Healthy Volunteers, Influenza Immunization
Conditions
Brief summary
Primary Objective: To demonstrate that high-dose quadrivalent influenza vaccine (QIV-HD) induces an immune response that is superior to the responses induced by standard-dose quadrivalent influenza vaccine (QIV-SD) for all 4 virus strains 28 days post-vaccination in participants 60 to 64 years of age and in participants 65 years of age and older. Secondary Objective: * Immunogenicity: To further describe the immune response induced by QIV-HD and QIV-SD in all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD). * Safety: To describe the safety profile of all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD).
Detailed description
Study duration per participant was approximately 6 months including: 1 day of screening and vaccination, an end of study visit and safety follow-up telephone call approximately at Day 28 and Day 180 after vaccination, respectively.
Interventions
BIOLOGICALStandard-Dose influenza virus surface antigens (haemagglutinin and neuraminidase), Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains (QIV-SD)
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
BIOLOGICALHigh-Dose Influenza Vaccine (split virion, inactivated), Quadrivalent (QIV-HD) 2019-2020 Northern Hemisphere formulation
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Modified double-blind: the participant and the Investigators remained unaware of the treatment assignments throughout the study. An unblinded qualified trial staff member administered the appropriate vaccine but were not involved in the immunogenicity and safety evaluations.
Intervention model description
Participants randomized in each group were stratified by age (60 to 64 years of age; 65 years of age and older).
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
: * Sixty years of age and older on the day of inclusion. * Able to attend all scheduled visits and complied with all trial procedures.
Exclusion criteria
* Participant was pregnant, or lactating, or of childbearing potential and did not used an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile. * Participation at the time of study enrollment (or in the 4 weeks \[28 days\] preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 02. * Previous vaccination against influenza (in the previous 6 months) with either the trial 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 any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances. * Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on Investigator's judgement. * Alcohol or substance abuse that, in the opinion of the Investigator might interfere with the trial conduct or completion. * Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion * Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature greater than or equal to (\>=) 38.0 degree Celsius) on the day of vaccination. A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided. * 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 (ie, 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 had been disease free for \>= 5 years) The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | Day 28 post-vaccination | GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).Titers were expressed in terms of 1/dilution. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | Day 0 (pre-vaccination), Day 28 (post-vaccination) | GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Titers were expressed in terms of 1/dilution. |
| Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants | Day 0 (pre-vaccination), Day 28 (post-vaccination) | GMTRs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0). |
| Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | Day 0 (pre-vaccination), Day 28 (post-vaccination) | GMTRs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0). |
| Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution) | Day 28 post-vaccination | Neutralizing Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Percentage of participants (all age group participants) with neutralizing antibody titers \>=40 (1/dilution) is reported in the outcome measure. |
| Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | Day 28 post-vaccination | Neutralizing Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Percentage of participants (aged 60-64 Years and \>=65 Years) with neutralizing antibody titers \>=40 (1/dilution) is reported in the outcome measure. |
| Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against Antigens | Day 28 post-vaccination | Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer less than (\<) 1:10 (1/dilution) and a post-vaccination titer \>=1:40 (1/dilution) or a pre-vaccination titer \>= 1:10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28. Percentage of participants (all age group participants) achieving seroconversion is reported in the outcome measure. |
| Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | Day 0 (pre-vaccination), Day 28 (post-vaccination) | GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).Titers were expressed in terms of 1/dilution. |
| Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Within 30 minutes post-vaccination | An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. 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 Reporting Solicited Injection Site Reactions | Within 7 days post-vaccination | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited injection site reactions included induration, bruising, pain, erythema, and swelling. |
| Number of Participants Reporting Solicited Systemic Reactions | Within 7 days post-vaccination | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering. |
| Number of Participants Reporting Unsolicited Adverse Events (AEs) | Within 28 days post-vaccination | An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. |
| Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs) | From Day 0 up to 6 months post-vaccination | A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. A SAE which caused death of the participant was considered as fatal SAE. Adverse events of special interest (AESIs) was defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. |
| Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens | Day 28 post-vaccination | Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 (1/dilution) and a post-vaccination titer \>= 1:40 (1/dilution) or a pre-vaccination titer \>= 1:10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28. Percentage of participants (aged 60-64 Years and \>=65 Years) achieving seroconversion is reported in the outcome measure. |
Countries
Belgium, France, Germany, Italy, Netherlands, Poland
Participant flow
Recruitment details
The study was conducted at 17 active centers in 6 countries. A total of 1539 participants were enrolled and randomized between 28 October 2019 to 15 November 2019.
