Influenza
Conditions
Brief summary
The administration of adjuvanted Trivalent Influenza Vaccine (aTIV) has come to result in a more immunogenic and effective response compared with conventional influenza vaccines in elderly and adults. The aim of this study is to evaluate safety and immunogenicity of Novartis aTIV in children 6 to \<72 months of age, Mexican population, in comparison to Fluzone, a non-adjuvanted trivalent influenza vaccine (TIV).
Interventions
BIOLOGICALAdjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjects (day 1), two doses for naive subjects (day 1 and day 29)
A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of aTIV, a trivalent (surface antigen, formaldehyde-inactivated) influenza virus vaccine, adjuvanted with MF59C.1, administered at day 1 (for all subjects) and day 29 (for naïve subjects).
BIOLOGICALNon-adjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjects (day 1), two doses for naive subjects (day 1 and day 29).
A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of TIV , an egg-derived trivalent split influenza vaccine licensed in Mexico, administered at day 1 (for all subjects) and day 29 (for naïve subjects)
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 71 Months
Healthy volunteers
Yes
Inclusion criteria
* Individuals of \>6 months through \<72 months of age on the day of informed consent. * Individuals whose parent(s)/legal guardian(s) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. * Individuals who can comply with study procedures. * Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
Exclusion criteria
* Progressive, unstable or uncontrolled clinical conditions. * Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study. * History of progressive or severe neurologic disorder, seizure disorder or Guillain-Barré syndrome. * Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule. * Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. * Any fatal prognosis of an underlying medical condition (\<12 month life expectancy). * Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. * Abnormal function of the immune system resulting from: 1. Clinical conditions. 2. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to informed consent. 3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. * Received immunoglobulins or any blood products within 180 days prior to informed consent. * Received an investigational or non-registered medicinal product within 30 days prior to informed consent. * Study personnel as an immediate family or household member. * Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study. * Received any influenza vaccine (licensed or investigational) or with laboratory confirmed influenza within 6 months prior enrollment. * Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. | Day 1 and Day 22 (vaccine non-naïve subjects) or Day 50 (vaccine naïve subjects) post vaccination | Antibody response was assessed in terms of GMTs in all three homologous virus strains, 21 days after last immunization, in subjects 6 to \<72 months of age. The study is considered a success if the 21 days after last immunization GMT ratios of aTIV relative to TIV demonstrate as non-inferior with the lower limit (LL) of the two sided 95% confidence interval (CI) above 0.67 (-0.176 on log10 scale) for each vaccine strain (Center for Biologics Evaluation and Research {CBER} Guideline on Seasonal Vaccines May 2007). |
| Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | From Day 1 to Day 7 | Number of non-naive subjects ≥36 months to \< 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination. |
| Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. | From Day 1 to Day 50 | Number of naive subjects aged 6 to \< 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and serious AEs (SAEs) from Day 1 to Day 50. |
| Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 | From Day 1 to Day 22 | Number of non-naive subjects aged 6 to \< 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and SAEs from Day 1 to Day 22. |
| Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | From Day 1 to Day 7 by vaccination | Number of naive subjects 6 to \< 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination. |
| Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | From Day 1 to Day 7 | Number of non-naive subjects 6 to \< 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination. |
| Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | From Day 1 to Day 7 by vaccination | Number of naive subjects ≥ 36 months to \< 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination | GMRs of HI, day 22/day 1 (non-naive subjects) or day 50/day 1 (naive subjects) in all three homologous virus strains, 21 days after last immunization, in subjects 6 to \<72 months of age. As the non-inferiority of aTIV to TIV has been established, GMT ratio of aTIV relative to TIV in all three homologous virus strains, 21 days after last immunization in subjects 6 to \<72 months of age was evaluated using margins greater than the non-inferiority cut-off of 0.67. |
| Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination | Percentage of subjects with a HI titer ≥ 40, ≥110 and ≥330 on Day 1, Day 22 (non naïve subjects) or Day 50 (naïve subjects), in all three homologous virus strains, 21 days after last immunization, in subjects 6 to \<72 months of age. |
| Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination | Percentages of subjects with seroconversion in all three homologous virus strains, 21 days after last immunization, in subjects 6 to \<72 months of age, defined as: HI ≥ 40 subject with a pre-vaccination HI titer \<10; a minimum 4-fold increase HI titer for subjects with a prevaccination HI titer ≥10, on Day 22 (non-naive subjects) or Day 50 (naive subjects), as applicable. |
Countries
Mexico
Participant flow
Recruitment details
Subjects were enrolled from 3 study centers in Mexico.
