Influenza, Human
Conditions
Brief summary
A Phase 2 trial to confirm the dose and formulation, demonstrate adjuvant effect, and evaluate the safety and tolerability of a single intramuscular injection of Quad-NIV with or without Matrix-M1 adjuvant in healthy adults ≥ 65 years of age. A total of approximately 1375 subjects were to be randomized to seven treatment groups to receive Quad-NIV or an active comparator.
Detailed description
This randomized, observer-blind, active-controlled, Phase 2 trial was conducted at multiple sites. The composition of the Quad-NIV Influenza Vaccines used in this trial included recombinant H1, H3, and two B hemagglutinin proteins for the 2018-2019 Northern Hemisphere influenza virus strains. Approximately 1375 healthy male and female subjects ≥ 65 years were randomized into 7 treatment groups (group A to group G), receiving various formulations of Quad-NIV, with or without Matrix-M1 adjuvant or one of two active comparator influenza vaccines. Within each site, randomization was stratified by history of receipt of 2017-2018 influenza vaccine. Subjects received two injections 28 days apart. On Day 0, subjects received one of the five Quad-NIV formulations or one of the two comparator influenza vaccines. On Day 28, subjects received either placebo or a licensed influenza vaccine rescue dose, depending on his or her initial randomization. Subjects were followed for safety for approximately 6 months, with primary immunogenicity results at Day 28.
Interventions
BIOLOGICALNanoFlu (Quad-NIV)
2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
OTHERMatrix-M Adjuvant
Adjuvant
OTHERPlacebo
Placebo
BIOLOGICALFluzone HD
2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
BIOLOGICALFlublok Quadrivalent
2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
BIOLOGICALInfluenza Vaccine
2018-19 Licensed Seasonal Influenza Vaccine
Sponsors
Novavax
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Clinically-stable adult male or female, ≥ 65 years of age. Subjects may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by: * Absence of changes in medical therapy within 1 month due to treatment failure or toxicity, * Absence of medical events qualifying as serious adverse events within 2 months; and * Absence of known, current, and life-limiting diagnoses which render survival to completion of the protocol unlikely in the opinion of the investigator. 2. Willing and able to give informed consent prior to trial enrollment, and 3. Living in the community and able to attend trial visits, comply with trial requirements, and provide timely, reliable, and complete reports of adverse events.
Exclusion criteria
1. Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first injection. 2. Participation in any previous Novavax's influenza vaccine clinical trial(s). 3. History of a serious reaction to prior influenza vaccination, known allergy to constituents of licensed comparator vaccines or polysorbate 80. 4. History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine. 5. Received any vaccine in the 4 weeks preceding the trial vaccination and any influenza vaccine within 6 months preceding the trial vaccination. 6. Any known or suspected immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination. 7. 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 trial vaccine. 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. 8. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the trial vaccine or during the trial. 9. 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). 10. Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of trial results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). 11. Known disturbance of coagulation. 12. Suspicion or recent history (within 1 year of planned vaccination) of alcohol or other substance abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Adverse Events (AEs) | Day 0 - Day 182 | Adverse Events over the 7 days post-injection; all adverse events (including adverse changes in clinical laboratory parameters) through 21 days post-injection; and Medically Attended Adverse Events (MAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs) through 6 months post-injection. |
| Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 - Day 28 | HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B strain(s) at Days 0 and Day 28 post-vaccination expressed as geometric man titer (GMT). |
| HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 - Day 28 | HAI antibody titers specific for at least 2 antigenically-drifted influenza strains, at Days 0 and 28 post-vaccination expressed as geometric man titer (GMT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 - Day 182 | HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as SPR on Day 28,56 and 182. |
| HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 - Day 182 | HAI antibody titers specific for antigenically-drifted influenza strains, at Days 0,28, 56 and 182 expressed as geometric man titer (GMT). |
| HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 - Day 182 | HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as GMT on Day 0,28,56 and 182. |
| Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 28 - Day 182 | HAI antibody titers specific for antigenically-drifted influenza strains, at Days 28, 56 and 182 expressed as SCR. |
| Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 28 - Day 182 | HAI antibody titers specific for antigenically-drifted influenza strains, at Days 28, 56 and 182 expressed as SPR. |
| HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 28 - Day 182 | HAI antibody titer responses specific for antigenically-drifted influenza strains, at Days 28, 56, and 182 expressed as Geometric Fold Ratio. |
| HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 - Day 182 | HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as GMFR on Day 28,56 and 182. |
| Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 - Day 182 | HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as SCR on Day 28,56 and 182. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A Alternating deltoid injections of 2018-2019 Quad-NIV-1 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo | 157 |
| Quad-NIV Preformulated With Adjuvant Dose A Alternating deltoid injections of 2018-2019 Quad-NIV-2 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo | 305 |
| Quad-NIV Preformulated With Adjuvant Dose B Alternating deltoid injections of 2018-2019 Quad-NIV-3 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo | 156 |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A Alternating deltoid injections of 2018-2019 Quad-NIV-4 (Day 0) and Placebo (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Matrix-M Adjuvant: Adjuvant
Placebo: Placebo | 132 |
| Quad-NIV Without Adjuvant Alternating deltoid injections of 2018-2019 Quad-NIV-5 (Day 0) and Licensed 2018-2019 Influenza vaccine (Day 28)
NanoFlu (Quad-NIV): 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine | 311 |
| Licensed High-Dose Trivalent Influenza Vaccine Alternating deltoid injections of 2018-2019 High-Dose Trivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Fluzone HD: 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine | 153 |
| Licensed Quadrivalent Influenza Vaccine Alternating deltoid injections of 2018-2019 Quadrivalent Vaccine (Day 0) and Placebo (Day 28)
Placebo: Placebo
Flublok Quadrivalent: 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine | 151 |
| Total | 1,365 |
Baseline characteristics
| Characteristic | Total | Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Quad-NIV Preformulated With Adjuvant Dose A | Quad-NIV Preformulated With Adjuvant Dose B | Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Quad-NIV Without Adjuvant | Licensed High-Dose Trivalent Influenza Vaccine | Licensed Quadrivalent Influenza Vaccine |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 72.7 years STANDARD_DEVIATION 6.3 | 72.7 years STANDARD_DEVIATION 5.5 | 72.0 years STANDARD_DEVIATION 5.5 | 71.8 years STANDARD_DEVIATION 5.6 | 72.6 years STANDARD_DEVIATION 6.1 | 72.6 years STANDARD_DEVIATION 6.3 | 72.5 years STANDARD_DEVIATION 5.5 | 72.9 years STANDARD_DEVIATION 5.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 40 Participants | 6 Participants | 6 Participants | 7 Participants | 4 Participants | 7 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1325 Participants | 151 Participants | 299 Participants | 149 Participants | 128 Participants | 304 Participants | 147 Participants | 147 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 141 Participants | 13 Participants | 41 Participants | 15 Participants | 12 Participants | 29 Participants | 17 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1204 Participants | 138 Participants | 261 Participants | 140 Participants | 120 Participants | 277 Participants | 133 Participants | 135 Participants |
| Sex: Female, Male Female | 798 Participants | 90 Participants | 179 Participants | 77 Participants | 81 Participants | 185 Participants | 99 Participants | 87 Participants |
| Sex: Female, Male Male | 567 Participants | 67 Participants | 126 Participants | 79 Participants | 51 Participants | 126 Participants | 54 Participants | 64 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 |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 157 | 3 / 305 | 0 / 156 | 2 / 132 | 0 / 311 | 0 / 153 | 1 / 151 |
| other Total, other adverse events | 4 / 157 | 14 / 305 | 7 / 156 | 2 / 132 | 16 / 311 | 10 / 153 | 2 / 151 |
| serious Total, serious adverse events | 12 / 157 | 21 / 305 | 16 / 156 | 22 / 132 | 7 / 311 | 8 / 153 | 6 / 151 |
Outcome results
Primary
HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT
HAI antibody titers specific for at least 2 antigenically-drifted influenza strains, at Days 0 and 28 post-vaccination expressed as geometric man titer (GMT).