Pre-assignment details
A total of 1533 participants were vaccinated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: QIV-HD Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0. | 774 |
| Group 2: QIV-SD Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0. | 765 |
| Total | 1,539 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Protocol Deviation | 0 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Group 1: QIV-HD | Group 2: QIV-SD | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 395 Participants | 384 Participants | 779 Participants |
| Age, Categorical Between 18 and 65 years | 379 Participants | 381 Participants | 760 Participants |
| Age, Continuous | 66.6 years STANDARD_DEVIATION 5.82 | 66.6 years STANDARD_DEVIATION 6.11 | 66.6 years STANDARD_DEVIATION 5.97 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) White | 758 Participants | 756 Participants | 1514 Participants |
| Sex: Female, Male Female | 385 Participants | 390 Participants | 775 Participants |
| Sex: Female, Male Male | 389 Participants | 375 Participants | 764 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 772 | 0 / 761 |
| other Total, other adverse events | 507 / 772 | 354 / 761 |
| serious Total, serious adverse events | 17 / 772 | 21 / 761 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).Titers were expressed in terms of 1/dilution.
Time frame: Day 28 post-vaccination
Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: QIV-HD | Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | A/H1N1: Day 28: 60-64 years | 471 titers |
| Group 1: QIV-HD | Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | A/H3N2: Day 28: 60-64 years | 303 titers |
| Group 1: QIV-HD | Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | B1: Day 28: 60-64 years | 497 titers |
| Group 1: QIV-HD | Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | B2: Day 28: 60-64 years | 766 titers |
| Group 1: QIV-HD | Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | A/H1N1: Day 28: >= 65 years | 286 titers |
| Group 1: QIV-HD | Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | A/H3N2: Day 28: >=65 years | 324 titers |
| Group 1: QIV-HD | Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | B1: Day 28: >=65 years | 405 titers |
| Group 1: QIV-HD | Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | B2: Day 28: >=65 years | 536 titers |
| Group 2: QIV-SD | Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | B2: Day 28: >=65 years | 305 titers |
| Group 2: QIV-SD | Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | A/H1N1: Day 28: 60-64 years | 248 titers |
| Group 2: QIV-SD | Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | A/H1N1: Day 28: >= 65 years | 162 titers |
| Group 2: QIV-SD | Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | A/H3N2: Day 28: 60-64 years | 178 titers |
| Group 2: QIV-SD | Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | B1: Day 28: >=65 years | 262 titers |
| Group 2: QIV-SD | Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | B1: Day 28: 60-64 years | 330 titers |
| Group 2: QIV-SD | Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | A/H3N2: Day 28: >=65 years | 151 titers |
| Group 2: QIV-SD | Geometric Mean Titers (GMTs) of Influenza Antibodies in Participants Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years | B2: Day 28: 60-64 years | 433 titers |
Comparison: A/H1N1: 60-64 years95% CI: [1.58, 2.28]
Comparison: A/H3N2: 60-64 years95% CI: [1.38, 2.08]
Comparison: B1: 60-64 years95% CI: [1.3, 1.74]
Comparison: B2: 60-64 years95% CI: [1.53, 2.04]
Comparison: A/H1N1: \>=65 years95% CI: [1.44, 2.15]
Comparison: A/H3N2: \>=65 years95% CI: [1.74, 2.65]
Comparison: B1: \>=65 years95% CI: [1.34, 1.79]
Comparison: B2: \>=65 years95% CI: [1.52, 2.03]
Secondary
Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants
GMTRs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).
