Influenza
Conditions
Keywords
Influenza, Influenza vaccine, Novartis, children
Brief summary
Evaluate safety and immunogenicity of three influenza vaccines in children ages greater than 4 years old to less than 18 years old.
Interventions
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female aged 4 years to less than 18 years of age. 2. Individual who had a parent or guardian who could give written informed consent after understanding the nature of the study and comply with study procedures and were available for follow-up. 3. If the individual was of an age where, according to local regulations, informed assent is required, that individual had provided assent to participate in the study.
Exclusion criteria
1. Individuals recently vaccinated against influenza 2. Subjects with contraindications to receive influenza vaccine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | Day 1,Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) | Immunogenicity of QIVc to comparator TIV1c (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by hemagglutination inhibition (HI) assay, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c. Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5. |
| Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c | Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) | Immunogenicity of QIVc to comparator TIVc (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase (at least a 4-fold increase in HI titer in subjects seropositive at baseline \[i.e., HI titer ≥1:10 at Day 1\] ) in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer \<1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age | Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) | Immunogenicity was measured in subjects (Previously vaccinated and Not previously vaccinated) as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c .For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The CHMP criterion for GMR in adult population is \>2.5 |
| GMT in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c Against B2 Strain | Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) | Immunogenicity of QIVc to comparator TIV1c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses of either QIVc or TIV1c. Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody did not exceed the superiority margin of 1 |
| Percentages of Subjects Achieving Seroconversion Against B2 Strain After One or Two Doses of Either QIVc or TIV1c | Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) | Immunogenicity of QIVc to comparator TIV1c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks after last vaccination with QIVc or TIV1c. Superiority criterion was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 0 points |
| Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) | Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c. The CBER criterion for adult population was that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70% |
| Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc or TIV2c | Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) | Immunogenicity of QIVc to comparator TIV2c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks after last vaccination with QIVc or TIV2c. Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody does not exceed the margin of 0 points |
| Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Day 1 to 7 after last vaccination | Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting solicited local and systemic reactions, day 1 to 7 after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c.For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c. |
| Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | Day 1 to 210 post vaccination | Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting unsolicited AEs (day 1 to 22 for Previously vaccinated and day 1 to day 50 for Not previously vaccinated subjects), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 for Previously vaccinated and day 1 to day 210 for Not previously vaccinated subjects) after receiving one or two doses of either QIVc, TIV1c or TIV2c. For A/H1N1, A/H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c. |
| GMT in Subjects After Receiving One or Two Doses of Either QIVc,TIV2c Against B1 Strain | Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) | Immunogenicity of QIVc to comparator TIV2c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses of either QIVc or TIV2c. Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1 |
| Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) | Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer \<1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer. The Center for Biologics Evaluation, Research, and Review (CBER) criterion for an adult population is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 90 centers in the United States (US)
Pre-assignment details
All enrolled subjects were included in the trial
Participants by arm
| Arm | Count |
|---|---|
| QIVc Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season | 1,159 |
| TIV1c Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season | 593 |
| TIV2c Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 | 581 |
| Total | 2,333 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative reasons | 2 | 0 | 0 |
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 46 | 22 | 26 |
| Overall Study | noncompliance and were unavailable | 7 | 3 | 2 |
| Overall Study | Withdrawal by Subject | 13 | 7 | 8 |
Baseline characteristics
| Characteristic | QIVc | TIV1c | TIV2c | Total |
|---|---|---|---|---|
| Age, Continuous | 9.5 year STANDARD_DEVIATION 3.8 | 9.5 year STANDARD_DEVIATION 3.8 | 9.3 year STANDARD_DEVIATION 3.7 | 9.5 year STANDARD_DEVIATION 3.8 |
| Sex: Female, Male Female | 556 Participants | 284 Participants | 284 Participants | 1124 Participants |
| Sex: Female, Male Male | 603 Participants | 309 Participants | 297 Participants | 1209 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 840 / 1,149 | 417 / 579 | 392 / 570 | 1,649 / 2,298 |
| serious Total, serious adverse events | 6 / 1,149 | 7 / 579 | 2 / 570 | 15 / 2,298 |
Outcome results
Primary
Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c
Immunogenicity of QIVc to comparator TIV1c (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by hemagglutination inhibition (HI) assay, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c. Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5.
