Influenza Virus
Conditions
Keywords
Influenza, children
Brief summary
Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to \<72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.
Interventions
1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months
BIOLOGICALNon-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)
1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months
Sponsors
Novartis Vaccines
Seqirus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 71 Months
Healthy volunteers
Yes
Inclusion criteria
* Children, males and females, healthy or at high risk of complications from influenza, between ≥6 months to \<72 months of age * Documented consent provided by the subject's parent(s)/legal guardian(s) * Subjects and/or subject's parent(s)/legal guardian(s) able to comply with all study procedures.
Exclusion criteria
* Children with history of allergy to vaccine components. * Additional eligibility criteria may be discussed by contacting the site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age | ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects ≥6 to \<72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with culture confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). |
| Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications | ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects ≥6 to \<72 months of age with RT-PCR confirmed and culture confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer, in healthy subjects and subjects at risk of influenza related complications. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). |
| Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately | ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). |
| Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age at ≥7 Days and at ≥14 Days After First Vaccination up to the Day of Second Vaccination in Vaccine naïve Subjects Only | ≥7 days and at ≥14 days after first vaccination up to day of second vaccination | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was based on the number of vaccine naive subjects ≥6 to \<72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥7 days and ≥14 days after the first vaccination up to the day of the second vaccination. TIV was used as the comparator in Season 1; and QIV was used as the comparator in Season 2. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). |
| Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age Occurring at ≥7 Days and ≤21 Days After Last Vaccination, in All Subjects. | ≥7 days and ≤21 days after the last vaccination | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was based on the number of vaccine naïve subjects ≥6 to \<72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥7 days and ≤21 after the last vaccination. TIV was used as the comparator in Season 1; and QIV was used as the comparator in Season 2. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). |
| Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | Baseline (Day 1), Day 29, Day 50 and Day 209 for vaccine naïve subjects; Baseline (Day 1), Day 22 and Day 181 for vaccine non-naïve subjects | Pooled GMT values across both naïve and non-naïve subjects are provided for the Day 22/50 (ie, 21 days after last vaccination) and Day 181/209 (ie, 180 days after last vaccination) assessments; Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/ Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis. |
| Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age | Day 29 and Day 50 | GMTs for vaccine naïve subjects are provided by strain for Day 29 and Day 50; Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/ Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis. |
| Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) | HI GMT was assessed on Day 1 and Day 50 for vaccine naïve healthy vs high risk subjects; and HI GMT were assessed on Day 1 and Day 22 for vaccine non-naïve healthy vs high risk subjects; pooled GMT values across both naïve and non-naïve subjects are provided for Day 22/50 (ie, 21 days after last vaccination) assessments. |
| Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age | Baseline (Day 1), Day 29, Day 50 and Day 209 for vaccine naïve subjects; Baseline (Day 1), Day 22 and Day 181 for vaccine non-naïve subjects | The fold-increase in HI antibodies in response to vaccination was assessed as the GMR between all post-vaccination titers (ie, Day 29, 50, 209 for vaccine naïve subjects; Day 22, 181 for vaccine non-naïve subjects) and the baseline (Day 1) titer. Assessed GMRs thus correspond to Day 29/Day 1, Day 50/Day 1, and Day 209/Day 1 for vaccine naïve subjects and Day 22/Day 1 and Day 181/Day 1 for vaccine non-naïve subjects. Pooled GMR values across both naïve and non-naïve subjects are provided for Day (22/50)/Day 1 (ie, 21 days after last vaccination) and Day (181/209)/Day 1 (ie, 180 days after last vaccination); Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis. |
| Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Seroconversion (SC) Rates and Difference in SC Rates at 21 Days in Subjects ≥6 to <72 Months of Age | Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) | SC rates were assessed on Day 1 and Day 50 (ie, 21 days after two vaccinations) for vaccine naïve subjects; and on Day 1 and Day 22 (ie, 21 days after one vaccination) for vaccine non-naïve subjects; values pooled across naive and non-naive subjects are provided. Seroconversion is defined as HI ≥ 1:40 for subjects negative at baseline (ie, HI titer\<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (ie, HI titer ≥ 1:10); Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strain: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine. comparison analysis (N=745 for aQIV, N=738 for comparator). |
| Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer | Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial). |
| Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) | Antibody response was assessed as the percentage of subjects and differences of percentage of subjects with HI titers of ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 at 21 days after last vaccination (ie, Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects. Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; B/Victoria results from Season 1 and Season 2 (aQIV) and Season 2 (comparator) are presented. |
| Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Geometric Mean Titers (GMTs) in Subjects ≥6 to <72 Months of Age | 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) | HI GMT was assessed 21 days after last vaccination (Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naive subjects) pooled GMT values across both naïve and non-naïve subjects are provided for the Day 22/50 (ie, 21 days after last vaccination); Heterologous strains: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013-like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups. |
| Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Heterologous Strains in Terms of Seroconversion (SC) Rates in Subjects ≥6 to <72 Months of Age | 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) | SC rates were assessed on Day 50 (ie, 21 days after two vaccinations) for vaccine naïve subjects; and on Day 22 (ie, 21 days after one vaccination) for vaccine non-naïve subjects; values pooled across naive and non-naive subjects are provided. Seroconversion is defined as HI ≥ 1:40 for subjects negative at baseline (ie, HI titer\<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (ie, HI titer ≥ 1:10); Heterologous strains include: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013- like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups |
| Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 in Subjects ≥6 to <72 Months of Age | 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) | Antibody persistence was assessed as the percentage of subjects with HI titer of ≥1:40 at 21 days after last vaccination (ie, Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects; Heterologous strains: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013- like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups. |
| Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs | 7 days following each vaccination | Subjects ≥6 to \<72 months of age reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with either aQIV or TIV/QIV. |
| Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs | Day 1 though Day 366 (vaccine non-naive)/Day 390 (vaccine naive) | Safety was assessed in terms of number of subjects ≥6 to \<72 months of age reporting unsolicited reactions (Day 1 to Day 50 for vaccine naïve subjects and from Day 1 to Day 22 for vaccine non-naïve subjects); Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases,(NOCD), Adverse Events of Special Interests (AESI), AEs leading to withdrawal from the study or study vaccination after vaccination with either aQIV or TIV/QIV were collected up to 12 months after last vaccination. |
| Healthcare Utilization and Health Economic Endpoints: Number of Days of Daycare, School or Preschool Missed by Subjects Associated With RT-PCR-confirmed Influenza | within a window of 14 days after influenza-like illness (ILI)-onset | — |
| Healthcare Utilization and Health Economic Endpoint: Number of Medical Visit for Respiratory Illness Associated With RT-PCR-confirmed Influenza | within a window of 14 days after ILI-onset | — |
| Healthcare Utilization and Health Economic Endpoint: Number of Employment Days Missed by Parent(s)/Guardian(s) of Subjects With RT-PCR-confirmed Influenza | within a window of 14 days after ILI-onset | — |
| Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2. | ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer | — |
| Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 and Percentage Differences at 180 Days After Last Vaccination in Subjects ≥6 to <72 Months of Age | Baseline (Day 1) and 180 days after the last vaccination (Day 209 for vaccine naive subjects; Day 181 for vaccine non-naïve subjects) | Antibody response was assessed as the percentage of subjects with HI titer of ≥1:40 at 180 days after last vaccination (ie, Day 209 for vaccine naïve subjects and Day 181 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects. Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; B/Victoria results from Season 1 and Season 2 (aQIV) and Season 2 (comparator) are presented. |
Countries
Canada, Finland, Italy, Mexico, Philippines, Poland, Puerto Rico, Spain, Taiwan, Thailand, United States
Participant flow
Recruitment details
Subjects were enrolled from 146 sites in 9 countries.
