Influenza
Conditions
Keywords
Influenza, Flu, Cell Culture-Derived, Egg-Derived, Healthy Children, Healthy Adolescents, Safety, Immunogenicity, Trivalent, Inactivated, Vaccination
Brief summary
The present study is the first study designed to evaluate safety, tolerability and immunogenicity of the cell culture-derived influenza vaccine in healthy children and adolescents aged 3 to 17 years. A step-down approach is utilized in which reactogenicity and safety will be assessed in children and adolescents 9 to 17 years of age (Cohort 1) prior to enrolling additional children and adolescents 9 to 17 years of age (Cohort 2) and children 3 to 8 years of age (Cohort 3).
Interventions
BIOLOGICALCell culture-derived influenza subunit vaccine (cTIV)
One 0.5 ml injection of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.
BIOLOGICALEgg derived influenza subunit vaccine (eTIV)
One 0.5 ml injection of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.
Sponsors
Novartis Vaccines
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects aged 9 to 17 years (Cohorts 1 and 2) and 3 to 8 years (Cohort 3), whose parents/legal guardians have given written informed consent prior to study entry. Assent will be obtained from subjects according to age requirements of the ECs/IRBs; 2. In good health as determined by: 1. medical history, 2. physical examination, 3. clinical judgment of the Investigator; 3. Able to comply with all study procedures and available for all clinic visits and telephone calls scheduled in the study.
Exclusion criteria
1. Any serious disease, such as: 1. cancer, 2. autoimmune disease (including rheumatoid arthritis), 3. diabetes mellitus, 4. chronic pulmonary disease, 5. acute or progressive hepatic disease, 6. acute or progressive renal disease; 2. History of any anaphylaxis or serious reaction following administration of vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, polymyxin, or any other vaccine component, chemically related substance, or component of the potential packaging materials; 3. Known or suspected impairment/alteration of immune function, including: 1. use of immunosuppressive therapy such as systemic corticosteroids known to be associated with the suppression of hypothalamic-pituitary-adrenal (HPA) axis or chronic use of inhaled high-potency corticosteroids within 60 days prior to Visit 1, 2. cancer chemotherapy, 3. receipt of immunostimulants within 60 days prior to Visit 1, 4. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study, 5. known HIV infection or HIV-related disease; 4. History of Guillain-Barré syndrome; 5. Bleeding diathesis; 6. Surgery planned during the study period; 7. Receipt of another investigational agent within 90 days, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the study; 8. Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Visit 1; 9. Laboratory-confirmed influenza disease within 6 months prior to Visit 1; 10. For subjects aged 3 to 8 years old, ever received two doses of an influenza vaccine in one influenza season; 11. Receipt of an influenza vaccine within 6 months prior to Visit 1; 12. Experienced a temperature 38.0°C \[100.4°F\]) and/or any acute illness within 3 days prior to Visit 1; 13. Pregnant or nursing mother; 14. Female of childbearing potential who is sexually active and has not used acceptable birth control measures for at least 2 months prior to study entry and who does not plan to use acceptable birth control measures during the 3 weeks following vaccination or refuses to have a urine pregnancy test prior to enrollment. Oral, injected, inserted or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device are considered acceptable forms of birth control; 15. Children of research staff or those living with research staff directly involved with the clinical study. Research staff are individuals with direct study subject contact, indirect contact with study subjects, or study site personnel who have access to any study documents containing subject information. This would include receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians, etc.; 16. Any condition, which in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | Day 50 post vaccination | To demonstrate non-inferiority of the post vaccination hemagglutination inhibition (HI) geometric mean titer (GMT) of the cell culture-derived influenza (cTIV) vaccine to the corresponding GMT of the egg-derived (eTIV) influenza vaccine, for all three strains, after two injections administered four weeks apart to a subset of children 3 to 8 years of age. GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay. |
| Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | Day 50 post vaccination | To demonstrate non-inferiority of the cell culture-derived influenza (cTIV) vaccine to the egg-derived (eTIV) influenza vaccine in the percentage of subjects achieving seroconversion or significant increase in antibody titer post vaccination, for all three strains, after two injections administered four weeks apart in children 3 to 8 years of age. Seroconversion rate was evaluated using two assays- HI egg derived antigen assay and HI cell derived antigen assay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 post vaccination | To evaluate immunogenicity in terms of percentage of 9 to 17 year-old children and adolescents achieving HI titers ≥40, after one injection of either the cTIV vaccine or the eTIV vaccine. This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is \>70% and according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%. |
| Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 post vaccination | Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer \<10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be \>40%. According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%. |
| Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day 29 and Day 50 post vaccination | To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 3 to 8 years of age after two doses of either cTIV vaccine or eTIV,administered 4 weeks apart. |
| Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day 29 and Day 50 post vaccination | To evaluate immunogenicity in terms of Geometric Mean Ratio (GMR) in children 3 to 8 years of age after two doses of either the cTIV vaccine or the eTIV vaccine, administered 4 weeks apart according to the CHMP criteria. The criterion is met according to the European (CHMP) guideline if the mean geometric increase (GMR day 29/day 1 and GMR day 50/day 1) in HI antibody titer is \>2.5 |
| Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 post vaccination | To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 9 to 17 years of age after one injection of either cTIV vaccine or eTIV. GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay. |
| Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day 29 and Day 50 post vaccination | Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer \<10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be \>40%. According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%. |
| Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | up to 7 days after vaccination | To evaluate safety and tolerability in terms of number of 9 to 17 year-old children and adolescents (cohorts 1 and 2) reporting local and systemic reactions following of one injection of the cTIV or the eTIV vaccine . |
| Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | up to 7 days after each vaccination | To evaluate the safety and tolerability of the cTIV and the eTIV influenza vaccines in 3 to 8 year-old children terms of number of participants reporting local and systemic reactions after each vaccination. |
| Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day 29 and Day 50 post vaccination | To evaluate immunogenicity in terms of HI titers ≥40, in children 3-8 years of age after two doses of either cTIV vaccine or eTIV vaccine, administered 4 weeks apart. The criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is \>70% and according to the US (CBER) guideline if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%. |
| Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Day 29 post vaccination | Immunogenicity was evaluated in terms of Geometric Mean Ratio (GMRs) in 9 to 17 year-old children and adolescents after one injection of either cTIV vaccine or eTIV. The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (day29/day1) in HI antibody titer is \>2.5. |
Countries
Croatia, Finland, Hungary, Italy, Lithuania, Romania, United States
Participant flow
Recruitment details
Participants were enrolled from 14 sites in Finland, 16 in the US, 9 in Croatia, 5 in Italy, 6 in Lithuania, 2 in Romania, 8 in Hungary.
Pre-assignment details
All subjects enrolled were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1+2 cTIV (9-17 Years) All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine. | 656 |
| Cohort 1+2 eTIV (9-17 Years) All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine. | 318 |
| Cohort 3 cTIV (3-8 Years) All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine. | 1,608 |
| Cohort 3 eTIV (3-8 Years) All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine. | 1,022 |
| Total | 3,604 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 2 |
| Overall Study | Inappropriate enrollment | 0 | 0 | 4 | 1 |
| Overall Study | Lost to Follow-up | 10 | 5 | 124 | 75 |
| Overall Study | Protocol Violation | 1 | 0 | 1 | 0 |
| Overall Study | Unable to classify | 0 | 0 | 3 | 4 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 19 | 21 |
Baseline characteristics
| Characteristic | Cohort 3 cTIV (3-8 Years) | Cohort 3 eTIV (3-8 Years) | Total | Cohort 1+2 cTIV (9-17 Years) | Cohort 1+2 eTIV (9-17 Years) |
|---|---|---|---|---|---|
| Age, Continuous | 5.5 years STANDARD_DEVIATION 1.7 | 5.4 years STANDARD_DEVIATION 1.7 | 7.4 years STANDARD_DEVIATION 3.7 | 12.6 years STANDARD_DEVIATION 2.6 | 12.6 years STANDARD_DEVIATION 2.5 |
| Sex: Female, Male Female | 795 Participants | 494 Participants | 1747 Participants | 304 Participants | 154 Participants |
| Sex: Female, Male Male | 813 Participants | 528 Participants | 1857 Participants | 352 Participants | 164 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 | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 328 / 652 | 168 / 316 | 799 / 1,599 | 507 / 1,013 | 670 / 1,557 | 413 / 977 |
| serious Total, serious adverse events | 5 / 652 | 3 / 316 | 2 / 1,599 | 0 / 1,013 | 7 / 1,557 | 5 / 977 |
Outcome results
Primary
Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children
To demonstrate non-inferiority of the post vaccination hemagglutination inhibition (HI) geometric mean titer (GMT) of the cell culture-derived influenza (cTIV) vaccine to the corresponding GMT of the egg-derived (eTIV) influenza vaccine, for all three strains, after two injections administered four weeks apart to a subset of children 3 to 8 years of age. GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay.