Time frame: Day 1,Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Population: Analysis was done on Per Protocol (PP) Population i.e. all subjects in the Full Analysis Set (FAS) efficacy/immunogenicity population correctly received the vaccine, had no major protocol deviations leading to exclusion as defined prior to unblinding/analysis and are not excluded due to other reasons defined prior to unblinding or analysis
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QIVc (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | B1: Day 1 (N=1013, 510) | 26 Titers |
| QIVc (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | A/H1N1: Day 1 (N=1014, 510) | 96 Titers |
| QIVc (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | A/H1N1: Day 22/Day 50 (N=1014, 510) | 1090 Titers |
| QIVc (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | A/H3N2: Day 22/Day 50 (N=1013, 510) | 738 Titers |
| QIVc (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | A/H3N2: Day 1 (N=1013, 510) | 206 Titers |
| QIVc (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | B2: Day 1(N=1009, 501) | 23 Titers |
| QIVc (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | B1: Day 22/Day 50 (N=1013, 510) | 155 Titers |
| QIVc (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | B2: Day 22/Day 50 (N=1009, 501) | 185 Titers |
| TIV1c (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | B2: Day 22/Day 50 (N=1009, 501) | NA Titers |
| TIV1c (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | A/H1N1: Day 22/Day 50 (N=1014, 510) | 1125 Titers |
| TIV1c (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | A/H3N2: Day 1 (N=1013, 510) | 196 Titers |
| TIV1c (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | B1: Day 1 (N=1013, 510) | 23 Titers |
| TIV1c (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | A/H1N1: Day 1 (N=1014, 510) | 100 Titers |
| TIV1c (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | A/H3N2: Day 22/Day 50 (N=1013, 510) | 776 Titers |
| TIV1c (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | B1: Day 22/Day 50 (N=1013, 510) | 154 Titers |
| TIV1c (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | B2: Day 1(N=1009, 501) | NA Titers |
| TIV2c (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | B1: Day 22/Day 50 (N=1013, 510) | NA Titers |
| TIV2c (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | A/H3N2: Day 22/Day 50 (N=1013, 510) | NA Titers |
| TIV2c (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | B2: Day 22/Day 50 (N=1009, 501) | 185 Titers |
| TIV2c (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | B2: Day 1(N=1009, 501) | 23 Titers |
| TIV2c (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | B1: Day 1 (N=1013, 510) | NA Titers |
| TIV2c (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | A/H1N1: Day 22/Day 50 (N=1014, 510) | NA Titers |
| TIV2c (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | A/H3N2: Day 1 (N=1013, 510) | NA Titers |
| TIV2c (≥4 to <18 Years) | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | A/H1N1: Day 1 (N=1014, 510) | NA Titers |
Comparison: Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain A/H1N195% CI: [0.93, 1.14]ANCOVA
Comparison: Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain A/H3N295% CI: [0.97, 1.14]ANCOVA
Comparison: Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain B195% CI: [0.89, 1.1]ANCOVA
Comparison: Non-inferiority of immune responses of QIVc to TIV2c, assessed in terms of ratios of GMT against influenza strain B295% CI: [0.87, 1.14]ANCOVA
Primary
Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c
Immunogenicity of QIVc to comparator TIVc (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase (at least a 4-fold increase in HI titer in subjects seropositive at baseline \[i.e., HI titer ≥1:10 at Day 1\] ) in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer \<1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.
