Influenza
Conditions
Keywords
Influenza
Brief summary
This phase I/II, randomized, modified double-blind, multi-center study assessed the safety and immunogenicity of a high-dose Quadrivalent influenza vaccine (QIV-HD) in older adults (greater than or equal to \[\>=\] 65 years).
Detailed description
This phase I/II, randomized, modified double-blind, multi-center study was conducted in 175 healthy Japanese adults aged 65 years and older to describe the safety profile and immune responses (geometric mean titers and seroconversion for the 4 common strains at 28 days post-vaccination) of the QIV-HD administered by intramuscular (IM) and subcutaneous (SC) methods. A local standard-dose Quadrivalent Influenza Vaccine (QIV-SD) administered by SC method served as a control arm.
Interventions
BIOLOGICALQIV-HD by IM
IM, injected into the upper arm (deltoid area)
BIOLOGICALQIV-SD by SC
SC, injected into the upper arm (posterior region)
BIOLOGICALQIV-HD by SC
SC, injection into the upper arm (posterior region)
Sponsors
Sanofi
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
QHD00008 was a modified double-blind study in which only the designated administrator at each study site knew which vaccine was administered to the participants. The participants and the Investigator/Sub-investigator in charge of the safety assessment were blinded in order to decrease the potential bias in safety assessment.
Intervention model description
Safety and tolerability was initially assessed in the first 10 participants in a smaller cohort (Cohort 1). Participants were randomized 1:1 into 2 groups in Cohort 1: QIV-HD by IM route (n=5) and QIV-HD by SC route (n=5). After review of the local and systemic adverse events, the remaining 165 participants were enrolled (Cohort 2). Participants were randomized 1:1:1 into 3 groups in Cohort 2: QIV-HD by IM route (n=55), QIV-HD by SC route (n=55), and QIV-SD by SC route (n=55).
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged \>= 65 years on the day of inclusion. * Informed consent form has been signed and dated. * Able to attend all scheduled visits and to comply with all study procedures.
Exclusion criteria
* Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccination with live vaccines within the past 27 days preceding the study vaccination or any vaccination with inactivated vaccines within the past 6 days preceding the study vaccination, or planned receipt of any vaccine prior to Visit 3. * Previous vaccination against influenza (in the preceding 6 months) with either the study vaccine or another vaccine. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances. * Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on Investigator's judgment. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Alcohol or substance abuse that, in the opinion of the Investigator might interfere with the study conduct or completion. * Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with study conduct or completion. * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. * Personal or family history of Guillain-Barré syndrome. * Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that was stable at the time of vaccination in the absence of therapy and participants who had a history of neoplastic disease and have been disease free for \>=5 years). * Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature \>=37.5°Celsius). A prospective participant were not be included in the study until the condition had resolved or the febrile event had subsided. * History of convulsions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participant With Serious Adverse Events (SAEs) After Vaccination | Up to 6 months after vaccination | An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. |
| Number of Participants With Immediate Unsolicited Adverse Events (AE) After Vaccination | Within 30 minutes after vaccination | An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB. |
| Number of Participants With Solicited Injection Site and Systemic Reactions | Within 7 days after vaccination | A solicited reaction was an adverse reaction observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions: pain, erythema, swelling, induration, and bruising. Solicited systemic reactions: fever, headache, malaise, myalgia, and shivering. |
| Number of Participants With Unsolicited Adverse Events After Vaccination | Within 28 days after vaccination | An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | Day 0 (pre-vaccination) and Day 28 (post-vaccination) | GMT of anti-influenza antibodies strains (A1, A1-like, A2, A2-like, B1, B2, B2-like) were measured using a hemagglutination inhibition (HAI) assay. |
| Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | Day 0 (pre-vaccination) and Day 28 (post-vaccination) | GMT of anti-influenza antibodies strains (A1, A1-like, A2, A2-like, B1, B2, B2-like) were measured using an HAI assay. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination. |
| Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | Day 28 (post-vaccination) | Anti-influenza antibodies were measured by using the HAI assay for the strains A1, A1-like, A2, A2-like, B1, B2, and B2-like. Seroconversion was defined as either a HAI titer lesser than (\<) 10 (1/dilution) at Day 0 and post-vaccination titer greater than or equal to (\>=) 40 (1/dilution) at Day 28, or HAI titer \>=10 (1/dilution) at Day 0 and a \>=4-fold increase in HAI titer (1/dilution) at Day 28. |
| Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | Day 0 (pre-vaccination) and Day 28 (post-vaccination) | Anti-influenza antibodies were measured by using the HAI assay for the strains A1, A1-like, A2, A2-like, B1, B2, and B2-like. Seroprotection was defined as a HAI titer \>=40 (1/dilution) at Day 0 and Day 28. |
Countries
Japan
Participant flow
Recruitment details
Study participants were enrolled from 15 September 2017 to 26 October 2017 at 2 centers in Japan.