Pre-assignment details
All enrolled subjects were included in the trial. Non-naive participants received 1 dose of vaccine on Day 1 only. Naive participants received 2 doses of vaccine, the first dose on Day 1 and the second dose on Day 29.
Participants by arm
| Arm | Count |
|---|---|
| aQIV (≥6 to <72 Months) Subjects ≥6 to \<72 months of age who received aQIV | 5,352 |
| TIV/QIV (≥6 to <72 Months) Subjects ≥6 to \<72 months of age who received TIV/QIV | 5,292 |
| Total | 10,644 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative Reason | 103 | 95 |
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Death | 1 | 3 |
| Overall Study | Lost to Follow-up | 254 | 232 |
| Overall Study | Other | 267 | 252 |
| Overall Study | Protocol Violation | 3 | 4 |
| Overall Study | Withdrawal by Subject | 156 | 160 |
Baseline characteristics
| Characteristic | aQIV (≥6 to <72 Months) | Total | TIV/QIV (≥6 to <72 Months) |
|---|---|---|---|
| Age, Continuous | 38.4 months STANDARD_DEVIATION 18.43 | 38.2 months STANDARD_DEVIATION 18.42 | 38 months STANDARD_DEVIATION 18.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 664 Participants | 1296 Participants | 632 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4678 Participants | 9325 Participants | 4647 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 23 Participants | 13 Participants |
| Naivety Status Vaccine Naive | 3611 Participants | 7208 Participants | 3597 Participants |
| Naivety Status Vaccine Non-Naive | 1741 Participants | 3436 Participants | 1695 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 10 Participants | 21 Participants | 11 Participants |
| Race (NIH/OMB) Asian | 2348 Participants | 4709 Participants | 2361 Participants |
| Race (NIH/OMB) Black or African American | 711 Participants | 1403 Participants | 692 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 14 Participants | 30 Participants | 16 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 116 Participants | 237 Participants | 121 Participants |
| Race (NIH/OMB) White | 2153 Participants | 4244 Participants | 2091 Participants |
| Sex: Female, Male Female | 2643 Participants | 5233 Participants | 2590 Participants |
| Sex: Female, Male Male | 2709 Participants | 5411 Participants | 2702 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 5,339 | 3 / 5,272 |
| other Total, other adverse events | 4,627 / 5,339 | 4,430 / 5,272 |
| serious Total, serious adverse events | 234 / 5,243 | 230 / 5,161 |
Outcome results
Primary
Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age
Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects ≥6 to \<72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).
Time frame: ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer
Population: The Full Analysis Set for Efficacy consisting of all enrolled subjects who actually received a study vaccination and were evaluated for efficacy at least 21 days after the last vaccination was used for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age | A/H1N1 | 7 Number of cases |
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age | B/Yamagata | 36 Number of cases |
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age | A/H3N2 | 200 Number of cases |
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age | B/Victoria | 14 Number of cases |
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age | Any strain | 256 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age | B/Victoria | 9 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age | Any strain | 252 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age | A/H1N1 | 17 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age | A/H3N2 | 196 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age | B/Yamagata | 36 Number of cases |
95% CI: [-19.81, 15.41]
Secondary
Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age
Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with culture confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).
Time frame: ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer
Population: The Full Analysis Set for Efficacy consisting of all enrolled subjects who actually received a study vaccination and were evaluated for efficacy at least 21 days after the last vaccination was used for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Any strain | 140 Number of cases |
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Unmatched strain | 65 Number of cases |
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Matched strain | 74 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Unmatched strain | 62 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Matched strain | 80 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Any strain | 146 Number of cases |
| aQIV (≥6 to <36 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Unmatched strain | 12 Number of cases |
| aQIV (≥6 to <36 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Any strain | 31 Number of cases |
| aQIV (≥6 to <36 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Matched strain | 19 Number of cases |
| TIV/QIV (≥6 to <36 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Any strain | 48 Number of cases |
| TIV/QIV (≥6 to <36 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Matched strain | 32 Number of cases |
| TIV/QIV (≥6 to <36 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Unmatched strain | 14 Number of cases |
| aQIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Matched strain | 35 Number of cases |
| aQIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Any strain | 64 Number of cases |
| aQIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Unmatched strain | 29 Number of cases |
| TIV/QIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Matched strain | 42 Number of cases |
| TIV/QIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Any strain | 68 Number of cases |
| TIV/QIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Unmatched strain | 23 Number of cases |
| aQIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Matched strain | 39 Number of cases |
| aQIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Any strain | 76 Number of cases |
| aQIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Unmatched strain | 36 Number of cases |
| TIV/QIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Any strain | 78 Number of cases |
| TIV/QIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Matched strain | 38 Number of cases |
| TIV/QIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age | Unmatched strain | 39 Number of cases |
Secondary
Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately
Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).
