Influenza
Conditions
Keywords
influenza, children, safety, tolerability, immunogenicity
Brief summary
To evaluate the safety and immunogenicity of four influenza vaccines in children 6 months to \< 48 months of age
Interventions
BIOLOGICALTrivalent influenza vaccine (TIVc)
BIOLOGICALTrivalent influenza vaccine-licensed
Licensed influenza vaccine
Sponsors
Novartis Vaccines
Seqirus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 48 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy subject, male or female, 6 through \< 48 months of age at the time of enrollment, who has never previously received an influenza vaccine * Individual who has a parent or guardian that can give written informed consent after understanding the nature of the study and are available for follow-up
Exclusion criteria
* Individuals recently vaccinated against influenza * Subjects with contraindications to receive influenza vaccine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | Day 50/Day 1 | Immunogenicity was assessed in terms of ratios of GMTs in subjects (6 to \<48 months old), measured by hemagglutination inhibition (HI) assay, day 1 to day 50 after vaccination with two doses of either TIVc or TIVe vaccine |
| Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | Day 50 post vaccination | Immunogenicity was assessed in terms number (%) of subjects (6 to \<48 months old) achieving seroconversion as measured by HI antibody titer, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer \< 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer |
| Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine | Day 1 to Day 3 | Differences in percentages of subjects (6 to \<48 months old) with severe local solicited AEs and severe solicited systemic AEs, 3 days after vaccination with either TIVc or TIVe vaccine was assessed in terms of an individual desirability index score (High dose, Full dose, Half dose TIVc vs. TIVe vaccine). An individual desirability index score was assigned to each (non-transformed) safety value based on predefined functions. Each desirability index score is assigned a value between 0 and 1, wherein 0 is an undesirable response and 1 is a highly desirable response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | Day 50 post vaccination | Immunogenicity was assessed in terms of number (%) of subjects (6 to \<48 months old) achieving seroconversion as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer \< 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer The Center for Biologics Evaluation, Research, and Review (CBER) criterion for pediatric population is that the lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% The Committee for Medicinal Products for Human Use (CHMP) criterion for pediatric population is that the percentage of subjects achieving seroconversion or significant increase in HI antibody titers \>40% |
| Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | Day 1, Day 50 post vaccination | Immunogenicity was assessed in terms of number (%) of subjects (6 to \<48 months old) achieving HI titer ≥1:40 as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine The CBER criterion for pediatric population is 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% The CHMP criterion for pediatric population is that the percentage of subjects achieving HI antibody titers ≥1:40 should be \>70% |
| Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | Day 50 post vaccination over day 1 | Immunogenicity was assessed in terms of GMR in subjects (6 to \<48 months old) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine The CHMP criterion is mean geometric ratio (GMR) \>2.5 |
| Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | Day 1 and Day 50 post vaccination | Immunogenicity was assessed in terms of number (%) of subjects (6 to \<48 months old) achieving post vaccination HI titers (i.e. HI titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine |
| Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine | Day 1 and Day 50 post vaccination | Immunogenicity was assessed in terms of number (%) of subjects (6 to \<48 months old) achieving MN titer ≥1:20 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Post-vaccination MN titer ≥1:20 was defined as for subjects with baseline (day 1) MN titer \<1:10, or a minimum 2-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI |
| Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | Day 1 and Day 50 post vaccination | Immunogenicity was assessed in terms of number (%) of subjects (6 to \<48 months old) achieving MN titer ≥1:40 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Post-vaccination MN titer ≥1:40 was defined as for subjects with baseline (day 1) MN titer \<1:10, or a minimum 4-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI |
| Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Day 1 to Day 7 | Safety was assessed in terms of number of subjects (6 to \<48 months old) reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination) |
| Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Unsolicited AEs after Each/any Vaccination from Day 1 to Day 29 and Day 29 to Day 50 , Day 1 to Day 209 | Safety was assessed in terms of number of subjects (6 to \<48 months old) reporting unsolicited reactions after Each /any Vaccination from Day 1 \[Post Vaccination\] to Day 29 \[Pre Clinic Visit\] and Day 29 \[Post Vaccination\] to Day 50 \[Pre Clinic Visit\] , Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases (NOCD), AEs leading to withdrawal from the study and concomitant medications (day 1 to day 209) after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination) |
Countries
Finland, Philippines, Thailand, United States
Participant flow
Recruitment details
6 centers in the United States, 1 center in Finland, 2 centers in Thailand, 2 centers in Philippines
Pre-assignment details
All enrolled Subjects were included in the trial
Participants by arm
| Arm | Count |
|---|---|
| TIVc-High Dose Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine | 174 |
| TIVc-Full Dose Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine | 166 |
| TIVc- Half Dose Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine | 167 |
| TIVe Subjects (6 to \<48 months old) received two doses of TIVe vaccine | 164 |
| Total | 671 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | TIVc-High Dose | TIVc-Full Dose | TIVc- Half Dose | TIVe | Total |
|---|---|---|---|---|---|
| Age, Continuous | 25.3 Months STANDARD_DEVIATION 11.5 | 25.0 Months STANDARD_DEVIATION 11.5 | 25.6 Months STANDARD_DEVIATION 11.5 | 25.3 Months STANDARD_DEVIATION 11.9 | 25.3 Months STANDARD_DEVIATION 11.6 |
| Sex: Female, Male FEMALE | 84 Participants | 82 Participants | 77 Participants | 87 Participants | 330 Participants |