Time frame: Day 0 - Day 28
Population: Per-Protocol Population for immunogenicity was used for the primary outcome measure and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 146.8 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 61.1 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Switzerland/9715293/2013 (H3N2))) | 54.6 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Wisconsin/19/2017 (H3N2)) | 21.7 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Switzerland/9715293/2013 (H3N2))) | 60.0 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 160.4 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Wisconsin/19/2017 (H3N2)) | 23.1 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 63.2 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Wisconsin/19/2017 (H3N2)) | 24.0 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 63.0 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 154.8 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Switzerland/9715293/2013 (H3N2))) | 60.9 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 58.2 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Wisconsin/19/2017 (H3N2)) | 23.9 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Switzerland/9715293/2013 (H3N2))) | 60.6 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 137.9 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Wisconsin/19/2017 (H3N2)) | 22.1 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 50.1 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 122.4 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Switzerland/9715293/2013 (H3N2))) | 58.6 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Wisconsin/19/2017 (H3N2)) | 24.5 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 46.1 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 133.4 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Switzerland/9715293/2013 (H3N2))) | 62.3 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Wisconsin/19/2017 (H3N2)) | 20.7 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Switzerland/9715293/2013 (H3N2))) | 54.8 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 64.3 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 158.8 titers |
Primary
Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT)
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B strain(s) at Days 0 and Day 28 post-vaccination expressed as geometric man titer (GMT).
Time frame: Day 0 - Day 28
Population: Per-Protocol Population for immunogenicity was used for the primary outcome measure and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (B/Colorado/06/2017 (Victoria Lineage)) | 47.6 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (A/Michigan/45/2015 (H1N1)) | 50.1 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (A/Michigan/45/2015 (H1N1)) | 98.9 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 86.8 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (B/Phuket/3073/2013 (Yamagata Lineage)) | 50.4 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 108.5 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 21.4 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 65.8 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (B/Colorado/06/2017 (Victoria Lineage)) | 46.4 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 65.4 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 101.7 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (A/Michigan/45/2015 (H1N1)) | 47.9 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (B/Phuket/3073/2013 (Yamagata Lineage)) | 47.7 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 22.0 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 83.2 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (A/Michigan/45/2015 (H1N1)) | 91.3 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 89.6 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (A/Michigan/45/2015 (H1N1)) | 99.1 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 22.8 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (B/Phuket/3073/2013 (Yamagata Lineage)) | 47.6 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (B/Colorado/06/2017 (Victoria Lineage)) | 48.5 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 104.9 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 64.2 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (A/Michigan/45/2015 (H1N1)) | 55.3 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (B/Phuket/3073/2013 (Yamagata Lineage)) | 53.6 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 113.8 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (A/Michigan/45/2015 (H1N1)) | 48.7 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (B/Colorado/06/2017 (Victoria Lineage)) | 52.7 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (A/Michigan/45/2015 (H1N1)) | 79.5 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 23.4 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 95.5 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 59.4 titers |
| Quad-NIV Without Adjuvant | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (B/Phuket/3073/2013 (Yamagata Lineage)) | 48.8 titers |
| Quad-NIV Without Adjuvant | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (A/Michigan/45/2015 (H1N1)) | 90.3 titers |
| Quad-NIV Without Adjuvant | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (B/Colorado/06/2017 (Victoria Lineage)) | 47.5 titers |
| Quad-NIV Without Adjuvant | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 73.2 titers |
| Quad-NIV Without Adjuvant | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 50.8 titers |
| Quad-NIV Without Adjuvant | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 87.5 titers |
| Quad-NIV Without Adjuvant | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 21.3 titers |
| Quad-NIV Without Adjuvant | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (A/Michigan/45/2015 (H1N1)) | 48.7 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 93.2 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 46.5 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (A/Michigan/45/2015 (H1N1)) | 96.9 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (B/Colorado/06/2017 (Victoria Lineage)) | 52.0 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (A/Michigan/45/2015 (H1N1)) | 50.5 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 23.2 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (B/Phuket/3073/2013 (Yamagata Lineage)) | 52.9 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 64.5 titers |
| Licensed Quadrivalent Influenza Vaccine | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (A/Michigan/45/2015 (H1N1)) | 82.1 titers |
| Licensed Quadrivalent Influenza Vaccine | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 102.0 titers |
| Licensed Quadrivalent Influenza Vaccine | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 83.3 titers |
| Licensed Quadrivalent Influenza Vaccine | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (B/Colorado/06/2017 (Victoria Lineage)) | 42.9 titers |
| Licensed Quadrivalent Influenza Vaccine | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 19.5 titers |
| Licensed Quadrivalent Influenza Vaccine | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (A/Michigan/45/2015 (H1N1)) | 44.0 titers |
| Licensed Quadrivalent Influenza Vaccine | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 66.6 titers |
| Licensed Quadrivalent Influenza Vaccine | Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT) | Day 0 (B/Phuket/3073/2013 (Yamagata Lineage)) | 46.9 titers |
Primary
Number of Subjects With Adverse Events (AEs)
Adverse Events over the 7 days post-injection; all adverse events (including adverse changes in clinical laboratory parameters) through 21 days post-injection; and Medically Attended Adverse Events (MAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs) through 6 months post-injection.