Time frame: Day 50 post vaccination
Population: The analysis was performed on the per-protocol dataset
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | A/H1N1 (egg derived antigen assay) | 407 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | A/H3N2 (egg derived antigen assay) | 768 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | B (egg derived antigen assay) | 25 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | A/H1N1 (cell derived antigen assay) (N=522,513) | 563 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | A/H3N2 (cell derived antigen assay) (N=522,513) | 858 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | B (cell derived antigen assay) (N=522,513) | 53 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | A/H3N2 (cell derived antigen assay) (N=522,513) | 1329 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | A/H1N1 (egg derived antigen assay) | 477 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | A/H1N1 (cell derived antigen assay) (N=522,513) | 610 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | A/H3N2 (egg derived antigen assay) | 1293 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | B (cell derived antigen assay) (N=522,513) | 62 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | B (egg derived antigen assay) | 44 Titers |
Comparison: Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI egg-derived antigen assay95% CI: [0.72, 1.01]ANOVA
Comparison: Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI egg-derived antigen assay.95% CI: [0.49, 0.72]ANOVA
Comparison: Non-inferiority of cTIV to eTIV against influenza B strain as measured by HI egg-derived antigen assay.95% CI: [0.46, 0.68]ANOVA
Comparison: Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI cell-derived antigen assay.95% CI: [0.79, 1.08]ANOVA
Comparison: Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI cell-derived antigen assay.95% CI: [0.54, 0.78]ANOVA
Comparison: Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI cell-derived antigen assay.95% CI: [0.71, 1.06]ANOVA
Primary
Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children
To demonstrate non-inferiority of the cell culture-derived influenza (cTIV) vaccine to the egg-derived (eTIV) influenza vaccine in the percentage of subjects achieving seroconversion or significant increase in antibody titer post vaccination, for all three strains, after two injections administered four weeks apart in children 3 to 8 years of age. Seroconversion rate was evaluated using two assays- HI egg derived antigen assay and HI cell derived antigen assay.
Time frame: Day 50 post vaccination
Population: The analysis was performed on the per-protocol dataset
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | A/H1N1 (egg derived antigen assay) | 94 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | A/H3N2 (egg derived antigen assay) | 77 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | B (egg derived antigen assay) | 38 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | A/H1N1 (cell derived antigen assay) (N=522,513) | 96 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | A/H3N2 (cell derived antigen assay) (N=522,513) | 80 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | B (cell derived antigen assay) (N=522,513) | 58 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | A/H3N2 (cell derived antigen assay) (N=522,513) | 85 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | A/H1N1 (egg derived antigen assay) | 96 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | A/H1N1 (cell derived antigen assay) (N=522,513) | 96 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | A/H3N2 (egg derived antigen assay) | 86 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | B (cell derived antigen assay) (N=522,513) | 58 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children | B (egg derived antigen assay) | 53 Percentages of subjects |
Comparison: Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI egg-derived antigen assay.95% CI: [-4, 1]binomial or the method of Miettinen and
Comparison: Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI egg-derived antigen assay.95% CI: [-13, -4]binomial or Miettinen & Nurimen method
Comparison: Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI egg-derived antigen assay.95% CI: [-21, -9]binominal or Miettinen &Nurimen method
Comparison: Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI cell-derived antigen assay.95% CI: [-3, 2]binominal or Miettinen &Nurimen method
Comparison: Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI cell-derived antigen assay.95% CI: [-9.5, 0]binominal or Miettinen &Nurimen method
Comparison: Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI cell-derived antigen assay.95% CI: [-6, 6]binominal or Miettinen &Nurimen method
Secondary
Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.
