Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TIVc · 2 trials · 2 indications
Safety was assessed in terms of number of the subjects (3 to \< 18 years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV
Safety was assessed in terms of number of the subjects (3 to \<6 years,(≥ 6 to \< 9 years and 9 to \<18 Years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV
Safety was assessed in terms of number of subjects who reported any unsolicited AEs (four weeks after 1st vaccination and up to three weeks after 2nd vaccination), serious adverse events (SAEs), new onset of chronic diseases (NOCD), medically attended AEs and AEs leading to vaccine/study withdrawal after receiving one or two doses of either TIVc or TIV by overall age group (3 to \<18 years) and age sub-strata (3 to \<9 years and 9 to \<18 years)
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 TIVc. The related European (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 TIVc. 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 TIVc 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 TIVc. 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 TIVc. 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 TIVc 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 TIVc. 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 TIVc 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 (throughout the study period), after receiving one dose of TIVc is reported.
| Arm | Type | Description |
|---|---|---|
| TIVc | EXPERIMENTAL | flu vaccine |
| TIV | ACTIVE_COMPARATOR | flu vaccine |
| TIVc (≥18 to ≤ 60 years) + TIVc (≥ 61 years) | EXPERIMENTAL | Subjects in each age cohort received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere |
| Name | Type | Description |
|---|---|---|
| TIVc | BIOLOGICAL | Madin Darby Canine Kidney (MDCK) cell culture derived subunit influenza vaccine TIVc contained the purified viral envelope glycoproteins, hemagglutinin (HA) and neuraminidase (NA) derived from 3 strains (including HA for each strain \[A/H1N1-like, A/H3N2-like, and B-like\]) intramuscular (IM) injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere |
| TIV | BIOLOGICAL | A conventional egg derived subunit influenza vaccine (TIV) contained the purified viral envelope-glycoproteins, HA and NA derived from 3 strains (including HA for each strain \[A/ H1N1-like, A/H3N2-like, and B-like\]) IM injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere. |
Inclusion Criteria: * Individuals 3 to \<18 years of age with underlying medical conditions that indicate an increased risk of complications from influenza infection. * Further eligibility criteria may be discussed by contacting the site(s) Exclusion Criteria: * Individuals with any fatal prognos...
TIVc is an investigational monoclonal antibody being developed for the prevention of human influenza and influenza. It is a trivalent, nonadjuvanted, cell-derived subunit influenza vaccine candidate studied in adults, children, and adolescents to assess safety and immunogenicity.
TIVc is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The company has conducted clinical trials to evaluate the vaccine's safety and immunogenicity in various age groups.
TIVc is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Clinical trials have been completed to evaluate its safety and immunogenicity in adults, children, and adolescents.
TIVc has been studied in two completed Phase 3 clinical trials. NCT01880697 evaluated safety and immunogenicity in adults aged 18 years and above in Germany. NCT01998477 assessed safety in children and adolescents aged 3 to less than 18 years at risk for influenza-related complications in Italy and Spain.
TIVc is a cell-derived subunit trivalent nonadjuvanted influenza vaccine. It is produced using cell culture technology rather than egg-based methods. The vaccine is designed to provide immunity against influenza virus strains included in the trivalent formulation.