Time frame: Day 0 - Day 182
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Subjects With Adverse Events (AEs) | All AE's | 100 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Subjects With Adverse Events (AEs) | SNMC's | 5 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Subjects With Adverse Events (AEs) | MAE's | 51 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Subjects With Adverse Events (AEs) | SAE's | 8 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Subjects With Adverse Events (AEs) | SNMC's | 18 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Subjects With Adverse Events (AEs) | MAE's | 87 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Subjects With Adverse Events (AEs) | All AE's | 189 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Subjects With Adverse Events (AEs) | SAE's | 16 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Subjects With Adverse Events (AEs) | All AE's | 92 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Subjects With Adverse Events (AEs) | MAE's | 29 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Subjects With Adverse Events (AEs) | SAE's | 8 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Subjects With Adverse Events (AEs) | SNMC's | 10 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Subjects With Adverse Events (AEs) | SNMC's | 10 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Subjects With Adverse Events (AEs) | All AE's | 71 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Subjects With Adverse Events (AEs) | SAE's | 12 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Subjects With Adverse Events (AEs) | MAE's | 38 participants |
| Quad-NIV Without Adjuvant | Number of Subjects With Adverse Events (AEs) | MAE's | 74 participants |
| Quad-NIV Without Adjuvant | Number of Subjects With Adverse Events (AEs) | All AE's | 165 participants |
| Quad-NIV Without Adjuvant | Number of Subjects With Adverse Events (AEs) | SNMC's | 15 participants |
| Quad-NIV Without Adjuvant | Number of Subjects With Adverse Events (AEs) | SAE's | 6 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Subjects With Adverse Events (AEs) | SAE's | 6 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Subjects With Adverse Events (AEs) | MAE's | 34 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Subjects With Adverse Events (AEs) | All AE's | 93 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Subjects With Adverse Events (AEs) | SNMC's | 6 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Subjects With Adverse Events (AEs) | SNMC's | 9 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Subjects With Adverse Events (AEs) | All AE's | 87 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Subjects With Adverse Events (AEs) | MAE's | 40 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Subjects With Adverse Events (AEs) | SAE's | 3 participants |
Secondary
HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR
HAI antibody titer responses specific for antigenically-drifted influenza strains, at Days 28, 56, and 182 expressed as Geometric Fold Ratio.
Time frame: Day 28 - Day 182
Population: Per-Protocol Population for immunogenicity was used for this display of secondary outcome measures and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 1.4 Fold Ratio |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 1.8 Fold Ratio |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 1.4 Fold Ratio |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 2.4 Fold Ratio |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 2.0 Fold Ratio |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 2.3 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 2.5 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 1.9 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 1.7 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 2.3 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 1.3 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 1.3 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 2.3 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 2.1 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 1.4 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 1.3 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 1.6 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 1.9 Fold Ratio |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 1.6 Fold Ratio |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 2.1 Fold Ratio |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 1.3 Fold Ratio |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 2.1 Fold Ratio |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 1.3 Fold Ratio |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 1.7 Fold Ratio |
| Quad-NIV Without Adjuvant | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 1.9 Fold Ratio |
| Quad-NIV Without Adjuvant | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 1.9 Fold Ratio |
| Quad-NIV Without Adjuvant | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 1.7 Fold Ratio |
| Quad-NIV Without Adjuvant | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 1.4 Fold Ratio |
| Quad-NIV Without Adjuvant | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 1.5 Fold Ratio |
| Quad-NIV Without Adjuvant | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 2.4 Fold Ratio |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 1.8 Fold Ratio |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 1.3 Fold Ratio |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 1.1 Fold Ratio |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 1.7 Fold Ratio |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 1.3 Fold Ratio |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 2.4 Fold Ratio |
| Licensed Quadrivalent Influenza Vaccine | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 2.7 Fold Ratio |
| Licensed Quadrivalent Influenza Vaccine | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 1.4 Fold Ratio |
| Licensed Quadrivalent Influenza Vaccine | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 1.3 Fold Ratio |
| Licensed Quadrivalent Influenza Vaccine | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 1.9 Fold Ratio |
| Licensed Quadrivalent Influenza Vaccine | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 1.8 Fold Ratio |
| Licensed Quadrivalent Influenza Vaccine | HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 2.5 Fold Ratio |
Secondary
HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT
HAI antibody titers specific for antigenically-drifted influenza strains, at Days 0,28, 56 and 182 expressed as geometric man titer (GMT).