Time frame: ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer
Population: The Full Analysis Set for Efficacy consisting of all enrolled subjects who actually received a study vaccination and were evaluated for efficacy at least 21 days after the last vaccination was used for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately | Vaccine Naive RT-PCR | 160 Number of cases |
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately | Vaccine Non-naive RT-PCR | 96 Number of cases |
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately | Vaccine Naive Culture-confirmed | 80 Number of cases |
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately | Vaccine Non-naive Culture-confirmed | 60 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately | Vaccine Non-naive Culture-confirmed | 45 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately | Vaccine Naive RT-PCR | 170 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately | Vaccine Naive Culture-confirmed | 101 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately | Vaccine Non-naive RT-PCR | 82 Number of cases |
Secondary
Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications
Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects ≥6 to \<72 months of age with RT-PCR confirmed and culture confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer, in healthy subjects and subjects at risk of influenza related complications. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).
Time frame: ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer
Population: The Full Analysis Set for Efficacy consisting of all enrolled subjects who actually received a study vaccination and were evaluated for efficacy at least 21 days after the last vaccination was used for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications | Healthy RT-PCR | 244 Number of cases |
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications | High Risk RT-PCR | 12 Number of cases |
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications | Healthy Culture-confirmed | 130 Number of cases |
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications | High Risk Culture-confirmed | 10 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications | High Risk Culture-confirmed | 10 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications | Healthy RT-PCR | 233 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications | Healthy Culture-confirmed | 136 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications | High Risk RT-PCR | 19 Number of cases |
Secondary
Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age.
Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).
Time frame: ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer
Population: The Full Analysis Set for Efficacy consisting of all enrolled subjects who actually received a study vaccination and were evaluated for efficacy at least 21 days after the last vaccination was used for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | B/Yamagata | 5 Number of cases |
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | A/H1N1 | 2 Number of cases |
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | Any Strain | 55 Number of cases |
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | B/Victoria | 4 Number of cases |
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | A/H3N2 | 44 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | A/H1N1 | 5 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | B/Yamagata | 9 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | Any Strain | 79 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | B/Victoria | 0 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | A/H3N2 | 66 Number of cases |
| aQIV (≥6 to <36 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | A/H1N1 | 5 Number of cases |
| aQIV (≥6 to <36 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | B/Yamagata | 13 Number of cases |
| aQIV (≥6 to <36 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | B/Victoria | 5 Number of cases |
| aQIV (≥6 to <36 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | A/H3N2 | 92 Number of cases |
| aQIV (≥6 to <36 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | Any Strain | 115 Number of cases |
| TIV/QIV (≥6 to <36 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | A/H3N2 | 99 Number of cases |
| TIV/QIV (≥6 to <36 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | Any Strain | 119 Number of cases |
| TIV/QIV (≥6 to <36 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | A/H1N1 | 8 Number of cases |
| TIV/QIV (≥6 to <36 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | B/Yamagata | 12 Number of cases |
| TIV/QIV (≥6 to <36 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | B/Victoria | 1 Number of cases |
| aQIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | B/Yamagata | 23 Number of cases |
| aQIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | Any Strain | 141 Number of cases |
| aQIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | B/Victoria | 9 Number of cases |
| aQIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | A/H1N1 | 2 Number of cases |
| aQIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | A/H3N2 | 108 Number of cases |
| TIV/QIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | Any Strain | 133 Number of cases |
| TIV/QIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | B/Yamagata | 24 Number of cases |
| TIV/QIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | A/H1N1 | 9 Number of cases |
| TIV/QIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | B/Victoria | 8 Number of cases |
| TIV/QIV (≥36 to <72 Months) | Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. | A/H3N2 | 97 Number of cases |
Secondary
Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age at ≥7 Days and at ≥14 Days After First Vaccination up to the Day of Second Vaccination in Vaccine naïve Subjects Only
Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was based on the number of vaccine naive subjects ≥6 to \<72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥7 days and ≥14 days after the first vaccination up to the day of the second vaccination. TIV was used as the comparator in Season 1; and QIV was used as the comparator in Season 2. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).
Time frame: ≥7 days and at ≥14 days after first vaccination up to day of second vaccination
Population: Full Analysis Set Early Efficacy: All subjects in the Enrolled Set who actually received a study vaccination and were evaluated for efficacy at least 7 days after the last vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age at ≥7 Days and at ≥14 Days After First Vaccination up to the Day of Second Vaccination in Vaccine naïve Subjects Only | ≥7 days after first and up to second vaccination | 16 Number of cases |
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age at ≥7 Days and at ≥14 Days After First Vaccination up to the Day of Second Vaccination in Vaccine naïve Subjects Only | ≥14 days after first and up to second vaccination | 8 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age at ≥7 Days and at ≥14 Days After First Vaccination up to the Day of Second Vaccination in Vaccine naïve Subjects Only | ≥7 days after first and up to second vaccination | 35 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age at ≥7 Days and at ≥14 Days After First Vaccination up to the Day of Second Vaccination in Vaccine naïve Subjects Only | ≥14 days after first and up to second vaccination | 27 Number of cases |
Secondary
Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age Occurring at ≥7 Days and ≤21 Days After Last Vaccination, in All Subjects.
Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was based on the number of vaccine naïve subjects ≥6 to \<72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥7 days and ≤21 after the last vaccination. TIV was used as the comparator in Season 1; and QIV was used as the comparator in Season 2. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).