Time frame: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Population: Analysis was done on PP population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c | A/H1N1: Day 22/Day 50 (N=1014,510) | 72 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c | B1: Day 22/Day 50 (N=1013,510) | 66 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c | A/H3N2: Day 22/Day 50 (N=1013, 510) | 47 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c | B2: Day 22/Day 50 (N=1009,501) | 73 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c | B1: Day 22/Day 50 (N=1013,510) | 66 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c | B2: Day 22/Day 50 (N=1009,501) | NA percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c | A/H1N1: Day 22/Day 50 (N=1014,510) | 75 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c | A/H3N2: Day 22/Day 50 (N=1013, 510) | 51 percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c | A/H3N2: Day 22/Day 50 (N=1013, 510) | NA percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c | A/H1N1: Day 22/Day 50 (N=1014,510) | NA percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c | B2: Day 22/Day 50 (N=1009,501) | 71 percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c | B1: Day 22/Day 50 (N=1013,510) | NA percentages of subjects |
Comparison: Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain A/H1N195% CI: [-2.5, 6.9]ANCOVA
Comparison: Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain A/H3N295% CI: [-1.4, 9.2]ANCOVA
Comparison: Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain B195% CI: [-5.5, 4.5]ANCOVA
Comparison: Non-inferiority of immune responses of QIVc to TIV2c in terms of differences in seroconversion rates against influenza strain B295% CI: [-6.5, 3.2]ANCOVA
Secondary
Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age
Immunogenicity was measured in subjects (Previously vaccinated and Not previously vaccinated) as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c .For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The CHMP criterion for GMR in adult population is \>2.5
Time frame: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Population: Analysis was done on FAS immunogenicity set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QIVc (≥4 to <18 Years) | Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age | A/H1N1: TIV1c/QIVc [Day 22 (Day 50)/Day1] | 11 Ratios |
| QIVc (≥4 to <18 Years) | Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age | B1: TIV1c/QIVc [Day 22 (Day 50)/Day1] | 6.15 Ratios |
| QIVc (≥4 to <18 Years) | Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age | A/H3N2: TIV1c/QIVc [Day 22 (Day 50)/Day1] | 3.65 Ratios |
| QIVc (≥4 to <18 Years) | Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age | B2: TIV2c/QIVc [Day 22 (Day 50)/Day1] | 8.17 Ratios |
| TIV1c (≥4 to <18 Years) | Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age | A/H1N1: TIV1c/QIVc [Day 22 (Day 50)/Day1] | 12 Ratios |
| TIV1c (≥4 to <18 Years) | Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age | A/H3N2: TIV1c/QIVc [Day 22 (Day 50)/Day1] | 3.97 Ratios |
| TIV1c (≥4 to <18 Years) | Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age | B1: TIV1c/QIVc [Day 22 (Day 50)/Day1] | 6.24 Ratios |
| TIV1c (≥4 to <18 Years) | Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age | B2: TIV2c/QIVc [Day 22 (Day 50)/Day1] | NA Ratios |
| TIV2c (≥4 to <18 Years) | Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age | B1: TIV1c/QIVc [Day 22 (Day 50)/Day1] | NA Ratios |
| TIV2c (≥4 to <18 Years) | Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age | A/H1N1: TIV1c/QIVc [Day 22 (Day 50)/Day1] | NA Ratios |
| TIV2c (≥4 to <18 Years) | Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age | A/H3N2: TIV1c/QIVc [Day 22 (Day 50)/Day1] | NA Ratios |
| TIV2c (≥4 to <18 Years) | Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age | B2: TIV2c/QIVc [Day 22 (Day 50)/Day1] | 8.45 Ratios |
Secondary
GMT in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c Against B2 Strain
Immunogenicity of QIVc to comparator TIV1c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses of either QIVc or TIV1c. Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody did not exceed the superiority margin of 1
Time frame: Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Population: Analysis was done on FAS population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QIVc (≥4 to <18 Years) | GMT in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c Against B2 Strain | Day1(N=1108,563) | 22 Titers |
| QIVc (≥4 to <18 Years) | GMT in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c Against B2 Strain | Day 22/Day 50(N=1108,563) | 176 Titers |
| TIV1c (≥4 to <18 Years) | GMT in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c Against B2 Strain | Day 22/Day 50(N=1108,563) | 45 Titers |
| TIV1c (≥4 to <18 Years) | GMT in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c Against B2 Strain | Day1(N=1108,563) | 21 Titers |
Comparison: Superiority of immune responses of QIVc to TIV1c in terms of ratios of GMT against influenza strain B2.The upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c/GMTQIVc) for HI antibody should not exceed the superiority margin of 1 met.95% CI: [0.22, 0.29]
Secondary
GMT in Subjects After Receiving One or Two Doses of Either QIVc,TIV2c Against B1 Strain
Immunogenicity of QIVc to comparator TIV2c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses of either QIVc or TIV2c. Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1
Time frame: Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Population: Analysis was done on FAS population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QIVc (≥4 to <18 Years) | GMT in Subjects After Receiving One or Two Doses of Either QIVc,TIV2c Against B1 Strain | Day1(N=1112,557) | 25 Titers |
| QIVc (≥4 to <18 Years) | GMT in Subjects After Receiving One or Two Doses of Either QIVc,TIV2c Against B1 Strain | Day 22/Day 50(N=1112,557) | 154 Titers |
| TIV1c (≥4 to <18 Years) | GMT in Subjects After Receiving One or Two Doses of Either QIVc,TIV2c Against B1 Strain | Day1(N=1112,557) | 24 Titers |
| TIV1c (≥4 to <18 Years) | GMT in Subjects After Receiving One or Two Doses of Either QIVc,TIV2c Against B1 Strain | Day 22/Day 50(N=1112,557) | 59 Titers |
Comparison: Superiority of immune responses of QIVc to TIV2c in terms of ratios of GMT against influenza strain B1.The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMTQIVc) for HI antibody should not exceed the superiority margin of 1 met.95% CI: [0.35, 0.42]
Secondary
Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata
Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting solicited local and systemic reactions, day 1 to 7 after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c.For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c.
Time frame: Day 1 to 7 after last vaccination
