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TIV · 2 trials · 2 indications
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.
Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIV . The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is \>70% for adults aged 18 to ≤60 years and \>60% for subjects aged ≥61 years.
Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains, three weeks after receiving one dose of TIV. Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤4mm2 achieving a post vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area \>4mm2 achieving at least 50% increase in post vaccination SRH area. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is \>40% for adults aged 18 to ≤60 years and \>30% for subjects aged ≥61 years.
The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \>2.5 for adults aged 18 to ≤60 years and \> 2.0 in for subjects aged ≥61 years.
Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is \>70% for adults aged 18 to ≤60 years and \>60% for subjects aged ≥61 years.
Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIV. Seroconversion is defined as percentage of subjects with a pre vaccination HI titer \<10 to a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 to at least a 4-fold increase in post vaccination HI antibody titers. The related European (CHMP) criterion for the assessment of immunogenicity is met if \>40% for adults aged 18 to ≤60 years and \>30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination HI titers.
The antibody responses following one dose of TIV were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \>2.5 for adults aged 18 to ≤60 years and \> 2.0 for subjects aged ≥61 years.
The number of adult and elderly subjects reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of TIV are reported.
The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (Day 1 to Day 22), after receiving one dose of TIV is reported.
| 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. |
| TIV (18 to ≤ 60 years) | EXPERIMENTAL | Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere |
| TIV (≥ 61 years) | EXPERIMENTAL | Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere |
| 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...
TIV is an investigational trivalent subunit inactivated influenza vaccine being developed for the prevention of seasonal influenza and human influenza. It is designed to be administered to healthy children, adolescents, and adults to generate an immune response against circulating influenza virus strains.
TIV is being developed by Novartis AG, which trades under the ticker NVS. The company has conducted clinical trials evaluating the vaccine's safety and immunogenicity in different age groups and geographic regions.
TIV has completed Phase 2 and Phase 3 clinical trials. The Phase 2 trial was completed in healthy adults aged 18 years and above, and the Phase 3 trial was completed in healthy children and adolescents aged 3 to 17 years. The vaccine remains investigational.
TIV has been evaluated in two completed trials. NCT01209780 was a Phase 3 study in 3,116 healthy children and adolescents aged 3 to 17 years across Colombia, Mexico, Panama, and the Philippines. NCT01879553 was a Phase 2 study in 126 healthy adults aged 18 years and above in Belgium.
Yes, TIV stands for trivalent inactivated vaccine, meaning it contains three influenza virus strains. It is a subunit vaccine, which includes only parts of the virus to stimulate immunity. The trials evaluated seasonal formulations for different years.