Time frame: ≥7 days and ≤21 days after the last vaccination
Population: Full Analysis Set Early Efficacy: All subjects in the Enrolled Set who actually received a study vaccination and were evaluated for efficacy at least 7 days after the last vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| aQIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age Occurring at ≥7 Days and ≤21 Days After Last Vaccination, in All Subjects. | 4 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age Occurring at ≥7 Days and ≤21 Days After Last Vaccination, in All Subjects. | 15 Number of cases |
Secondary
Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2.
Time frame: ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer
Population: Full Analysis Set Health Economic Outcomes (Season 2)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2. | A/H1N1 | 0 Number of cases |
| aQIV (≥6 to <72 Months) | Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2. | B/Yamagata | 4 Number of cases |
| aQIV (≥6 to <72 Months) | Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2. | A/H3N2 | 27 Number of cases |
| aQIV (≥6 to <72 Months) | Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2. | B/Victoria | 3 Number of cases |
| aQIV (≥6 to <72 Months) | Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2. | Any Strain | 34 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2. | B/Victoria | 0 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2. | Any Strain | 32 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2. | A/H1N1 | 1 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2. | A/H3N2 | 29 Number of cases |
| TIV/QIV (≥6 to <72 Months) | Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2. | B/Yamagata | 2 Number of cases |
Secondary
Healthcare Utilization and Health Economic Endpoint: Number of Employment Days Missed by Parent(s)/Guardian(s) of Subjects With RT-PCR-confirmed Influenza
Time frame: within a window of 14 days after ILI-onset
Population: Full Analysis Set Health Economic Outcomes (Season 2): This analysis set includes all subjects in the Enrolled Set in Season 2 who: actually received a study vaccination and provided efficacy data and Health Economic data collected within 14 days of ILI-onset; and had a first-occurrence RT-PCR-confirmed influenza as included in the primary efficacy objective.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Healthcare Utilization and Health Economic Endpoint: Number of Employment Days Missed by Parent(s)/Guardian(s) of Subjects With RT-PCR-confirmed Influenza | 1.0 Number of days | Standard Deviation 1.68 |
| TIV/QIV (≥6 to <72 Months) | Healthcare Utilization and Health Economic Endpoint: Number of Employment Days Missed by Parent(s)/Guardian(s) of Subjects With RT-PCR-confirmed Influenza | 1.0 Number of days | Standard Deviation 1.88 |
Secondary
Healthcare Utilization and Health Economic Endpoint: Number of Medical Visit for Respiratory Illness Associated With RT-PCR-confirmed Influenza
Time frame: within a window of 14 days after ILI-onset
Population: Full Analysis Set Health Economic Outcomes (Season 2): This analysis set includes all subjects in the Enrolled Set in Season 2 who: actually received a study vaccination and provided efficacy data and Health Economic data collected within 14 days of ILI-onset; and had a first-occurrence RT-PCR-confirmed influenza as included in the primary efficacy objective.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Healthcare Utilization and Health Economic Endpoint: Number of Medical Visit for Respiratory Illness Associated With RT-PCR-confirmed Influenza | 1.0 Number of visits | Standard Deviation 0.84 |
| TIV/QIV (≥6 to <72 Months) | Healthcare Utilization and Health Economic Endpoint: Number of Medical Visit for Respiratory Illness Associated With RT-PCR-confirmed Influenza | 1.0 Number of visits | Standard Deviation 0.74 |
Secondary
Healthcare Utilization and Health Economic Endpoints: Number of Days of Daycare, School or Preschool Missed by Subjects Associated With RT-PCR-confirmed Influenza
Time frame: within a window of 14 days after influenza-like illness (ILI)-onset
Population: Full Analysis Set Health Economic Outcomes (Season 2): This analysis set includes all subjects in the Enrolled Set in Season 2 who: actually received a study vaccination and provided efficacy data and Health Economic data collected within 14 days of ILI-onset; and had a first-occurrence RT-PCR-confirmed influenza as included in the primary efficacy objective.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Healthcare Utilization and Health Economic Endpoints: Number of Days of Daycare, School or Preschool Missed by Subjects Associated With RT-PCR-confirmed Influenza | 2.1 Number of days | Standard Deviation 2.43 |
| TIV/QIV (≥6 to <72 Months) | Healthcare Utilization and Health Economic Endpoints: Number of Days of Daycare, School or Preschool Missed by Subjects Associated With RT-PCR-confirmed Influenza | 2.2 Number of days | Standard Deviation 2.48 |
Secondary
Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age
Pooled GMT values across both naïve and non-naïve subjects are provided for the Day 22/50 (ie, 21 days after last vaccination) and Day 181/209 (ie, 180 days after last vaccination) assessments; Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/ Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis.
Time frame: Baseline (Day 1), Day 29, Day 50 and Day 209 for vaccine naïve subjects; Baseline (Day 1), Day 22 and Day 181 for vaccine non-naïve subjects
Population: The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | A/H1N1, Day 1 | 40.08 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | A/H1N1, D22/50 | 996.40 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | A/H1N1, D181/209 | 351.59 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | A/H3N2, Day 1 | 72.96 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | A/H3N2, D22/50 | 1153.4 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | A/H3N2, D181/209 | 458.07 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | B/Yamagata, Day 1 | 10.17 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | B/Yamagata, Day 22/50 | 198.89 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | B/Yamagata, Day 181/209 | 48.65 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | B/Victoria, Day 1 | 10.45 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | B/Victoria, Day 22/50 | 315.52 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | B/Victoria, Day 181/209 | 65.78 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | B/Victoria, Day 22/50 | 138.82 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | A/H1N1, Day 1 | 39.49 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | B/Yamagata, Day 1 | 10.12 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | A/H1N1, D22/50 | 522.50 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | B/Victoria, Day 1 | 10.36 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | A/H1N1, D181/209 | 189.43 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | B/Yamagata, Day 22/50 | 90.68 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | A/H3N2, Day 1 | 70.38 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | B/Victoria, Day 181/209 | 36.46 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | A/H3N2, D22/50 | 674.01 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | B/Yamagata, Day 181/209 | 26.22 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age | A/H3N2, D181/209 | 290.88 titer |
Comparison: GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H1N1, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.95% CI: [1.8, 2]
Comparison: GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H1N1, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.95% CI: [1.7, 2]
Comparison: GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H3N2, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.95% CI: [1.6, 1.8]
Comparison: GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H3N2, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.95% CI: [1.4, 1.7]
Comparison: GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/YAM, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.95% CI: [2, 2.4]
Comparison: GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/YAM, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.95% CI: [1.7, 2]
Comparison: GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/VIC, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.95% CI: [2, 2.6]
Comparison: GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/VIC, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.95% CI: [1.6, 2.1]
Secondary
Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Geometric Mean Titers (GMTs) in Subjects ≥6 to <72 Months of Age
HI GMT was assessed 21 days after last vaccination (Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naive subjects) pooled GMT values across both naïve and non-naïve subjects are provided for the Day 22/50 (ie, 21 days after last vaccination); Heterologous strains: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013-like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups.