Immunogenicity was evaluated in terms of Geometric Mean Ratio (GMRs) in 9 to 17 year-old children and adolescents after one injection of either cTIV vaccine or eTIV. The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (day29/day1) in HI antibody titer is \>2.5.
Time frame: Day 29 post vaccination
Population: The analysis was performed on the per-protocol dataset.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Day 29 (A/H1N1)egg derived antigen assay | 16 Ratio |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Day 29 (A/H3N2) egg derived antigen assay | 5.84 Ratio |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Day 29 (B) egg derived antigen assay | 6.03 Ratio |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Day29(A/H1N1)cell derived antigen assay(N=141,144) | 15 Ratio |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Day29(A/H3N2)cell derived antigen assay(N=141,144) | 5.45 Ratio |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Day29(B) cell derived antigen assay(N=141,144) | 6.15 Ratio |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Day29(A/H3N2)cell derived antigen assay(N=141,144) | 11 Ratio |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Day 29 (A/H1N1)egg derived antigen assay | 14 Ratio |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Day29(A/H1N1)cell derived antigen assay(N=141,144) | 14 Ratio |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Day 29 (A/H3N2) egg derived antigen assay | 12 Ratio |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Day29(B) cell derived antigen assay(N=141,144) | 7.37 Ratio |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Day 29 (B) egg derived antigen assay | 11 Ratio |
Secondary
Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children
To evaluate immunogenicity in terms of Geometric Mean Ratio (GMR) in children 3 to 8 years of age after two doses of either the cTIV vaccine or the eTIV vaccine, administered 4 weeks apart according to the CHMP criteria. The criterion is met according to the European (CHMP) guideline if the mean geometric increase (GMR day 29/day 1 and GMR day 50/day 1) in HI antibody titer is \>2.5
Time frame: Day 29 and Day 50 post vaccination
Population: The analysis was performed on the per-protocol dataset.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day29 (A/H1N1)egg derived antigen assay(N=515,507) | 9.58 Ratio |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day 50 (B) egg derived antigen assay | 3.99 Ratio |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day29 (A/H3N2)egg derived antigen assay(N=515,507) | 8.65 Ratio |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day 29 (A/H1N1) cell derived antigen assay | 13 Ratio |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day 29 (B) cell derived antigen assay | 3.59 Ratio |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day 50 (A/H3N2) egg derived antigen assay | 11 Ratio |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day 29 (A/H3N2) cell derived antigen assay | 8.73 Ratio |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day 50 (A/H1N1) egg derived antigen assay | 25 Ratio |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day50(A/H3N2)cell derived antigen assay(N=522,513) | 12 Ratio |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day 29 (B) egg derived assay (N=515,507 | 3.04 Ratio |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day 50 (B) cell derived antigen assay(N=522,513) | 6.5 Ratio |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day50(A/H1N1)cell derived antigen assay(N=522,513 | 30 Ratio |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day 50 (B) cell derived antigen assay(N=522,513) | 7.06 Ratio |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day50(A/H3N2)cell derived antigen assay(N=522,513) | 16 Ratio |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day29 (A/H1N1)egg derived antigen assay(N=515,507) | 11 Ratio |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day 50 (A/H1N1) egg derived antigen assay | 33 Ratio |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day29 (A/H3N2)egg derived antigen assay(N=515,507) | 15 Ratio |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day 50 (A/H3N2) egg derived antigen assay | 17 Ratio |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day 29 (B) egg derived assay (N=515,507 | 4.36 Ratio |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day 50 (B) egg derived antigen assay | 7.04 Ratio |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day 29 (A/H1N1) cell derived antigen assay | 12 Ratio |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day50(A/H1N1)cell derived antigen assay(N=522,513 | 37 Ratio |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day 29 (A/H3N2) cell derived antigen assay | 13 Ratio |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children | Day 29 (B) cell derived antigen assay | 4.14 Ratio |
Secondary
Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents
To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 9 to 17 years of age after one injection of either cTIV vaccine or eTIV. GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay.