Time frame: Day 0 - Day 182
Population: Per-Protocol Population for immunogenicity was used for this display of secondary outcome measures and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Switzerland/9715293/2013 (H3N2)) | 51.7 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 93.9 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 118.5 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 73.4 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 124.7 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 72.4 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Switzerland/9715293/2013 (H3N2)) | 53.8 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 91.4 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 92.2 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Switzerland/9715293/2013 (H3N2)) | 57.1 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 73.4 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 120.0 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 72.0 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 115.1 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Switzerland/9715293/2013 (H3N2)) | 55.3 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 88.3 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Switzerland/9715293/2013 (H3N2)) | 55.7 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 77.2 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 97.3 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 105.4 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 102.7 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Switzerland/9715293/2013 (H3N2)) | 60.5 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 77.2 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 66.1 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 0 (A/Switzerland/9715293/2013 (H3N2)) | 54.3 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 138.2 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 77.2 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 96.3 titers |
Secondary
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR)
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as GMFR on Day 28,56 and 182.
Time frame: Day 28 - Day 182
Population: Per-Protocol Population for immunogenicity was used for this display of secondary outcome measures and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 1.2 Fold Ratio |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 1.2 Fold Ratio |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 1.9 Fold Ratio |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 1.9 Fold Ratio |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (A/Michigan/45/2015 (H1N1)) | 1.6 Fold Ratio |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (A/Michigan/45/2015 (H1N1)) | 1.9 Fold Ratio |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (A/Michigan/45/2015 (H1N1)) | 1.3 Fold Ratio |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 1.9 Fold Ratio |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 1.6 Fold Ratio |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 2.0 Fold Ratio |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 1.3 Fold Ratio |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 1.3 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (A/Michigan/45/2015 (H1N1)) | 1.7 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 1.2 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (A/Michigan/45/2015 (H1N1)) | 1.2 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 2.0 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 1.2 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 2.0 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 1.3 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 2.0 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (A/Michigan/45/2015 (H1N1)) | 1.4 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 1.6 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 1.7 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 1.4 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 1.3 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 1.4 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (A/Michigan/45/2015 (H1N1)) | 1.3 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 1.8 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 1.6 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 1.8 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 1.3 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 2.1 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 1.4 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 2.2 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (A/Michigan/45/2015 (H1N1)) | 1.4 Fold Ratio |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (A/Michigan/45/2015 (H1N1)) | 1.7 Fold Ratio |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 1.6 Fold Ratio |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (A/Michigan/45/2015 (H1N1)) | 1.5 Fold Ratio |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (A/Michigan/45/2015 (H1N1)) | 1.2 Fold Ratio |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (A/Michigan/45/2015 (H1N1)) | 1.1 Fold Ratio |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 1.6 Fold Ratio |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 1.4 Fold Ratio |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 1.2 Fold Ratio |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 2.0 Fold Ratio |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 1.9 Fold Ratio |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 1.4 Fold Ratio |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 1.8 Fold Ratio |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 1.1 Fold Ratio |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 1.3 Fold Ratio |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (A/Michigan/45/2015 (H1N1)) | 1.7 Fold Ratio |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (A/Michigan/45/2015 (H1N1)) | 1.4 Fold Ratio |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 1.4 Fold Ratio |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 1.7 Fold Ratio |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 2.0 Fold Ratio |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 1.8 Fold Ratio |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 2.1 Fold Ratio |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 1.6 Fold Ratio |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (A/Michigan/45/2015 (H1N1)) | 1.8 Fold Ratio |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 1.4 Fold Ratio |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 1.4 Fold Ratio |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 1.4 Fold Ratio |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 1.6 Fold Ratio |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 1.4 Fold Ratio |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 1.9 Fold Ratio |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 1.1 Fold Ratio |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (A/Michigan/45/2015 (H1N1)) | 1.4 Fold Ratio |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 1.2 Fold Ratio |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 1.9 Fold Ratio |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (A/Michigan/45/2015 (H1N1)) | 1.5 Fold Ratio |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 1.7 Fold Ratio |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (A/Michigan/45/2015 (H1N1)) | 1.9 Fold Ratio |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 1.4 Fold Ratio |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 2.0 Fold Ratio |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 1.6 Fold Ratio |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 2.0 Fold Ratio |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 1.2 Fold Ratio |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 1.7 Fold Ratio |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (A/Michigan/45/2015 (H1N1)) | 1.8 Fold Ratio |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 1.3 Fold Ratio |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (A/Michigan/45/2015 (H1N1)) | 1.3 Fold Ratio |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 1.2 Fold Ratio |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 2.1 Fold Ratio |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 1.4 Fold Ratio |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR) | Day 56 (A/Michigan/45/2015 (H1N1)) | 1.4 Fold Ratio |
Secondary
HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as GMT on Day 0,28,56 and 182.