Pre-assignment details
10 participants were randomized 1:1 to receive either QIV-HD by intramuscular (IM) route or QIV-HD by subcutaneous (SC) route (Cohort 1). After review of local and systemic AEs for 7 days post-vaccination in Cohort 1, remaining 165 participants were randomized 1:1:1 to receive QIV-HD by IM route, QIV-HD by SC route, or QIV-SD by SC route (Cohort 2)
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: QIV-HD by IM Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0. | 5 |
| Cohort 1: QIV-HD by SC Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0. | 5 |
| Cohort 2: QIV-HD by IM Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0. | 55 |
| Cohort 2: QIV-HD by SC Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0. | 55 |
| Cohort 2: QIV-SD by SC Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0. | 55 |
| Total | 175 |
Baseline characteristics
| Characteristic | Cohort 1: QIV-HD by IM | Total | Cohort 2: QIV-SD by SC | Cohort 2: QIV-HD by SC | Cohort 2: QIV-HD by IM | Cohort 1: QIV-HD by SC |
|---|---|---|---|---|---|---|
| Age, Continuous | 70.8 years STANDARD_DEVIATION 2 | 70.2 years STANDARD_DEVIATION 3.6 | 69.9 years STANDARD_DEVIATION 3.8 | 70.5 years STANDARD_DEVIATION 3.6 | 70.1 years STANDARD_DEVIATION 3.7 | 70.8 years STANDARD_DEVIATION 2.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 175 Participants | 55 Participants | 55 Participants | 55 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 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 |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 80 Participants | 25 Participants | 26 Participants | 27 Participants | 1 Participants |
| Sex: Female, Male Male | 4 Participants | 95 Participants | 30 Participants | 29 Participants | 28 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 | 0 / 55 |
| other Total, other adverse events | 4 / 60 | 4 / 60 | 7 / 55 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 | 1 / 55 |
Outcome results
Primary
Number of Participants With Immediate Unsolicited Adverse Events (AE) After Vaccination
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Time frame: Within 30 minutes after vaccination
Population: The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 and 2: QIV-HD by IM | Number of Participants With Immediate Unsolicited Adverse Events (AE) After Vaccination | 0 Participants |
| Cohort 1 and 2: QIV-HD by SC | Number of Participants With Immediate Unsolicited Adverse Events (AE) After Vaccination | 0 Participants |
| Cohort 2: QIV-SD by SC | Number of Participants With Immediate Unsolicited Adverse Events (AE) After Vaccination | 0 Participants |
Primary
Number of Participants With Solicited Injection Site and Systemic Reactions
A solicited reaction was an adverse reaction observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions: pain, erythema, swelling, induration, and bruising. Solicited systemic reactions: fever, headache, malaise, myalgia, and shivering.