| Sex: Female, Male MALE | 90 Participants | 84 Participants | 90 Participants | 77 Participants | 341 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 142 / 174 | 133 / 166 | 141 / 167 | 127 / 164 | 543 / 671 |
| serious Total, serious adverse events | 4 / 174 | 8 / 166 | 10 / 167 | 6 / 164 | 28 / 671 |
Outcome results
Primary
Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine
Differences in percentages of subjects (6 to \<48 months old) with severe local solicited AEs and severe solicited systemic AEs, 3 days after vaccination with either TIVc or TIVe vaccine was assessed in terms of an individual desirability index score (High dose, Full dose, Half dose TIVc vs. TIVe vaccine). An individual desirability index score was assigned to each (non-transformed) safety value based on predefined functions. Each desirability index score is assigned a value between 0 and 1, wherein 0 is an undesirable response and 1 is a highly desirable response.
Time frame: Day 1 to Day 3
Population: Analysis was done on PPSd-All subjects in the FASd who:Correctly received the vaccine (i.e., received the vaccine to which the subjects is randomized and at the scheduled time points).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVc-High Dose | Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine | Severe solicited local AEs | 0.000 percentage of participants |
| TIVc-High Dose | Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine | Severe solicited systemic AEs | 0.040 percentage of participants |
| TIVc-Full Dose | Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine | Severe solicited local AEs | 0.000 percentage of participants |
| TIVc-Full Dose | Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine | Severe solicited systemic AEs | 0.000 percentage of participants |
| TIVc- Half Dose | Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine | Severe solicited local AEs | 0.000 percentage of participants |
| TIVc- Half Dose | Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine | Severe solicited systemic AEs | 0.000 percentage of participants |
Primary
Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine
Immunogenicity was assessed in terms number (%) of subjects (6 to \<48 months old) achieving seroconversion as measured by HI antibody titer, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer \< 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer
Time frame: Day 50 post vaccination
Population: Analysis was done on PP population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1_Day 50 | 83 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | B_Day 50 | 69 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2_Day 50 | 94 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1_Day 50 | 81 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | B_Day 50 | 69 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2_Day 50 | 90 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2_Day 50 | 87 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1_Day 50 | 79 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | B_Day 50 | 62 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1_Day 50 | 74 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | B_Day 50 | 80 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2_Day 50 | 92 Percentages of subjects |
Comparison: Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N195% CI: [0, 18.9]
Comparison: Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N295% CI: [-4, 8]
Comparison: Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B95% CI: [-21.1, -1.5]
Comparison: Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N195% CI: [-2.5, 16.8]
Comparison: Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N295% CI: [-9.5, 4.1]
Comparison: Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B95% CI: [-20.5, -1]
Comparison: Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N195% CI: [-4.2, 15.4]
Comparison: Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N295% CI: [-13.4, 1.3]
Comparison: Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B95% CI: [-27.8, -7.2]
Primary
Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine
Immunogenicity was assessed in terms of ratios of GMTs in subjects (6 to \<48 months old), measured by hemagglutination inhibition (HI) assay, day 1 to day 50 after vaccination with two doses of either TIVc or TIVe vaccine
Time frame: Day 50/Day 1
Population: Analysis was done on Per Protocol (PP) population i.e. all subjects in the FAS Efficacy/Immunogenicity Set who are not excluded due to reasons defined prior to unblinding or analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVc-High Dose | Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 7.82 Ratios |
| TIVc-High Dose | Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 5.18 Ratios |
| TIVc-High Dose | Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 10.53 Ratios |
| TIVc-Full Dose | Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 5.5 Ratios |
| TIVc-Full Dose | Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 4.27 Ratios |
| TIVc-Full Dose | Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 10.84 Ratios |
| TIVc- Half Dose | Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 6.47 Ratios |
| TIVc- Half Dose | Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 5.93 Ratios |
| TIVc- Half Dose | Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 3.87 Ratios |
| TIVe | Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 3.69 Ratios |
| TIVe | Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 6.65 Ratios |
| TIVe | Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 11.95 Ratios |
Comparison: Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 195% CI: [0.65, 1.52]
Comparison: Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 5095% CI: [1.5, 2.98]
Comparison: Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 195% CI: [0.43, 1.06]
Comparison: Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 5095% CI: [0.58, 0.87]
Comparison: Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 195% CI: [0.92, 1.08]
Comparison: Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 5095% CI: [0.6, 1.01]
Comparison: Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 195% CI: [0.83, 1.96]
Comparison: Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 5095% CI: [1.13, 2.28]
Comparison: Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 195% CI: [0.33, 0.81]
Comparison: Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 5095% CI: [0.52, 0.78]
Comparison: Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 195% CI: [0.89, 1.04]
Comparison: Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 5095% CI: [0.49, 0.84]
Comparison: Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 195% CI: [0.66, 1.58]
Comparison: Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 5095% CI: [1.14, 2.3]
