 | 2.6 percentage of participants |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 182 | 2.7 percentage of participants |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 28 | 0 percentage of participants |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 182 | 0 percentage of participants |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 70 | 5.3 percentage of participants |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 56 | 0 percentage of participants |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 84 | 5.3 percentage of participants |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 70 | 13.9 percentage of participants |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 56 | 8.1 percentage of participants |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 84 | 5.9 percentage of participants |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 28 | 12.8 percentage of participants |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 182 | 0 percentage of participants |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 182 | 5.3 percentage of participants |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 56 | 5.3 percentage of participants |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 28 | 7.7 percentage of participants |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 70 | 13.5 percentage of participants |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 84 | 10.8 percentage of participants |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 56 | 5.0 percentage of participants |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 28 | 4.9 percentage of participants |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 70 | 17.1 percentage of participants |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 84 | 7.3 percentage of participants |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 182 | 2.6 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 70 | 10.5 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 182 | 2.6 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 84 | 7.9 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 28 | 15.4 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR) | Day 56 | 10.3 percentage of participants |
Secondary
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 2.2 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.2 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.9 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 2.1 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.3 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 2.2 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.6 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.9 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.3 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 2.2 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.7 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.9 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.2 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.9 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.6 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.5 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.8 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.1 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.7 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.7 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 2.2 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.8 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.4 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 2.2 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.1 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.8 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.6 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.9 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.2 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.9 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.4 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 2.2 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.9 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 2.2 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.1 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.2 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.6 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.9 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.0 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.5 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.0 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.5 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.7 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.7 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.0 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 2.4 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 2.2 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 2.5 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.3 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.6 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.1 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 2.0 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.6 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 2.1 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 2.4 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.8 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.1 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.9 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.9 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.6 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.9 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 2.1 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.1 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.9 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 2.2 geometric mean fold rise |
Secondary
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 56.8 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 94.5 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 85.8 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 98.1 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 50.4 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 43.9 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 92.2 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 65.2 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 41.8 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 80.0 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 55.6 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 90.3 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 40.4 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 78.4 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 48.1 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 67.9 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 68.3 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 38.0 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 48.3 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 42.3 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 33.5 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 45.5 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 70.2 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 74.1 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 92.7 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 93.9 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 57.1 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 45.7 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 42.1 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 73.4 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 84.2 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 45.6 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 80.0 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 85.7 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 55.5 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 42.6 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 78.2 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 68.0 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 50.7 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 35.5 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 38.0 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 78.2 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 51.6 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 83.0 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 40.0 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 44.8 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 40.7 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 66.4 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 48.4 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 46.1 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 40.0 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 77.1 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 46.0 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 79.3 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 85.6 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 89.0 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 79.3 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 44.9 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 36.4 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 53.8 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 70.8 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 110.2 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 47.6 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 97.4 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 88.4 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 45.3 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 41.4 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 79.3 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 76.0 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 46.6 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 38.6 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 64.4 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 94.3 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 41.9 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 46.9 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 51.2 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 104.4 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 89.0 Geometric Mean Titers |
Secondary
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.9 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.0 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.2 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.9 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.7 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.6 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 2.1 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.8 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.4 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.2 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.9 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.4 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.1 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.8 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.4 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.6 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.4 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.9 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.3 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.1 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.2 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.7 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.7 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.3 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.0 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.4 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.9 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.4 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.6 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.1 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.9 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.9 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.8 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.5 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.1 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.3 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.1 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.5 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.9 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.5 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.1 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.6 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.6 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.0 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.5 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 2.0 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.7 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.5 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 2.1 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.2 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.1 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.6 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.4 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.9 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.8 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.6 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.7 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.7 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.4 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.1 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.8 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.0 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.2 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.9 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.6 geometric mean fold rise |
Secondary
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 72.6 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 137.9 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 88.6 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 121.9 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 71.4 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 134.0 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 111.1 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 69.6 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 142.5 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 81.4 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 126.6 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 99.0 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 76.0 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 115.4 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 68.2 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 91.5 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 59.5 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 98.7 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 100.2 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 117.6 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 80.8 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 70.8 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 95.1 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 62.5 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 131.1 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 102.9 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 78.0 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 134.0 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 77.9 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 97.3 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 90.9 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 79.3 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 113.1 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 110.2 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 69.8 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 127.7 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 58.6 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 115.7 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 61.8 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 104.1 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 112.1 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 86.8 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 73.2 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 93.9 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 107.3 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 83.7 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 69.5 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 112.1 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 123.9 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 113.1 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 77.2 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 125.9 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 83.7 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 74.9 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 56.6 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 117.2 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 79.2 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 95.6 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 111.0 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 66.6 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 130.9 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 113.1 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 155.0 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 150.4 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 81.4 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 85.3 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 93.1 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 103.7 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 72.5 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 67.6 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 117.0 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 115.1 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 87.6 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 73.0 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 132.1 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 121.5 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 142.5 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 74.5 Geometric Mean Titers |
Secondary
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 3.1 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 3.6 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 4.1 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 4.5 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 4.1 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 2.8 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 3.9 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 3.0 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 3.6 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 4.3 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 2.7 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 2.8 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 2.9 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 3.8 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 3.9 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 3.5 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 2.6 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 2.5 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.8 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 2.2 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 3.6 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 3.4 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 2.6 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 4.0 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 2.5 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 2.2 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 2.2 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 2.7 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 2.8 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 3.3 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 3.0 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 4.1 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 3.6 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 4.8 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 4.4 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 3.1 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 2.1 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 2.6 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 2.3 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 2.0 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 2.1 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 2.5 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 2.7 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 2.2 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 2.1 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 2.6 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 4.4 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 4.4 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 3.3 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 3.5 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 4.0 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 3.8 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 2.5 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 3.4 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 3.2 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 3.6 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 3.4 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 2.8 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 3.2 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 3.7 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 4.2 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 4.1 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 3.6 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 5.4 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 2.5 geometric mean fold rise |
Secondary
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 110.7 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 122.1 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 98.8 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 110.7 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 83.8 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 27.1 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 115.2 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 104.4 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 27.1 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 79.3 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 74.5 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 96.8 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 21.1 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 77.7 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 82.5 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 58.1 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 60.5 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 57.7 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 71.3 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 31.1 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 57.1 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 85.7 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 77.1 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 111.0 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 127.7 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 110.3 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 118.3 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 82.2 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 32.4 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 82.8 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 80.7 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 29.8 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 65.5 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 98.5 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 88.4 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 65.5 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 104.9 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 93.7 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 114.2 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 26.0 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 75.0 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 125.6 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 88.4 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 104.2 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 67.0 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 68.2 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 32.9 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 75.8 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 93.4 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 37.3 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 80.7 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 102.3 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 80.0 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 81.4 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 115.3 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 116.2 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 87.0 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 68.6 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 26.4 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 90.4 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 101.1 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 112.1 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 70.4 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 111.0 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 91.7 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 28.3 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 30.5 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 113.1 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 109.4 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 104.8 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 80.7 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 96.8 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 70 | 116.3 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 182 | 68.5 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 0 | 27.1 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 84 | 99.6 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 28 | 145.1 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs | Day 56 | 111.1 Geometric Mean Titers |
Secondary
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR
Hemagglutination-Inhibition (HAI) Antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 67.5 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 71.1 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 39.2 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 63.3 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 60.3 percentage of participants |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 45.0 percentage of participants |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 33.3 percentage of participants |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 46.2 percentage of participants |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 53.8 percentage of participants |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 38.5 percentage of participants |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 41.7 percentage of participants |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 52.9 percentage of participants |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 42.1 percentage of participants |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 41.2 percentage of participants |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 54.3 percentage of participants |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 37.8 percentage of participants |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 42.9 percentage of participants |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 61.1 percentage of participants |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 27.8 percentage of participants |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 20.0 percentage of participants |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 38.5 percentage of participants |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 37.5 percentage of participants |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 53.8 percentage of participants |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 51.2 percentage of participants |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 67.5 percentage of participants |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 28.9 percentage of participants |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 47.5 percentage of participants |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 30.0 percentage of participants |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 37.5 percentage of participants |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 42.1 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 65.8 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 51.9 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 65.8 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 46.7 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 56.4 percentage of participants |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 39.5 percentage of participants |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 33.3 percentage of participants |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 25.6 percentage of participants |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 52.6 percentage of participants |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 21.6 percentage of participants |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 28.2 percentage of participants |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 39.5 percentage of participants |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 36.8 percentage of participants |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 21.6 percentage of participants |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 26.3 percentage of participants |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 58.8 percentage of participants |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 45.9 percentage of participants |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 38.9 percentage of participants |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 51.3 percentage of participants |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 55.6 percentage of participants |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 28.9 percentage of participants |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 44.7 percentage of participants |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 54.1 percentage of participants |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 61.5 percentage of participants |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 64.9 percentage of participants |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 56.1 percentage of participants |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 45.0 percentage of participants |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 51.2 percentage of participants |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 51.2 percentage of participants |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 43.6 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 34.2 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 57.9 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 52.6 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 61.5 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 69.2 percentage of participants |
Secondary
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre)
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.8 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.9 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.4 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.3 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.5 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.3 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.3 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.8 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.6 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.1 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.2 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.2 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.1 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.7 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.6 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.0 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.6 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.1 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.2 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.7 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.1 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.4 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.5 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.9 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.7 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.8 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.1 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.0 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.6 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.2 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.8 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.4 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.7 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.2 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.4 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.1 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.3 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.7 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.6 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.1 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.0 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.5 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.6 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.1 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.1 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.3 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.6 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.3 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.7 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.2 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.1 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.6 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.2 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.2 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.7 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.1 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.8 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.4 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.7 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.3 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.2 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.3 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.7 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.2 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.6 geometric mean fold rise |
Secondary
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 56 | 127.4 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 0 | 96.6 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 28 | 139.9 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 182 | 70.9 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 84 | 87.4 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 70 | 148.2 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 84 | 68.2 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 182 | 50.4 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 70 | 109.2 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 28 | 108.3 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 56 | 95.6 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 0 | 85.0 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 0 | 87.4 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 84 | 62.6 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 28 | 98.7 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 182 | 50.6 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 70 | 107.7 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 56 | 93.3 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 28 | 111.0 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 56 | 105.8 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 182 | 57.1 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 70 | 125.8 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 0 | 100.2 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 84 | 69.6 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 0 | 90.8 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 56 | 107.4 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 84 | 81.4 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 70 | 140.5 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 182 | 65.2 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 28 | 124.2 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 28 | 117.0 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 0 | 96.0 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 182 | 60.3 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 56 | 100.2 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 70 | 107.4 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 84 | 72.4 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 84 | 86.4 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 56 | 119.3 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 28 | 138.8 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 70 | 138.9 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 182 | 65.0 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 0 | 102.3 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 70 | 114.2 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 56 | 98.1 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 0 | 89.0 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 28 | 100.8 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 84 | 66.7 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 182 | 54.0 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 70 | 110.1 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 182 | 49.6 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 56 | 102.3 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 28 | 115.2 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 84 | 58.7 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 0 | 108.2 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 182 | 70.6 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 84 | 79.2 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 28 | 132.8 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 0 | 104.6 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 56 | 126.6 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 70 | 146.7 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 84 | 79.3 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 182 | 60.9 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 70 | 140.3 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 0 | 111.1 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 56 | 119.5 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 28 | 130.4 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 28 | 114.1 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 70 | 121.1 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 0 | 87.8 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 182 | 61.3 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 84 | 74.1 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 56 | 98.5 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 182 | 64.9 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 56 | 135.1 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 84 | 75.7 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 0 | 115.2 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 28 | 146.4 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs | Day 70 | 137.0 Geometric Mean Titers |
Secondary