Time frame: Day 0 - Day 182
Population: Per-Protocol Population for immunogenicity was used for this display of secondary outcome measures and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 140.1 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (B/Colorado/06/2017 (Victoria Lineage)) | 99.8 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 132.2 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (A/Michigan/45/2015 (H1N1)) | 71.0 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 159.3 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 202.4 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 128 (B/Colorado/06/2017 (Victoria Lineage)) | 119.6 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (A/Michigan/45/2015 (H1N1)) | 45.7 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 87.1 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 132.0 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (A/Michigan/45/2015 (H1N1)) | 62.0 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (A/Michigan/45/2015 (H1N1)) | 86.4 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 132.6 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 192.7 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 69.9 titers |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (B/Phuket/3073/2013 (Yamagata Lineage)) | 104.0 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (A/Michigan/45/2015 (H1N1)) | 45.6 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (B/Phuket/3073/2013 (Yamagata Lineage)) | 97.1 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (B/Colorado/06/2017 (Victoria Lineage)) | 90.4 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 142.1 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 190.5 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (A/Michigan/45/2015 (H1N1)) | 78.9 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 195.6 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 126.8 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 128 (B/Colorado/06/2017 (Victoria Lineage)) | 107.2 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (A/Michigan/45/2015 (H1N1)) | 62.8 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 90.2 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 132.2 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (A/Michigan/45/2015 (H1N1)) | 55.5 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 122.5 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 147.9 titers |
| Quad-NIV Preformulated With Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 75.8 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 91.4 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 205.9 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 199.2 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (A/Michigan/45/2015 (H1N1)) | 84.5 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 126.4 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (A/Michigan/45/2015 (H1N1)) | 68.2 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (A/Michigan/45/2015 (H1N1)) | 63.1 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 128.8 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (B/Colorado/06/2017 (Victoria Lineage)) | 95.0 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (A/Michigan/45/2015 (H1N1)) | 48.3 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 154.8 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 70.3 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 134.0 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 128 (B/Colorado/06/2017 (Victoria Lineage)) | 122.1 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 127.2 titers |
| Quad-NIV Preformulated With Adjuvant Dose B | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (B/Phuket/3073/2013 (Yamagata Lineage)) | 94.1 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 147.3 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (A/Michigan/45/2015 (H1N1)) | 43.1 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 140.7 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (A/Michigan/45/2015 (H1N1)) | 50.4 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (A/Michigan/45/2015 (H1N1)) | 52.7 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 120.5 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 211.2 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 128 (B/Colorado/06/2017 (Victoria Lineage)) | 131.8 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 85.1 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 143.4 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 77.7 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (B/Phuket/3073/2013 (Yamagata Lineage)) | 105.0 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 173.9 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (A/Michigan/45/2015 (H1N1)) | 66.2 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (B/Colorado/06/2017 (Victoria Lineage)) | 108.1 titers |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 200.9 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 122.1 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 97.8 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (A/Michigan/45/2015 (H1N1)) | 46.3 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (A/Michigan/45/2015 (H1N1)) | 80.3 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (A/Michigan/45/2015 (H1N1)) | 81.4 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (A/Michigan/45/2015 (H1N1)) | 66.8 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (B/Colorado/06/2017 (Victoria Lineage)) | 100.2 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 156.0 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 128 (B/Colorado/06/2017 (Victoria Lineage)) | 141.4 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (B/Phuket/3073/2013 (Yamagata Lineage)) | 99.7 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 179.5 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 199.3 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 131.4 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 71.8 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 135.8 titers |
| Quad-NIV Without Adjuvant | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 150.4 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (A/Michigan/45/2015 (H1N1)) | 67.0 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 86.1 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 141.7 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 156.4 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (A/Michigan/45/2015 (H1N1)) | 48.3 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (A/Michigan/45/2015 (H1N1)) | 72.4 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 111.2 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (A/Michigan/45/2015 (H1N1)) | 92.7 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 184.1 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 125.4 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 73.0 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (B/Phuket/3073/2013 (Yamagata Lineage)) | 100.0 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 137.0 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (B/Colorado/06/2017 (Victoria Lineage)) | 99.5 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 137.1 titers |
| Licensed High-Dose Trivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 128 (B/Colorado/06/2017 (Victoria Lineage)) | 141.9 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 168.9 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 128 (B/Colorado/06/2017 (Victoria Lineage)) | 108.5 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 125.3 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 113.4 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 141.9 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (B/Colorado/06/2017 (Victoria Lineage)) | 88.7 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 71.3 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (A/Michigan/45/2015 (H1N1)) | 50.6 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 149.2 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (A/Michigan/45/2015 (H1N1)) | 57.1 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (A/Michigan/45/2015 (H1N1)) | 74.2 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 84.0 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 119.3 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 174.9 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (A/Michigan/45/2015 (H1N1)) | 40.8 titers |
| Licensed Quadrivalent Influenza Vaccine | HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT | Day 0 (B/Phuket/3073/2013 (Yamagata Lineage)) | 85.4 titers |