Time frame: Day 0 (pre-vaccination), Day 28 (post-vaccination)
Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: QIV-HD | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants | B2: Day 28/Day 0 | 7.13 ratio |
| Group 1: QIV-HD | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants | A/H3N2: Day 28/Day 0 | 23.7 ratio |
| Group 1: QIV-HD | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants | A/H1N1: Day 28/Day 0 | 7.50 ratio |
| Group 1: QIV-HD | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants | B1: Day 28/Day 0 | 7.02 ratio |
| Group 2: QIV-SD | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants | B1: Day 28/Day 0 | 3.95 ratio |
| Group 2: QIV-SD | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants | A/H1N1: Day 28/Day 0 | 4.34 ratio |
| Group 2: QIV-SD | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants | A/H3N2: Day 28/Day 0 | 12.6 ratio |
| Group 2: QIV-SD | Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Participants | B2: Day 28/Day 0 | 3.77 ratio |
Secondary
Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years
GMTRs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).
Time frame: Day 0 (pre-vaccination), Day 28 (post-vaccination)
Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: QIV-HD | Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | A/H1N1: Day 28/Day 0: 60-64 Years | 9.36 ratio |
| Group 1: QIV-HD | Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | A/H3N2: Day 28/Day 0: 60-64 Years | 26.2 ratio |
| Group 1: QIV-HD | Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | B1: Day 28/Day 0: 60-64 Years | 9.07 ratio |
| Group 1: QIV-HD | Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | B2: Day 28/Day 0: 60-64 Years | 9.52 ratio |
| Group 1: QIV-HD | Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | A/H1N1: Day 28/Day 0: >=65 Years | 6.07 ratio |
| Group 1: QIV-HD | Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | A/H3N2: Day 28/Day 0: >=65 Years | 21.4 ratio |
| Group 1: QIV-HD | Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | B1: Day 28/Day 0: >=65 Years | 5.48 ratio |
| Group 1: QIV-HD | Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | B2: Day 28/Day 0: >=65 Years | 5.39 ratio |
| Group 2: QIV-SD | Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | B2: Day 28/Day 0: >=65 Years | 3.06 ratio |
| Group 2: QIV-SD | Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | A/H1N1: Day 28/Day 0: 60-64 Years | 4.96 ratio |
| Group 2: QIV-SD | Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | A/H1N1: Day 28/Day 0: >=65 Years | 3.80 ratio |
| Group 2: QIV-SD | Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | A/H3N2: Day 28/Day 0: 60-64 Years | 14.2 ratio |
| Group 2: QIV-SD | Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | B1: Day 28/Day 0: >=65 Years | 3.25 ratio |
| Group 2: QIV-SD | Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | B1: Day 28/Day 0: 60-64 Years | 4.80 ratio |
| Group 2: QIV-SD | Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | A/H3N2: Day 28/Day 0: >=65 Years | 11.2 ratio |
| Group 2: QIV-SD | Geometric Mean Titer Ratios of Influenza Antibodies in Participants Aged 60-64 Years and >=65 Years | B2: Day 28/Day 0: 60-64 Years | 4.66 ratio |
Secondary
Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants
GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).Titers were expressed in terms of 1/dilution.
Time frame: Day 0 (pre-vaccination), Day 28 (post-vaccination)
Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | A/H3N2: Day 0 | 13.3 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | B1: Day 28 | 447 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | A/H1N1: Day 28 | 365 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | B2: Day 0 | 89.7 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | A/H3N2: Day 28 | 313 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | B1: Day 0 | 63.9 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | B2: Day 28 | 638 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | A/H1N1: Day 0 | 48.6 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | B2: Day 28 | 363 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | A/H1N1: Day 0 | 46.2 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | A/H1N1: Day 28 | 200 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | A/H3N2: Day 0 | 13.0 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | B1: Day 0 | 74.5 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | B1: Day 28 | 294 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | A/H3N2: Day 28 | 164 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Participants | B2: Day 0 | 96.6 titers |
Secondary
Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years
GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Titers were expressed in terms of 1/dilution.