Time frame: Within 7 days after vaccination
Population: The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population for Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 and 2: QIV-HD by IM | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site pain | 18 Participants |
| Cohort 1 and 2: QIV-HD by IM | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site erythema | 11 Participants |
| Cohort 1 and 2: QIV-HD by IM | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site swelling | 9 Participants |
| Cohort 1 and 2: QIV-HD by IM | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site induration | 2 Participants |
| Cohort 1 and 2: QIV-HD by IM | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site bruising | 0 Participants |
| Cohort 1 and 2: QIV-HD by IM | Number of Participants With Solicited Injection Site and Systemic Reactions | Fever | 0 Participants |
| Cohort 1 and 2: QIV-HD by IM | Number of Participants With Solicited Injection Site and Systemic Reactions | Headache | 3 Participants |
| Cohort 1 and 2: QIV-HD by IM | Number of Participants With Solicited Injection Site and Systemic Reactions | Malaise | 1 Participants |
| Cohort 1 and 2: QIV-HD by IM | Number of Participants With Solicited Injection Site and Systemic Reactions | Myalgia | 9 Participants |
| Cohort 1 and 2: QIV-HD by IM | Number of Participants With Solicited Injection Site and Systemic Reactions | Shivering | 0 Participants |
| Cohort 1 and 2: QIV-HD by SC | Number of Participants With Solicited Injection Site and Systemic Reactions | Myalgia | 16 Participants |
| Cohort 1 and 2: QIV-HD by SC | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site pain | 27 Participants |
| Cohort 1 and 2: QIV-HD by SC | Number of Participants With Solicited Injection Site and Systemic Reactions | Fever | 1 Participants |
| Cohort 1 and 2: QIV-HD by SC | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site bruising | 0 Participants |
| Cohort 1 and 2: QIV-HD by SC | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site erythema | 19 Participants |
| Cohort 1 and 2: QIV-HD by SC | Number of Participants With Solicited Injection Site and Systemic Reactions | Shivering | 2 Participants |
| Cohort 1 and 2: QIV-HD by SC | Number of Participants With Solicited Injection Site and Systemic Reactions | Malaise | 4 Participants |
| Cohort 1 and 2: QIV-HD by SC | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site swelling | 17 Participants |
| Cohort 1 and 2: QIV-HD by SC | Number of Participants With Solicited Injection Site and Systemic Reactions | Headache | 8 Participants |
| Cohort 1 and 2: QIV-HD by SC | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site induration | 7 Participants |
| Cohort 2: QIV-SD by SC | Number of Participants With Solicited Injection Site and Systemic Reactions | Malaise | 3 Participants |
| Cohort 2: QIV-SD by SC | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site induration | 2 Participants |
| Cohort 2: QIV-SD by SC | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site bruising | 0 Participants |
| Cohort 2: QIV-SD by SC | Number of Participants With Solicited Injection Site and Systemic Reactions | Fever | 0 Participants |
| Cohort 2: QIV-SD by SC | Number of Participants With Solicited Injection Site and Systemic Reactions | Myalgia | 7 Participants |
| Cohort 2: QIV-SD by SC | Number of Participants With Solicited Injection Site and Systemic Reactions | Headache | 1 Participants |
| Cohort 2: QIV-SD by SC | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site pain | 15 Participants |
| Cohort 2: QIV-SD by SC | Number of Participants With Solicited Injection Site and Systemic Reactions | Shivering | 2 Participants |
| Cohort 2: QIV-SD by SC | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site erythema | 11 Participants |
| Cohort 2: QIV-SD by SC | Number of Participants With Solicited Injection Site and Systemic Reactions | Injection site swelling | 13 Participants |
Primary
Number of Participants With Unsolicited Adverse Events After Vaccination
An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Time frame: Within 28 days after vaccination
Population: The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 and 2: QIV-HD by IM | Number of Participants With Unsolicited Adverse Events After Vaccination | 4 Participants |
| Cohort 1 and 2: QIV-HD by SC | Number of Participants With Unsolicited Adverse Events After Vaccination | 4 Participants |
| Cohort 2: QIV-SD by SC | Number of Participants With Unsolicited Adverse Events After Vaccination | 8 Participants |
Primary
Number of Participant With Serious Adverse Events (SAEs) After Vaccination
An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Time frame: Up to 6 months after vaccination
Population: The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 and 2: QIV-HD by IM | Number of Participant With Serious Adverse Events (SAEs) After Vaccination | 0 Participants |
| Cohort 1 and 2: QIV-HD by SC | Number of Participant With Serious Adverse Events (SAEs) After Vaccination | 0 Participants |
| Cohort 2: QIV-SD by SC | Number of Participant With Serious Adverse Events (SAEs) After Vaccination | 1 Participants |
Secondary
Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
GMT of anti-influenza antibodies strains (A1, A1-like, A2, A2-like, B1, B2, B2-like) were measured using an HAI assay. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.