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR
Hemagglutination-Inhibition (HAI) Antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 9.2 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 2.7 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 6.4 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 10.1 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 3.9 percentage of participants |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 5.0 percentage of participants |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 2.6 percentage of participants |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 5.1 percentage of participants |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 7.7 percentage of participants |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 5.1 percentage of participants |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 2.6 percentage of participants |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 0 percentage of participants |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 0 percentage of participants |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 0 percentage of participants |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 0 percentage of participants |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 0 percentage of participants |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 0 percentage of participants |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 0 percentage of participants |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 0 percentage of participants |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 0 percentage of participants |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 2.5 percentage of participants |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 2.6 percentage of participants |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 4.9 percentage of participants |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 2.6 percentage of participants |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 7.5 percentage of participants |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 0 percentage of participants |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 0 percentage of participants |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 2.6 percentage of participants |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 2.6 percentage of participants |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 2.6 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 2.6 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 9.0 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 5.1 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 2.7 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 6.6 percentage of participants |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 2.6 percentage of participants |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 2.6 percentage of participants |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 2.6 percentage of participants |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 5.3 percentage of participants |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 0 percentage of participants |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 0 percentage of participants |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 0 percentage of participants |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 0 percentage of participants |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 0 percentage of participants |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 0 percentage of participants |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 2.9 percentage of participants |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 2.7 percentage of participants |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 5.6 percentage of participants |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 5.1 percentage of participants |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 2.8 percentage of participants |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 0 percentage of participants |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 2.6 percentage of participants |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 0 percentage of participants |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 2.6 percentage of participants |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 2.7 percentage of participants |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 2.4 percentage of participants |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 2.4 percentage of participants |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 0 percentage of participants |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 0 percentage of participants |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 0 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 2.6 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 5.1 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 5.3 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 5.1 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 2.6 percentage of participants |
Secondary
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre)
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.7 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.6 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.7 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.6 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.5 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.3 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.6 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.6 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.7 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.5 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.3 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.2 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.5 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.3 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.1 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.5 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.3 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.3 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.4 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.4 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.8 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.7 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.5 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.2 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.5 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.2 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.3 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.3 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.4 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.6 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.6 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.6 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.5 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.9 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.6 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.2 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.3 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.4 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.3 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.2 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.3 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.2 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.3 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.3 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.1 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.5 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.3 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.5 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.3 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.3 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.3 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.2 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.6 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.4 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.4 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.3 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.4 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.5 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.6 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.3 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.6 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.5 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.7 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.8 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.6 geometric mean fold rise |
Secondary
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 76.2 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 71.3 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 73.7 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 69.5 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 77.5 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 46.6 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 40.3 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 60.2 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 54.6 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 69.4 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 63.3 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 65.2 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 56.6 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 43.6 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 47.8 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 36.6 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 40.7 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 49.0 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 50.7 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 61.1 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 57.7 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 39.3 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 55.5 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 52.0 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 58.1 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 53.3 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 34.6 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 52.2 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 42.5 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 61.8 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 48.0 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 36.4 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 47.0 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 44.8 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 50.5 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 56.6 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 61.0 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 38.1 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 63.4 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 62.6 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 74.0 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 57.3 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 55.5 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 51.6 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 41.4 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 49.1 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 49.6 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 47.8 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 52.0 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 50.7 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 52.1 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 45.3 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 44.6 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 38.9 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 57.1 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 59.7 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 65.2 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 66.0 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 55.5 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 45.9 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 41.1 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 60.4 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 54.0 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 56.6 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 67.6 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 48.4 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 58.0 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 42.1 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 55.1 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 65.3 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 52.3 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 64.2 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 63.1 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 58.1 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 36.0 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 56.1 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 65.8 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 58.1 Geometric Mean Titers |
Secondary
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre)
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 2.0 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 2.2 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.8 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 2.0 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 2.3 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.6 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.5 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.7 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 2.0 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 2.0 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.5 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 2.1 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.4 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.9 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.8 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.3 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.8 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.6 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.8 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.4 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 2.0 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 2.3 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.9 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.6 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 2.5 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.5 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.3 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.7 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.8 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.4 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.7 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.9 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 2.3 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 2.1 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.8 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.8 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.7 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.5 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.6 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.5 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.5 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.3 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.6 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.5 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.2 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 2.0 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.5 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.7 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.6 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 2.2 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.7 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.5 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.6 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 2.2 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.9 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 2.2 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.9 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.8 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 2.1 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.8 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 2.4 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 2.3 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 1.8 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 2.3 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 2.7 geometric mean fold rise |
Secondary
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 70 | 87.9 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 56 | 72.3 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 84 | 86.7 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 182 | 77.1 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 28 | 78.3 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 0 | 40.4 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 182 | 61.3 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 28 | 57.6 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 56 | 53.2 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 0 | 36.1 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 70 | 72.5 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 84 | 71.9 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 84 | 52.1 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 0 | 24.3 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 28 | 35.2 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 56 | 36.0 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 182 | 43.8 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 70 | 45.0 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 56 | 44.5 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 70 | 61.7 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 84 | 60.6 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 28 | 47.8 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 0 | 33.2 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 182 | 53.3 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 0 | 35.8 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 84 | 87.4 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 70 | 84.3 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 182 | 70.0 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 56 | 58.6 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 28 | 67.6 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 28 | 50.7 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 56 | 47.2 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 70 | 59.1 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 182 | 52.6 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 0 | 35.4 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 84 | 63.7 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 56 | 52.7 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 70 | 65.8 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 0 | 31.3 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 182 | 55.5 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 28 | 58.1 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 84 | 72.7 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 84 | 65.5 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 0 | 38.3 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 70 | 67.9 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 182 | 57.1 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 56 | 57.1 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 28 | 60.2 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 56 | 44.6 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 84 | 60.3 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 0 | 36.9 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 182 | 54.5 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 28 | 48.6 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 70 | 56.1 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 84 | 73.0 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 0 | 36.1 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 182 | 61.7 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 28 | 59.7 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 70 | 69.9 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 56 | 55.5 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 0 | 33.5 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 56 | 49.8 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 84 | 72.8 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 70 | 63.3 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 28 | 57.6 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 182 | 54.0 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 70 | 74.1 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 28 | 68.7 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 182 | 60.7 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 84 | 76.7 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 56 | 62.2 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 0 | 35.5 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 0 | 40.0 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 56 | 86.7 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 70 | 85.3 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 84 | 89.3 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 28 | 100.8 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs | Day 182 | 68.5 Geometric Mean Titers |
Secondary
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre)
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.2 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.4 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.9 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.3 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.8 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.9 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.2 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.8 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.2 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.3 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.7 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.2 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.1 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.8 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.0 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.3 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.7 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.8 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.2 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.2 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.7 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.9 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.3 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.4 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.1 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.2 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.2 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.1 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.7 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.7 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.2 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.8 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.3 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.9 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.3 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.1 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.1 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.2 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.7 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.8 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.7 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.7 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.1 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.2 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.1 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.8 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.1 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.4 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.9 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.2 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.1 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.2 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.2 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.9 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.7 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.2 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.2 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.2 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.8 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 0.8 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 84 | 1.0 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 182 | 0.9 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 28 | 1.5 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 70 | 1.5 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre) | Day 56 | 1.4 geometric mean fold rise |
Secondary
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 63.5 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 75.9 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 91.7 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 107.2 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 61.2 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 101.5 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 62.4 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 52.7 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 83.6 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 89.8 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 84.3 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 67.9 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 75.8 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 50.6 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 88.3 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 73.4 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 57.1 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 82.2 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 91.5 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 54.9 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 67.6 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 80.8 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 81.5 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 49.7 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 70.3 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 62.1 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 83.5 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 48.2 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 85.0 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 58.6 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 78.0 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 70.3 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 43.4 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 48.4 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 65.5 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 77.3 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 89.4 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 69.5 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 55.8 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 93.4 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 85.4 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 66.1 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 45.6 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 48.4 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 70.0 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 75.1 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 73.9 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 65.2 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 67.6 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 75.8 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 77.1 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 50.2 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 50.1 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 80.7 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 87.4 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 58.3 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 72.7 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 77.8 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 95.1 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 56.0 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 75.2 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 88.2 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 92.9 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 82.2 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 67.0 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 51.6 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 90.8 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 63.1 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 74.8 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 85.7 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 90.8 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 57.1 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 84 | 65.5 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 28 | 99.9 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 182 | 58.7 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 0 | 64.6 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 56 | 91.4 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs | Day 70 | 94.3 Geometric Mean Titers |
Secondary
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs)
Hemagglutination-inhibition (HAI) antibody titers specific for the hemagglutinin (HA) receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 0 | 83.6 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 56 | 129.1 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 84 | 107.7 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 182 | 85.0 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 70 | 149.6 Geometric Mean Titers |
| Group A and Group C - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 28 | 141.1 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 182 | 57.1 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 84 | 85.1 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 0 | 66.7 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 70 | 124.8 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 56 | 86.7 Geometric Mean Titers |
| Group B -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 28 | 91.9 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 0 | 62.4 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 70 | 113.1 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 182 | 68.7 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 28 | 81.5 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 56 | 84.8 Geometric Mean Titers |
| Group D - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 84 | 96.1 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 70 | 142.5 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 182 | 72.5 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 28 | 107.0 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 84 | 98.5 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 56 | 100.8 Geometric Mean Titers |
| Group E - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 0 | 91.2 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 0 | 85.6 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 56 | 100.2 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 28 | 112.2 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 84 | 101.7 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 182 | 70.6 Geometric Mean Titers |
| Group F- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 70 | 135.7 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 182 | 60.9 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 28 | 106.6 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 70 | 113.1 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 0 | 77.3 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 84 | 68.5 Geometric Mean Titers |
| Group G- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 56 | 95.1 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 56 | 107.3 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 84 | 99.1 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 0 | 78.3 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 182 | 67.4 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 28 | 126.4 Geometric Mean Titers |
| Group H and Group N- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 70 | 128.5 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 84 | 75.1 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 0 | 89.8 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 28 | 105.4 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 56 | 94.7 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 70 | 123.9 Geometric Mean Titers |
| Group I- ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 182 | 58.7 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 56 | 73.7 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 70 | 95.1 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 182 | 56.6 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 0 | 77.9 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 28 | 105.4 Geometric Mean Titers |
| Group J -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 84 | 74.4 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 70 | 156.9 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 56 | 126.6 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 84 | 103.2 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 28 | 141.3 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 0 | 96.8 Geometric Mean Titers |
| Group K - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 182 | 83.1 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 28 | 129.3 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 70 | 148.4 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 84 | 110.0 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 182 | 76.4 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 0 | 97.3 Geometric Mean Titers |
| Group L - ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 56 | 109.1 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 28 | 103.1 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 70 | 129.5 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 56 | 99.3 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 84 | 89.3 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 182 | 65.2 Geometric Mean Titers |
| Group M -ICC Vaccine Formulation | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 0 | 81.4 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 28 | 133.9 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 0 | 83.6 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 70 | 119.5 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 182 | 66.1 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 84 | 90.1 Geometric Mean Titers |
| Group O - qNIV With Matrix-M1 Adjuvant | Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs) | Day 56 | 118.3 Geometric Mean Titers |
Secondary
Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Brisbane (H1N1 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 84 | 5.5 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 70 | 2.4 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.8 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.9 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 182 | 4.1 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 70 | 2.5 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.6 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 84 | 6.6 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.9 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 182 | 3.6 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.3 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 84 | 4.2 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.5 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 182 | 2.7 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 70 | 1.8 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 84 | 5.0 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 182 | 3.3 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.7 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.4 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 70 | 2.4 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 182 | 3.4 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 84 | 5.2 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.7 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.4 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 70 | 2.3 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 70 | 1.5 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 182 | 2.2 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.1 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.2 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 84 | 2.8 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 70 | 2.1 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 84 | 5.5 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.9 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.5 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 182 | 3.8 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 84 | 4.8 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.4 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.2 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 70 | 1.8 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 182 | 2.9 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 70 | 1.5 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.2 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 84 | 3.6 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.1 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 182 | 2.3 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 84 | 5.7 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.4 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.7 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 182 | 3.7 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 70 | 2.0 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 182 | 2.0 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.3 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.4 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 84 | 3.8 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 70 | 1.7 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 70 | 2.1 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.5 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 84 | 5.1 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.5 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 182 | 3.5 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 28 | 2.1 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 84 | 4.3 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.8 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 70 | 1.6 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR | Day 182 | 3.4 geometric mean fold rise |
Secondary
Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Cambodia (H3N2 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 84 | 1.8 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.4 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 56 | 1.7 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 70 | 2.0 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 28 | 1.9 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 56 | 1.8 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 84 | 2.0 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.5 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 70 | 2.2 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 28 | 2.0 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 70 | 1.8 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.3 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 84 | 1.7 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 28 | 1.5 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 56 | 1.5 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 84 | 1.7 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 70 | 1.8 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 28 | 1.7 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.3 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 56 | 1.5 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.4 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 28 | 2.2 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 70 | 2.2 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 84 | 1.9 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 56 | 1.6 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 56 | 1.3 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 84 | 1.4 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 28 | 1.5 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 70 | 1.6 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.2 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.3 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 84 | 1.7 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 56 | 1.6 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 70 | 1.9 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 28 | 1.8 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 56 | 1.3 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 28 | 1.4 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 70 | 1.5 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 84 | 1.5 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.2 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.2 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 70 | 1.6 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 84 | 1.5 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 56 | 1.4 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 28 | 1.5 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 70 | 2.4 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 56 | 2.2 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 84 | 2.8 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.9 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 28 | 2.6 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 28 | 1.9 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 70 | 2.1 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.5 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 84 | 2.1 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 56 | 1.7 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 84 | 1.6 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 28 | 1.6 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 70 | 1.8 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.3 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 56 | 1.6 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 70 | 1.4 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.2 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 56 | 1.5 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 84 | 1.3 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR | Day 28 | 1.8 geometric mean fold rise |
Secondary
Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Hong Kong (H3N2 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 28 | 2.2 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 70 | 2.3 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.5 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 56 | 1.9 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 84 | 2.1 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 182 | 2.1 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 56 | 2.1 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 28 | 2.6 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 84 | 3.0 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 70 | 2.9 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.4 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 84 | 2.0 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 70 | 2.2 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 28 | 1.7 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 56 | 1.5 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 28 | 2.0 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.6 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 70 | 2.2 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 56 | 1.6 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 84 | 2.0 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 70 | 2.5 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 84 | 2.2 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.7 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 28 | 2.3 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 56 | 1.7 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 84 | 1.8 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 70 | 2.1 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.5 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 28 | 1.8 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 56 | 1.6 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.8 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 84 | 2.6 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 56 | 2.1 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 70 | 2.7 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 28 | 2.6 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 70 | 1.8 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 28 | 1.6 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 56 | 1.4 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 84 | 2.0 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.4 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 84 | 2.2 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.6 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 70 | 2.2 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 56 | 1.8 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 28 | 1.9 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 28 | 3.2 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 56 | 2.4 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 70 | 2.8 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 84 | 3.2 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 182 | 2.2 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 56 | 2.1 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 70 | 2.5 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.6 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 84 | 2.3 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 28 | 2.3 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 56 | 2.0 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 84 | 2.3 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 70 | 2.6 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.8 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 28 | 2.3 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.4 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 56 | 2.0 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 84 | 1.7 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 70 | 1.9 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR | Day 28 | 2.4 geometric mean fold rise |
Secondary
Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Kansas (H3N2 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 70 | 5.0 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 182 | 3.3 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 84 | 4.8 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 28 | 4.3 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 56 | 3.7 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 56 | 2.7 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 70 | 4.1 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 28 | 3.4 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 84 | 3.6 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 182 | 2.3 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 182 | 2.1 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 56 | 2.3 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 84 | 3.7 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 70 | 3.6 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 28 | 2.7 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 70 | 4.4 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 28 | 3.1 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 182 | 2.4 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 56 | 2.6 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 84 | 3.6 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 84 | 4.2 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 70 | 4.1 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 28 | 3.7 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 56 | 2.7 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 182 | 2.9 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 56 | 2.5 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 182 | 2.2 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 28 | 2.8 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 70 | 3.5 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 84 | 3.0 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 70 | 4.9 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 28 | 4.1 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 56 | 3.4 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 84 | 5.0 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 182 | 3.2 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 56 | 2.1 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 84 | 3.4 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 70 | 3.1 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 182 | 2.1 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 28 | 2.5 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 84 | 2.7 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 28 | 2.2 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 70 | 2.7 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 182 | 1.8 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 56 | 2.0 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 70 | 4.7 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 56 | 3.6 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 84 | 5.0 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 28 | 4.7 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 182 | 3.3 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 182 | 2.3 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 56 | 3.1 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 84 | 3.9 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 70 | 3.9 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 28 | 3.6 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 56 | 3.2 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 28 | 3.6 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 70 | 4.0 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 84 | 4.1 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 182 | 2.7 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 70 | 4.7 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 182 | 3.2 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 84 | 4.8 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 28 | 6.2 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR | Day 56 | 4.9 geometric mean fold rise |
Secondary
Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Wisconsin (H1N1 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 70 | 1.4 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 84 | 1.5 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.1 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.2 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 182 | 1.2 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 70 | 1.2 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 84 | 1.3 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.1 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.0 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 182 | 1.0 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.1 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 182 | 1.1 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 70 | 1.3 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.0 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 84 | 1.4 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 182 | 1.1 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 70 | 1.3 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 84 | 1.4 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 56 | 0.9 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.0 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.0 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 84 | 1.5 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.0 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 182 | 1.1 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 70 | 1.3 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 56 | 0.9 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 84 | 1.2 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.0 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 70 | 1.0 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 182 | 1.0 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 182 | 1.2 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.2 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 84 | 1.4 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.0 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 70 | 1.3 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 182 | 0.9 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 28 | 0.9 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 56 | 0.9 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 70 | 1.0 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 84 | 1.2 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 70 | 0.9 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 56 | 0.9 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 28 | 0.9 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 84 | 1.0 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 182 | 0.8 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 70 | 1.4 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.4 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 182 | 1.4 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 84 | 1.8 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.1 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 84 | 1.4 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 182 | 1.0 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 70 | 1.2 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 56 | 0.9 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.0 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.1 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.1 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 84 | 1.6 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 182 | 1.3 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 70 | 1.3 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 84 | 1.3 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 28 | 1.1 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 56 | 1.1 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 70 | 1.1 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR | Day 182 | 1.1 geometric mean fold rise |
Secondary
Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza B/Maryland (Victoria Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 182 | 2.9 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 84 | 3.4 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 28 | 1.7 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 70 | 1.9 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 56 | 1.6 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 56 | 1.3 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 182 | 1.9 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 84 | 2.5 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 70 | 1.7 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 28 | 1.5 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 182 | 1.9 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 28 | 1.3 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 84 | 2.4 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 70 | 1.4 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 56 | 1.2 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 70 | 1.6 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 182 | 2.5 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 28 | 1.5 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 56 | 1.3 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 84 | 3.0 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 182 | 2.1 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 28 | 1.7 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 84 | 2.7 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 56 | 1.5 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 70 | 1.8 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 56 | 1.2 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 28 | 1.3 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 182 | 1.9 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 84 | 2.1 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 70 | 1.4 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 56 | 1.5 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 70 | 1.7 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 28 | 1.6 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 182 | 2.3 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 84 | 2.8 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 70 | 1.3 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 28 | 1.2 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 182 | 1.7 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 84 | 2.2 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 56 | 1.2 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 182 | 1.7 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 28 | 1.2 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 56 | 1.2 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 70 | 1.3 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 84 | 2.0 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 56 | 1.4 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 84 | 3.2 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 70 | 1.6 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 182 | 2.4 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 28 | 1.5 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 182 | 2.0 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 70 | 1.6 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 28 | 1.5 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 84 | 2.5 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 56 | 1.4 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 84 | 3.2 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 56 | 1.4 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 28 | 1.5 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 70 | 1.6 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 182 | 2.4 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 182 | 2.4 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 56 | 1.9 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 84 | 2.8 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 70 | 1.7 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR | Day 28 | 2.2 geometric mean fold rise |
Secondary
Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza B/Phuket (Yamagata Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 28 | 1.7 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 84 | 2.9 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 56 | 1.6 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 182 | 2.3 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 70 | 1.9 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 182 | 1.3 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 84 | 1.8 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 70 | 1.4 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 56 | 1.1 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 28 | 1.3 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 28 | 1.1 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 182 | 1.4 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 84 | 2.0 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 56 | 1.1 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 70 | 1.2 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 182 | 1.8 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 28 | 1.2 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 56 | 1.2 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 84 | 2.1 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 70 | 1.5 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 70 | 1.9 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 28 | 1.6 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 56 | 1.5 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 84 | 2.6 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 182 | 2.0 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 56 | 1.2 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 182 | 1.3 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 28 | 1.2 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 70 | 1.4 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 84 | 1.6 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 84 | 2.4 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 56 | 1.3 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 182 | 1.8 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 28 | 1.5 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 70 | 1.6 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 182 | 1.5 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 28 | 1.3 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 84 | 2.0 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 70 | 1.5 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 56 | 1.2 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 70 | 1.3 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 84 | 1.9 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 28 | 1.2 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 182 | 1.4 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 56 | 1.1 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 56 | 1.4 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 70 | 2.0 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 84 | 2.9 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 28 | 1.6 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 182 | 2.1 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 84 | 1.9 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 28 | 1.3 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 70 | 1.4 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 56 | 1.3 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 182 | 1.6 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 28 | 1.6 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 182 | 2.2 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 84 | 3.0 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 56 | 1.5 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 70 | 1.7 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 70 | 1.5 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 182 | 1.8 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 28 | 1.7 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 56 | 1.6 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR | Day 84 | 2.1 geometric mean fold rise |
Secondary
Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza B/Washington (Victoria Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 182 | 1.6 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 70 | 1.9 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 28 | 1.7 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 84 | 2.0 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 56 | 1.6 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 28 | 1.7 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 182 | 1.3 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 70 | 1.8 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 56 | 1.4 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 84 | 1.8 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 56 | 1.1 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 28 | 1.2 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 84 | 1.5 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 70 | 1.3 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 182 | 1.1 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 28 | 1.6 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 70 | 1.7 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 182 | 1.7 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 56 | 1.4 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 84 | 2.1 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 84 | 1.9 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 70 | 1.8 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 56 | 1.5 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 28 | 1.8 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 182 | 1.4 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 84 | 1.5 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 56 | 1.3 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 70 | 1.5 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 182 | 1.2 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 28 | 1.4 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 56 | 1.5 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 84 | 1.8 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 182 | 1.6 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 28 | 1.7 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 70 | 1.7 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 84 | 1.4 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 28 | 1.3 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 70 | 1.3 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 182 | 1.1 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 56 | 1.2 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 84 | 1.6 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 56 | 1.2 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 70 | 1.4 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 28 | 1.2 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 182 | 1.3 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 56 | 1.4 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 28 | 1.5 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 84 | 2.1 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 70 | 1.6 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 182 | 1.6 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 182 | 1.5 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 84 | 1.7 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 28 | 1.6 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 70 | 1.6 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 56 | 1.5 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 182 | 1.4 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 56 | 1.4 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 84 | 1.8 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 70 | 1.6 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 28 | 1.5 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 182 | 1.6 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 28 | 2.3 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 84 | 1.9 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 56 | 1.9 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR | Day 70 | 1.8 geometric mean fold rise |
Secondary
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 11.5 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 12.7 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 51.9 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 18.4 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 40.5 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 12.8 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 10.3 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 53.8 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 28.2 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 12.5 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 14.3 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 11.1 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 13.2 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 38.2 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 26.5 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 22.2 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 5.4 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 28.6 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 5.6 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 54.3 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 46.2 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 38.5 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 9.8 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 17.5 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 2.5 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 10.0 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 2.5 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 0 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 31.6 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 21.1 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 37.3 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 10.1 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 21.1 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 12.8 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 52.6 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 7.7 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 18.4 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 5.1 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 21.6 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 47.4 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 21.6 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 5.3 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 5.1 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 2.6 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 42.1 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 10.8 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 19.4 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 50.0 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 38.9 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 17.9 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 5.3 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 13.5 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 29.7 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 10.3 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 21.1 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 9.8 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 12.2 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 10.0 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 33.3 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 63.4 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 44.7 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 28.9 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 10.3 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 7.9 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 10.3 Percentage of participants |
Secondary
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 18.4 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 8.1 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 15.6 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 10.3 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 14.1 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 15.4 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 23.1 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 17.5 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 20.5 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 17.9 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 2.9 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 8.3 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 20.6 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 22.9 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 13.2 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 16.7 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 10.8 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 8.6 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 5.6 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 14.3 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 15.4 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 20.0 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 14.6 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 10.0 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 10.3 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 10.0 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 5.3 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 10.0 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 17.5 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 10.5 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 15.8 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 15.4 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 12.7 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 17.1 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 8.0 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 2.6 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 2.6 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 7.9 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 2.7 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 5.1 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 13.2 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 10.3 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 15.8 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 8.1 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 10.5 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 30.6 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 21.6 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 38.2 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 30.8 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 19.4 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 10.5 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 18.4 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 24.3 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 21.6 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 17.9 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 10.0 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 14.6 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 12.2 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 17.1 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 7.7 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 10.5 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 5.3 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 7.9 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 10.3 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 10.3 Percentage of participants |
Secondary
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 15.8 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 10.8 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 18.2 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 16.5 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 14.1 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 25.6 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 33.3 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 27.5 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 28.2 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 20.5 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 14.7 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 16.7 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 26.5 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 22.9 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 15.8 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 22.2 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 16.2 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 17.1 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 11.1 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 14.3 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 17.9 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 25.0 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 17.1 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 15.0 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 15.4 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 15.0 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 15.8 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 17.5 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 20.0 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 26.3 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 30.3 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 26.9 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 22.8 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 34.2 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 16.0 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 7.7 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 23.7 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 18.4 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 5.4 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 10.3 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 28.9 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 23.1 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 31.6 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 13.5 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 15.8 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 30.6 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 27.0 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 32.4 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 35.9 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 16.7 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 7.9 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 23.7 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 27.0 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 18.9 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 28.2 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 22.5 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 29.3 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 26.8 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 26.8 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 20.5 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 26.3 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 10.5 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 18.4 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 25.6 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 23.1 Percentage of participants |
Secondary