Pre-assignment details
All enrolled subjects were included in study.
Participants by arm
| Arm | Count |
|---|---|
| aTIV (6 Months to < 72 Months) A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of aTIV to be administered. | 144 |
| TIV (6 Months to < 72 Months) A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of TIV to be administered. | 143 |
| Total | 287 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 6 |
Baseline characteristics
| Characteristic | aTIV (6 Months to < 72 Months) | TIV (6 Months to < 72 Months) | Total |
|---|---|---|---|
| Age, Continuous | 29.5 Months STANDARD_DEVIATION 18.2 | 30.1 Months STANDARD_DEVIATION 19.1 | 29.8 Months STANDARD_DEVIATION 18.6 |
| Gender FEMALE | 68 Participants | 72 Participants | 140 Participants |
| Gender MALE | 76 Participants | 71 Participants | 147 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 58 / 77 | 52 / 78 | 35 / 67 | 31 / 64 |
| serious Total, serious adverse events | 0 / 77 | 0 / 78 | 0 / 67 | 0 / 64 |
Outcome results
Primary
Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age.
Antibody response was assessed in terms of GMTs in all three homologous virus strains, 21 days after last immunization, in subjects 6 to \<72 months of age. The study is considered a success if the 21 days after last immunization GMT ratios of aTIV relative to TIV demonstrate as non-inferior with the lower limit (LL) of the two sided 95% confidence interval (CI) above 0.67 (-0.176 on log10 scale) for each vaccine strain (Center for Biologics Evaluation and Research {CBER} Guideline on Seasonal Vaccines May 2007).
Time frame: Day 1 and Day 22 (vaccine non-naïve subjects) or Day 50 (vaccine naïve subjects) post vaccination
Population: Analysis performed on the Per Protocol Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Naive_aTIV (6 to <36 Months) | Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. | A/H1N1 (Day 1) (N= 113,112) | 14 Titers |
| Naive_aTIV (6 to <36 Months) | Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. | A/H1N1 (Day 22 or Day 50) | 675 Titers |
| Naive_aTIV (6 to <36 Months) | Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. | A/H3N2 (Day 1) | 59 Titers |
| Naive_aTIV (6 to <36 Months) | Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. | A/H3N2 (Day 22 or Day 50) | 1280 Titers |
| Naive_aTIV (6 to <36 Months) | Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. | B (Day 1) | 7.47 Titers |
| Naive_aTIV (6 to <36 Months) | Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. | B (Day 22 or Day 50) | 76 Titers |
| Naive_TIV (6 to <36 Months) | Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. | B (Day 1) | 6.92 Titers |
| Naive_TIV (6 to <36 Months) | Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. | A/H1N1 (Day 1) (N= 113,112) | 15 Titers |
| Naive_TIV (6 to <36 Months) | Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. | A/H3N2 (Day 22 or Day 50) | 495 Titers |
| Naive_TIV (6 to <36 Months) | Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. | A/H1N1 (Day 22 or Day 50) | 166 Titers |
| Naive_TIV (6 to <36 Months) | Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. | B (Day 22 or Day 50) | 16 Titers |
| Naive_TIV (6 to <36 Months) | Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. | A/H3N2 (Day 1) | 55 Titers |
Comparison: Geometric mean titers (GMTs), in H1N1 strain of all the tree strains in Subjects 6 to \< 72 months of Age.95% CI: [3, 5.51]ANCOVA
Comparison: Geometric mean titers (GMTs), in H3N2 strain of all three homologous virus strains in Subjects 6 to \< 72 months of Age.95% CI: [2.05, 3.25]ANCOVA
Comparison: Geometric mean titers (GMTs), in B strain of all three homologous virus strains in Subjects 6 to \< 72 months of Age.95% CI: [3.52, 6.2]ANCOVA
Primary
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.