Time frame: 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)
Population: The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Geometric Mean Titers (GMTs) in Subjects ≥6 to <72 Months of Age | A/H3N2, D22/50 | 576.84 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Geometric Mean Titers (GMTs) in Subjects ≥6 to <72 Months of Age | B/Victoria, Day 22/50 | 186.65 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Geometric Mean Titers (GMTs) in Subjects ≥6 to <72 Months of Age | B/Yamagata, Day 22/50 | 145.89 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Geometric Mean Titers (GMTs) in Subjects ≥6 to <72 Months of Age | A/H1N1, D22/50 | 7.46 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Geometric Mean Titers (GMTs) in Subjects ≥6 to <72 Months of Age | A/H1N1, D22/50 | 6.52 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Geometric Mean Titers (GMTs) in Subjects ≥6 to <72 Months of Age | A/H3N2, D22/50 | 297.70 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Geometric Mean Titers (GMTs) in Subjects ≥6 to <72 Months of Age | B/Yamagata, Day 22/50 | 67.24 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Geometric Mean Titers (GMTs) in Subjects ≥6 to <72 Months of Age | B/Victoria, Day 22/50 | 88.09 titer |
Secondary
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age
HI GMT was assessed on Day 1 and Day 50 for vaccine naïve healthy vs high risk subjects; and HI GMT were assessed on Day 1 and Day 22 for vaccine non-naïve healthy vs high risk subjects; pooled GMT values across both naïve and non-naïve subjects are provided for Day 22/50 (ie, 21 days after last vaccination) assessments.
Time frame: Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)
Population: The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | A/H1N1, Day 1 | 35.34 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | A/H1N1, Day 22/50 | 988.65 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | A/H3N2, Day 1 | 76.80 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | A/H3N2, Day 22/50 | 1159.57 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | B/YAM, Day 1 | 9.95 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | B/YAM, Day 22/50 | 203.14 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | B/VIC, Day 1 | 10.87 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | B/VIC, Day 22/50 | 323.42 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | A/H3N2, Day 22/50 | 1179.55 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | A/H1N1, Day 1 | 48.29 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | B/VIC, Day 1 | 10.51 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | A/H1N1, Day 22/50 | 906.86 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | B/VIC, Day 22/50 | 298.20 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | B/YAM, Day 1 | 11.72 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | A/H3N2, Day 1 | 104.07 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | B/YAM, Day 22/50 | 198.58 titer |
| aQIV (≥6 to <36 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | B/VIC, Day 22/50 | 151.17 titer |
| aQIV (≥6 to <36 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | B/VIC, Day 1 | 8.17 titer |
| aQIV (≥6 to <36 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | A/H1N1, Day 1 | 31.64 titer |
| aQIV (≥6 to <36 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | A/H3N2, Day 22/50 | 693.27 titer |
| aQIV (≥6 to <36 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | B/YAM, Day 1 | 8.76 titer |
| aQIV (≥6 to <36 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | B/YAM, Day 22/50 | 94.76 titer |
| aQIV (≥6 to <36 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | A/H1N1, Day 22/50 | 563.87 titer |
| aQIV (≥6 to <36 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | A/H3N2, Day 1 | 55.08 titer |
| TIV/QIV (≥6 to <36 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | A/H1N1, Day 22/50 | 533.71 titer |
| TIV/QIV (≥6 to <36 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | A/H3N2, Day 1 | 59.89 titer |
| TIV/QIV (≥6 to <36 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | A/H3N2, Day 22/50 | 680.08 titer |
| TIV/QIV (≥6 to <36 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | B/YAM, Day 1 | 10.18 titer |
| TIV/QIV (≥6 to <36 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | B/YAM, Day 22/50 | 89.59 titer |
| TIV/QIV (≥6 to <36 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | B/VIC, Day 22/50 | 138.94 titer |
| TIV/QIV (≥6 to <36 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | A/H1N1, Day 1 | 45.12 titer |
| TIV/QIV (≥6 to <36 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age | B/VIC, Day 1 | 9.03 titer |
Comparison: aQIV GMT ratio (High risk/Healthy) for A/H1N1 at D22/50 (Pooled Naïve \& Non-naïve).95% CI: [0.8, 1]
Comparison: aQIV GMT ratio (High risk/Healthy) for A/H3N2 at D22/50 (Pooled Naïve \& Non-naïve).95% CI: [0.9, 1.1]
Comparison: aQIV GMT ratio (High risk/Healthy) for B/YAM at D22/50 (Pooled Naïve \& Non-naïve).95% CI: [0.8, 1.1]
Comparison: aQIV GMT ratio (High risk/Healthy) for B/VIC at D22/50 (Pooled Naïve \& Non-naïve).95% CI: [0.8, 1.1]
Comparison: TIV/QIV GMT ratio (High risk/Healthy) for A/H1N1 at D22/50 (Pooled Naïve \& Non-naïve).95% CI: [0.8, 1.1]
Comparison: TIV/QIV GMT ratio (High risk/Healthy) for A/H3N2 at D22/50 (Pooled Naïve \& Non-naïve).95% CI: [0.8, 1.1]
Comparison: TIV/QIV GMT ratio (High risk/Healthy) for B/YAM at D22/50 (Pooled Naïve \& Non-naïve).95% CI: [0.8, 1.1]
Comparison: TIV/QIV GMT ratio (High risk/Healthy) for B/VIC at D22/50 (Pooled Naïve \& Non-naïve).95% CI: [0.7, 1.2]
Secondary
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age
The fold-increase in HI antibodies in response to vaccination was assessed as the GMR between all post-vaccination titers (ie, Day 29, 50, 209 for vaccine naïve subjects; Day 22, 181 for vaccine non-naïve subjects) and the baseline (Day 1) titer. Assessed GMRs thus correspond to Day 29/Day 1, Day 50/Day 1, and Day 209/Day 1 for vaccine naïve subjects and Day 22/Day 1 and Day 181/Day 1 for vaccine non-naïve subjects. Pooled GMR values across both naïve and non-naïve subjects are provided for Day (22/50)/Day 1 (ie, 21 days after last vaccination) and Day (181/209)/Day 1 (ie, 180 days after last vaccination); Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis.