Population: Analysis was done on solicited safety data set i.e. all subjects in the exposed set with solicited adverse event data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Vomiting | 8 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Nausea | 0 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Change of eating habits | 19 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Chills | 10 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Treatment | 12 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Body temperature(>=38C) | 7 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Headache | 0 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Tenderness | 83 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any systemic | 51 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Induration | 24 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Irritability | 29 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Diarrhea | 8 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any local | 103 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Arthralgia | 0 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Myalgia | 0 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Preventive | 13 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Loss of appetite | 0 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Sleepiness | 34 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Fatigue | 0 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Ecchymosis | 16 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Erythema | 32 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Pain | 0 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any local | 51 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Preventive | 1 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Chills | 2 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Sleepiness | 11 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Arthralgia | 0 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Myalgia | 0 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Pain | 0 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Change of eating habits | 6 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any systemic | 18 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Irritability | 9 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Fatigue | 0 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Vomiting | 2 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Diarrhea | 2 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Induration | 18 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Treatment | 4 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Erythema | 21 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Ecchymosis | 10 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Loss of appetite | 0 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Tenderness | 41 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Headache | 0 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Nausea | 0 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Body temperature(>=38C) | 4 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Fatigue | 0 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Irritability | 9 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Ecchymosis | 7 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Body temperature(>=38C) | 3 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Change of eating habits | 6 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Myalgia | 0 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Chills | 1 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Loss of appetite | 0 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Tenderness | 40 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Nausea | 0 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Arthralgia | 0 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Headache | 0 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Pain | 0 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any local | 47 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Diarrhea | 2 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Induration | 12 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Vomiting | 2 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Sleepiness | 9 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Treatment | 3 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Preventive | 1 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any systemic | 17 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Erythema | 16 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Change of eating habits | 9 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Irritability | 15 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Treatment | 2 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Sleepiness | 13 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Tenderness | 49 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Nausea | 0 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Myalgia | 0 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Preventive | 2 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Arthralgia | 0 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Headache | 0 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Fatigue | 0 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Body temperature(>=38C) | 4 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any local | 52 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Loss of appetite | 0 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Ecchymosis | 6 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Erythema | 17 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Diarrhea | 3 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Induration | 11 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Pain | 0 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any systemic | 30 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Vomiting | 3 Subjects |
| QIVc _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Chills | 4 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Chills | 2 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Body temperature(>=38C) | 1 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Irritability | 6 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Headache | 0 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Induration | 2 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Diarrhea | 1 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Loss of appetite | 0 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Treatment | 2 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Vomiting | 0 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Nausea | 0 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any local | 17 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Change of eating habits | 3 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Ecchymosis | 3 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Erythema | 3 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Myalgia | 0 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any systemic | 9 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Pain | 0 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Fatigue | 0 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Tenderness | 15 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Sleepiness | 3 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Arthralgia | 0 Subjects |