Number of naive subjects ≥ 36 months to \< 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.
Time frame: From Day 1 to Day 7 by vaccination
Population: Analysis performed on the Solicited Safety Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site ecchymosis (Vac-2, N= 6,3) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Arthralgia (Vac-1) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site erythema (Vac-1) | 1 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Arthralgia (Vac-2, N= 6,2) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Any Local (Vac-2, N= 6,3) | 4 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Headache (Vac-1) | 1 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site erythema (Vac-2, N= 6,3) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Headache (Vac-2, N= 6,2) | 1 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site induration (Vac-1) | 2 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Body Temperature (>= 40.0°C) (Vac-1) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site pain (Vac-1) | 3 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Body Temperature (>= 40.0°C) (Vac-2, N= 6,3) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Any Local (Vac-1) | 5 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Fever (Vac-1) | 2 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site pain (Vac-2, N= 6,3) | 3 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Fever (Vac-2, N= 6,3) | 1 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site induration (Vac-2, N= 6,3) | 2 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Chills (Vac-1) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Any Systemic (Vac-1) | 3 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Chills (Vac-2, N= 6,3) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Change in Eating Habits (Vac-2, N= 6,3) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site ecchymosis (Vac-1) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Diarrhea (Vac-1) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Any Systemic (Vac-2, N= 6,3) | 2 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Diarrhea (Vac-2, N= 6,3) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site swelling (Vac-1) | 2 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Vomiting (Vac-1) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Fatigue (Vac-1) | 1 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Vomiting (Vac-2, N= 6,3) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Change in Eating Habits (Vac-1, N= 5,4) | 2 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Prevention of Pain and or Fever (Vac-1, N= 6,2) | 1 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Fatigue (Vac-2, N= 6,3) | 2 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Prevention of Pain and or Fever (Vac-2, N= 4,2) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site swelling (Vac-2, N= 6,3) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Treatment of Pain and or Fever (Vac-1, N= 6,2) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Myalgia (Vac-1) | 2 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Treatment of Pain and or Fever (Vac-2, N= 5,2) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Myalgia (Vac-2, N= 6,3) | 1 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Myalgia (Vac-2, N= 6,3) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site swelling (Vac-2, N= 6,3) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Myalgia (Vac-1) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Chills (Vac-2, N= 6,3) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Change in Eating Habits (Vac-1, N= 5,4) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Any Local (Vac-1) | 2 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Any Local (Vac-2, N= 6,3) | 2 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site ecchymosis (Vac-1) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site ecchymosis (Vac-2, N= 6,3) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site induration (Vac-1) | 1 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site induration (Vac-2, N= 6,3) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site swelling (Vac-1) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site erythema (Vac-1) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site erythema (Vac-2, N= 6,3) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site pain (Vac-1) | 2 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site pain (Vac-2, N= 6,3) | 2 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Any Systemic (Vac-1) | 1 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Any Systemic (Vac-2, N= 6,3) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Fatigue (Vac-1) | 1 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Fatigue (Vac-2, N= 6,3) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Arthralgia (Vac-1) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Arthralgia (Vac-2, N= 6,2) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Headache (Vac-1) | 1 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Headache (Vac-2, N= 6,2) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Body Temperature (>= 40.0°C) (Vac-1) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Body Temperature (>= 40.0°C) (Vac-2, N= 6,3) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Fever (Vac-1) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Fever (Vac-2, N= 6,3) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Chills (Vac-1) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Change in Eating Habits (Vac-2, N= 6,3) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Diarrhea (Vac-1) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Diarrhea (Vac-2, N= 6,3) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Vomiting (Vac-1) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Vomiting (Vac-2, N= 6,3) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Prevention of Pain and or Fever (Vac-1, N= 6,2) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Prevention of Pain and or Fever (Vac-2, N= 4,2) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Treatment of Pain and or Fever (Vac-1, N= 6,2) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Treatment of Pain and or Fever (Vac-2, N= 5,2) | 0 Participants |
Primary
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination.