Secondary
Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains
HAI antibody titers specific for antigenically-drifted influenza strains, at Days 28, 56 and 182 expressed as SPR.
Time frame: Day 28 - Day 182
Population: Per-Protocol Population for immunogenicity was used for this display of secondary outcome measures and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 104 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 107 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 130 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 139 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 113 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 110 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 288 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 276 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 215 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 215 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 233 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 234 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 111 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 112 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 103 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 134 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 138 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 108 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 87 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 112 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 85 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 90 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 108 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 91 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 246 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 212 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 245 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 213 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 224 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 276 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 101 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 129 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 87 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 109 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 129 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 105 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 112 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 101 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 105 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 130 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 103 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 135 participants |
Secondary
Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as SPR on Day 28,56 and 182.
Time frame: Day 28 - Day 182
Population: Per-Protocol Population for immunogenicity was used for this display of secondary outcome measures and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 141 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 109 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 146 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 149 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Michigan/45/2015 (H1N1)) | 94 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Michigan/45/2015 (H1N1)) | 133 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Michigan/45/2015 (H1N1)) | 106 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 130 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 149 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 147 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 141 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 137 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Michigan/45/2015 (H1N1)) | 260 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 233 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Michigan/45/2015 (H1N1)) | 188 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 293 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 277 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 295 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 279 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 292 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Michigan/45/2015 (H1N1)) | 174 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 295 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 272 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 282 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 108 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 139 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Michigan/45/2015 (H1N1)) | 99 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 145 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 147 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 126 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 136 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 141 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 133 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 147 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Michigan/45/2015 (H1N1)) | 92 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Michigan/45/2015 (H1N1)) | 131 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 105 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Michigan/45/2015 (H1N1)) | 105 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Michigan/45/2015 (H1N1)) | 58 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Michigan/45/2015 (H1N1)) | 73 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 120 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 114 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 115 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 120 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 118 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 114 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 120 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 88 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 274 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Michigan/45/2015 (H1N1)) | 257 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Michigan/45/2015 (H1N1)) | 212 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 290 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 285 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 286 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 290 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 265 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 282 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Michigan/45/2015 (H1N1)) | 203 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 280 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 224 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 143 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 134 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 137 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 142 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 134 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Michigan/45/2015 (H1N1)) | 110 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 113 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 142 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Michigan/45/2015 (H1N1)) | 95 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 124 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Michigan/45/2015 (H1N1)) | 133 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 140 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 143 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 144 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 135 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 104 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 120 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Michigan/45/2015 (H1N1)) | 126 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 129 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Michigan/45/2015 (H1N1)) | 88 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 134 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 143 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 130 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Michigan/45/2015 (H1N1)) | 76 participants |
Secondary
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains
HAI antibody titers specific for antigenically-drifted influenza strains, at Days 28, 56 and 182 expressed as SCR.