Time frame: Baseline (Day 1), Day 29, Day 50 and Day 209 for vaccine naïve subjects; Baseline (Day 1), Day 22 and Day 181 for vaccine non-naïve subjects
Population: The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age | A/H1N1, Day 22/50:Day 1 | 24.96 ratio |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age | A/H3N2, Day 22/50:Day 1 | 21.68 ratio |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age | B/Yamagata, Day 22/50:Day 1 | 18.08 ratio |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age | B/Victoria, Day 22/50/Day 1 | 29.70 ratio |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age | A/H1N1, Day 181/209:Day 1 | 8.57 ratio |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age | A/H3N2, Day 181/209:Day 1 | 8.64 ratio |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age | B/Yamagata Day 181/209:Day 1 | 4.38 ratio |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age | B/Victoria, Day 181/209/Day 1 | 6.28 ratio |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age | B/Victoria, Day 181/209/Day 1 | 3.56 ratio |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age | A/H1N1, Day 22/50:Day 1 | 13.09 ratio |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age | A/H1N1, Day 181/209:Day 1 | 4.62 ratio |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age | A/H3N2, Day 22/50:Day 1 | 12.67 ratio |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age | B/Yamagata Day 181/209:Day 1 | 2.36 ratio |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age | B/Yamagata, Day 22/50:Day 1 | 8.25 ratio |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age | A/H3N2, Day 181/209:Day 1 | 5.49 ratio |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age | B/Victoria, Day 22/50/Day 1 | 13.28 ratio |
Secondary
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age
GMTs for vaccine naïve subjects are provided by strain for Day 29 and Day 50; Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/ Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis.
Time frame: Day 29 and Day 50
Population: The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age | A/H1N1, Day 29 | 483.55 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age | A/H1N1, Day 50 | 1065.19 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age | A/H3N2, Day 29 | 742.82 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age | A/H3N2, Day 50 | 1275.18 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age | B/Yamagata, Day 29 | 62.73 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age | B/Yamagata, Day 50 | 224.77 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age | B/Victoria, Day 29 | 81.98 titer |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age | B/Victoria, Day 50 | 418.16 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age | B/Victoria, Day 50 | 160.35 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age | A/H1N1, Day 29 | 172.92 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age | B/Yamagata, Day 29 | 31.40 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age | A/H1N1, Day 50 | 553.57 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age | B/Victoria, Day 29 | 33.44 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age | A/H3N2, Day 29 | 342.90 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age | B/Yamagata, Day 50 | 86.91 titer |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age | A/H3N2, Day 50 | 720.44 titer |
Secondary
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 and Percentage Differences at 180 Days After Last Vaccination in Subjects ≥6 to <72 Months of Age
Antibody response was assessed as the percentage of subjects with HI titer of ≥1:40 at 180 days after last vaccination (ie, Day 209 for vaccine naïve subjects and Day 181 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects. Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; B/Victoria results from Season 1 and Season 2 (aQIV) and Season 2 (comparator) are presented.
Time frame: Baseline (Day 1) and 180 days after the last vaccination (Day 209 for vaccine naive subjects; Day 181 for vaccine non-naïve subjects)
Population: The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 and Percentage Differences at 180 Days After Last Vaccination in Subjects ≥6 to <72 Months of Age | A/H1N1 | 97.1 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 and Percentage Differences at 180 Days After Last Vaccination in Subjects ≥6 to <72 Months of Age | A/H3N2 | 98.1 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 and Percentage Differences at 180 Days After Last Vaccination in Subjects ≥6 to <72 Months of Age | B/Yamagata | 66.6 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 and Percentage Differences at 180 Days After Last Vaccination in Subjects ≥6 to <72 Months of Age | B/Victoria | 74.0 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 and Percentage Differences at 180 Days After Last Vaccination in Subjects ≥6 to <72 Months of Age | B/Victoria | 53.1 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 and Percentage Differences at 180 Days After Last Vaccination in Subjects ≥6 to <72 Months of Age | A/H1N1 | 85.6 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 and Percentage Differences at 180 Days After Last Vaccination in Subjects ≥6 to <72 Months of Age | B/Yamagata | 44.7 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 and Percentage Differences at 180 Days After Last Vaccination in Subjects ≥6 to <72 Months of Age | A/H3N2 | 90.2 percentage of subjects |
Comparison: Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for A/H1N1.95% CI: [9.4, 13.7]
Comparison: Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for A/H3N2.95% CI: [6.1, 9.7]
Comparison: Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for B/YAM.95% CI: [18.1, 25.6]
Comparison: Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for B/VIC.95% CI: [15.9, 25.7]
Secondary
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age
Antibody response was assessed as the percentage of subjects and differences of percentage of subjects with HI titers of ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 at 21 days after last vaccination (ie, Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects. Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; B/Victoria results from Season 1 and Season 2 (aQIV) and Season 2 (comparator) are presented.