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Kansas (H3N2 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 51.3 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 36.5 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 48.1 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 45.6 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 38.5 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 28.2 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 38.5 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 27.5 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 38.5 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 25.6 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 26.5 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 22.2 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 52.9 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 48.6 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 28.9 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 55.6 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 27.0 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 22.9 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 27.8 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 45.7 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 48.7 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 47.5 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 31.7 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 27.5 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 25.6 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 27.5 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 26.3 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 20.0 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 32.5 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 31.6 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 56.6 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 43.6 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 39.2 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 55.3 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 38.7 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 23.1 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 34.2 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 31.6 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 21.6 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 25.6 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 26.3 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 25.6 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 28.9 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 16.2 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 21.1 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 50.0 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 40.5 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 47.1 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 46.2 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 30.6 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 13.2 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 28.9 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 32.4 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 40.5 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 38.5 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 30.0 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 36.6 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 43.9 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 41.5 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 28.2 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 70 | 47.4 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 182 | 39.5 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 84 | 52.6 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 28 | 53.8 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR | Day 56 | 48.7 Percentage of participants |
Secondary
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 6.6 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 5.4 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 13.0 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 3.8 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 1.3 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 5.1 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 7.7 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 7.5 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 12.8 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 5.1 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 0 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 0 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 2.9 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 2.9 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 2.6 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 2.8 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 0 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 2.9 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 0 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 2.9 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 7.7 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 2.5 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 0 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 0 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 2.6 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 0 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 0 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 0 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 2.5 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 0 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 7.9 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 1.3 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 1.3 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 11.8 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 5.3 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 0 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 5.3 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 2.6 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 2.7 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 0 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 2.6 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 0 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 0 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 0 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 0 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 11.1 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 8.1 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 20.6 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 12.8 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 13.9 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 2.6 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 0 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 2.7 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 2.7 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 0 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 5.0 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 4.9 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 4.9 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 14.6 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 2.6 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 70 | 2.6 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 182 | 5.3 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 84 | 5.3 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 28 | 2.6 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR | Day 56 | 2.6 Percentage of participants |
Secondary
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza B/Maryland (Victoria Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 13.2 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 10.3 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 13.2 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 35.1 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 10.1 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 10.3 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 7.7 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 10.0 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 23.1 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 15.4 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 2.8 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 20.6 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 2.9 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 5.7 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 2.6 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 20.0 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 5.6 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 20.0 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 2.7 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 2.8 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 2.5 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 20.5 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 4.9 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 15.4 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 2.5 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 2.5 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 5.0 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 13.2 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 2.5 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 21.1 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 5.1 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 25.0 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 17.3 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 5.1 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 5.3 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 0 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 5.4 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 0 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 2.6 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 15.8 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 10.5 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 2.6 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 2.6 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 2.7 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 0 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 7.7 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 8.1 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 22.2 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 38.2 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 8.3 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 7.7 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 7.9 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 16.2 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 5.3 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 10.8 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 9.8 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 20.5 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 31.7 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 4.9 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 5.0 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 70 | 13.2 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 28 | 17.9 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 84 | 21.1 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 182 | 13.2 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR | Day 56 | 15.4 Percentage of participants |
Secondary
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza B/Phuket (Yamagata Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 10.8 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 24.7 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 7.6 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 10.5 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 9.0 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 5.0 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 5.1 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 10.3 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 5.1 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 5.1 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 14.7 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 0 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 5.7 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 8.8 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 2.6 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 8.3 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 20.0 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 5.4 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 11.4 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 5.6 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 17.9 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 12.5 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 9.8 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 33.3 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 10.0 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 5.3 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 0 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 2.6 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 0 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 2.5 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 19.7 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 5.1 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 3.8 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 9.2 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 9.3 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 5.4 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 15.8 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 2.6 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 5.1 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 5.3 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 0 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 2.7 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 2.6 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 10.5 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 0 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 35.3 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 13.9 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 5.4 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 5.1 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 16.7 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 5.4 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 13.5 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 2.6 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 2.6 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 7.9 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 10.0 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 9.8 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 29.3 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 7.3 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 23.1 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 70 | 13.2 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 182 | 15.8 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 84 | 18.4 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 56 | 12.8 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR | Day 28 | 15.4 Percentage of participants |
Secondary
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza B/Washington (Victoria Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 7.7 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 8.9 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 8.1 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 13.0 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 9.2 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 10.3 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 10.3 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 17.9 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 12.5 Percentage of participants |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 15.4 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 5.7 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 2.9 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 14.7 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 0 Percentage of participants |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 2.6 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 8.1 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 5.6 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 11.1 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 14.3 Percentage of participants |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 14.3 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 9.8 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 5.0 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 2.6 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 7.5 Percentage of participants |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 7.7 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 5.0 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 7.9 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 7.5 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 7.5 Percentage of participants |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 10.5 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 6.3 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 8.0 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 10.5 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 9.2 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 9.0 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 2.6 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 5.3 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 2.7 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 5.1 Percentage of participants |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 0 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 2.6 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 5.3 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 5.3 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 5.1 Percentage of participants |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 2.7 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 10.3 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 8.3 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 20.6 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 8.1 Percentage of participants |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 11.1 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 8.1 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 2.6 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 13.5 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 7.9 Percentage of participants |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 15.4 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 4.9 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 7.5 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 9.8 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 2.6 Percentage of participants |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 14.6 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 70 | 15.8 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 28 | 23.1 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 84 | 26.3 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 56 | 17.9 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR | Day 182 | 13.2 Percentage of participants |
Secondary
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Brisbane (H1N1 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Time frame: Day 0 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 84 | 4673.3 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 70 | 2022.0 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 56 | 1503.2 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 28 | 1597.5 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 182 | 3339.6 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 0 | 844.5 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 70 | 1462.2 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 84 | 3767.7 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 0 | 561.5 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 56 | 947.1 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 182 | 2097.3 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 28 | 1043.8 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 0 | 737.2 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 70 | 1482.5 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 84 | 3539.2 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 28 | 1099.4 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 56 | 1078.1 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 182 | 2368.2 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 56 | 1000.7 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 0 | 737.0 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 182 | 2287.1 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 84 | 3530.8 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 28 | 1065.2 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 70 | 1768.3 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 70 | 1750.8 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 28 | 1225.2 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 84 | 4025.5 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 182 | 2646.0 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 0 | 723.6 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 56 | 1514.7 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 28 | 1088.6 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 0 | 865.1 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 56 | 952.5 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 70 | 1316.3 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 84 | 2248.0 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 182 | 1882.2 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 28 | 1426.2 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 56 | 1139.6 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 84 | 3979.8 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 0 | 746.4 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 182 | 2846.0 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 70 | 1570.6 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 84 | 3938.5 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 70 | 1463.6 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 56 | 954.7 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 182 | 2341.7 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 0 | 806.4 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 28 | 1102.0 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 84 | 2636.7 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 0 | 794.3 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 56 | 831.2 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 70 | 1062.2 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 182 | 1660.1 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 28 | 971.8 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 70 | 1756.8 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 28 | 1426.2 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 56 | 1229.2 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 182 | 3172.3 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 0 | 837.0 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 84 | 5100.1 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 84 | 4844.1 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 28 | 1617.1 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 182 | 2407.0 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 70 | 2095.7 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 56 | 1514.7 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 0 | 1197.5 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 0 | 761.1 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 70 | 1600.4 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 28 | 1173.6 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 84 | 3887.2 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 182 | 2684.6 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 56 | 1093.0 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 70 | 1381.8 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 182 | 2849.4 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 0 | 923.8 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 84 | 3576.7 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 28 | 1935.2 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT | Day 56 | 1637.7 geometric mean titer |
Secondary
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Brisbane (H1N1 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.19 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.97 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.46 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.86 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.29 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.10 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.24 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.27 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.70 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.89 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.76 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.94 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.81 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.66 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.82 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.09 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.98 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.72 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.91 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.10 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.64 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.04 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.38 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.73 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.98 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.00 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.74 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.33 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.76 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.18 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.64 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.61 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.93 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.66 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.57 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.71 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.84 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.81 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.24 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.22 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.07 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.94 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.85 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.82 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.63 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.08 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.64 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.12 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.65 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.81 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.64 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.85 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.61 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.56 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.94 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.79 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.37 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.24 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.09 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.78 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.77 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.16 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.93 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.70 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.65 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.06 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.10 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.01 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.78 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.69 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.16 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.23 Geometric mean titer ratio |
Secondary
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Cambodia (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Time frame: Day 0 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 28 | 56.5 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 70 | 57.8 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 182 | 40.4 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 84 | 51.4 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 56 | 51.1 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 0 | 29.1 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 28 | 64.3 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 182 | 48.2 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 70 | 71.2 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 0 | 31.6 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 84 | 64.5 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 56 | 56.9 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 84 | 49.3 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 56 | 42.1 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 28 | 43.7 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 70 | 51.7 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 182 | 38.6 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 0 | 29.0 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 70 | 56.6 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 0 | 30.3 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 182 | 42.1 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 84 | 54.5 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 56 | 45.7 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 28 | 50.8 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 84 | 54.7 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 70 | 63.2 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 182 | 40.5 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 0 | 28.4 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 28 | 61.6 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 56 | 46.6 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 84 | 44.6 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 182 | 37.1 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 56 | 40.7 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 0 | 30.8 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 70 | 50.8 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 28 | 45.9 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 28 | 48.4 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 84 | 45.9 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 182 | 35.5 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 70 | 51.9 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 56 | 43.3 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 0 | 26.7 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 28 | 45.2 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 0 | 32.7 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 56 | 41.3 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 70 | 51.0 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 84 | 48.9 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 182 | 39.6 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 56 | 37.8 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 84 | 41.9 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 182 | 32.9 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 28 | 40.5 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 0 | 27.5 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 70 | 43.5 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 70 | 55.6 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 56 | 49.7 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 0 | 24.6 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 84 | 66.4 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 28 | 63.4 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 182 | 44.7 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 0 | 30.6 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 182 | 45.9 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 84 | 62.4 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 28 | 59.4 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 70 | 63.1 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 56 | 51.6 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 182 | 32.2 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 56 | 36.5 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 84 | 39.3 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 28 | 39.2 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 70 | 43.1 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 0 | 24.2 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 182 | 34.6 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 84 | 39.0 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 0 | 28.5 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 56 | 42.9 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 28 | 51.2 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT | Day 70 | 39.5 geometric mean titer |
Secondary
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Cambodia (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.44 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.30 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.14 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 1.07 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.16 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.09 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.27 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 1.13 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.24 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.17 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.50 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.61 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.83 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.30 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.99 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.23 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.09 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.97 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.04 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.15 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.32 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.36 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.94 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.00 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.08 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.16 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.22 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 1.21 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.61 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.39 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.89 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.99 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.93 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.83 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.21 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.06 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.40 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 1.00 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.24 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.09 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.06 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.07 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.78 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.12 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.10 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.86 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.84 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.03 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.87 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.82 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.11 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.97 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.14 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.90 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.54 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.30 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.98 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.41 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.74 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 1.40 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.52 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.15 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 1.09 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.16 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.53 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.29 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.98 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.05 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.09 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.17 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.89 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.31 Geometric mean titer ratio |
Secondary
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Hong Kong (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Time frame: Day 0 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 0 | 74.6 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 84 | 154.8 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 28 | 162.5 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 56 | 141.2 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 70 | 174.2 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 182 | 113.5 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 28 | 167.7 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 84 | 202.2 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 70 | 194.0 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 56 | 141.8 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 0 | 64.4 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 182 | 138.0 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 56 | 100.6 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 0 | 64.4 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 182 | 92.7 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 84 | 143.1 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 28 | 113.1 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 70 | 145.0 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 56 | 102.6 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 182 | 101.2 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 28 | 123.0 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 0 | 60.9 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 70 | 139.8 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 84 | 130.0 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 28 | 154.2 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 0 | 67.3 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 56 | 116.7 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 70 | 165.5 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 84 | 157.2 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 182 | 119.3 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 182 | 109.3 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 70 | 163.2 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 84 | 143.5 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 0 | 77.0 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 56 | 120.8 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 28 | 141.7 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 56 | 120.2 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 182 | 98.5 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 70 | 160.0 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 0 | 57.0 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 84 | 150.2 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 28 | 152.9 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 84 | 144.5 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 182 | 101.9 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 28 | 110.7 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 70 | 129.3 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 0 | 69.6 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 56 | 98.4 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 28 | 136.1 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 56 | 128.4 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 0 | 71.1 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 182 | 118.3 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 84 | 161.5 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 70 | 155.5 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 0 | 50.0 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 56 | 112.3 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 70 | 129.7 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 182 | 102.5 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 84 | 150.9 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 28 | 157.2 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 84 | 212.1 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 70 | 225.9 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 182 | 134.7 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 56 | 182.5 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 0 | 89.4 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 28 | 209.5 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 0 | 55.9 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 84 | 130.0 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 70 | 142.6 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 56 | 104.6 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 28 | 128.7 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 182 | 103.2 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 56 | 135.9 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 70 | 133.6 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 84 | 122.4 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 182 | 101.4 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 28 | 165.8 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT | Day 0 | 68.7 geometric mean titer |