Comparison: Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 195% CI: [0.47, 1.17]
Comparison: Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 5095% CI: [0.38, 0.57]
Comparison: Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 195% CI: [0.87, 1.02]
Comparison: Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 5095% CI: [0.44, 0.75]
Secondary
Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine
Immunogenicity was assessed in terms of GMR in subjects (6 to \<48 months old) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine The CHMP criterion is mean geometric ratio (GMR) \>2.5
Time frame: Day 50 post vaccination over day 1
Population: Analysis was done on FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVc-High Dose | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 12 Ratios |
| TIVc-High Dose | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 6.14 Ratios |
| TIVc-High Dose | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 12 Ratios |
| TIVc-Full Dose | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 8.58 Ratios |
| TIVc-Full Dose | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 5.29 Ratios |
| TIVc-Full Dose | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 13 Ratios |
| TIVc- Half Dose | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 7.68 Ratios |
| TIVc- Half Dose | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 8.94 Ratios |
| TIVc- Half Dose | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 4.72 Ratios |
| TIVe | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 5.14 Ratios |
| TIVe | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 7.57 Ratios |
| TIVe | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 14 Ratios |
Secondary
Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine
Immunogenicity was assessed in terms of GMR in subjects (6 to \<48 months old) as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine
Time frame: Day 50 post vaccination over day 1
Population: Analysis was done on PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVc-High Dose | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 12.78 Ratios |
| TIVc-High Dose | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 8.4 Ratios |
| TIVc-High Dose | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 7.84 Ratios |
| TIVc-Full Dose | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 8.97 Ratios |
| TIVc-Full Dose | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 5.81 Ratios |
| TIVc-Full Dose | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 10.43 Ratios |
| TIVc- Half Dose | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 5.98 Ratios |
| TIVc- Half Dose | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 5.58 Ratios |
| TIVc- Half Dose | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 9.99 Ratios |
| TIVe | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 8.9 Ratios |
| TIVe | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 17.55 Ratios |
| TIVe | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 17.82 Ratios |
Secondary
Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine
Safety was assessed in terms of number of subjects (6 to \<48 months old) reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination)
Time frame: Day 1 to Day 7
Population: Analyses was done on solicited safety data set. 4 subjects (3 subjects from the TIVe group, and 1 subject from the full dose TIVc group, were excluded from the solicited safety set analyses (6h -day3, day4-day7 and 6h - day 7) as these subjects did not provide any post vaccination solicited safety data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Change in eating habits | 29 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Chills | 7 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Injection site ecchymosis | 9 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Fever (≥ 38°C ) | 15 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any Systemic | 78 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Injection site tenderness | 50 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any local AEs | 64 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Diarrhea | 31 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Vomiting | 21 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Injection site erythema | 19 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Therapeutic use of antipyretics/analgesics | 17 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Irritability | 30 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Sleepiness | 30 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Injection site induration | 13 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Prophylactic use of antipyretics/analgesics | 9 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Injection site induration | 14 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any local AEs | 56 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Injection site tenderness | 43 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Injection site erythema | 24 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Injection site ecchymosis | 9 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any Systemic | 72 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Chills | 5 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Change in eating habits | 35 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Sleepiness | 28 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Irritability | 31 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Vomiting | 20 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Diarrhea | 31 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Fever (≥ 38°C ) | 20 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Prophylactic use of antipyretics/analgesics | 21 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Therapeutic use of antipyretics/analgesics | 21 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Injection site induration | 9 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Change in eating habits | 28 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Therapeutic use of antipyretics/analgesics | 24 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Sleepiness | 21 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Injection site erythema | 24 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Prophylactic use of antipyretics/analgesics | 25 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Irritability | 29 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Vomiting | 22 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Injection site tenderness | 42 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any local AEs | 60 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Diarrhea | 29 