Time frame: Day 0 (pre-vaccination), Day 28 (post-vaccination)
Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | A/H1N1: Day 0: 60-64 Years | 50.2 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | A/H1N1: Day 28: 60-64 Years | 471 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | A/H3N2: Day 0: 60-64 Years | 11.5 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | A/H3N2: Day 28: 60-64 Years | 303 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | B1: Day 0: 60-64 Years | 54.7 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | B1: Day 28: 60-64 Years | 497 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | B2: Day 0: 60-64 Years | 80.4 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | B2: Day 28: 60-64 Years | 766 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | A/H1N1: Day 0: >=65 Years | 47.1 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | A/H1N1: Day 28: >=65 Years | 286 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | A/H3N2: Day 0: >=65 Years | 15.2 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | A/H3N2: Day 28: >=65 Years | 324 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | B1: Day 28: >=65 Years | 405 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | B2: Day 0: >=65 Years | 99.7 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | B1: Day 0: >=65 Years | 74.2 titers |
| Group 1: QIV-HD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | B2: Day 28: >=65 Years | 536 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | B1: Day 0: >=65 Years | 80.7 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | A/H1N1: Day 0: 60-64 Years | 50.0 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | A/H1N1: Day 0: >=65 Years | 42.8 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | A/H1N1: Day 28: 60-64 Years | 248 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | B1: Day 28: >=65 Years | 262 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | A/H3N2: Day 0: 60-64 Years | 12.5 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | A/H1N1: Day 28: >=65 Years | 162 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | A/H3N2: Day 28: 60-64 Years | 178 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | B2: Day 0: >=65 Years | 100 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | B1: Day 0: 60-64 Years | 68.7 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | A/H3N2: Day 0: >=65 Years | 13.5 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | B1: Day 28: 60-64 Years | 330 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | B2: Day 28: >=65 Years | 305 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | B2: Day 0: 60-64 Years | 93.2 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | A/H3N2: Day 28: >=65 Years | 151 titers |
| Group 2: QIV-SD | Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Participants Aged 60-64 Years and >=65 Years | B2: Day 28: 60-64 Years | 433 titers |
Secondary
Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. 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 post-vaccination
Population: Analysis was performed on safety analysis set (SafAS) which included participants who had received the study vaccine and had any safety data available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: QIV-HD | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | 2 Participants |
| Group 2: QIV-SD | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | 1 Participants |
Secondary
Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs)
A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. A SAE which caused death of the participant was considered as fatal SAE. Adverse events of special interest (AESIs) was defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.
Time frame: From Day 0 up to 6 months post-vaccination
Population: Analysis was performed on the SafAS population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD | Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs) | SAE | 17 Participants |
| Group 1: QIV-HD | Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs) | AESI | 0 Participants |
| Group 2: QIV-SD | Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs) | SAE | 21 Participants |
| Group 2: QIV-SD | Number of Participants Reporting Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs) | AESI | 0 Participants |
Secondary
Number of Participants Reporting Solicited Injection Site Reactions
A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited injection site reactions included induration, bruising, pain, erythema, and swelling.
Time frame: Within 7 days post-vaccination
Population: Analysis was performed on the SafAS population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD | Number of Participants Reporting Solicited Injection Site Reactions | Swelling | 140 Participants |
| Group 1: QIV-HD | Number of Participants Reporting Solicited Injection Site Reactions | Bruising | 12 Participants |
| Group 1: QIV-HD | Number of Participants Reporting Solicited Injection Site Reactions | Erythema | 157 Participants |
| Group 1: QIV-HD | Number of Participants Reporting Solicited Injection Site Reactions | Induration | 132 Participants |
| Group 1: QIV-HD | Number of Participants Reporting Solicited Injection Site Reactions | Pain | 350 Participants |
| Group 2: QIV-SD | Number of Participants Reporting Solicited Injection Site Reactions | Pain | 159 Participants |
| Group 2: QIV-SD | Number of Participants Reporting Solicited Injection Site Reactions | Induration | 64 Participants |
| Group 2: QIV-SD | Number of Participants Reporting Solicited Injection Site Reactions | Bruising | 7 Participants |
| Group 2: QIV-SD | Number of Participants Reporting Solicited Injection Site Reactions | Swelling | 62 Participants |
| Group 2: QIV-SD | Number of Participants Reporting Solicited Injection Site Reactions | Erythema | 85 Participants |
Secondary
Number of Participants Reporting Solicited Systemic Reactions
A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering.