Time frame: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Population: The analysis was performed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Data for this outcome measure was not planned to be analyzed for Cohort 1.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A1: Day 28/Day 0 | 16.00 ratio |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B1: Day 28/Day 0 | 7.51 ratio |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A2-like: Day 28/Day 0 | 12.36 ratio |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A1-like: Day 28/Day 0 | 9.25 ratio |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B2-like: Day 28/Day 0 | 8.26 ratio |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B2: Day 28/Day 0 | 10.69 ratio |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A2: Day 28/Day 0 | 16.93 ratio |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A1: Day 28/Day 0 | 9.25 ratio |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A1-like: Day 28/Day 0 | 6.34 ratio |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A2: Day 28/Day 0 | 8.31 ratio |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A2-like: Day 28/Day 0 | 7.42 ratio |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B1: Day 28/Day 0 | 4.68 ratio |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B2: Day 28/Day 0 | 6.92 ratio |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B2-like: Day 28/Day 0 | 5.55 ratio |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B1: Day 28/Day 0 | 3.11 ratio |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A1-like: Day 28/Day 0 | 5.13 ratio |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B2-like: Day 28/Day 0 | 2.67 ratio |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B2: Day 28/Day 0 | 2.88 ratio |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A2-like: Day 28/Day 0 | 4.56 ratio |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A2: Day 28/Day 0 | 4.85 ratio |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A1: Day 28/Day 0 | 6.56 ratio |
Secondary
Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
GMT of anti-influenza antibodies strains (A1, A1-like, A2, A2-like, B1, B2, B2-like) were measured using a hemagglutination inhibition (HAI) assay.
Time frame: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Population: Analyzed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Here, 'number analyzed' = participants with available data for each category. Data for this outcome measure was not planned to be analyzed for Cohort 1.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A1-like: Day 0 | 46.2 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A1-like: Day 28 | 427.6 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B2: Day 0 | 76.1 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B2: Day 28 | 813.2 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A1: Day 28 | 712.4 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B2-like: Day 0 | 32.7 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B1: Day 28 | 877.0 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A2: Day 0 | 62.6 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A1: Day 0 | 44.5 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A2-like: Day 28 | 940.0 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A2-like: Day 0 | 76.1 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B2-like: Day 28 | 269.9 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A2: Day 28 | 1059.5 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B1: Day 0 | 116.8 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A1-like: Day 0 | 56.2 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A1: Day 0 | 59.5 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A2: Day 0 | 101.0 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A2-like: Day 0 | 107.6 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B1: Day 0 | 134.1 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B2: Day 0 | 109.6 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B2-like: Day 0 | 47.1 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A1: Day 28 | 550.2 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A1-like: Day 28 | 356.2 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A2: Day 28 | 839.2 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A2-like: Day 28 | 797.9 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B1: Day 28 | 628.0 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B2: Day 28 | 758.7 titers (1/dilution) |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B2-like: Day 28 | 261.6 titers (1/dilution) |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A2-like: Day 0 | 91.0 titers (1/dilution) |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B2: Day 28 | 281.5 titers (1/dilution) |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A2: Day 28 | 405.8 titers (1/dilution) |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A2: Day 0 | 83.7 titers (1/dilution) |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B2-like: Day 28 | 111.0 titers (1/dilution) |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A2-like: Day 28 | 402.3 titers (1/dilution) |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A1-like: Day 0 | 42.1 titers (1/dilution) |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B2-like: Day 0 | 41.6 titers (1/dilution) |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B2: Day 0 | 97.6 titers (1/dilution) |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A1: Day 0 | 41.0 titers (1/dilution) |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A1: Day 28 | 269.1 titers (1/dilution) |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B1: Day 0 | 108.2 titers (1/dilution) |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | B1: Day 28 | 336.9 titers (1/dilution) |
| Cohort 2: QIV-SD by SC | Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD | A1-like: Day 28 | 216.3 titers (1/dilution) |
Secondary
Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD
Anti-influenza antibodies were measured by using the HAI assay for the strains A1, A1-like, A2, A2-like, B1, B2, and B2-like. Seroconversion was defined as either a HAI titer lesser than (\<) 10 (1/dilution) at Day 0 and post-vaccination titer greater than or equal to (\>=) 40 (1/dilution) at Day 28, or HAI titer \>=10 (1/dilution) at Day 0 and a \>=4-fold increase in HAI titer (1/dilution) at Day 28.