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Injection site ecchymosis | 7 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any Systemic | 69 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Fever (≥ 38°C ) | 21 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Chills | 7 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Fever (≥ 38°C ) | 21 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any Systemic | 66 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Change in eating habits | 29 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Injection site erythema | 17 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Injection site induration | 8 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Diarrhea | 34 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Sleepiness | 24 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any local AEs | 54 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Injection site ecchymosis | 7 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Chills | 9 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Irritability | 27 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Injection site tenderness | 45 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Prophylactic use of antipyretics/analgesics | 13 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Therapeutic use of antipyretics/analgesics | 22 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Vomiting | 14 Subjects |
Secondary
Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine
Safety was assessed in terms of number of subjects (6 to \<48 months old) reporting unsolicited reactions after Each /any Vaccination from Day 1 \[Post Vaccination\] to Day 29 \[Pre Clinic Visit\] and Day 29 \[Post Vaccination\] to Day 50 \[Pre Clinic Visit\] , Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases (NOCD), AEs leading to withdrawal from the study and concomitant medications (day 1 to day 209) after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination)
Time frame: Unsolicited AEs after Each/any Vaccination from Day 1 to Day 29 and Day 29 to Day 50 , Day 1 to Day 209
Population: Analyses was done on unsolicited safety data set i.e. all subjects in the exposed set who have post-vaccination unsolicited AE data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any AEs(after any vaccination) | 102 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any AEs(after vaccination 2) | 56 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any possibly/probably related SAE | 0 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Possibly/probably related AEs (after any vaccin.) | 38 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any SAE | 4 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Possibly/probably related AEs (after vaccination 1 | 30 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any AEs(after vaccination 1) | 79 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Death | 0 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | New onset of chronic disease | 0 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Possibly/probably related AEs (after vaccination 2 | 11 Subjects |
| TIVc-High Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any AE leading to premature withdrawal from study | 0 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Possibly/probably related AEs (after vaccination 2 | 20 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any AE leading to premature withdrawal from study | 0 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any SAE | 8 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any possibly/probably related SAE | 0 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any AEs(after vaccination 1) | 84 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Death | 0 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any AEs(after vaccination 2) | 64 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | New onset of chronic disease | 1 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Possibly/probably related AEs (after vaccination 1 | 33 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Possibly/probably related AEs (after any vaccin.) | 43 Subjects |
| TIVc-Full Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any AEs(after any vaccination) | 107 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | New onset of chronic disease | 1 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any AEs(after any vaccination) | 91 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Possibly/probably related AEs (after any vaccin.) | 43 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any AEs(after vaccination 1) | 69 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any AEs(after vaccination 2) | 50 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Possibly/probably related AEs (after vaccination 1 | 31 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Possibly/probably related AEs (after vaccination 2 | 18 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any SAE | 10 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any possibly/probably related SAE | 0 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any AE leading to premature withdrawal from study | 0 Subjects |
| TIVc- Half Dose | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Death | 0 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Possibly/probably related AEs (after vaccination 2 | 14 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Death | 0 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any AE leading to premature withdrawal from study | 0 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Possibly/probably related AEs (after vaccination 1 | 31 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any AEs(after vaccination 2) | 48 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any AEs(after vaccination 1) | 76 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | New onset of chronic disease | 1 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Possibly/probably related AEs (after any vaccin.) | 35 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any AEs(after any vaccination) | 94 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any possibly/probably related SAE | 0 Subjects |
| TIVe | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Any SAE | 6 Subjects |
Secondary
Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine
Immunogenicity was assessed in terms of number (%) of subjects (6 to \<48 months old) achieving HI titer ≥1:40 as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine The CBER criterion for pediatric population is 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% The CHMP criterion for pediatric population is that the percentage of subjects achieving HI antibody titers ≥1:40 should be \>70%