Secondary
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Hong Kong (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.22 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.97 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.97 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.91 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.21 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.07 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 1.07 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.52 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.20 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.72 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.42 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.07 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.70 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.94 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.77 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.14 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.90 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.17 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.07 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.81 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.13 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.14 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.82 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.89 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.88 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.95 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.18 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.29 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.29 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.02 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.90 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.78 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.81 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.14 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.04 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.05 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.21 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.10 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.04 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 1.05 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.43 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.39 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.66 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.99 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.75 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.94 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.72 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.15 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.10 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.91 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.29 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.80 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.90 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.14 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.64 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.41 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.15 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.43 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 1.22 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.09 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.07 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.41 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 1.00 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.34 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.09 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.11 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.01 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.21 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.96 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.26 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.28 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.91 Geometric mean titer ratio |
Secondary
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Kansas (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Time frame: Day 0 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 56 | 682.7 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 0 | 184.4 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 28 | 794.0 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 182 | 611.6 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 70 | 917.5 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 84 | 874.0 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 182 | 520.7 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 28 | 749.1 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 84 | 810.7 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 70 | 922.9 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 0 | 220.6 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 56 | 613.1 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 182 | 339.1 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 0 | 153.5 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 28 | 416.9 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 70 | 588.6 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 84 | 617.5 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 56 | 416.9 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 84 | 664.6 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 0 | 178.9 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 70 | 812.2 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 182 | 449.5 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 28 | 550.5 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 56 | 550.5 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 28 | 654.0 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 84 | 802.3 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 182 | 539.1 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 0 | 177.5 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 56 | 654.0 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 70 | 736.1 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 0 | 203.9 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 70 | 722.8 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 182 | 436.4 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 28 | 583.6 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 84 | 637.5 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 56 | 583.6 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 56 | 764.3 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 84 | 907.2 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 28 | 764.3 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 0 | 185.3 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 182 | 563.7 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 70 | 899.2 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 84 | 681.8 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 0 | 185.7 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 28 | 461.8 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 56 | 394.5 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 70 | 614.5 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 182 | 415.6 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 0 | 276.6 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 70 | 772.9 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 56 | 561.4 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 84 | 768.0 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 182 | 528.7 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 28 | 607.2 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 70 | 691.4 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 182 | 486.3 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 56 | 544.4 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 0 | 156.4 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 84 | 714.4 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 28 | 713.9 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 182 | 497.1 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 84 | 865.7 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 28 | 790.6 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 70 | 884.9 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 0 | 220.0 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 56 | 650.7 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 56 | 688.7 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 70 | 866.1 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 84 | 902.3 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 0 | 218.2 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 28 | 781.7 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 182 | 547.9 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 182 | 510.1 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 84 | 754.5 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 28 | 1013.1 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 70 | 747.7 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 0 | 162.5 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT | Day 56 | 788.9 geometric mean titer |
Secondary
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Kansas (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.73 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.19 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.19 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.81 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.16 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.29 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.64 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.89 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.89 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.24 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.61 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.02 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.81 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.81 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.47 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.78 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.43 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.98 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.52 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.00 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.57 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.91 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.91 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.10 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.98 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.62 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.58 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.93 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.18 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.98 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.66 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.64 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.66 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.57 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.51 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.86 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.11 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.07 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.75 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.07 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.22 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.70 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.43 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.47 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.74 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.85 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.12 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.85 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.65 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.81 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.44 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.76 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.65 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.52 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.96 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.09 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.72 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.73 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.37 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.09 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.65 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.65 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.98 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.65 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.70 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.06 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.01 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.76 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.16 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.66 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.98 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.01 Geometric mean titer ratio |
Secondary
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Wisconsin (H1N1 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Time frame: Day 0 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 182 | 97.4 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 0 | 88.8 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 28 | 103.9 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 84 | 135.6 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 56 | 95.3 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 70 | 122.6 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 0 | 64.3 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 84 | 87.5 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 56 | 68.0 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 70 | 78.1 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 28 | 72.7 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 182 | 66.0 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 56 | 58.2 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 182 | 64.6 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 84 | 87.1 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 0 | 56.0 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 70 | 74.4 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 28 | 56.7 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 182 | 81.1 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 56 | 67.5 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 28 | 73.8 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 70 | 96.3 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 84 | 100.0 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 0 | 71.9 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 28 | 78.4 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 0 | 74.9 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 182 | 86.3 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 70 | 97.5 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 56 | 73.4 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 84 | 115.5 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 84 | 79.9 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 70 | 77.2 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 182 | 68.9 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 0 | 74.9 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 28 | 80.4 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 56 | 68.9 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 182 | 92.9 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 0 | 80.5 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 28 | 93.7 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 56 | 78.9 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 70 | 102.7 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 84 | 115.9 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 84 | 101.8 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 56 | 76.0 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 28 | 79.1 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 0 | 84.3 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 182 | 80.1 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 70 | 90.5 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 70 | 74.6 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 182 | 66.3 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 84 | 81.1 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 28 | 76.4 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 0 | 87.2 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 56 | 69.5 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 28 | 106.0 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 56 | 87.9 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 0 | 76.7 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 70 | 114.8 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 182 | 115.3 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 84 | 154.7 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 182 | 95.8 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 28 | 96.8 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 84 | 129.5 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 56 | 85.0 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 0 | 95.5 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 70 | 113.3 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 70 | 94.0 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 0 | 71.8 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 182 | 89.9 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 28 | 79.0 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 56 | 77.4 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 84 | 113.6 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 28 | 112.5 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 70 | 109.8 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 84 | 126.1 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 182 | 104.1 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 0 | 99.8 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT | Day 56 | 106.7 geometric mean titer |
Secondary
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Wisconsin (H1N1 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.16 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.08 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.20 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 1.02 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.18 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.99 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.01 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.89 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.98 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.92 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.95 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.01 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.06 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.88 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.94 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.04 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.04 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.88 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.13 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.04 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.13 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.83 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.01 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.88 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.88 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.91 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.12 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.14 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.03 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.12 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.84 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.89 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.90 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.86 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.87 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.90 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.07 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.88 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.99 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.06 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.09 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.08 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.91 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.90 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.82 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.83 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.92 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.84 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.79 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.74 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.80 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.77 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.81 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.77 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.18 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.38 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.26 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.98 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 1.16 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.19 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.04 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.97 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.05 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.06 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.85 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.90 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.12 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.13 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.95 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.19 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.13 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.96 Geometric mean titer ratio |
Secondary
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Maryland (Victoria Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Time frame: Day 0 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 84 | 508.5 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 70 | 284.8 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 56 | 242.3 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 0 | 153.4 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 182 | 433.4 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 28 | 265.9 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 56 | 209.6 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 182 | 300.7 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 84 | 396.5 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 70 | 266.5 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 0 | 153.1 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 28 | 236.3 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 28 | 173.3 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 182 | 267.3 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 0 | 136.2 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 84 | 330.6 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 70 | 194.0 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 56 | 168.8 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 28 | 183.1 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 56 | 165.3 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 182 | 302.6 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 0 | 125.9 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 84 | 364.4 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 70 | 199.4 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 0 | 145.0 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 84 | 390.7 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 56 | 215.9 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 70 | 267.4 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 28 | 249.0 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 182 | 302.7 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 56 | 179.1 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 0 | 148.2 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 28 | 184.7 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 70 | 203.2 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 182 | 278.6 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 84 | 310.1 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 182 | 384.4 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 56 | 243.7 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 0 | 163.7 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 84 | 464.3 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 28 | 270.0 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 70 | 274.2 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 0 | 167.2 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 28 | 207.8 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 84 | 365.9 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 70 | 209.2 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 182 | 272.3 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 56 | 197.1 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 70 | 212.9 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 0 | 162.5 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 28 | 196.5 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 56 | 193.0 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 84 | 335.4 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 182 | 284.5 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 0 | 176.9 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 182 | 407.3 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 28 | 261.9 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 70 | 271.3 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 56 | 236.4 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 84 | 521.9 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 0 | 152.1 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 182 | 306.6 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 84 | 381.4 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 28 | 229.4 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 56 | 210.9 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 70 | 242.7 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 56 | 205.6 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 28 | 218.7 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 70 | 245.1 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 0 | 148.6 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 84 | 477.2 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 182 | 337.3 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 182 | 312.4 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 70 | 219.4 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 0 | 129.4 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 28 | 280.6 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 56 | 246.7 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT | Day 84 | 364.1 geometric mean titer |
Secondary
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Maryland (Victoria Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.31 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.28 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.22 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.88 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.91 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.96 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.77 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.87 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.86 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.99 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.78 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.10 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.66 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.67 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.61 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.86 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.81 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.87 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.69 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.00 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.93 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.73 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.03 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.66 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.85 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.83 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.15 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.02 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.91 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.91 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.87 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.63 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.83 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.68 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.67 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.81 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.10 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.86 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.03 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.85 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.09 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.87 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.84 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.66 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.67 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.88 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.76 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.69 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.67 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.67 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.75 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.84 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.62 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.78 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.83 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.09 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.28 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.14 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.87 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.85 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.78 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.01 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.85 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.88 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.76 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.80 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.21 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.02 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 00.78 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.04 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.82 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.73 Geometric mean titer ratio |
Secondary
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Phuket (Yamagata Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Time frame: Day 0 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 84 | 195.6 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 56 | 110.2 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 182 | 158.7 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 70 | 132.3 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 28 | 118.4 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 0 | 69.4 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 0 | 76.9 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 182 | 100.0 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 70 | 110.8 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 56 | 86.4 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 28 | 97.7 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 84 | 137.8 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 56 | 63.0 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 0 | 57.8 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 28 | 63.3 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 70 | 73.9 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 84 | 120.1 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 182 | 83.0 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 56 | 76.3 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 0 | 65.0 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 182 | 121.0 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 84 | 143.5 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 28 | 79.7 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 70 | 100.3 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 70 | 118.6 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 56 | 89.9 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 84 | 159.5 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 0 | 60.8 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 28 | 97.5 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 182 | 125.7 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 182 | 96.3 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 70 | 95.5 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 56 | 84.2 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 28 | 87.8 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 84 | 117.2 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 0 | 69.9 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 84 | 144.9 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 28 | 89.6 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 0 | 61.3 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 56 | 81.3 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 70 | 96.0 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 182 | 108.4 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 28 | 85.1 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 70 | 98.3 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 84 | 135.9 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 182 | 101.4 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 0 | 66.4 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 56 | 79.4 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 28 | 73.1 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 0 | 62.1 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 56 | 70.0 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 84 | 120.7 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 70 | 82.3 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 182 | 91.9 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 84 | 187.7 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 28 | 111.9 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 70 | 135.9 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 0 | 69.0 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 182 | 142.5 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 56 | 92.8 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 0 | 67.6 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 84 | 129.6 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 28 | 89.9 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 182 | 106.2 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 56 | 84.2 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 70 | 93.4 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 70 | 109.8 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 182 | 128.1 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 84 | 187.5 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 28 | 99.0 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 0 | 63.0 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 56 | 91.5 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 56 | 102.0 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 28 | 111.5 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 70 | 95.3 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 182 | 118.3 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 0 | 65.2 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT | Day 84 | 135.0 geometric mean titer |
Secondary
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Phuket (Yamagata Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.14 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.39 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.28 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.32 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 1.01 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 1.01 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.85 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.87 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.72 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.97 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.71 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.76 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.70 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.66 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.91 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.62 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.81 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.72 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.03 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.03 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.98 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.72 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.89 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.74 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.29 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.20 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.09 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.92 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.11 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.92 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.79 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.81 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.73 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.74 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.78 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.93 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.85 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.95 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.84 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.91 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.12 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.06 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.77 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.75 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.84 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.97 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.99 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.86 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.76 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.71 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.91 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.88 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.68 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.78 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.37 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.88 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.19 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.16 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.95 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.37 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.94 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.82 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.78 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.82 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.88 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.93 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.16 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.17 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.41 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.93 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 1.01 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.91 Geometric mean titer ratio |