Time frame: Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)
Population: The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:110, A/H1N1, Day 22/50 | 97.3 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:151, A/H1N1, Day 22/50 | 96.5 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:215, A/H1N1, Day 22/50 | 94.0 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:330, A/H1N1, Day 22/50 | 83.8 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:629, A/H1N1, Day 22/50 | 76.2 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:110, A/H3N2, Day 22/50 | 99.0 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:151, A/H3N2, Day 22/50 | 98.4 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:215, A/H3N2, Day 22/50 | 96.5 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:330, A/H3N2, Day 22/50 | 89.4 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:629, A/H3N2, Day 22/50 | 84.2 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:110, B/YAM, Day 22/50 | 69.4 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:151, B/YAM, Day 22/50 | 60.7 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:215, B/YAM, Day 22/50 | 45.6 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:330, B/YAM, Day 22/50 | 24.9 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:629, B/YAM, Day 22/50 | 16.2 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:110, B/VIC, Day 22/50 | 78.3 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:151, B/VIC, Day 22/50 | 73.5 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:215, B/VIC, Day 22/50 | 62.3 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:330, B/VIC, Day 22/50 | 41.7 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:629, B/VIC, Day 22/50 | 31.9 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:215, B/VIC, Day 22/50 | 38.6 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:110, A/H1N1, Day 22/50 | 89.5 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:110, B/YAM, Day 22/50 | 40.6 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:151, A/H1N1, Day 22/50 | 86.8 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:110, B/VIC, Day 22/50 | 58.1 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:215, A/H1N1, Day 22/50 | 77.9 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:151, B/YAM, Day 22/50 | 34.4 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:330, A/H1N1, Day 22/50 | 60.7 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:629, B/VIC, Day 22/50 | 16.9 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:629, A/H1N1, Day 22/50 | 52.1 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:215, B/YAM, Day 22/50 | 23.8 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:110, A/H3N2, Day 22/50 | 93.0 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:151, B/VIC, Day 22/50 | 52.4 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:151, A/H3N2, Day 22/50 | 90.6 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:330, B/YAM, Day 22/50 | 13.3 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:215, A/H3N2, Day 22/50 | 84.8 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:330, B/VIC, Day 22/50 | 21.8 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:330, A/H3N2, Day 22/50 | 70.4 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:629, B/YAM, Day 22/50 | 9.4 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age | HI Titers ≥1:629, A/H3N2, Day 22/50 | 63.1 percentage of subjects |
Comparison: Difference in HI titers ≥ 1:110 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.95% CI: [5.9, 9.7]
Comparison: Difference in HI Titers ≥ 1:151 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.95% CI: [7.8, 11.9]
Comparison: Difference in HI Titers ≥ 1:215 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.95% CI: [13.5, 18.7]
Comparison: Difference in HI Titers ≥ 1:330 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.95% CI: [19.8, 26.4]
Comparison: Difference in HI Titers ≥ 1:629 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.95% CI: [20.6, 27.6]
Comparison: Difference in HI Titers ≥ 1:110 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.95% CI: [4.5, 7.5]
Comparison: Difference in HI Titers ≥ 1:151 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.95% CI: [6.1, 9.6]
Comparison: Difference in HI Titers ≥ 1:215 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.95% CI: [9.6, 13.9]
Comparison: Difference in HI Titers ≥ 1:330 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.95% CI: [16.1, 22]
Comparison: Difference in HI Titers ≥ 1:629 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.95% CI: [17.8, 24.3]
Comparison: Difference in HI Titers ≥ 1:110 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.95% CI: [25.1, 32.3]
Comparison: Difference in HI Titers ≥ 1:151 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.95% CI: [22.6, 29.9]
Comparison: Difference in HI Titers ≥ 1:215 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.95% CI: [18.3, 25.3]
Comparison: Difference in HI Titers ≥ 1:330 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.95% CI: [8.6, 14.5]
Comparison: Difference in HI Titers ≥ 1:629 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.95% CI: [4.3, 9.4]
Secondary
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Seroconversion (SC) Rates and Difference in SC Rates at 21 Days in Subjects ≥6 to <72 Months of Age
SC rates were assessed on Day 1 and Day 50 (ie, 21 days after two vaccinations) for vaccine naïve subjects; and on Day 1 and Day 22 (ie, 21 days after one vaccination) for vaccine non-naïve subjects; values pooled across naive and non-naive subjects are provided. Seroconversion is defined as HI ≥ 1:40 for subjects negative at baseline (ie, HI titer\<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (ie, HI titer ≥ 1:10); Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strain: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine. comparison analysis (N=745 for aQIV, N=738 for comparator).
Time frame: Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)
Population: The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Seroconversion (SC) Rates and Difference in SC Rates at 21 Days in Subjects ≥6 to <72 Months of Age | A/H1N1 | 81.9 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Seroconversion (SC) Rates and Difference in SC Rates at 21 Days in Subjects ≥6 to <72 Months of Age | A/H3N2 | 78.4 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Seroconversion (SC) Rates and Difference in SC Rates at 21 Days in Subjects ≥6 to <72 Months of Age | B/Yamagata | 86.0 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Seroconversion (SC) Rates and Difference in SC Rates at 21 Days in Subjects ≥6 to <72 Months of Age | B/Victoria | 91.0 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Seroconversion (SC) Rates and Difference in SC Rates at 21 Days in Subjects ≥6 to <72 Months of Age | B/Victoria | 77.4 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Seroconversion (SC) Rates and Difference in SC Rates at 21 Days in Subjects ≥6 to <72 Months of Age | A/H1N1 | 73.7 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Seroconversion (SC) Rates and Difference in SC Rates at 21 Days in Subjects ≥6 to <72 Months of Age | B/Yamagata | 64.7 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Seroconversion (SC) Rates and Difference in SC Rates at 21 Days in Subjects ≥6 to <72 Months of Age | A/H3N2 | 73.2 percentage of subjects |
Comparison: Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for A/H1N1.95% CI: [5, 11.3]
Comparison: Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for A/H3N2.95% CI: [1.9, 8.4]
Comparison: Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for B/YAM.95% CI: [18.1, 24.5]
Comparison: Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for B/VIC.95% CI: [10, 17.3]
Secondary
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 in Subjects ≥6 to <72 Months of Age
Antibody persistence was assessed as the percentage of subjects with HI titer of ≥1:40 at 21 days after last vaccination (ie, Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects; Heterologous strains: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013- like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups.