Time frame: Within 7 days post-vaccination
Population: Analysis was performed on the SafAS population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: QIV-HD | Number of Participants Reporting Solicited Systemic Reactions | Headache | 184 Participants |
| Group 1: QIV-HD | Number of Participants Reporting Solicited Systemic Reactions | Myalgia | 202 Participants |
| Group 1: QIV-HD | Number of Participants Reporting Solicited Systemic Reactions | Malaise | 164 Participants |
| Group 1: QIV-HD | Number of Participants Reporting Solicited Systemic Reactions | Shivering | 128 Participants |
| Group 1: QIV-HD | Number of Participants Reporting Solicited Systemic Reactions | Fever | 18 Participants |
| Group 2: QIV-SD | Number of Participants Reporting Solicited Systemic Reactions | Shivering | 54 Participants |
| Group 2: QIV-SD | Number of Participants Reporting Solicited Systemic Reactions | Fever | 4 Participants |
| Group 2: QIV-SD | Number of Participants Reporting Solicited Systemic Reactions | Headache | 141 Participants |
| Group 2: QIV-SD | Number of Participants Reporting Solicited Systemic Reactions | Malaise | 89 Participants |
| Group 2: QIV-SD | Number of Participants Reporting Solicited Systemic Reactions | Myalgia | 93 Participants |
Secondary
Number of Participants Reporting Unsolicited Adverse Events (AEs)
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination.
Time frame: Within 28 days post-vaccination
Population: Analysis was performed on SafAS population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: QIV-HD | Number of Participants Reporting Unsolicited Adverse Events (AEs) | 190 Participants |
| Group 2: QIV-SD | Number of Participants Reporting Unsolicited Adverse Events (AEs) | 172 Participants |
Secondary
Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens
Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 (1/dilution) and a post-vaccination titer \>= 1:40 (1/dilution) or a pre-vaccination titer \>= 1:10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28. Percentage of participants (aged 60-64 Years and \>=65 Years) achieving seroconversion is reported in the outcome measure.
Time frame: Day 28 post-vaccination
Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: QIV-HD | Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens | A/H3N2: Day 28: >=65 Years | 87.0 percentage of participants |
| Group 1: QIV-HD | Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens | A/H1N1: Day 28: 60-64 Years | 66.5 percentage of participants |
| Group 1: QIV-HD | Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens | A/H3N2: Day 28: 60-64 Years | 89.4 percentage of participants |
| Group 1: QIV-HD | Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens | B1: Day 28: 60-64 Years | 68.2 percentage of participants |
| Group 1: QIV-HD | Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens | B2: Day 28: 60-64 Years | 70.6 percentage of participants |
| Group 1: QIV-HD | Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens | A/H1N1: Day 28: >=65 Years | 57.9 percentage of participants |
| Group 1: QIV-HD | Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens | B1: Day 28: >=65 Years | 56.9 percentage of participants |
| Group 1: QIV-HD | Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens | B2: Day 28: >=65 Years | 55.2 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens | B1: Day 28: 60-64 Years | 47.7 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens | A/H3N2: Day 28: >=65 Years | 71.8 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens | B2: Day 28: >=65 Years | 34.7 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens | A/H1N1: Day 28: >=65 Years | 37.0 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens | A/H1N1: Day 28: 60-64 Years | 41.4 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens | B2: Day 28: 60-64 Years | 48.5 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens | A/H3N2: Day 28: 60-64 Years | 76.7 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens | B1: Day 28: >=65 Years | 34.7 percentage of participants |
Secondary
Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution)
Neutralizing Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Percentage of participants (aged 60-64 Years and \>=65 Years) with neutralizing antibody titers \>=40 (1/dilution) is reported in the outcome measure.
