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Adjusted LOA
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TIVf · 1 trial · 1 indication
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 TIVf. 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 TIVf. 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 TIVf. The related European Committee for Human Medicinal Products (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.
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 TIVf. 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 TIVf. 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 TIVf 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 TIVf. 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 AEs and other solicited AEs after receiving one dose of TIVf 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 TIVf is reported.
| Arm | Type | Description |
|---|---|---|
| TIVf (18 to ≤ 60 years) | EXPERIMENTAL | Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere |
| TIVf (≥ 61 years) | EXPERIMENTAL | Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere |
| Name | Type | Description |
|---|---|---|
| TIVf | BIOLOGICAL | Trivalent Influenza Virus Vaccine (purified surface antigen, inactivated, egg-derived) |
Inclusion Criteria: * Male or female volunteer aged 18 years or older, mentally competent, who gave written informed consent prior to study entry; * Able to comply with all the study requirements; and * In good health as determined by the outcome of medical history, physical examination, and clinic...
TIVf is an investigational seasonal trivalent influenza virus vaccine being developed for the prevention of human influenza. It is a purified surface antigen, inactivated, egg-derived vaccine intended for use in adults aged 18 years and above. The vaccine is currently in clinical development and has not been approved by regulatory authorities.
TIVf is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The company conducted a Phase 3 clinical trial of the vaccine in Germany to evaluate its safety and immunogenicity in adults.
TIVf is in Phase 3 clinical development. A Phase 3 trial has been completed, but the vaccine remains investigational and is not yet approved for commercial use. The completed trial enrolled 125 adult participants in Germany to assess the vaccine's safety and immune response.
TIVf has one completed Phase 3 clinical trial registered under NCT01885117. The trial, titled 'Safety and Immunogenicity of One Dose of Seasonal Trivalent Influenza Virus Vaccine (TIVf, Purified Surface Antigen, Inactivated, Egg Derived) in Adults, Aged 18 Years and Above,' enrolled 125 participants in Germany. The study was controlled but not randomized or double-blinded.
TIVf is a seasonal trivalent influenza virus vaccine, meaning it is designed to protect against three strains of influenza virus. It is a purified surface antigen, inactivated, egg-derived vaccine. However, it is an investigational product and not the same as commercially available seasonal flu vaccines, as it has not yet received regulatory approval.