Number of naive subjects 6 to \< 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.
Time frame: From Day 1 to Day 7 by vaccination
Population: Analysis performed on the Solicited Safety Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Fever (Vac-1) | 7 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Injection site swelling (Vac-2, N= 66,67) | 2 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Fever (Vac-2, N= 67,67) | 7 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Injection site induration (Vac-2, N= 66,67) | 3 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Change in eating habits (Vac-1, N= 67,69) | 14 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Injection site erythema (Vac-1, N= 64,69) | 9 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Vomiting (Vac-2, N= 65,67) | 2 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Change in eating habits (Vac-2, N= 66,67) | 11 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Injection site induration (Vac-1, N= 66,69) | 5 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Diarrhea (Vac-2, N= 66,67) | 11 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Injection site erythema (Vac-2, N= 66,67) | 7 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Irritability (Vac-1, N= 67,69) | 18 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Diarrhea (Vac-1, N= 67,69) | 15 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Irritability (Vac-2, N= 66,67) | 17 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Injection site tenderness (Vac-1, N= 66,69) | 26 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Persistent Crying (Vac-1, N= 67,69) | 15 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Any Local (Vac-1) | 35 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Persistent Crying (Vac-2, N= 66,67) | 11 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Injection site tenderness (Vac-1, N= 66,66) | 17 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Sleepiness (Vac-1, N= 67,68) | 10 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Any Systemic (Vac-1) | 34 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Sleepiness (Vac-2, N= 65,67) | 8 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Injection site swelling (Vac-1, N= 65,69) | 8 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Vomiting (Vac-1, N= 67,68) | 5 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Any Systemic (Vac-2, N=67,67) | 27 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Any Local (Vac-2, N= 67,67) | 21 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Prevention of Pain and or Fever (Vac-1, N= 67,67) | 2 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Body Temperature (>=40°C) (Vac-1, N= 67,68) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Prevention of Pain and or Fever (Vac-2, N= 64,67) | 3 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Injection site ecchymosis (Vac-2, N= 66,67) | 1 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Treatment of Pain and or Fever (Vac-1, N= 67,67) | 9 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Body Temperature (>=40°C) (Vac-2, N= 67,67) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Treatment of Pain and or Fever (Vac-1, N= 66,67) | 10 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Injection site ecchymosis (Vac-1, N= 65,69) | 2 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Treatment of Pain and or Fever (Vac-1, N= 66,67) | 2 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Injection site ecchymosis (Vac-2, N= 66,67) | 1 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Injection site induration (Vac-1, N= 66,69) | 6 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Injection site induration (Vac-2, N= 66,67) | 4 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Injection site swelling (Vac-1, N= 65,69) | 2 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Injection site tenderness (Vac-1, N= 66,66) | 13 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Change in eating habits (Vac-2, N= 66,67) | 7 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Any Local (Vac-1) | 20 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Any Local (Vac-2, N= 67,67) | 15 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Injection site swelling (Vac-2, N= 66,67) | 2 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Injection site erythema (Vac-1, N= 64,69) | 8 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Injection site erythema (Vac-2, N= 66,67) | 4 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Injection site tenderness (Vac-1, N= 66,69) | 16 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Any Systemic (Vac-1) | 27 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Any Systemic (Vac-2, N=67,67) | 22 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Body Temperature (>=40°C) (Vac-1, N= 67,68) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Body Temperature (>=40°C) (Vac-2, N= 67,67) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Fever (Vac-1) | 5 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Fever (Vac-2, N= 67,67) | 2 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Change in eating habits (Vac-1, N= 67,69) | 4 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Diarrhea (Vac-1, N= 67,69) | 15 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Diarrhea (Vac-2, N= 66,67) | 11 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Irritability (Vac-1, N= 67,69) | 13 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Irritability (Vac-2, N= 66,67) | 9 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Persistent Crying (Vac-1, N= 67,69) | 11 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Persistent Crying (Vac-2, N= 66,67) | 9 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Sleepiness (Vac-1, N= 67,68) | 11 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Sleepiness (Vac-2, N= 65,67) | 9 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Vomiting (Vac-1, N= 67,68) | 4 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Vomiting (Vac-2, N= 65,67) | 2 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Prevention of Pain and or Fever (Vac-1, N= 67,67) | 2 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Prevention of Pain and or Fever (Vac-2, N= 64,67) | 2 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Treatment of Pain and or Fever (Vac-1, N= 67,67) | 7 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. | Injection site ecchymosis (Vac-1, N= 65,69) | 2 Participants |
Primary
Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50.