Time frame: Day 29 post vaccination
Population: The analysis was performed on the per-protocol dataset.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Baseline(A/H3N2)cell derived assay(N=141,144) | 125 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Baseline (A/H1N1) egg derived antigen assay | 55 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (A/H1N1) egg derived antigen assay | 879 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Baseline (A/H3N2) egg derived antigen assay | 121 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (A/H3N2) egg derived antigen assay | 706 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Baseline (B) Egg derived antigen assay | 9.65 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (B) egg derived antigen assay | 58 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Baseline(A/H1N1)Cell derived assay | 70 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (A/H1N1) cell derived antigen assay | 1076 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (A/H3N2) cell derived antigen assay | 676 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Baseline(B)cell derived assay(N=141,144) | 22 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (B) cell derived antigen assay | 136 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Baseline(B)cell derived assay(N=141,144) | 25 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Baseline(A/H3N2)cell derived assay(N=141,144) | 144 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (B) egg derived antigen assay | 105 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Baseline (A/H1N1) egg derived antigen assay | 78 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (A/H3N2) cell derived antigen assay | 1651 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (A/H1N1) egg derived antigen assay | 1107 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Baseline(A/H1N1)Cell derived assay | 90 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Baseline (A/H3N2) egg derived antigen assay | 151 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (B) cell derived antigen assay | 186 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (A/H3N2) egg derived antigen assay | 1857 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (A/H1N1) cell derived antigen assay | 1296 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Baseline (B) Egg derived antigen assay | 9.92 Titers |
Secondary
Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children
To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 3 to 8 years of age after two doses of either cTIV vaccine or eTIV,administered 4 weeks apart.
Time frame: Day 29 and Day 50 post vaccination
Population: The analysis was performed on the per-protocol dataset.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Baseline (A/H1N1) egg derived antigen assay | 16 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day29(A/H1N1)egg derived antigen assay(N=515,507) | 152 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day50(A/H1N1)egg derived antigen assay | 407 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Baseline (A/H3N2) egg derived antigen assay | 68 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day29(A/H3N2)egg derived antigen assay(N=515,507) | 584 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day50(A/H3N2)egg derived antigen assay | 768 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Baseline (B) egg derived antigen assay | 6.16 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day29(B) egg derived antigen assay (N=515,507) | 19 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day 50 (B) egg derived antigen assay | 25 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Baseline (A/H1N1) cell derived antigen assay | 19 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day 29 (A/H1N1) cell derived antigen assay | 234 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day50(A/H1N1)cell derived antigen assay(N=522,513) | 563 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Baseline (A/H3N2) cell derived antigen assay | 75 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day 29 (A/H3N2) cell derived antigen assay | 653 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day50(A/H3N2)cell derived antigen assay(N=522,513) | 858 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Baseline (B) cell derived antigen assay | 8.22 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day 29 (B) cell derived antigen assay | 29 Titers |
| Cohort 3 cTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day50 (B) cell derived antigen assay(N=522,513) | 53 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day 29 (A/H3N2) cell derived antigen assay | 1099 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Baseline (A/H1N1) egg derived antigen assay | 15 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Baseline (A/H1N1) cell derived antigen assay | 17 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day29(A/H1N1)egg derived antigen assay(N=515,507) | 157 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day50 (B) cell derived antigen assay(N=522,513) | 62 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day50(A/H1N1)egg derived antigen assay | 477 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day 29 (A/H1N1) cell derived antigen assay | 192 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Baseline (A/H3N2) egg derived antigen assay | 74 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day50(A/H3N2)cell derived antigen assay(N=522,513) | 1329 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day29(A/H3N2)egg derived antigen assay(N=515,507) | 1075 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day50(A/H1N1)cell derived antigen assay(N=522,513) | 610 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day50(A/H3N2)egg derived antigen assay | 1293 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day 29 (B) cell derived antigen assay | 36 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Baseline (B) egg derived antigen assay | 6.24 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Baseline (A/H3N2) cell derived antigen assay | 85 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day29(B) egg derived antigen assay (N=515,507) | 27 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Baseline (B) cell derived antigen assay | 8.72 Titers |
| Cohort 3 eTIV (3-8 Years) | Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children | Day 50 (B) egg derived antigen assay | 44 Titers |
Secondary
Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.