Time frame: Day 28 (post-vaccination)
Population: Analyzed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Here, 'number analyzed' = participants with available data for each category. Data for this outcome measure was not planned to be analyzed for Cohort 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | A1 | 74.5 percentage of participants |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | B1 | 58.2 percentage of participants |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | A2-like | 74.5 percentage of participants |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | A1-like | 74.5 percentage of participants |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | B2-like | 67.3 percentage of participants |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | B2 | 65.5 percentage of participants |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | A2 | 85.5 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | A2-like | 58.2 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | A1-like | 69.1 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | A1 | 67.3 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | A2 | 63.6 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | B1 | 47.3 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | B2 | 63.6 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | B2-like | 60.0 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | B1 | 37.0 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | A1-like | 56.6 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | B2-like | 33.3 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | B2 | 33.3 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | A2-like | 43.4 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | A2 | 42.6 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD | A1 | 55.6 percentage of participants |
Secondary
Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD
Anti-influenza antibodies were measured by using the HAI assay for the strains A1, A1-like, A2, A2-like, B1, B2, and B2-like. Seroprotection was defined as a HAI titer \>=40 (1/dilution) at Day 0 and Day 28.
Time frame: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Population: Analyzed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Here, 'number analyzed' = participants with available data for each category. Data for this outcome measure was not planned to be analyzed for Cohort 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | B1: Day 0 | 76.4 percentage of participants |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A1: Day 0 | 60.0 percentage of participants |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A2-like: day 28 | 100 percentage of participants |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | B2: Day 0 | 67.3 percentage of participants |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | B2: Day 28 | 98.2 percentage of participants |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A2: Day 28 | 100 percentage of participants |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | B2-like: Day 0 | 49.1 percentage of participants |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A2: Day 0 | 63.6 percentage of participants |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A1-like: Day 28 | 98.2 percentage of participants |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | B2-like: Day 28 | 98.2 percentage of participants |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | B1: Day 28 | 98.2 percentage of participants |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A2-like: Day 0 | 65.5 percentage of participants |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A1-like: Day 0 | 58.2 percentage of participants |
| Cohort 1 and 2: QIV-HD by IM | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A1: Day 28 | 98.2 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A2-like: day 28 | 100 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A1: Day 28 | 100 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A1: Day 0 | 65.5 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A1-like: Day 0 | 60.0 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A2: Day 0 | 83.6 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A2-like: Day 0 | 81.8 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | B1: Day 0 | 87.3 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | B2: Day 0 | 78.2 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | B2-like: Day 0 | 52.7 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A1-like: Day 28 | 100 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A2: Day 28 | 100 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | B1: Day 28 | 100 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | B2: Day 28 | 100 percentage of participants |
| Cohort 1 and 2: QIV-HD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | B2-like: Day 28 | 100 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | B2: Day 28 | 98.1 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A2: Day 28 | 96.3 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | B1: Day 0 | 81.5 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A2-like: Day 0 | 70.4 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A2-like: day 28 | 96.2 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A2: Day 0 | 68.5 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A1: Day 0 | 53.7 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | B1: Day 28 | 98.1 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A1-like: Day 0 | 54.7 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A1: Day 28 | 92.6 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | B2-like: Day 0 | 57.4 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | B2-like: Day 28 | 94.4 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | A1-like: Day 28 | 98.1 percentage of participants |
| Cohort 2: QIV-SD by SC | Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD | B2: Day 0 | 79.6 percentage of participants |