Number of naive subjects aged 6 to \< 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and serious AEs (SAEs) from Day 1 to Day 50.
Time frame: From Day 1 to Day 50
Population: Analysis performed on the Unsolicited Safety Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. | SAE | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. | AE leading to study withdrawal | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. | At least Possibly related AE | 4 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. | Medically attended AE | 26 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. | At least possibly related SAE | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. | Death | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. | Any AE | 33 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. | Death | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. | Any AE | 28 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. | At least Possibly related AE | 4 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. | SAE | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. | At least possibly related SAE | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. | AE leading to study withdrawal | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. | Medically attended AE | 25 Participants |
Primary
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.
Number of non-naive subjects ≥36 months to \< 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.
Time frame: From Day 1 to Day 7
Population: Analysis performed on the Solicited Safety Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Diarrhea (N= 44,39) | 4 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site induration | 6 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Arthralgia (N= 44,40) | 4 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site erythema (N= 43,40) | 6 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Vomiting (N= 44,40) | 2 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site pain (N= 44,40) | 14 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Body Temperature (>= 40.0°C) (N= 44,40) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site tenderness | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Prevention of Pain and or Fever (N= 42,40) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Any Systemic | 15 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Treatment of Pain and or Fever (N=42,40) | 5 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Fatigue (N= 44,40) | 6 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Change in eating habits (N= 44,39) | 8 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Myalgia (N= 44,40) | 7 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Any Local | 17 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Fever | 2 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Headache (N= 44,40) | 3 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Chills (N= 44,40) | 2 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site ecchymosis | 2 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site swelling | 4 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Prevention of Pain and or Fever (N= 42,40) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site swelling | 3 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Myalgia (N= 44,40) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Arthralgia (N= 44,40) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Headache (N= 44,40) | 2 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Change in eating habits (N= 44,39) | 3 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Diarrhea (N= 44,39) | 3 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Vomiting (N= 44,40) | 1 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Treatment of Pain and or Fever (N=42,40) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Any Local | 20 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site ecchymosis | 1 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site induration | 3 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site erythema (N= 43,40) | 7 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site pain (N= 44,40) | 16 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Injection site tenderness | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Any Systemic | 7 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Fatigue (N= 44,40) | 2 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Body Temperature (>= 40.0°C) (N= 44,40) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Fever | 1 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. | Chills (N= 44,40) | 0 Participants |
Primary
Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination.
Number of non-naive subjects 6 to \< 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.