To evaluate safety and tolerability in terms of number of 9 to 17 year-old children and adolescents (cohorts 1 and 2) reporting local and systemic reactions following of one injection of the cTIV or the eTIV vaccine .
Time frame: up to 7 days after vaccination
Population: The analysis was performed on the safety dataset
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Any Local | 276 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Injection site pain | 220 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Injection site erythema | 91 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Injection site induration | 44 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Injection site ecchymosis | 34 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Injection site swelling | 32 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Any Systemic | 188 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Chills | 26 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Malaise | 60 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Myalgia | 99 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Arthralgia | 27 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Headache | 92 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Sweating | 14 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Fatigue | 57 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Fever (≥38C) (N=651,316) | 5 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Any Other | 44 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Stayed at home (n=649,316) | 9 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Analgesic Medication Used | 42 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Fatigue | 41 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Any Local | 141 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Myalgia | 59 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Injection site pain | 120 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Analgesic Medication Used | 31 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Injection site erythema | 45 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Arthralgia | 17 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Injection site induration | 28 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Fever (≥38C) (N=651,316) | 3 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Injection site ecchymosis | 10 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Headache | 44 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Injection site swelling | 17 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Stayed at home (n=649,316) | 10 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Any Systemic | 95 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Sweating | 3 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Chills | 13 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Any Other | 37 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents. | Malaise | 34 Subjects |
Secondary
Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children.
To evaluate the safety and tolerability of the cTIV and the eTIV influenza vaccines in 3 to 8 year-old children terms of number of participants reporting local and systemic reactions after each vaccination.
Time frame: up to 7 days after each vaccination
Population: The analysis was performed on the safety dataset set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Injection site swelling | 119 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Headache | 182 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Injection site induration | 141 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Sweating | 47 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Chills | 70 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Injection site erythema | 337 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Fever (≥ 38C) | 75 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Malaise | 156 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Oral temp; 38 to <38.9 C (N=1598,1013) | 48 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Injection site ecchymosis | 144 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Stayed at home (N=1582,1003,1519, 955) | 77 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Myalgia | 202 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Analgesic Medication Used | 221 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Injection site pain | 653 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Oral temp; 39 to < 40 C (N=1598,1013) | 16 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Arthralgia | 65 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Oral temp; ≥ 40 C (N=1598,1013) | 6 Subjects |
| Cohort 3 cTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Fatigue | 210 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Oral temp; ≥ 40 C (N=1598,1013) | 1 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Injection site pain | 398 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Injection site erythema | 206 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Injection site induration | 84 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Injection site ecchymosis | 99 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Injection site swelling | 85 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Chills | 68 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Malaise | 117 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Myalgia | 119 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Arthralgia | 28 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Headache | 144 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Sweating | 28 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Fatigue | 170 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Fever (≥ 38C) | 60 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Oral temp; 38 to <38.9 C (N=1598,1013) | 43 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Stayed at home (N=1582,1003,1519, 955) | 63 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Analgesic Medication Used | 148 Subjects |
| Cohort 3 eTIV (3-8 Years) | Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children. | Oral temp; 39 to < 40 C (N=1598,1013) | 15 Subjects |
Secondary
Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents
To evaluate immunogenicity in terms of percentage of 9 to 17 year-old children and adolescents achieving HI titers ≥40, after one injection of either the cTIV vaccine or the eTIV vaccine. This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is \>70% and according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%.