Secondary
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Washington (Victoria Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Time frame: Day 0 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 56 | 245.2 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 28 | 269.6 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 70 | 285.7 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 84 | 297.3 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 0 | 155.0 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 182 | 247.3 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 84 | 240.2 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 28 | 221.3 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 182 | 178.3 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 70 | 238.8 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 56 | 191.9 geometric mean titer |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 0 | 131.8 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 70 | 199.8 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 84 | 236.2 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 182 | 176.1 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 0 | 148.6 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 56 | 168.2 geometric mean titer |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 28 | 177.5 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 84 | 259.5 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 70 | 217.7 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 0 | 131.1 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 28 | 210.5 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 56 | 180.9 geometric mean titer |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 182 | 219.9 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 84 | 259.0 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 182 | 192.1 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 28 | 242.5 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 70 | 250.5 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 56 | 204.2 geometric mean titer |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 0 | 136.5 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 28 | 194.5 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 0 | 143.9 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 84 | 200.4 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 56 | 180.7 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 182 | 176.6 geometric mean titer |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 70 | 210.8 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 182 | 235.9 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 84 | 270.6 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 70 | 250.9 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 0 | 149.2 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 56 | 223.3 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 28 | 252.7 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 56 | 184.3 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 84 | 217.8 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 0 | 158.6 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 28 | 206.7 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 182 | 173.5 geometric mean titer |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 70 | 204.3 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 70 | 183.9 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 28 | 161.9 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 0 | 131.6 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 84 | 216.5 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 182 | 179.4 geometric mean titer |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 56 | 162.9 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 84 | 320.5 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 28 | 246.3 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 56 | 215.2 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 70 | 246.1 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 0 | 173.0 geometric mean titer |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 182 | 245.3 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 0 | 147.1 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 182 | 227.5 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 70 | 253.9 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 84 | 280.0 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 56 | 225.3 geometric mean titer |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 28 | 239.2 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 0 | 148.8 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 28 | 219.0 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 70 | 237.1 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 84 | 268.8 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 182 | 203.3 geometric mean titer |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 56 | 214.6 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 28 | 282.0 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 56 | 238.1 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 182 | 196.7 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 70 | 285.7 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 84 | 241.5 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT | Day 0 | 124.4 geometric mean titer |
Secondary
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Washington(VictoriaSubtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.11 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.91 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.85 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.16 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.10 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.91 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.87 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.96 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.04 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.82 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.76 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.78 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.76 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.58 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.64 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.81 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.62 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.87 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.73 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.11 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.76 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.74 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.97 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.07 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.00 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.81 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.91 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.84 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.07 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.82 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.64 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.79 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.70 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.88 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.69 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.82 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.06 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.81 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.01 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.83 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.79 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.01 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.63 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.63 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.80 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.79 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.66 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.77 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.65 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.62 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.79 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.85 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.85 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.55 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.76 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.19 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.79 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.97 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.77 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.08 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 1.02 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 0.99 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 1.01 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.84 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.77 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.80 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 84 (Comparison to qNIV Reference [Group O] Day 84) | 1.00 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day70 (Comparison to qNIV Reference [Group O] Day 28)** | 0.75 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 182 (Comparison to qNIV Reference [Group O] Day 182) | 0.94 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 70 (Comparison to qNIV Reference [Group O] Day 70) | 0.96 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 56 (Comparison to qNIV Reference [Group O] Day 56) | 0.80 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR | Day 28 (Comparison to qNIV Reference [Group O] Day 28) | 0.70 Geometric mean titer ratio |
Secondary
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.96 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.66 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.90 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.70 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.41 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.59 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.89 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.55 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.73 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.67 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.96 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.93 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.81 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.71 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.48 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 1.18 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.42 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 1.24 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.75 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.65 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.75 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.76 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.49 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.82 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.75 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.65 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.43 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.92 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.61 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.91 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.61 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.70 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.37 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.87 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.70 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.44 Geometric mean titer ratio |
Secondary
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 70
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 28 | 1.6 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 56 | 1.4 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 70 | 2.2 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 56 | 1.0 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 28 | 1.0 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 70 | 1.4 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 56 | 1.3 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 70 | 1.9 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 28 | 1.3 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 56 | 1.4 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 28 | 1.6 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 70 | 2.3 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 70 | 1.7 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 28 | 1.2 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 56 | 1.2 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 70 | 2.4 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 56 | 1.8 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 28 | 2.1 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 70 | 1.4 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 28 | 1.1 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 56 | 1.1 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 28 | 1.3 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 56 | 1.2 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 70 | 1.8 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 28 | 1.2 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 56 | 1.1 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 70 | 1.5 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 28 | 1.6 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 70 | 2.1 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 56 | 1.3 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 28 | 1.1 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 70 | 1.3 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 56 | 1.0 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 56 | 1.3 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 28 | 1.2 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 70 | 1.5 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 70 | 3.4 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 56 | 1.5 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR | Day 28 | 1.8 geometric mean fold rise |
Secondary
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 70
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 56 | 15.0 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 0 | 10.7 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 28 | 17.0 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 70 | 24.2 geometric mean titer |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 0 | 11.9 geometric mean titer |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 28 | 12.3 geometric mean titer |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 56 | 10.9 geometric mean titer |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 70 | 14.8 geometric mean titer |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 28 | 13.1 geometric mean titer |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 0 | 10.2 geometric mean titer |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 70 | 19.6 geometric mean titer |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 56 | 13.3 geometric mean titer |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 0 | 10.2 geometric mean titer |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 28 | 16.6 geometric mean titer |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 56 | 14.4 geometric mean titer |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 70 | 23.8 geometric mean titer |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 70 | 17.1 geometric mean titer |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 28 | 12.9 geometric mean titer |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 0 | 10.3 geometric mean titer |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 56 | 12.3 geometric mean titer |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 56 | 18.3 geometric mean titer |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 0 | 10.0 geometric mean titer |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 28 | 20.7 geometric mean titer |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 70 | 24.2 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 28 | 12.4 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 56 | 11.7 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 0 | 10.8 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 70 | 15.4 geometric mean titer |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 28 | 13.3 geometric mean titer |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 0 | 10.0 geometric mean titer |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 56 | 12.2 geometric mean titer |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 70 | 17.6 geometric mean titer |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 0 | 10.7 geometric mean titer |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 56 | 11.8 geometric mean titer |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 28 | 12.4 geometric mean titer |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 70 | 15.8 geometric mean titer |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 0 | 10.4 geometric mean titer |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 70 | 21.6 geometric mean titer |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 56 | 13.9 geometric mean titer |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 28 | 16.4 geometric mean titer |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 56 | 10.6 geometric mean titer |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 70 | 13.2 geometric mean titer |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 28 | 11.1 geometric mean titer |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 0 | 10.4 geometric mean titer |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 28 | 13.4 geometric mean titer |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 70 | 16.2 geometric mean titer |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 56 | 13.7 geometric mean titer |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 0 | 10.9 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 70 | 36.5 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 0 | 10.7 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 28 | 19.0 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT | Day 56 | 15.6 geometric mean titer |
Secondary
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 70 | 32.5 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 56 | 8.9 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 28 | 21.3 Percentage of participants |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 56 | 0 Percentage of participants |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 70 | 10.3 Percentage of participants |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 28 | 0 Percentage of participants |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 56 | 11.1 Percentage of participants |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 28 | 13.2 Percentage of participants |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 70 | 28.6 Percentage of participants |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 70 | 41.7 Percentage of participants |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 28 | 21.6 Percentage of participants |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 56 | 16.7 Percentage of participants |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 56 | 7.5 Percentage of participants |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 28 | 7.3 Percentage of participants |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 70 | 22.5 Percentage of participants |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 70 | 45.0 Percentage of participants |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 28 | 29.3 Percentage of participants |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 56 | 22.5 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 28 | 2.6 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 56 | 2.6 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 70 | 14.7 Percentage of participants |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 56 | 5.1 Percentage of participants |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 70 | 23.7 Percentage of participants |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 28 | 12.8 Percentage of participants |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 70 | 13.2 Percentage of participants |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 56 | 2.6 Percentage of participants |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 28 | 7.7 Percentage of participants |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 70 | 31.4 Percentage of participants |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 28 | 21.1 Percentage of participants |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 56 | 13.9 Percentage of participants |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 28 | 0 Percentage of participants |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 70 | 8.1 Percentage of participants |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 56 | 0 Percentage of participants |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 28 | 15.0 Percentage of participants |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 56 | 10.0 Percentage of participants |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 70 | 17.5 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 28 | 17.9 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 56 | 12.8 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR | Day 70 | 63.2 Percentage of participants |
Secondary
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR)
MN50 GMTs to the SARS-CoV-2 Wuhan Strain from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 182 | 5.5 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 70 | 4.2 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 56 | 2.5 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 28 | 3.7 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 84 | 5.6 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 182 | 6.0 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 84 | 3.7 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 70 | 2.7 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 28 | 2.4 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 56 | 1.5 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 28 | 3.4 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 84 | 4.0 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 70 | 3.4 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 182 | 5.2 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 56 | 2.5 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 28 | 5.2 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 84 | 6.8 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 70 | 4.8 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 182 | 7.2 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 56 | 3.0 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 56 | 2.1 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 84 | 4.1 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 182 | 4.2 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 70 | 3.3 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 28 | 3.0 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 70 | 5.0 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 182 | 7.4 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 56 | 3.7 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 28 | 5.0 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 84 | 7.4 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 70 | 1.8 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 84 | 2.8 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 182 | 3.8 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 28 | 2.1 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 56 | 1.5 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 182 | 7.4 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 28 | 3.5 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 84 | 5.0 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 70 | 3.5 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 56 | 2.4 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 28 | 2.9 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 182 | 6.0 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 84 | 3.5 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 56 | 1.8 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 70 | 2.4 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 28 | 4.1 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 182 | 7.0 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 84 | 4.8 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 56 | 3.0 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 70 | 5.5 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 56 | 1.3 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 70 | 1.6 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 182 | 3.5 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 28 | 1.8 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 84 | 2.3 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 70 | 2.6 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 28 | 2.9 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 84 | 3.7 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 182 | 3.3 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 56 | 1.8 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 70 | 9.1 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 28 | 5.8 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 56 | 4.1 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 84 | 12.2 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR) | Day 182 | 13.3 geometric mean fold rise |
Secondary
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT)
MN50 GMTs to the SARS-CoV-2 Wuhan Strain from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 28 | 476.7 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 182 | 711.7 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 70 | 554.2 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 0 | 127.7 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 56 | 328.5 geometric mean titer |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 84 | 731.3 geometric mean titer |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 56 | 168.8 geometric mean titer |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 0 | 123.4 geometric mean titer |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 182 | 823.5 geometric mean titer |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 28 | 293.4 geometric mean titer |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 84 | 403.2 geometric mean titer |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 70 | 298.0 geometric mean titer |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 84 | 452.5 geometric mean titer |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 70 | 430.7 geometric mean titer |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 56 | 290.6 geometric mean titer |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 182 | 702.0 geometric mean titer |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 0 | 112.1 geometric mean titer |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 28 | 377.1 geometric mean titer |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 0 | 140.3 geometric mean titer |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 84 | 932.4 geometric mean titer |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 28 | 729.7 geometric mean titer |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 182 | 1000.9 geometric mean titer |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 56 | 419.0 geometric mean titer |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 70 | 665.1 geometric mean titer |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 84 | 535.8 geometric mean titer |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 28 | 378.9 geometric mean titer |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 56 | 259.9 geometric mean titer |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 0 | 126.3 geometric mean titer |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 182 | 535.5 geometric mean titer |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 70 | 407.9 geometric mean titer |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 84 | 905.1 geometric mean titer |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 0 | 114.1 geometric mean titer |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 28 | 568.6 geometric mean titer |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 56 | 452.5 geometric mean titer |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 70 | 607.6 geometric mean titer |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 182 | 895.6 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 56 | 232.4 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 84 | 430.1 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 28 | 331.7 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 0 | 158.6 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 182 | 610.9 geometric mean titer |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 70 | 286.4 geometric mean titer |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 84 | 478.0 geometric mean titer |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 56 | 232.4 geometric mean titer |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 0 | 95.6 geometric mean titer |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 182 | 721.2 geometric mean titer |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 70 | 338.0 geometric mean titer |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 28 | 331.6 geometric mean titer |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 0 | 124.8 geometric mean titer |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 28 | 356.0 geometric mean titer |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 70 | 292.1 geometric mean titer |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 56 | 226.3 geometric mean titer |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 84 | 428.4 geometric mean titer |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 182 | 699.9 geometric mean titer |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 182 | 752.4 geometric mean titer |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 84 | 518.8 geometric mean titer |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 28 | 469.4 geometric mean titer |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 0 | 116.2 geometric mean titer |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 70 | 579.7 geometric mean titer |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 56 | 332.6 geometric mean titer |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 182 | 503.9 geometric mean titer |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 0 | 136.3 geometric mean titer |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 28 | 245.1 geometric mean titer |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 56 | 169.0 geometric mean titer |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 84 | 320.0 geometric mean titer |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 70 | 224.2 geometric mean titer |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 0 | 125.5 geometric mean titer |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 56 | 226.3 geometric mean titer |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 28 | 367.6 geometric mean titer |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 182 | 452.5 geometric mean titer |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 70 | 325.6 geometric mean titer |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 84 | 460.5 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 182 | 1403.9 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 84 | 1280.0 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 0 | 106.3 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 70 | 956.0 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 28 | 617.7 geometric mean titer |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT) | Day 56 | 432.9 geometric mean titer |
Secondary
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR
MN50 GMTs to the SARS-CoV-2 Wuhan Strain from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.70 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.52 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.69 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.53 Geometric mean titer ratio |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.47 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.56 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.31 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.31 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.43 Geometric mean titer ratio |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.38 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.60 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.48 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.42 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.34 Geometric mean titer ratio |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.64 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.64 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 1.05 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.86 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.67 Geometric mean titer ratio |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.64 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.56 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.58 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.40 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.37 Geometric mean titer ratio |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.41 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.89 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.67 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.62 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.61 Geometric mean titer ratio |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.97 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.38 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.28 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.24 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.44 Geometric mean titer ratio |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.42 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.57 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.57 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.36 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.39 Geometric mean titer ratio |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.52 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.32 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.29 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.48 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.54 Geometric mean titer ratio |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.49 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.61 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.40 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.75 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.74 Geometric mean titer ratio |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.53 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.32 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.35 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.36 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.22 Geometric mean titer ratio |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.21 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.28 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.55 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.69 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0) | 0.53 Geometric mean titer ratio |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.34 Geometric mean titer ratio |
Secondary
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR
MN50 GMTs to the SARS-CoV-2 Wuhan Strain from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 84 | 75.6 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 182 | 69.4 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 70 | 64.9 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 28 | 67.5 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 56 | 44.3 Percentage of participants |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 182 | 60.6 Percentage of participants |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 56 | 17.9 Percentage of participants |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 84 | 61.5 Percentage of participants |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 70 | 48.7 Percentage of participants |
| Group B -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 28 | 42.5 Percentage of participants |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 70 | 54.3 Percentage of participants |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 182 | 66.7 Percentage of participants |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 84 | 67.6 Percentage of participants |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 56 | 44.4 Percentage of participants |
| Group D - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 28 | 55.3 Percentage of participants |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 84 | 77.1 Percentage of participants |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 182 | 80.6 Percentage of participants |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 56 | 44.4 Percentage of participants |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 28 | 70.3 Percentage of participants |
| Group E - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 70 | 69.4 Percentage of participants |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 56 | 37.5 Percentage of participants |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 28 | 41.5 Percentage of participants |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 84 | 53.8 Percentage of participants |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 70 | 52.5 Percentage of participants |
| Group F- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 182 | 54.3 Percentage of participants |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 70 | 75.0 Percentage of participants |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 182 | 81.8 Percentage of participants |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 28 | 82.9 Percentage of participants |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 56 | 62.5 Percentage of participants |
| Group G- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 84 | 84.2 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 28 | 36.4 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 182 | 56.7 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 84 | 52.0 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 70 | 29.3 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 56 | 23.1 Percentage of participants |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 70 | 55.3 Percentage of participants |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 182 | 72.4 Percentage of participants |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 28 | 61.5 Percentage of participants |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 56 | 33.3 Percentage of participants |