| TIV1c_Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Preventive | 1 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Irritability | 6 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Pain | 0 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Headache | 0 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Sleepiness | 5 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Induration | 4 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Myalgia | 0 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Arthralgia | 0 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Diarrhea | 2 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Preventive | 0 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Loss of appetite | 0 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Fatigue | 0 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Treatment | 1 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Change of eating habits | 1 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Ecchymosis | 2 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Tenderness | 15 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any systemic | 9 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any local | 17 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Nausea | 0 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Body temperature(>=38C) | 0 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Vomiting | 0 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Chills | 1 Subjects |
| TIV2c _Second Vaccine (≥4 to <6 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Erythema | 7 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Body temperature(>=38C) | 16 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Irritability | 0 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Diarrhea | 13 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Ecchymosis | 35 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Tenderness | 1 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Erythema | 83 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Loss of appetite | 33 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Arthralgia | 13 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Sleepiness | 0 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Vomiting | 12 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Chills | 16 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Nausea | 29 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Induration | 59 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Fatigue | 47 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any local | 237 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Treatment | 27 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Preventive | 14 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Pain | 201 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Myalgia | 43 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Headache | 52 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Change of eating habits | 0 Subjects |
| QIVc _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any systemic | 117 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Treatment | 13 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Fatigue | 26 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Tenderness | 0 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Body temperature(>=38C) | 5 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Preventive | 6 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any local | 124 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Loss of appetite | 10 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Irritability | 0 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Nausea | 9 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Chills | 6 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Diarrhea | 11 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Erythema | 43 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Ecchymosis | 17 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Induration | 35 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Sleepiness | 0 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Vomiting | 6 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any systemic | 67 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Pain | 105 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Change of eating habits | 0 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Myalgia | 26 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Arthralgia | 10 Subjects |
| TIV1c_First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Headache | 24 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Loss of appetite | 15 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Diarrhea | 9 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Pain | 107 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any systemic | 65 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Change of eating habits | 0 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Fatigue | 33 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Body temperature(>=38C) | 4 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Chills | 8 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Irritability | 0 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Headache | 23 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Tenderness | 0 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any local | 116 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Vomiting | 6 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Nausea | 10 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Induration | 24 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Preventive | 8 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Ecchymosis | 14 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Arthralgia | 7 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Sleepiness | 0 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Myalgia | 19 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Treatment | 10 Subjects |
| TIV2c _First Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Erythema | 38 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Erythema | 29 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Pain | 95 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Ecchymosis | 9 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Arthralgia | 6 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Preventive | 7 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Change of eating habits | 0 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Chills | 2 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Irritability | 0 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Nausea | 7 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any systemic | 46 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Treatment | 15 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any local | 102 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Loss of appetite | 6 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Body temperature(>=38C) | 6 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Fatigue | 18 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Tenderness | 0 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Headache | 9 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Diarrhea | 4 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Vomiting | 7 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Myalgia | 18 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Induration | 25 Subjects |