Time frame: From Day 1 to Day 7
Population: Analysis performed on the Solicited Safety Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Any Local | 10 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Injection site tenderness (N= 22,21) | 9 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Any Systemic | 9 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Body Temperature (>= 40.0°C) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Injection site ecchymosis | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Fever | 6 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Sleepiness | 2 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Change in eating habits | 4 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Irritability | 4 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Injection site induration | 2 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Persistent Crying | 1 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Diarrhea | 3 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Injection site swelling | 1 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Prevention of Pain and or Fever (N= 21,22) | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Vomiting (N= 21,21) | 1 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Treatment of Pain and or Fever (N= 21,22) | 2 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Injection site erythema | 2 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Treatment of Pain and or Fever (N= 21,22) | 1 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Change in eating habits | 3 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Diarrhea | 6 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Sleepiness | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Any Local | 7 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Injection site ecchymosis | 1 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Injection site induration | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Injection site swelling | 1 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Injection site erythema | 4 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Any Systemic | 7 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Body Temperature (>= 40.0°C) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Fever | 1 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Irritability | 3 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Persistent Crying | 1 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Vomiting (N= 21,21) | 1 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Prevention of Pain and or Fever (N= 21,22) | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. | Injection site tenderness (N= 22,21) | 4 Participants |
Primary
Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22
Number of non-naive subjects aged 6 to \< 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and SAEs from Day 1 to Day 22.
Time frame: From Day 1 to Day 22
Population: Analysis performed on the Unsolicited Safety Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 | Death | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 | At least possibly related SAE | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 | At least Possibly related AE | 2 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 | AE leading to study withdrawal | 0 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 | Any AE | 9 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 | Medically attended AE | 3 Participants |
| Naive_aTIV (6 to <36 Months) | Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 | SAE | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 | Medically attended AE | 4 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 | Death | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 | Any AE | 6 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 | At least Possibly related AE | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 | SAE | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 | At least possibly related SAE | 0 Participants |
| Naive_TIV (6 to <36 Months) | Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 | AE leading to study withdrawal | 0 Participants |
Secondary
Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.
GMRs of HI, day 22/day 1 (non-naive subjects) or day 50/day 1 (naive subjects) in all three homologous virus strains, 21 days after last immunization, in subjects 6 to \<72 months of age. As the non-inferiority of aTIV to TIV has been established, GMT ratio of aTIV relative to TIV in all three homologous virus strains, 21 days after last immunization in subjects 6 to \<72 months of age was evaluated using margins greater than the non-inferiority cut-off of 0.67.
Time frame: Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination
Population: Analysis performed on the Per Protocol Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Naive_aTIV (6 to <36 Months) | Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H1N1 strain (N=113,112) | 46 Ratios |
| Naive_aTIV (6 to <36 Months) | Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H3N2 strain | 21 Ratios |
| Naive_aTIV (6 to <36 Months) | Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | B strain | 10 Ratios |
| Naive_TIV (6 to <36 Months) | Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H1N1 strain (N=113,112) | 11 Ratios |
| Naive_TIV (6 to <36 Months) | Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H3N2 strain | 8.39 Ratios |
| Naive_TIV (6 to <36 Months) | Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | B strain | 2.30 Ratios |
Secondary
Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.
Percentages of subjects with seroconversion in all three homologous virus strains, 21 days after last immunization, in subjects 6 to \<72 months of age, defined as: HI ≥ 40 subject with a pre-vaccination HI titer \<10; a minimum 4-fold increase HI titer for subjects with a prevaccination HI titer ≥10, on Day 22 (non-naive subjects) or Day 50 (naive subjects), as applicable.
Time frame: Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination
Population: Analysis performed on the Per Protocol Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H1N1 strain (N= 113,112) | 90 Percentages of subjects |
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H3N2 strain | 77 Percentages of subjects |
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | B strain | 78 Percentages of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H1N1 strain (N= 113,112) | 75 Percentages of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H3N2 strain | 67 Percentages of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | B strain | 22 Percentages of subjects |
Comparison: Percentage of subjects achieving seroconversion in H1N1 strain after last vaccination with aTIV or TIV in naïve and non-naive subjects.95% CI: [8.1, 26.3]Loglinear model
Comparison: Percentage of subjects achieving seroconversion in H3N2 strain after last vaccination with aTIV or TIV in naive and non-naive subjects.95% CI: [-1.8, 21]Loglinear model
Comparison: Percentage of subjects achieving seroconversion in B strains after last vaccination with aTIV or TIV in naïve and non naive subjects.95% CI: [47.5, 68.5]Loglinear model
Secondary
Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.
