Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01209780 | Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age | PHASE3 | COMPLETED | 3,116 | — | — | Sep 1, 2010 | Sep 1, 2011 | Mar 11, 2014 | 13 | Colombia, Mexico +2 |
The non-inferiority of the antibody responses of investigational TIV compared to control TIV assessed in terms of the percentage of subjects achieving seroconversion, against the three homologous vaccine strains,in children 3 to 8 years of age, at 21 days after last vaccination. Seroconversion was defined as a pre-vaccination haemagglutinin inhibition (HI) titer \<1:10 and post-vaccination HI titer ≥1:40 or as a pre-vaccination HI titer ≥1:10 and at minimum four-fold rise in post-vaccination antibody titer
The non-inferiority of the antibody responses of investigational TIV compared to control vaccine assessed in terms of post vaccination GMTs, at 21 days after last vaccination against the three homologous vaccine strains in 3 to 8 year old children.
| Arm | Type | Description |
|---|---|---|
| TIV (3-8 years) | EXPERIMENTAL | Non-Naive subjects received one dose and naive subjects received two doses, administered 4 weeks apart, of investigational trivalent influenza vaccine (TIV) |
| Control TIV (3-8 years) | ACTIVE_COMPARATOR | Non-Naive subjects received one dose and Naive subjects received two doses, administered 4 weeks apart, of control vaccine. Subjects aged 3 to \<4 years and subjects aged 4 to 8 years received different control TIV. |
| TIV ( 9-17 years) | EXPERIMENTAL | All subjects received one dose of investigational TIV. The subjects in this cohort were included only for safety analysis. |
| Control TIV ( (9-17 years) | ACTIVE_COMPARATOR | All subjects received one dose of the control vaccine. The subjects from this cohort were included only for safety analysis. |
| Name | Type | Description |
|---|---|---|
| TIV | BIOLOGICAL | Investigational egg-derived trivalent subunit influenza vaccine. |
| TIVf | BIOLOGICAL | US licensed trivalent inactivated subunit influenza vaccine -Fluvirin (Novartis Vaccines and Diagnostics) is approved for use in subjects ≥4 years. |
| Comparator TIV | BIOLOGICAL | US licensed trivalent subunit inactivated influenza vaccine- Fluzone (Sanofi Pasteur) is approved for use in children \<4 years. |
Inclusion Criteria: * Males and females aged 3 to 17 years, in good health as determined by medical history, physical examination and clinical judgment of the investigator * Documented consent provided by parents or legal guardians * For individuals 8 years of age and older, informed assent to part...