| QIVc _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Sleepiness | 0 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Arthralgia | 5 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Ecchymosis | 9 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Sleepiness | 0 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Irritability | 0 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Nausea | 6 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Myalgia | 11 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Fatigue | 12 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Vomiting | 2 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Diarrhea | 4 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any local | 64 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Tenderness | 0 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Erythema | 17 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Induration | 18 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Pain | 61 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any systemic | 30 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Change of eating habits | 0 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Chills | 3 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Headache | 8 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Loss of appetite | 9 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Body temperature(>=38C) | 2 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Preventive | 4 Subjects |
| TIV1c_Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Treatment | 4 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Arthralgia | 4 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Tenderness | 0 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Diarrhea | 1 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Pain | 62 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Irritability | 0 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Induration | 12 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Erythema | 19 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Ecchymosis | 7 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Chills | 0 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Myalgia | 11 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Headache | 7 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Sleepiness | 0 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Body temperature(>=38C) | 2 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Fatigue | 10 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Change of eating habits | 0 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Vomiting | 1 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Loss of appetite | 8 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Nausea | 4 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any systemic | 27 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Treatment | 10 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any local | 66 Subjects |
| TIV2c _Second Vaccine (≥6 to <9 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Preventive | 4 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Vomiting | 10 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Arthralgia | 36 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Chills | 43 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Change of eating habits | 0 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any systemic | 232 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Pain | 334 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Induration | 88 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Ecchymosis | 24 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Diarrhea | 22 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Tenderness | 0 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any local | 377 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Loss of appetite | 51 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Fatigue | 104 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Treatment | 24 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Body temperature(>=38C) | 7 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Headache | 127 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Myalgia | 94 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Preventive | 15 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Irritability | 0 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Sleepiness | 0 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Erythema | 110 Subjects |
| QIVc (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Nausea | 55 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Myalgia | 50 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Induration | 43 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Chills | 17 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Nausea | 24 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Treatment | 20 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Loss of appetite | 25 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Preventive | 6 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Headache | 68 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Arthralgia | 19 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Ecchymosis | 16 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Sleepiness | 0 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Body temperature(>=38C) | 8 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any systemic | 121 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Diarrhea | 11 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Change of eating habits | 0 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Tenderness | 0 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any local | 175 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Vomiting | 4 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Fatigue | 46 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Pain | 150 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Erythema | 51 Subjects |
| TIV1c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Irritability | 0 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Body temperature(>=38C) | 4 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Loss of appetite | 25 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Diarrhea | 9 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any systemic | 94 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Fatigue | 44 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Headache | 50 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Treatment | 14 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Any local | 156 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Change of eating habits | 0 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Irritability | 0 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Myalgia | 41 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Sleepiness | 0 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Chills | 10 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Erythema | 43 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Ecchymosis | 13 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Vomiting | 5 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Nausea | 21 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Tenderness | 0 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Arthralgia | 22 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Induration | 36 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Analgesics and antipyretics-Preventive | 8 Subjects |
| TIV2c (≥9 to <18 Years) | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Pain | 142 Subjects |
Secondary
Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group
Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting unsolicited AEs (day 1 to 22 for Previously vaccinated and day 1 to day 50 for Not previously vaccinated subjects), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 for Previously vaccinated and day 1 to day 210 for Not previously vaccinated subjects) after receiving one or two doses of either QIVc, TIV1c or TIV2c. For A/H1N1, A/H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c.