| Group I- ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 84 | 71.1 Percentage of participants |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 70 | 39.5 Percentage of participants |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 56 | 28.9 Percentage of participants |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 182 | 67.7 Percentage of participants |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 84 | 52.6 Percentage of participants |
| Group J -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 28 | 51.3 Percentage of participants |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 70 | 74.3 Percentage of participants |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 182 | 86.7 Percentage of participants |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 56 | 52.8 Percentage of participants |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 84 | 69.7 Percentage of participants |
| Group K - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 28 | 60.5 Percentage of participants |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 56 | 10.5 Percentage of participants |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 28 | 28.2 Percentage of participants |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 70 | 29.7 Percentage of participants |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 84 | 35.1 Percentage of participants |
| Group L - ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 182 | 65.5 Percentage of participants |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 70 | 50.0 Percentage of participants |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 84 | 57.5 Percentage of participants |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 56 | 27.5 Percentage of participants |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 28 | 52.5 Percentage of participants |
| Group M -ICC Vaccine Formulation | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 182 | 45.2 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 70 | 86.8 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 182 | 86.7 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 84 | 94.7 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 56 | 61.5 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR | Day 28 | 76.9 Percentage of participants |
Secondary
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR).
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 84 | 94.9 percentage of participants(SPR) |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 70 | 97.4 percentage of participants(SPR) |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 182 | 90.7 percentage of participants(SPR) |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 28 | 96.3 percentage of participants(SPR) |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 56 | 96.2 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 28 | 85.0 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 182 | 82.1 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 84 | 89.7 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 70 | 94.9 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 56 | 87.2 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 56 | 97.2 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 84 | 94.1 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 28 | 94.7 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 182 | 85.3 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 70 | 94.3 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 28 | 94.6 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 84 | 94.3 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 70 | 97.2 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 56 | 91.7 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 182 | 85.7 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 182 | 79.5 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 56 | 87.5 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 84 | 87.2 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 28 | 92.7 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 70 | 95.0 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 182 | 68.4 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 70 | 95.0 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 56 | 87.5 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 28 | 85.4 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 84 | 78.9 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 84 | 92.1 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 56 | 94.9 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 70 | 98.7 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 182 | 82.7 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 28 | 98.7 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 84 | 97.4 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 28 | 92.3 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 56 | 89.7 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 70 | 97.4 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 182 | 75.7 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 56 | 84.2 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 84 | 89.5 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 28 | 87.2 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 182 | 78.4 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 70 | 92.1 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 56 | 91.9 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 28 | 92.3 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 70 | 97.2 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 84 | 94.1 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 182 | 83.3 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 182 | 81.6 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 84 | 91.9 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 28 | 94.9 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 70 | 97.3 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 56 | 92.1 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 70 | 100.0 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 56 | 97.5 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 84 | 95.1 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 28 | 95.1 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 182 | 82.1 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 84 | 94.7 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 28 | 100.0 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 56 | 100.0 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 70 | 100.0 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR). | Day 182 | 78.9 percentage of participants(SPR) |
Secondary
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 70 | 90.9 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 182 | 66.7 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 84 | 73.1 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 28 | 90.0 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 56 | 86.1 percentage of participants |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 56 | 79.5 percentage of participants |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 70 | 84.6 percentage of participants |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 28 | 77.5 percentage of participants |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 84 | 71.8 percentage of participants |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 182 | 71.8 percentage of participants |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 182 | 50.0 percentage of participants |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 56 | 72.2 percentage of participants |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 84 | 64.7 percentage of participants |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 70 | 80.0 percentage of participants |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 28 | 71.1 percentage of participants |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 70 | 88.9 percentage of participants |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 28 | 89.2 percentage of participants |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 182 | 45.7 percentage of participants |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 56 | 77.8 percentage of participants |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 84 | 62.9 percentage of participants |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 84 | 76.9 percentage of participants |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 70 | 95.0 percentage of participants |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 28 | 90.2 percentage of participants |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 56 | 87.5 percentage of participants |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 182 | 66.7 percentage of participants |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 56 | 82.5 percentage of participants |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 182 | 63.2 percentage of participants |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 28 | 87.8 percentage of participants |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 70 | 85.0 percentage of participants |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 84 | 68.4 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 70 | 92.1 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 28 | 87.2 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 56 | 82.3 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 84 | 71.1 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 182 | 57.3 percentage of participants |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 56 | 74.4 percentage of participants |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 84 | 71.1 percentage of participants |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 70 | 84.2 percentage of participants |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 182 | 62.2 percentage of participants |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 28 | 82.1 percentage of participants |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 84 | 63.2 percentage of participants |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 28 | 87.2 percentage of participants |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 70 | 81.6 percentage of participants |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 182 | 64.9 percentage of participants |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 56 | 78.9 percentage of participants |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 70 | 80.6 percentage of participants |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 56 | 75.7 percentage of participants |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 84 | 61.8 percentage of participants |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 28 | 76.9 percentage of participants |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 182 | 55.6 percentage of participants |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 182 | 63.2 percentage of participants |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 56 | 76.3 percentage of participants |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 84 | 75.7 percentage of participants |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 70 | 89.2 percentage of participants |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 28 | 94.9 percentage of participants |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 56 | 75.0 percentage of participants |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 28 | 85.4 percentage of participants |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 70 | 92.7 percentage of participants |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 84 | 61.0 percentage of participants |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 182 | 56.4 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 70 | 97.4 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 182 | 65.8 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 84 | 78.9 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 28 | 100.0 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR | Day 56 | 89.7 percentage of participants |
Secondary
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype)on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 84 | 88.5 percentage of participants(SPR) |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 28 | 98.8 percentage of participants(SPR) |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 70 | 97.4 percentage of participants(SPR) |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 182 | 84.0 percentage of participants(SPR) |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 56 | 97.5 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 28 | 92.5 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 70 | 94.9 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 182 | 82.1 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 56 | 89.7 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 84 | 84.6 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 84 | 85.3 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 70 | 100.0 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 182 | 73.5 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 28 | 97.4 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 56 | 97.2 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 182 | 77.1 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 56 | 88.9 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 70 | 97.2 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 28 | 91.9 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 84 | 82.9 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 70 | 97.5 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 28 | 95.1 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 182 | 84.6 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 84 | 92.3 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 56 | 95.0 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 182 | 78.9 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 56 | 95.0 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 28 | 97.6 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 70 | 97.5 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 84 | 86.8 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 84 | 88.2 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 28 | 100.0 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 182 | 85.3 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 56 | 97.5 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 70 | 100.0 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 28 | 100.0 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 182 | 86.5 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 84 | 86.8 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 56 | 92.3 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 70 | 100.0 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 56 | 100.0 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 182 | 86.5 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 28 | 100.0 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 70 | 97.4 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 84 | 81.6 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 182 | 88.9 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 56 | 97.3 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 70 | 97.2 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 84 | 88.2 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 28 | 97.4 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 182 | 81.6 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 84 | 89.2 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 70 | 100.0 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 56 | 100.0 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 28 | 100.0 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 28 | 95.1 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 182 | 84.6 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 70 | 97.6 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 84 | 87.8 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 56 | 95.0 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 28 | 97.4 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 56 | 100.0 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 182 | 86.8 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 84 | 89.5 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR | Day 70 | 100.0 percentage of participants(SPR) |
Secondary
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 56 | 89.9 percentage of participants(SPR) |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 70 | 98.7 percentage of participants(SPR) |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 28 | 93.8 percentage of participants(SPR) |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 84 | 94.9 percentage of participants(SPR) |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 182 | 86.7 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 182 | 79.5 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 56 | 71.8 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 84 | 89.7 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 28 | 75.0 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 70 | 89.7 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 70 | 85.7 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 182 | 73.5 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 56 | 77.8 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 28 | 73.7 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 84 | 82.4 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 70 | 97.2 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 28 | 78.4 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 182 | 77.1 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 56 | 75.0 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 84 | 91.4 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 84 | 94.9 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 70 | 90.0 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 28 | 87.8 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 56 | 85.0 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 182 | 92.3 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 56 | 85.0 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 182 | 81.6 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 28 | 85.4 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 70 | 95.0 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 84 | 92.1 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 70 | 94.7 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 28 | 89.7 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 56 | 91.1 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 84 | 96.1 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 182 | 90.7 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 56 | 79.5 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 84 | 92.1 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 70 | 94.7 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 182 | 83.8 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 28 | 79.5 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 84 | 94.7 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 28 | 89.7 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 70 | 92.1 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 182 | 97.3 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 56 | 89.5 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 70 | 83.3 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 56 | 83.8 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 84 | 85.3 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 28 | 87.2 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 182 | 83.3 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 182 | 86.8 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 56 | 81.6 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 84 | 91.9 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 70 | 91.9 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 28 | 92.3 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 56 | 85.0 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 28 | 90.2 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 70 | 87.8 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 84 | 87.8 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 182 | 84.6 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 70 | 89.5 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 182 | 81.6 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 84 | 86.8 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 28 | 92.3 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR | Day 56 | 89.7 percentage of participants(SPR) |
Secondary
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 70 | 98.7 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 182 | 89.3 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 84 | 93.6 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 28 | 98.8 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 56 | 97.5 percentage of participants |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 56 | 97.4 percentage of participants |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 70 | 100.0 percentage of participants |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 28 | 100.0 percentage of participants |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 84 | 89.7 percentage of participants |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 182 | 79.5 percentage of participants |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 182 | 88.2 percentage of participants |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 56 | 100.0 percentage of participants |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 84 | 88.2 percentage of participants |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 70 | 100.0 percentage of participants |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 28 | 100.0 percentage of participants |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 70 | 100.0 percentage of participants |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 28 | 100.0 percentage of participants |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 182 | 77.1 percentage of participants |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 56 | 97.2 percentage of participants |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 84 | 88.6 percentage of participants |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 84 | 87.2 percentage of participants |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 70 | 100.0 percentage of participants |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 28 | 100.0 percentage of participants |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 56 | 97.5 percentage of participants |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 182 | 87.2 percentage of participants |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 56 | 95.0 percentage of participants |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 182 | 76.3 percentage of participants |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 28 | 97.6 percentage of participants |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 70 | 97.5 percentage of participants |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 84 | 86.8 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 70 | 98.7 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 28 | 100.0 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 56 | 98.7 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 84 | 90.8 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 182 | 86.7 percentage of participants |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 56 | 100.0 percentage of participants |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 84 | 89.5 percentage of participants |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 70 | 100.0 percentage of participants |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 182 | 75.7 percentage of participants |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 28 | 100.0 percentage of participants |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 84 | 81.6 percentage of participants |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 28 | 100.0 percentage of participants |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 70 | 100.0 percentage of participants |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 182 | 73.0 percentage of participants |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 56 | 97.4 percentage of participants |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 70 | 100.0 percentage of participants |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 56 | 100.0 percentage of participants |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 84 | 88.2 percentage of participants |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 28 | 97.4 percentage of participants |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 182 | 83.3 percentage of participants |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 182 | 73.7 percentage of participants |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 56 | 100.0 percentage of participants |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 84 | 89.2 percentage of participants |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 70 | 97.3 percentage of participants |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 28 | 100.0 percentage of participants |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 56 | 97.5 percentage of participants |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 28 | 97.6 percentage of participants |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 70 | 100.0 percentage of participants |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 84 | 92.7 percentage of participants |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 182 | 89.7 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 70 | 100.0 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 182 | 86.8 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 84 | 86.8 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 28 | 100.0 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR | Day 56 | 97.4 percentage of participants |
Secondary
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 84 | 85.9 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 182 | 88.0 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 56 | 87.3 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 28 | 90.0 percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 70 | 92.2 percentage of participants |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 28 | 77.5 percentage of participants |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 70 | 82.1 percentage of participants |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 84 | 89.7 percentage of participants |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 182 | 89.7 percentage of participants |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 56 | 74.4 percentage of participants |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 28 | 73.7 percentage of participants |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 56 | 66.7 percentage of participants |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 70 | 74.3 percentage of participants |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 84 | 82.4 percentage of participants |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 182 | 73.5 percentage of participants |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 28 | 75.7 percentage of participants |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 70 | 88.9 percentage of participants |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 84 | 88.6 percentage of participants |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 56 | 83.3 percentage of participants |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 182 | 80.0 percentage of participants |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 84 | 84.6 percentage of participants |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 28 | 78.0 percentage of participants |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 182 | 84.6 percentage of participants |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 56 | 67.5 percentage of participants |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 70 | 77.5 percentage of participants |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 28 | 73.2 percentage of participants |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 56 | 70.0 percentage of participants |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 84 | 81.6 percentage of participants |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 182 | 76.3 percentage of participants |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 70 | 77.5 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 28 | 83.3 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 84 | 89.5 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 56 | 79.7 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 182 | 84.0 percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 70 | 88.2 percentage of participants |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 182 | 73.0 percentage of participants |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 56 | 74.4 percentage of participants |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 70 | 81.6 percentage of participants |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 84 | 76.3 percentage of participants |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 28 | 76.9 percentage of participants |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 84 | 78.9 percentage of participants |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 28 | 66.7 percentage of participants |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 56 | 65.8 percentage of participants |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 70 | 76.3 percentage of participants |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 182 | 81.1 percentage of participants |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 70 | 88.9 percentage of participants |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 28 | 82.1 percentage of participants |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 182 | 75.0 percentage of participants |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 84 | 85.3 percentage of participants |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 56 | 83.8 percentage of participants |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 84 | 91.9 percentage of participants |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 28 | 76.9 percentage of participants |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 182 | 76.3 percentage of participants |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 70 | 81.1 percentage of participants |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 56 | 71.1 percentage of participants |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 28 | 80.5 percentage of participants |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 56 | 85.0 percentage of participants |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 84 | 85.4 percentage of participants |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 70 | 87.8 percentage of participants |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 182 | 79.5 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 182 | 84.2 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 28 | 87.2 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 56 | 76.9 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 70 | 84.2 percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR | Day 84 | 86.8 percentage of participants |
Secondary
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 28 | 90.0 percentage of participants(SPR) |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 56 | 89.9 percentage of participants(SPR) |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 84 | 94.9 percentage of participants(SPR) |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 182 | 92.0 percentage of participants(SPR) |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 70 | 90.9 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 56 | 76.9 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 70 | 87.2 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 182 | 87.2 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 28 | 80.0 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 84 | 94.9 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 70 | 62.9 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 56 | 55.6 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 28 | 57.9 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 84 | 73.5 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 182 | 73.5 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 182 | 77.1 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 70 | 80.6 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 84 | 80.0 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 56 | 66.7 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 28 | 67.6 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 70 | 90.0 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 56 | 85.0 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 84 | 97.4 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 28 | 92.7 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 182 | 89.7 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 84 | 89.5 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 70 | 82.5 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 182 | 76.3 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 28 | 73.2 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 56 | 75.0 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 56 | 77.2 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 84 | 92.1 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 28 | 83.3 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 70 | 88.2 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 182 | 82.7 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 182 | 89.2 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 70 | 89.5 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 56 | 89.7 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 28 | 87.2 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 84 | 92.1 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 84 | 86.8 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 70 | 84.2 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 182 | 83.8 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 28 | 74.4 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 56 | 68.4 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 70 | 91.7 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 56 | 89.2 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 28 | 89.7 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 182 | 88.9 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 84 | 88.2 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 28 | 79.5 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 56 | 73.7 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 182 | 78.9 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 84 | 89.2 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 70 | 86.5 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 182 | 89.7 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 56 | 85.0 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 70 | 92.7 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 84 | 90.2 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 28 | 85.4 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 84 | 100.0 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 56 | 97.4 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 182 | 92.1 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 28 | 97.4 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR | Day 70 | 94.7 percentage of participants(SPR) |
Secondary
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) on Days 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 182 | 82.7 percentage of participants(SPR) |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 84 | 83.3 percentage of participants(SPR) |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 56 | 98.7 percentage of participants(SPR) |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 70 | 98.7 percentage of participants(SPR) |
| Group A and Group C - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 28 | 97.5 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 70 | 97.4 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 56 | 97.4 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 84 | 84.6 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 28 | 100.0 percentage of participants(SPR) |
| Group B -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 182 | 82.1 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 70 | 97.1 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 56 | 91.7 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 28 | 97.4 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 84 | 79.4 percentage of participants(SPR) |
| Group D - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 182 | 76.5 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 70 | 100.0 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 182 | 77.1 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 28 | 100.0 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 56 | 97.2 percentage of participants(SPR) |
| Group E - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 84 | 82.9 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 84 | 82.1 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 56 | 90.0 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 28 | 95.1 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 182 | 79.5 percentage of participants(SPR) |
| Group F- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 70 | 92.5 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 70 | 90.0 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 84 | 78.9 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 182 | 71.1 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 56 | 90.0 percentage of participants(SPR) |
| Group G- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 28 | 92.7 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 56 | 97.5 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 70 | 98.7 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 28 | 96.2 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 84 | 85.5 percentage of participants(SPR) |
| Group H and Group N- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 182 | 82.7 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 182 | 70.3 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 70 | 94.7 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 84 | 71.1 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 28 | 92.3 percentage of participants(SPR) |
| Group I- ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 56 | 89.7 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 182 | 81.1 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 28 | 94.9 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 56 | 97.4 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 84 | 73.7 percentage of participants(SPR) |
| Group J -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 70 | 94.7 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 84 | 82.4 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 56 | 97.3 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 182 | 80.6 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 28 | 97.4 percentage of participants(SPR) |
| Group K - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 70 | 100.0 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 56 | 94.7 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 70 | 94.6 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 28 | 94.9 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 84 | 91.9 percentage of participants(SPR) |
| Group L - ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 182 | 73.7 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 182 | 82.1 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 70 | 97.6 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 56 | 95.0 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 28 | 95.1 percentage of participants(SPR) |
| Group M -ICC Vaccine Formulation | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 84 | 85.4 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 84 | 78.9 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 70 | 97.4 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 182 | 78.9 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 28 | 97.4 percentage of participants(SPR) |
| Group O - qNIV With Matrix-M1 Adjuvant | Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR | Day 56 | 97.4 percentage of participants(SPR) |
Secondary