Time frame: Day 28 post-vaccination
Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: QIV-HD | Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | B2: Day 28: 60-64 Years | 99.7 percentage of participants |
| Group 1: QIV-HD | Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | A/H3N2: Day 28: >=65 Years | 92.6 percentage of participants |
| Group 1: QIV-HD | Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | A/H1N1: Day 28: 60-64 Years | 98.1 percentage of participants |
| Group 1: QIV-HD | Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | A/H1N1: Day 28: >=65 Years | 95.2 percentage of participants |
| Group 1: QIV-HD | Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | A/H3N2: Day 28: 60-64 Years | 94.9 percentage of participants |
| Group 1: QIV-HD | Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | B1: Day 28: >=65 Years | 99.0 percentage of participants |
| Group 1: QIV-HD | Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | B1: Day 28: 60-64 Years | 100 percentage of participants |
| Group 1: QIV-HD | Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | B2: Day 28: >=65 Years | 99.2 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | B1: Day 28: >=65 Years | 99.0 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | B2: Day 28: 60-64 Years | 99.5 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | A/H1N1: Day 28: >=65 Years | 84.5 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | A/H3N2: Day 28: >=65 Years | 83.7 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | B1: Day 28: 60-64 Years | 99.5 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | B2: Day 28: >=65 Years | 97.1 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | A/H1N1: Day 28: 60-64 Years | 92.3 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (Aged 60-64 Years and >=65 Years) With Neutralizing Antibody Titers >=40 (1/Dilution) | A/H3N2: Day 28: 60-64 Years | 89.1 percentage of participants |
Secondary
Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against Antigens
Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer less than (\<) 1:10 (1/dilution) and a post-vaccination titer \>=1:40 (1/dilution) or a pre-vaccination titer \>= 1:10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28. Percentage of participants (all age group participants) achieving seroconversion is reported in the outcome measure.
Time frame: Day 28 post-vaccination
Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: QIV-HD | Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against Antigens | A/H1N1: Day 28 | 62.1 percentage of participants |
| Group 1: QIV-HD | Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against Antigens | A/H3N2: Day 28 | 88.1 percentage of participants |
| Group 1: QIV-HD | Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against Antigens | B1: Day 28 | 62.5 percentage of participants |
| Group 1: QIV-HD | Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against Antigens | B2: Day 28 | 62.7 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against Antigens | B2: Day 28 | 41.6 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against Antigens | A/H1N1: Day 28 | 39.2 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against Antigens | B1: Day 28 | 41.2 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (All Age Group Participants) Achieving Seroconversion Against Antigens | A/H3N2: Day 28 | 74.2 percentage of participants |
Secondary
Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution)
Neutralizing Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Percentage of participants (all age group participants) with neutralizing antibody titers \>=40 (1/dilution) is reported in the outcome measure.
Time frame: Day 28 post-vaccination
Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: QIV-HD | Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution) | A/H1N1: Day 28 | 96.6 percentage of participants |
| Group 1: QIV-HD | Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution) | A/H3N2: Day 28 | 93.8 percentage of participants |
| Group 1: QIV-HD | Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution) | B1: Day 28 | 99.5 percentage of participants |
| Group 1: QIV-HD | Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution) | B2: Day 28 | 99.5 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution) | B2: Day 28 | 98.3 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution) | A/H1N1: Day 28 | 88.4 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution) | B1: Day 28 | 99.2 percentage of participants |
| Group 2: QIV-SD | Percentage of Participants (All Age Group Participants) With Neutralizing Antibody Titers >=40 (1/Dilution) | A/H3N2: Day 28 | 86.4 percentage of participants |