Time frame: Day 1, Day 50 post vaccination
Population: Analysis was done on FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 1 | 26 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 50 | 86 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 1 | 45 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 50 | 98 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 1 | 2 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 50 | 69 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 50 | 70 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 50 | 98 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 1 | 32 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 1 | 40 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 50 | 85 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 1 | 0 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 50 | 86 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 1 | 48 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 50 | 97 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 50 | 63 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 1 | 1 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 1 | 29 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 1 | 3 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 50 | 80 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 50 | 77 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 50 | 99 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 1 | 26 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 1 | 52 Percentages of subjects |
Secondary
Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine
Immunogenicity was assessed in terms of number (%) of subjects (6 to \<48 months old) achieving MN titer ≥1:20 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Post-vaccination MN titer ≥1:20 was defined as for subjects with baseline (day 1) MN titer \<1:10, or a minimum 2-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI
Time frame: Day 1 and Day 50 post vaccination
Population: Analysis was done on PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 94 Percentage of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 92 Percentage of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 95 Percentage of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 93 Percentage of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 92 Percentage of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 94 Percentage of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 94 Percentage of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 91 Percentage of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 93 Percentage of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 97 Percentage of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 97 Percentage of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 94 Percentage of subjects |
Secondary
Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine
Immunogenicity was assessed in terms of number (%) of subjects (6 to \<48 months old) achieving MN titer ≥1:40 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Post-vaccination MN titer ≥1:40 was defined as for subjects with baseline (day 1) MN titer \<1:10, or a minimum 4-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI
Time frame: Day 1 and Day 50 post vaccination
Population: Analysis was done on PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 87 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 83 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 85 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 89 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 87 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 85 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 82 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 84 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 83 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 95 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 96 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 80 Percentages of subjects |
Secondary
Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine
Immunogenicity was assessed in terms of number (%) of subjects (6 to \<48 months old) achieving seroconversion as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer \< 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer The Center for Biologics Evaluation, Research, and Review (CBER) criterion for pediatric population is that the lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% The Committee for Medicinal Products for Human Use (CHMP) criterion for pediatric population is that the percentage of subjects achieving seroconversion or significant increase in HI antibody titers \>40%
Time frame: Day 50 post vaccination
Population: Analysis was done on Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 84 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 68 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 94 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 80 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 70 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 91 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 88 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 82 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 63 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1 | 73 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | B | 79 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2 | 93 Percentages of subjects |
Secondary
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine
Immunogenicity was assessed in terms of number (%) of subjects (6 to \<48 months old) achieving post vaccination HI titers (i.e. HI titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine
Time frame: Day 1 and Day 50 post vaccination
Population: Analysis was done on PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 1: HI titers ≥1:151 | 25 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 50: HI titers ≥1:110 | 78 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 1: HI titers ≥1:110 | 40 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 50: HI titers ≥1:110 | 88 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 1: HI titers ≥1:110 | 1 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 50: HI titers ≥1:110 | 40 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 1: HI titers ≥1:110 | 26 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 50: HI titers ≥1:151 | 76 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 1: HI titers ≥1:151 | 40 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 50: HI titers ≥1:150 | 88 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 1: HI titers ≥1:151 | 0 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 50: HI titers ≥1:151 | 40 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 1: HI titers ≥1:330 | 12 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 50: HI titers ≥1:330 | 51 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 1: HI titers ≥1:330 | 16 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 50: HI titers ≥1:330 | 62 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 1: HI titers ≥1:330 | 0 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 50: HI titers ≥1:330 | 4 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 1: HI titers ≥1:629 | 9 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 50: HI titers ≥1:629 | 48 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 1: HI titers ≥1:629 | 16 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 50: HI titers ≥1:629 | 62 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 1: HI titers ≥1:629 | 0 Percentages of subjects |