Time frame: Day 28 - Day 182
Population: Per-Protocol Population for immunogenicity was used for this display of secondary outcome measures and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 45 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 28 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 15 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 15 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 8 participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 50 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 94 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 22 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 17 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 49 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 27 participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 89 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 8 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 38 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 9 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 6 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 41 participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 23 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 28 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 30 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 8 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 16 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 9 participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 8 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 21 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 21 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 26 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 69 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 63 participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 63 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 20 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 44 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 5 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 18 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 4 participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 6 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 28 (A/Wisconsin/19/2017 (H3N2)) | 50 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 182 (A/Wisconsin/19/2017 (H3N2)) | 8 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 28 (A/Switzerland/9715293/2013 (H3N2)) | 47 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 182 (A/Switzerland/9715293/2013 (H3N2)) | 14 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 56 (A/Switzerland/9715293/2013 (H3N2)) | 18 participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains | Day 56 (A/Wisconsin/19/2017 (H3N2)) | 26 participants |
Secondary
Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains
HAI antibody titers specific for the HA receptor binding domains of vaccine-homologous A and B strain(s) expressed as SCR on Day 28,56 and 182.
Time frame: Day 28 - Day 182
Population: Per-Protocol Population for immunogenicity was used for this display of secondary outcome measures and included all randomized subjects that received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 25 Participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 7 Participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 6 Participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 16 Participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 29 Participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Michigan/45/2015 (H1N1)) | 15 Participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Michigan/45/2015 (H1N1)) | 31 Participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 40 Participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 6 Participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Michigan/45/2015 (H1N1)) | 8 Participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 24 Participants |
| Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 32 Participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Michigan/45/2015 (H1N1)) | 14 Participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 32 Participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 41 Participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Michigan/45/2015 (H1N1)) | 41 Participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 11 Participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 21 Participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 10 Participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 11 Participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 46 Participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 68 Participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 70 Participants |
| Quad-NIV Preformulated With Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Michigan/45/2015 (H1N1)) | 23 Participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 7 Participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 33 Participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Michigan/45/2015 (H1N1)) | 22 Participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Michigan/45/2015 (H1N1)) | 10 Participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Michigan/45/2015 (H1N1)) | 7 Participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 20 Participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 7 Participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 43 Participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 7 Participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 29 Participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 16 Participants |
| Quad-NIV Preformulated With Adjuvant Dose B | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 10 Participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 10 Participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 20 Participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Michigan/45/2015 (H1N1)) | 4 Participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 23 Participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 8 Participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 35 Participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Michigan/45/2015 (H1N1)) | 13 Participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Michigan/45/2015 (H1N1)) | 5 Participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 27 Participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 7 Participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 11 Participants |
| Quad-NIV Preformulated With Increased B HA Adjuvant Dose A | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 5 Participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 57 Participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 10 Participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 52 Participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 54 Participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Michigan/45/2015 (H1N1)) | 52 Participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 12 Participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 17 Participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 52 Participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 21 Participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Michigan/45/2015 (H1N1)) | 23 Participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 23 Participants |
| Quad-NIV Without Adjuvant | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Michigan/45/2015 (H1N1)) | 39 Participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 12 Participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 9 Participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Michigan/45/2015 (H1N1)) | 8 Participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 10 Participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 7 Participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Michigan/45/2015 (H1N1)) | 10 Participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 0 Participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 31 Participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Michigan/45/2015 (H1N1)) | 32 Participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 6 Participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 21 Participants |
| Licensed High-Dose Trivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 32 Participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Colorado/06/2017 (Victoria Lineage)) | 6 Participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Phuket/3073/2013 (Yamagata Lineage)) | 34 Participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Michigan/45/2015 (H1N1)) | 13 Participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Michigan/45/2015 (H1N1)) | 6 Participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 20 Participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Phuket/3073/2013 (Yamagata Lineage)) | 37 Participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (B/Colorado/06/2017 (Victoria Lineage)) | 18 Participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Michigan/45/2015 (H1N1)) | 26 Participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (B/Phuket/3073/2013 (Yamagata Lineage)) | 5 Participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 56 (B/Colorado/06/2017 (Victoria Lineage)) | 8 Participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 28 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 37 Participants |
| Licensed Quadrivalent Influenza Vaccine | Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains | Day 182 (A/Singapore/INFIMH-16-0019/2016 (H3N2)) | 15 Participants |