Time frame: Day 1 to 210 post vaccination
Population: Analysis was done on unsolicited safety data set i.e. all subjects in the exposed set with unsolicited adverse event data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | AE leading to study withdrawal | 0 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | Any AE | 279 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | Possibly/probably related AE | 56 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | SAE | 6 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | Possibly/probably related SAE | 0 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | Medically attended AE | 310 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | NOCD | 20 Subjects |
| QIVc (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | Death | 0 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | NOCD | 11 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | AE leading to study withdrawal | 1 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | Possibly/probably related SAE | 0 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | Medically attended AE | 156 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | Any AE | 139 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | SAE | 7 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | Death | 0 Subjects |
| TIV1c (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | Possibly/probably related AE | 34 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | NOCD | 11 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | SAE | 2 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | Possibly/probably related SAE | 0 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | AE leading to study withdrawal | 0 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | Possibly/probably related AE | 31 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | Death | 0 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | Any AE | 152 Subjects |
| TIV2c (≥4 to <18 Years) | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | Medically attended AE | 153 Subjects |
Secondary
Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years
Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The Committee for Medicinal Products for Human Use (CHMP) criterion for an adult population was that the percentage of subjects achieving an HI titer ≥1:40 is \>70%
Time frame: Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Population: Analysis was done on FAS immunogenicity set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H1N1: Day 1(N=1113,566) | 76 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H3N2: Day 22/Day 50(N=1112,566) | 100 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B1: Day 1(N=1112,566) | 49 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B1: Day 22/Day 50(N=1112,566) | 92 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B2: Day 1(N=1108,556) | 46 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H1N1: Day 22/Day 50(N=1113,566) | 99 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H3N2: Day 1(N=1112,566) | 90 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B2: Day 22/Day 50(N=1108,556) | 91 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B1: Day 22/Day 50(N=1112,566) | 93 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H1N1: Day 1(N=1113,566) | 79 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H3N2: Day 1(N=1112,566) | 89 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H1N1: Day 22/Day 50(N=1113,566) | 99 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H3N2: Day 22/Day 50(N=1112,566) | 99 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B2: Day 1(N=1108,556) | NA percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B2: Day 22/Day 50(N=1108,556) | NA percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B1: Day 1(N=1112,566) | 45 percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B2: Day 1(N=1108,556) | 47 percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B1: Day 1(N=1112,566) | NA percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B1: Day 22/Day 50(N=1112,566) | NA percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B2: Day 22/Day 50(N=1108,556) | 91 percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H1N1: Day 1(N=1113,566) | NA percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H1N1: Day 22/Day 50(N=1113,566) | NA percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H3N2: Day 1(N=1112,566) | NA percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H3N2: Day 22/Day 50(N=1112,566) | NA percentages of subjects |
Secondary
Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years
Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c. The CBER criterion for adult population was that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%
Time frame: Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Population: Analysis was done on FAS immunogenicity set (FAS) i.e. all subjects in the enrolled set who received at least one study vaccination and provided immunogenicity data at day 22 (day 50 for not previously vaccinated subjects)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H3N2: Day 1(N=1112,566) | 90 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B2: Day 22 or Day 50(N=1108,556) | 91 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H1N1: Day 1(N=1113,566) | 76 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H3N2: Day 22 or Day 50(N=1112,566) | 100 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B1: Day 22 or Day 50(N=1112,566) | 92 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H1N1: Day 22 or Day 50(N=1113,566) | 99 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B2: Day 1(N=1108,556) | 46 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B1: Day 1(N=1112,566) | 49 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H3N2: Day 22 or Day 50(N=1112,566) | 99 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H1N1: Day 1(N=1113,566) | 79 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H1N1: Day 22 or Day 50(N=1113,566) | 99 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H3N2: Day 1(N=1112,566) | 89 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B1: Day 1(N=1112,566) | 45 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B1: Day 22 or Day 50(N=1112,566) | 93 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B2: Day 1(N=1108,556) | NA percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B2: Day 22 or Day 50(N=1108,556) | NA percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B1: Day 1(N=1112,566) | NA percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H1N1: Day 1(N=1113,566) | NA percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B1: Day 22 or Day 50(N=1112,566) | NA percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B2: Day 1(N=1108,556) | 47 percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H3N2: Day 1(N=1112,566) | NA percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H3N2: Day 22 or Day 50(N=1112,566) | NA percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H1N1: Day 22 or Day 50(N=1113,566) | NA percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B2: Day 22 or Day 50(N=1108,556) | 91 percentages of subjects |
Secondary
Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc or TIV2c
Immunogenicity of QIVc to comparator TIV2c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks after last vaccination with QIVc or TIV2c. Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody does not exceed the margin of 0 points
Time frame: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Population: Analysis was done on FAS population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc or TIV2c | 67 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc or TIV2c | 33 percentages of subjects |
Comparison: Superiority of immune responses of QIVc to TIV2c in terms of seroconversion rates against influenza strain B1.The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c - %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points met.95% CI: [-38.8, -29.3]
Secondary
Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years
Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer \<1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.