| TIVc-High Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 50: HI titers ≥1:629 | 4 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 50: HI titers ≥1:629 | 3 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 1: HI titers ≥1:330 | 14 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 50: HI titers ≥1:110 | 86 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 1: HI titers ≥1:629 | 0 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 50: HI titers ≥1:629 | 56 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 50: HI titers ≥1:330 | 50 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 1: HI titers ≥1:151 | 37 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 1: HI titers ≥1:330 | 0 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 50: HI titers ≥1:110 | 30 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 1: HI titers ≥1:330 | 12 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 1: HI titers ≥1:110 | 37 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 50: HI titers ≥1:330 | 56 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 1: HI titers ≥1:629 | 12 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 50: HI titers ≥1:150 | 86 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 50: HI titers ≥1:629 | 47 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 50: HI titers ≥1:110 | 80 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 50: HI titers ≥1:151 | 76 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 1: HI titers ≥1:151 | 0 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 1: HI titers ≥1:151 | 30 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 1: HI titers ≥1:629 | 12 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 1: HI titers ≥1:110 | 31 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 50: HI titers ≥1:151 | 30 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 1: HI titers ≥1:110 | 0 Percentages of subjects |
| TIVc-Full Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 50: HI titers ≥1:330 | 4 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 1: HI titers ≥1:151 | 0 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 1: HI titers ≥1:151 | 26 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 50: HI titers ≥1:151 | 70 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 1: HI titers ≥1:151 | 43 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 50: HI titers ≥1:150 | 81 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 1: HI titers ≥1:629 | 12 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 50: HI titers ≥1:629 | 43 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 50: HI titers ≥1:151 | 23 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 1: HI titers ≥1:330 | 11 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 50: HI titers ≥1:330 | 43 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 50: HI titers ≥1:629 | 52 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 1: HI titers ≥1:330 | 13 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 50: HI titers ≥1:330 | 52 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 50: HI titers ≥1:629 | 3 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 1: HI titers ≥1:330 | 0 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 50: HI titers ≥1:330 | 3 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 1: HI titers ≥1:629 | 0 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 1: HI titers ≥1:110 | 26 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 50: HI titers ≥1:110 | 71 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 1: HI titers ≥1:629 | 11 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 1: HI titers ≥1:110 | 43 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 50: HI titers ≥1:110 | 82 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 1: HI titers ≥1:110 | 0 Percentages of subjects |
| TIVc- Half Dose | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 50: HI titers ≥1:110 | 24 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 1: HI titers ≥1:629 | 0 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 1: HI titers ≥1:629 | 21 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 50: HI titers ≥1:151 | 58 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 1: HI titers ≥1:110 | 26 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 1: HI titers ≥1:151 | 0 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 50: HI titers ≥1:150 | 97 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 50: HI titers ≥1:110 | 39 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 50: HI titers ≥1:110 | 59 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 1: HI titers ≥1:110 | 0 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 1: HI titers ≥1:151 | 47 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 50: HI titers ≥1:629 | 33 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 1: HI titers ≥1:110 | 47 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 50: HI titers ≥1:629 | 68 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 1: HI titers ≥1:330 | 21 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 1: HI titers ≥1:629 | 8 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 50: HI titers ≥1:330 | 68 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 50: HI titers ≥1:629 | 7 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 50: HI titers ≥1:330 | 34 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 1: HI titers ≥1:151 | 25 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 1: HI titers ≥1:330 | 0 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H1N1: Day 1: HI titers ≥1:330 | 11 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 50: HI titers ≥1:151 | 39 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | A/H3N2: Day 50: HI titers ≥1:110 | 97 Percentages of subjects |
| TIVe | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | B: Day 50: HI titers ≥1:330 | 8 Percentages of subjects |