Time frame: Day 29 post vaccination
Population: The analysis was performed on the per-protocol dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (A/H1N1) egg derived antigen assay | 99 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Prevaccination (H1N1)cell derived assay(N=141,144) | 67 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (A/H3N2) egg derived antigen assay | 100 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (A/H1N1)cell derived antigen assay | 99 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Prevaccination (A/H1N1)egg derived antigen assay | 65 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Prevaccination (H3N2)cell derived assay(N=141,144) | 83 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Prevaccination(B)egg derived antigen assay | 17 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (A/H3N2) cell derived antigen assay | 100 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Prevaccination (A/H3N2) egg derived antigen assay | 82 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Prevaccination (B) cell derived assay(N=141,144) | 40 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (B) egg derived antigen assay | 75 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (B) cell derived antigen assay | 95 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (B) cell derived antigen assay | 94 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Prevaccination (A/H1N1)egg derived antigen assay | 75 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (A/H1N1) egg derived antigen assay | 99 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Prevaccination (A/H3N2) egg derived antigen assay | 86 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (A/H3N2) egg derived antigen assay | 100 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Prevaccination(B)egg derived antigen assay | 13 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (B) egg derived antigen assay | 84 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Prevaccination (H1N1)cell derived assay(N=141,144) | 78 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (A/H1N1)cell derived antigen assay | 98 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Prevaccination (H3N2)cell derived assay(N=141,144) | 86 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (A/H3N2) cell derived antigen assay | 100 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Prevaccination (B) cell derived assay(N=141,144) | 47 Percentages of subjects |
Secondary
Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children
To evaluate immunogenicity in terms of HI titers ≥40, in children 3-8 years of age after two doses of either cTIV vaccine or eTIV vaccine, administered 4 weeks apart. The criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is \>70% and according to the US (CBER) guideline if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%.
Time frame: Day 29 and Day 50 post vaccination
Population: The analysis was performed on the per-protocol dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Prevaccination (A/H1N1) egg derived antigen assay | 35 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day29(A/H1N1)egg derived antigen assay (N=515,507) | 72 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day 50 (A/H1N1) egg derived antigen assay | 96 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Prevaccination (A/H3N2) egg derived antigen assay | 67 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day29(A/H3N2)egg derived antigen assay(N=515,507) | 87 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day50 (A/H3N2) egg derived antigen assay | 96 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Prevaccination (B) egg derived antigen assay | 4 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day 29 (B) egg derived antigen assay (N=515,507) | 35 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day 50 (B) egg derived antigen assay | 40 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Prevaccination (A/H1N1) cell derived antigen assay | 36 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day 29 (A/H1N1) cell derived antigen assay | 82 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day50(A/H1N1)cell derived antigen assay(N=522,513) | 98 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Prevaccination (A/H3N2) cell derived antigen assay | 71 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day 29 (A/H3N2) cell derived antigen assay | 89 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day50(A/H3N2)cell derived antigen assay(N=522,513) | 98 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Prevaccination (B) cell derived antigen assay | 11 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day 29 (B) cell derived antigen assay | 43 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day 50 (B) cell derived antigen assay (N=522,513) | 60 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day 29 (A/H3N2) cell derived antigen assay | 85 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Prevaccination (A/H1N1) egg derived antigen assay | 31 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Prevaccination (A/H1N1) cell derived antigen assay | 33 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day29(A/H1N1)egg derived antigen assay (N=515,507) | 68 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day 50 (B) cell derived antigen assay (N=522,513) | 62 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day 50 (A/H1N1) egg derived antigen assay | 97 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day 29 (A/H1N1) cell derived antigen assay | 76 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Prevaccination (A/H3N2) egg derived antigen assay | 70 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day50(A/H3N2)cell derived antigen assay(N=522,513) | 93 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day29(A/H3N2)egg derived antigen assay(N=515,507) | 85 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day50(A/H1N1)cell derived antigen assay(N=522,513) | 98 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day50 (A/H3N2) egg derived antigen assay | 94 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day 29 (B) cell derived antigen assay | 45 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Prevaccination (B) egg derived antigen assay | 4 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Prevaccination (A/H3N2) cell derived antigen assay | 75 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day 29 (B) egg derived antigen assay (N=515,507) | 40 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Prevaccination (B) cell derived antigen assay | 12 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children | Day 50 (B) egg derived antigen assay | 55 Percentages of subjects |
Secondary
Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children
Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer \<10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be \>40%. According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%.