Time frame: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Population: Analysis was done on FAS immunogenicity set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B1: Day 22/Day 50(N=1112,566) | 67 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B2: Day 22/Day 50(N=1108,556) | 73 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H1N1: Day 22/Day 50(N=1113,566) | 73 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H3N2: Day 22/Day 50(N=1112,566) | 47 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B1: Day 22/Day 50(N=1112,566) | 66 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H3N2: Day 22/Day 50(N=1112,566) | 51 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B2: Day 22/Day 50(N=1108,556) | NA percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H1N1: Day 22/Day 50(N=1113,566) | 74 percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B2: Day 22/Day 50(N=1108,556) | 72 percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H1N1: Day 22/Day 50(N=1113,566) | NA percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B1: Day 22/Day 50(N=1112,566) | NA percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H3N2: Day 22/Day 50(N=1112,566) | NA percentages of subjects |
Secondary
Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years
Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer \<1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer. The Center for Biologics Evaluation, Research, and Review (CBER) criterion for an adult population is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%
Time frame: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Population: Analysis was done on Full Analysis Set (FAS) immunogenicity set i.e. all subjects in the enrolled set who received ▫ Received at least one study vaccination and provided immunogenicity data at day 1 and day 22 (day 50 for not previously vaccinated subjects)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H1N1: Day 22 or Day 50 (N=1113,566) | 73 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H3N2: Day 22 or Day 50 (N=1112,566) | 47 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B1: Day 22 or Day 50 (N=1112,566) | 67 percentages of subjects |
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B2: Day 22 or Day 50 (N=1108,556) | 73 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H1N1: Day 22 or Day 50 (N=1113,566) | 74 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H3N2: Day 22 or Day 50 (N=1112,566) | 51 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B1: Day 22 or Day 50 (N=1112,566) | 66 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B2: Day 22 or Day 50 (N=1108,556) | NA percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B1: Day 22 or Day 50 (N=1112,566) | NA percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | B2: Day 22 or Day 50 (N=1108,556) | 72 percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H1N1: Day 22 or Day 50 (N=1113,566) | NA percentages of subjects |
| TIV2c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | A/H3N2: Day 22 or Day 50 (N=1112,566) | NA percentages of subjects |
Secondary
Percentages of Subjects Achieving Seroconversion Against B2 Strain After One or Two Doses of Either QIVc or TIV1c
Immunogenicity of QIVc to comparator TIV1c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks after last vaccination with QIVc or TIV1c. Superiority criterion was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 0 points
Time frame: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Population: Analysis was done on FAS population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QIVc (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion Against B2 Strain After One or Two Doses of Either QIVc or TIV1c | 73 percentages of subjects |
| TIV1c (≥4 to <18 Years) | Percentages of Subjects Achieving Seroconversion Against B2 Strain After One or Two Doses of Either QIVc or TIV1c | 26 percentages of subjects |
Comparison: Superiority of immune responses of QIVc to TIV1c in terms of seroconversion rates against influenza strain B2.The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points met.95% CI: [-51.1, -42.1]