Percentage of subjects with a HI titer ≥ 40, ≥110 and ≥330 on Day 1, Day 22 (non naïve subjects) or Day 50 (naïve subjects), in all three homologous virus strains, 21 days after last immunization, in subjects 6 to \<72 months of age.
Time frame: Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination
Population: Analysis performed on the Per Protocol Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H1N1 strain (HI titer ≥ 40, Day 1) (N=113,112) | 32 Percentage of subjects |
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H1N1 strain (HI titer ≥ 330, Day 1) | 4 Percentage of subjects |
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H1N1 strain (HI titer ≥ 330, Day 22 or Day 50) | 78 Percentage of subjects |
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H3N2 strain (HI titer ≥ 40, Day 22 or Day 50) | 100 Percentage of subjects |
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H3N2 strain (HI titer ≥ 110, Day 1) | 44 Percentage of subjects |
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H3N2 strain (HI titer ≥ 110, Day 22 or Day 50) | 99 Percentage of subjects |
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H3N2 strain (HI titer ≥ 330, Day 1) | 33 Percentage of subjects |
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H3N2 strain (HI titer ≥ 330, Day 22 or Day 50) | 86 Percentage of subjects |
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | B strain (HI titer ≥ 40, Day 1) | 9 Percentage of subjects |
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | B strain (HI titer ≥ 110, Day 1) | 2 Percentage of subjects |
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | B strain (HI titer ≥ 110, Day 22 or Day 50) | 43 Percentage of subjects |
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | B strain (HI titer ≥ 330, Day 1) | 0 Percentage of subjects |
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | B strain (HI titer ≥ 330, Day 22 or Day 50) | 8 Percentage of subjects |
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H1N1 strain (HI titer ≥ 40, Day 22 or Day 50) | 99 Percentage of subjects |
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H1N1 strain (HI titer ≥ 110, Day 1) (N=113,112) | 19 Percentage of subjects |
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H1N1 strain (HI titer ≥ 110, Day 22 or Day 50) | 96 Percentage of subjects |
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H3N2 strain (HI titer ≥ 40, Day 1) | 56 Percentage of subjects |
| Naive_aTIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | B strain (HI titer ≥ 40, Day 22 or Day 50) | 84 Percentage of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | B strain (HI titer ≥ 110, Day 1) | 1 Percentage of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | B strain (HI titer ≥ 40, Day 1) | 9 Percentage of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H1N1 strain (HI titer ≥ 330, Day 1) | 7 Percentage of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | B strain (HI titer ≥ 110, Day 22 or Day 50) | 6 Percentage of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H1N1 strain (HI titer ≥ 330, Day 22 or Day 50) | 37 Percentage of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H1N1 strain (HI titer ≥ 110, Day 1) (N=113,112) | 20 Percentage of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H3N2 strain (HI titer ≥ 40, Day 22 or Day 50) | 97 Percentage of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | B strain (HI titer ≥ 330, Day 1) | 0 Percentage of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H3N2 strain (HI titer ≥ 110, Day 1) | 44 Percentage of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H3N2 strain (HI titer ≥ 40, Day 1) | 58 Percentage of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H3N2 strain (HI titer ≥ 110, Day 22 or Day 50) | 84 Percentage of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | B strain (HI titer ≥ 330, Day 22 or Day 50) | 0 Percentage of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H3N2 strain (HI titer ≥ 330, Day 1) | 30 Percentage of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H1N1 strain (HI titer ≥ 40, Day 1) (N=113,112) | 33 Percentage of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H3N2 strain (HI titer ≥ 330, Day 22 or Day 50) | 61 Percentage of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H1N1 strain (HI titer ≥ 110, Day 22 or Day 50) | 68 Percentage of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | B strain (HI titer ≥ 40, Day 22 or Day 50) | 32 Percentage of subjects |
| Naive_TIV (6 to <36 Months) | Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. | H1N1 strain (HI titer ≥ 40, Day 22 or Day 50) | 88 Percentage of subjects |