Time frame: 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)
Population: The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 in Subjects ≥6 to <72 Months of Age | A/H1N1 | 6.1 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 in Subjects ≥6 to <72 Months of Age | A/H3N2 | 99.3 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 in Subjects ≥6 to <72 Months of Age | B/Yamagata | 88.8 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 in Subjects ≥6 to <72 Months of Age | B/Victoria | 95.7 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 in Subjects ≥6 to <72 Months of Age | B/Victoria | 83.4 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 in Subjects ≥6 to <72 Months of Age | A/H1N1 | 3.4 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 in Subjects ≥6 to <72 Months of Age | B/Yamagata | 68.2 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 in Subjects ≥6 to <72 Months of Age | A/H3N2 | 93.1 percentage of subjects |
Secondary
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Heterologous Strains in Terms of Seroconversion (SC) Rates in Subjects ≥6 to <72 Months of Age
SC rates were assessed on Day 50 (ie, 21 days after two vaccinations) for vaccine naïve subjects; and on Day 22 (ie, 21 days after one vaccination) for vaccine non-naïve subjects; values pooled across naive and non-naive subjects are provided. Seroconversion is defined as HI ≥ 1:40 for subjects negative at baseline (ie, HI titer\<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (ie, HI titer ≥ 1:10); Heterologous strains include: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013- like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups
Time frame: 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)
Population: The Full Analysis Set for Immunogenicity consisting of all enrolled/randomized subjects who received a study vaccination AND provided evaluable serum samples (immunogenicity) for both before (baseline) and after vaccination was used for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Heterologous Strains in Terms of Seroconversion (SC) Rates in Subjects ≥6 to <72 Months of Age | A/H1N1 | 2.7 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Heterologous Strains in Terms of Seroconversion (SC) Rates in Subjects ≥6 to <72 Months of Age | A/H3N2 | 86.0 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Heterologous Strains in Terms of Seroconversion (SC) Rates in Subjects ≥6 to <72 Months of Age | B/Yamagata | 82.7 percentage of subjects |
| aQIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Heterologous Strains in Terms of Seroconversion (SC) Rates in Subjects ≥6 to <72 Months of Age | B/Victoria | 90.7 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Heterologous Strains in Terms of Seroconversion (SC) Rates in Subjects ≥6 to <72 Months of Age | B/Victoria | 75.8 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Heterologous Strains in Terms of Seroconversion (SC) Rates in Subjects ≥6 to <72 Months of Age | A/H1N1 | 1.4 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Heterologous Strains in Terms of Seroconversion (SC) Rates in Subjects ≥6 to <72 Months of Age | B/Yamagata | 59.9 percentage of subjects |
| TIV/QIV (≥6 to <72 Months) | Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Heterologous Strains in Terms of Seroconversion (SC) Rates in Subjects ≥6 to <72 Months of Age | A/H3N2 | 73.4 percentage of subjects |
Secondary
Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs
Subjects ≥6 to \<72 months of age reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with either aQIV or TIV/QIV.
Time frame: 7 days following each vaccination
Population: The Solicited Safety Set consisting of all subjects who received a study vaccination and had any assessment of local and systemic reactions and/or assessment of any use of analgesics/antipyretics was used for analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs | Local | 2651 Participants |
| aQIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs | Others | 1536 Participants |
| aQIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs | Systemic | 2714 Participants |
| aQIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs | Any | 3748 Participants |
| TIV/QIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs | Systemic | 2174 Participants |
| TIV/QIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs | Local | 2188 Participants |
| TIV/QIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs | Any | 3242 Participants |
| TIV/QIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs | Others | 907 Participants |
Secondary
Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs
Safety was assessed in terms of number of subjects ≥6 to \<72 months of age reporting unsolicited reactions (Day 1 to Day 50 for vaccine naïve subjects and from Day 1 to Day 22 for vaccine non-naïve subjects); Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases,(NOCD), Adverse Events of Special Interests (AESI), AEs leading to withdrawal from the study or study vaccination after vaccination with either aQIV or TIV/QIV were collected up to 12 months after last vaccination.
Time frame: Day 1 though Day 366 (vaccine non-naive)/Day 390 (vaccine naive)
Population: The Unsolicited Safety Set consisting of all subjects who received a study vaccination and had any AE assessments was used for analysis (ie, a subject did not have to have an AE to be included in this population).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| aQIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs | Any unsolicited AEs | 3576 Participants |
| aQIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs | Possibly or probably related unsolicited AEs | 686 Participants |
| aQIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs | SAEs | 234 Participants |
| aQIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs | Possibly or probably related SAEs | 6 Participants |
| aQIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs | AEs with an outcome of death | 1 Participants |
| aQIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs | AEs leading to withdrawal | 10 Participants |
| aQIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs | AEs leading to NOCD | 87 Participants |
| aQIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs | AESIs | 5 Participants |
| TIV/QIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs | AESIs | 4 Participants |
| TIV/QIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs | Any unsolicited AEs | 3543 Participants |
| TIV/QIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs | AEs with an outcome of death | 3 Participants |
| TIV/QIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs | Possibly or probably related unsolicited AEs | 533 Participants |
| TIV/QIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs | AEs leading to NOCD | 96 Participants |
| TIV/QIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs | SAEs | 230 Participants |
| TIV/QIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs | AEs leading to withdrawal | 9 Participants |
| TIV/QIV (≥6 to <72 Months) | Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs | Possibly or probably related SAEs | 1 Participants |