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR)
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Omicron BA.1 Variant spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.30 ratio |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.41 ratio |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.29 ratio |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.68 ratio |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.68 ratio |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.19 ratio |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.50 ratio |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.35 ratio |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.18 ratio |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.37 ratio |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.66 ratio |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.67 ratio |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.29 ratio |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.29 ratio |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.45 ratio |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.97 ratio |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.57 ratio |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 1.01 ratio |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.58 ratio |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.72 ratio |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.33 ratio |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.56 ratio |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.52 ratio |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.26 ratio |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.26 ratio |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 1.01 ratio |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.50 ratio |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.87 ratio |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.52 ratio |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.56 ratio |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.47 ratio |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.16 ratio |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.32 ratio |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.15 ratio |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.44 ratio |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.32 ratio |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.33 ratio |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.56 ratio |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.58 ratio |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.55 ratio |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.48 ratio |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.25 ratio |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.24 ratio |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.46 ratio |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.44 ratio |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.35 ratio |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.83 ratio |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.40 ratio |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.34 ratio |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.75 ratio |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.36 ratio |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.25 ratio |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.38 ratio |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.14 ratio |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.15 ratio |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.20 ratio |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.20 ratio |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.56 ratio |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.57 ratio |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR) | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.24 ratio |
Secondary
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Omicron BA.1 spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 70 | 10131.1 EU/mL |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 84 | 9816.0 EU/mL |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 0 | 2509.4 EU/mL |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 182 | 11537.2 EU/mL |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 28 | 7178.0 EU/mL |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 56 | 4944.6 EU/mL |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 56 | 2401.9 EU/mL |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 84 | 5433.7 EU/mL |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 70 | 5996.7 EU/mL |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 0 | 2352.1 EU/mL |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 182 | 13357.2 EU/mL |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 28 | 3681.8 EU/mL |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 0 | 1640.8 EU/mL |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 28 | 5540.0 EU/mL |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 84 | 8251.7 EU/mL |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 182 | 11651.7 EU/mL |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 56 | 4066.0 EU/mL |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 70 | 8505.0 EU/mL |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 84 | 17296.1 EU/mL |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 28 | 9164.6 EU/mL |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 182 | 18548.4 EU/mL |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 0 | 2223.5 EU/mL |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 56 | 6627.4 EU/mL |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 70 | 17713.1 EU/mL |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 70 | 7554.2 EU/mL |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 84 | 7548.7 EU/mL |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 56 | 3169.4 EU/mL |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 182 | 8631.2 EU/mL |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 28 | 5016.6 EU/mL |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 0 | 1891.7 EU/mL |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 70 | 15278.3 EU/mL |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 182 | 13600.4 EU/mL |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 84 | 17095.5 EU/mL |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 0 | 2118.1 EU/mL |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 28 | 9532.8 EU/mL |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 56 | 5695.2 EU/mL |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 182 | 8827.8 EU/mL |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 56 | 3153.4 EU/mL |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 28 | 4771.3 EU/mL |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 0 | 2338.1 EU/mL |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 70 | 5213.9 EU/mL |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 84 | 4820.6 EU/mL |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 182 | 14569.4 EU/mL |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 70 | 8810.1 EU/mL |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 56 | 3025.0 EU/mL |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 28 | 4523.6 EU/mL |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 0 | 1546.0 EU/mL |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 84 | 9228.5 EU/mL |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 28 | 4449.2 EU/mL |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 0 | 2169.7 EU/mL |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 56 | 3104.4 EU/mL |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 70 | 7595.8 EU/mL |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 84 | 7392.8 EU/mL |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 182 | 11423.9 EU/mL |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 28 | 6525.9 EU/mL |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 0 | 1836.6 EU/mL |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 70 | 9771.5 EU/mL |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 182 | 9692.8 EU/mL |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 56 | 4874.6 EU/mL |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 84 | 9687.1 EU/mL |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 0 | 2026.9 EU/mL |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 28 | 3337.6 EU/mL |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 182 | 6533.1 EU/mL |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 84 | 4501.4 EU/mL |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 70 | 4807.0 EU/mL |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 56 | 2486.6 EU/mL |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 70 | 5959.0 EU/mL |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 182 | 6134.1 EU/mL |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 84 | 5899.3 EU/mL |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 56 | 3418.5 EU/mL |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 28 | 5146.3 EU/mL |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 0 | 1907.4 EU/mL |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 182 | 25661.9 EU/mL |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 0 | 1924.5 EU/mL |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 28 | 9022.0 EU/mL |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 84 | 29386.3 EU/mL |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 70 | 29688.8 EU/mL |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU | Day 56 | 6174.1 EU/mL |
Secondary
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Omicron BA.1 Variant spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 56 | 2.0 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 182 | 4.8 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 84 | 3.9 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 70 | 4.0 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 28 | 2.9 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 28 | 1.6 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 84 | 2.6 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 182 | 5.5 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 70 | 2.9 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 56 | 1.1 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 182 | 5.7 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 28 | 3.3 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 56 | 2.2 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 70 | 4.4 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 84 | 4.6 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 84 | 8.1 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 182 | 8.7 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 56 | 3.0 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 70 | 8.0 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 28 | 4.1 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 56 | 1.7 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 28 | 2.7 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 84 | 3.9 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 70 | 4.1 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 182 | 4.3 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 70 | 7.2 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 84 | 7.6 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 182 | 6.3 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 28 | 4.5 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 56 | 2.7 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 70 | 2.2 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 56 | 1.3 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 182 | 3.3 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 84 | 2.1 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 28 | 2.1 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 70 | 5.9 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 84 | 6.2 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 182 | 9.3 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 28 | 2.9 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 56 | 2.0 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 70 | 3.6 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 56 | 1.5 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 182 | 5.7 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 28 | 2.1 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 84 | 3.5 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 182 | 6.1 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 84 | 5.6 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 56 | 2.8 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 28 | 3.6 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 70 | 5.8 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 84 | 2.0 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 56 | 1.2 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 182 | 3.2 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 28 | 1.6 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 70 | 2.1 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 70 | 3.1 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 28 | 2.7 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 182 | 3.2 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 56 | 1.8 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 84 | 3.1 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 84 | 15.3 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 56 | 3.2 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 70 | 15.4 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 182 | 13.0 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR | Day 28 | 4.7 geometric mean fold rise |
Secondary
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Omicron BA.1 Variant spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 56 | 14.1 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 182 | 54.1 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 28 | 35.4 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 70 | 47.4 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 84 | 46.8 Percentage of participants |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 56 | 0 Percentage of participants |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 28 | 7.5 Percentage of participants |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 182 | 60.6 Percentage of participants |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 84 | 28.2 Percentage of participants |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 70 | 30.8 Percentage of participants |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 84 | 52.9 Percentage of participants |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 28 | 50.0 Percentage of participants |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 182 | 53.3 Percentage of participants |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 70 | 60.0 Percentage of participants |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 56 | 19.4 Percentage of participants |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 70 | 66.7 Percentage of participants |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 28 | 35.1 Percentage of participants |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 182 | 67.7 Percentage of participants |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 56 | 33.3 Percentage of participants |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 84 | 62.9 Percentage of participants |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 56 | 17.5 Percentage of participants |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 28 | 29.3 Percentage of participants |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 70 | 60.0 Percentage of participants |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 182 | 52.8 Percentage of participants |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 84 | 48.7 Percentage of participants |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 84 | 71.1 Percentage of participants |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 28 | 57.5 Percentage of participants |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 182 | 66.7 Percentage of participants |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 56 | 35.0 Percentage of participants |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 70 | 72.5 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 56 | 2.6 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 182 | 47.8 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 84 | 17.3 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 70 | 24.0 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 28 | 18.2 Percentage of participants |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 84 | 60.5 Percentage of participants |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 70 | 60.5 Percentage of participants |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 182 | 65.5 Percentage of participants |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 28 | 30.8 Percentage of participants |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 56 | 23.1 Percentage of participants |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 84 | 34.2 Percentage of participants |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 28 | 17.9 Percentage of participants |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 56 | 10.5 Percentage of participants |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 70 | 36.8 Percentage of participants |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 182 | 58.1 Percentage of participants |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 28 | 47.4 Percentage of participants |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 84 | 60.6 Percentage of participants |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 182 | 60.0 Percentage of participants |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 70 | 62.9 Percentage of participants |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 56 | 30.6 Percentage of participants |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 56 | 5.3 Percentage of participants |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 182 | 37.9 Percentage of participants |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 28 | 12.8 Percentage of participants |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 84 | 16.2 Percentage of participants |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 70 | 21.6 Percentage of participants |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 70 | 30.0 Percentage of participants |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 84 | 32.5 Percentage of participants |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 56 | 10.0 Percentage of participants |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 28 | 25.0 Percentage of participants |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 182 | 45.2 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 182 | 86.7 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 84 | 92.1 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 56 | 30.8 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 70 | 92.1 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR | Day 28 | 56.4 Percentage of participants |
Secondary
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 (Wuhan) spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.71 ratio |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.45 ratio |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.35 ratio |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.35 ratio |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.67 ratio |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.43 ratio |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.61 ratio |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.41 ratio |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.22 ratio |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.23 ratio |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.34 ratio |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.66 ratio |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.32 ratio |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.47 ratio |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.69 ratio |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.90 ratio |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 1.05 ratio |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.68 ratio |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.58 ratio |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.64 ratio |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.30 ratio |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.57 ratio |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.35 ratio |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.28 ratio |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.51 ratio |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.90 ratio |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.50 ratio |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.46 ratio |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.58 ratio |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.79 ratio |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.18 ratio |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.42 ratio |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.40 ratio |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.17 ratio |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.35 ratio |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.30 ratio |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.48 ratio |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.57 ratio |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.30 ratio |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.55 ratio |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.26 ratio |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.27 ratio |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.53 ratio |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.52 ratio |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.46 ratio |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.39 ratio |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.54 ratio |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.42 ratio |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.72 ratio |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.83 ratio |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.44 ratio |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.39 ratio |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.31 ratio |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.18 ratio |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.17 ratio |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 84 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.26 ratio |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 56 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.67 ratio |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 70 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.24 ratio |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 28 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.56 ratio |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR | Day 182 (Comparison to SARS-CoV-2 Reference [Group P]) | 0.25 ratio |
Secondary
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Wuhan Strain spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 84 | 3.3 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 28 | 2.5 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 56 | 1.9 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 70 | 3.5 geometric mean fold rise |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 182 | 4.5 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 70 | 2.7 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 182 | 6.2 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 28 | 1.6 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 56 | 1.4 geometric mean fold rise |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 84 | 2.5 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 84 | 3.6 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 56 | 2.1 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 182 | 5.0 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 28 | 2.8 geometric mean fold rise |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 70 | 3.9 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 182 | 7.6 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 70 | 7.1 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 56 | 2.8 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 84 | 6.2 geometric mean fold rise |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 28 | 4.0 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 28 | 2.2 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 70 | 3.5 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 182 | 4.0 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 84 | 3.0 geometric mean fold rise |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 56 | 1.7 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 28 | 3.2 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 84 | 4.3 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 182 | 5.0 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 56 | 2.4 geometric mean fold rise |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 70 | 5.9 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 182 | 3.0 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 28 | 1.5 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 56 | 1.2 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 70 | 1.8 geometric mean fold rise |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 84 | 1.6 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 70 | 3.8 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 56 | 1.6 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 182 | 7.2 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 28 | 2.3 geometric mean fold rise |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 84 | 3.6 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 28 | 1.7 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 84 | 2.8 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 56 | 1.7 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 182 | 6.1 geometric mean fold rise |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 70 | 3.0 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 28 | 3.2 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 56 | 2.3 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 70 | 4.8 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 84 | 4.3 geometric mean fold rise |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 182 | 6.5 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 84 | 1.7 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 182 | 3.5 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 28 | 1.7 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 70 | 2.0 geometric mean fold rise |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 56 | 1.2 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 70 | 2.6 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 56 | 1.6 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 28 | 2.1 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 182 | 2.6 geometric mean fold rise |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 84 | 2.7 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 84 | 10.6 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 56 | 3.2 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 28 | 3.8 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 182 | 10.7 geometric mean fold rise |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR | Day 70 | 11.2 geometric mean fold rise |
Secondary
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Wuhan Strain spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 28 to Day 182
Population: Per Protocol Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 56 | 9.0 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 182 | 50.8 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 70 | 44.7 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 84 | 39.0 Percentage of participants |
| Group A and Group C - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 28 | 17.7 Percentage of participants |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 56 | 5.1 Percentage of participants |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 28 | 10.0 Percentage of participants |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 70 | 23.1 Percentage of participants |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 182 | 63.6 Percentage of participants |
| Group B -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 84 | 25.6 Percentage of participants |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 56 | 19.4 Percentage of participants |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 28 | 28.9 Percentage of participants |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 70 | 54.3 Percentage of participants |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 84 | 32.4 Percentage of participants |
| Group D - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 182 | 60.0 Percentage of participants |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 182 | 64.5 Percentage of participants |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 56 | 27.8 Percentage of participants |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 70 | 63.9 Percentage of participants |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 28 | 48.6 Percentage of participants |
| Group E - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 84 | 62.9 Percentage of participants |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 56 | 12.5 Percentage of participants |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 182 | 52.8 Percentage of participants |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 28 | 12.2 Percentage of participants |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 84 | 35.9 Percentage of participants |
| Group F- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 70 | 42.5 Percentage of participants |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 28 | 40.0 Percentage of participants |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 84 | 55.3 Percentage of participants |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 56 | 20.0 Percentage of participants |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 182 | 60.6 Percentage of participants |
| Group G- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 70 | 62.5 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 84 | 6.7 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 70 | 12.0 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 28 | 3.9 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 56 | 0 Percentage of participants |
| Group H and Group N- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 182 | 43.3 Percentage of participants |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 70 | 42.1 Percentage of participants |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 182 | 65.5 Percentage of participants |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 56 | 12.8 Percentage of participants |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 84 | 42.1 Percentage of participants |
| Group I- ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 28 | 30.8 Percentage of participants |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 70 | 31.6 Percentage of participants |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 84 | 21.1 Percentage of participants |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 182 | 64.5 Percentage of participants |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 56 | 10.5 Percentage of participants |
| Group J -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 28 | 10.3 Percentage of participants |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 56 | 22.2 Percentage of participants |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 84 | 54.5 Percentage of participants |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 70 | 57.1 Percentage of participants |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 182 | 66.7 Percentage of participants |
| Group K - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 28 | 34.2 Percentage of participants |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 70 | 10.8 Percentage of participants |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 56 | 2.6 Percentage of participants |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 28 | 5.1 Percentage of participants |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 84 | 8.1 Percentage of participants |
| Group L - ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 182 | 58.6 Percentage of participants |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 182 | 32.3 Percentage of participants |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 70 | 25.0 Percentage of participants |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 56 | 7.5 Percentage of participants |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 84 | 30.0 Percentage of participants |
| Group M -ICC Vaccine Formulation | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 28 | 17.5 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 84 | 78.9 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 56 | 30.8 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 70 | 86.8 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 28 | 35.9 Percentage of participants |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR | Day 182 | 76.7 Percentage of participants |
Secondary
Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU)
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Wuhan Strain spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Time frame: Day 0 to Day 182
Population: Per-Protocol Analysis Set Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A and Group C - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 84 | 18638.7 EU/mL |
| Group A and Group C - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 70 | 20242.6 EU/mL |
| Group A and Group C - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 56 | 11135.2 EU/mL |
| Group A and Group C - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 28 | 13942.2 EU/mL |
| Group A and Group C - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 182 | 24291.7 EU/mL |
| Group A and Group C - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 0 | 5683.8 EU/mL |
| Group B -ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 70 | 10953.8 EU/mL |
| Group B -ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 84 | 9995.0 EU/mL |
| Group B -ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 0 | 4454.2 EU/mL |
| Group B -ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 56 | 5386.6 EU/mL |
| Group B -ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 182 | 30967.6 EU/mL |
| Group B -ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 28 | 7335.6 EU/mL |
| Group D - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 0 | 3856.6 EU/mL |
| Group D - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 70 | 16790.1 EU/mL |
| Group D - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 84 | 14734.9 EU/mL |
| Group D - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 28 | 10956.0 EU/mL |
| Group D - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 56 | 8964.0 EU/mL |
| Group D - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 182 | 23902.3 EU/mL |
| Group E - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 56 | 12767.0 EU/mL |
| Group E - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 0 | 4495.9 EU/mL |
| Group E - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 182 | 33992.1 EU/mL |
| Group E - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 84 | 26887.4 EU/mL |
| Group E - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 28 | 17807.1 EU/mL |
| Group E - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 70 | 31832.6 EU/mL |
| Group F- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 70 | 14239.8 EU/mL |
| Group F- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 28 | 9117.3 EU/mL |
| Group F- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 84 | 13044.7 EU/mL |
| Group F- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 182 | 17658.7 EU/mL |
| Group F- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 0 | 4091.0 EU/mL |
| Group F- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 56 | 6818.0 EU/mL |
| Group G- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 28 | 16742.3 EU/mL |
| Group G- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 0 | 5180.7 EU/mL |
| Group G- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 56 | 12182.9 EU/mL |
| Group G- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 70 | 30516.7 EU/mL |
| Group G- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 84 | 23187.1 EU/mL |
| Group G- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 182 | 26514.4 EU/mL |
| Group H and Group N- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 28 | 8417.5 EU/mL |
| Group H and Group N- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 56 | 6794.8 EU/mL |
| Group H and Group N- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 84 | 9036.4 EU/mL |
| Group H and Group N- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 0 | 5741.8 EU/mL |
| Group H and Group N- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 182 | 18724.8 EU/mL |
| Group H and Group N- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 70 | 10034.7 EU/mL |
| Group I- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 84 | 13272.6 EU/mL |
| Group I- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 70 | 14056.4 EU/mL |
| Group I- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 56 | 6241.6 EU/mL |
| Group I- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 182 | 27578.7 EU/mL |
| Group I- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 0 | 3804.2 EU/mL |
| Group I- ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 28 | 8841.9 EU/mL |
| Group J -ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 84 | 12165.5 EU/mL |
| Group J -ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 0 | 4523.3 EU/mL |
| Group J -ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 56 | 7333.3 EU/mL |
| Group J -ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 70 | 13323.0 EU/mL |
| Group J -ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 182 | 25514.6 EU/mL |
| Group J -ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 28 | 7891.9 EU/mL |
| Group K - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 70 | 20057.8 EU/mL |
| Group K - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 28 | 14050.0 EU/mL |
| Group K - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 56 | 9943.2 EU/mL |
| Group K - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 182 | 26561.5 EU/mL |
| Group K - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 0 | 4544.0 EU/mL |
| Group K - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 84 | 17551.8 EU/mL |
| Group L - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 84 | 8452.8 EU/mL |
| Group L - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 28 | 7458.5 EU/mL |
| Group L - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 182 | 15001.9 EU/mL |
| Group L - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 70 | 9499.5 EU/mL |
| Group L - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 56 | 5372.8 EU/mL |
| Group L - ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 0 | 4391.3 EU/mL |
| Group M -ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 0 | 4626.8 EU/mL |
| Group M -ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 70 | 12008.6 EU/mL |
| Group M -ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 28 | 9746.3 EU/mL |
| Group M -ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 84 | 12333.7 EU/mL |
| Group M -ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 182 | 13145.9 EU/mL |
| Group M -ICC Vaccine Formulation | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 56 | 7345.8 EU/mL |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 70 | 49648.9 EU/mL |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 182 | 50766.4 EU/mL |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 0 | 4429.2 EU/mL |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 84 | 47019.7 EU/mL |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 28 | 16916.6 EU/mL |
| Group O - qNIV With Matrix-M1 Adjuvant | Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU) | Day 56 | 14045.3 EU/mL |