Time frame: Day 29 and Day 50 post vaccination
Population: The analysis was performed on the per-protocol dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day 50 (H1N1) egg derived antigen assay | 94 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day 29 (A/H1N1) cell derived antigen assay | 79 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day 50 (A/H3N2) egg derived antigen assay | 77 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day50(A/H1N1)cell derived antigen assay(N=522,513) | 96 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day29(A/H1N1) egg derived antigen assay(N=515,507) | 70 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day29(B) egg derived antigen assay(N=515,507) | 33 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day50(A/H3N2)cell derived antigen assay(N=522,513) | 80 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day29(A/H3N2) egg derived antigen assay(N=515,507) | 65 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day 29 (B) cell derived antigen assay | 40 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day 50 (B) egg derived antigen assay | 38 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day 50(B)cell derived antigen assay(N=522,513) | 58 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day 29 (A/H3N2) cell derived antigen assay | 70 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day 50(B)cell derived antigen assay(N=522,513) | 58 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day29(A/H1N1) egg derived antigen assay(N=515,507) | 67 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day 50 (H1N1) egg derived antigen assay | 96 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day29(A/H3N2) egg derived antigen assay(N=515,507) | 78 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day 50 (A/H3N2) egg derived antigen assay | 86 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day29(B) egg derived antigen assay(N=515,507) | 38 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day 50 (B) egg derived antigen assay | 53 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day 29 (A/H1N1) cell derived antigen assay | 75 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day50(A/H1N1)cell derived antigen assay(N=522,513) | 96 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day 29 (A/H3N2) cell derived antigen assay | 76 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day50(A/H3N2)cell derived antigen assay(N=522,513) | 85 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children | Day 29 (B) cell derived antigen assay | 41 Percentages of subjects |
Secondary
Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents
Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer \<10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be \>40%. According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%.
Time frame: Day 29 post vaccination
Population: The analysis was performed on the per-protocol dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (A/H1N1) egg derived antigen assay | 77 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (A/H3N2) egg derived antigen assay | 56 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (B) egg derived antigen assay | 56 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day29(A/H1N1)cell derived antigen assay(N=141,144) | 74 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day29(A/H3N2)cell derived antigen assay(N=141,144) | 52 Percentages of subjects |
| Cohort 3 cTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day29(B)cell derived antigen assay (N=141,144) | 63 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day29(A/H3N2)cell derived antigen assay(N=141,144) | 78 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (A/H1N1) egg derived antigen assay | 77 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day29(A/H1N1)cell derived antigen assay(N=141,144) | 74 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (A/H3N2) egg derived antigen assay | 77 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day29(B)cell derived antigen assay (N=141,144) | 69 Percentages of subjects |
| Cohort 3 eTIV (3-8 Years) | Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents | Day 29 (B) egg derived antigen assay | 71 Percentages of subjects |