Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
cTIV or eTIV_a · 1 trial · 1 indication
Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection. Local reactions reported for Influenza Vaccine Injection site.
Non-inferiority of the influenza vaccine FLU (cell-culture derived seasonal trivalent influenza vaccine (cTIV); and influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a)) when administered alone versus administered concomitantly with pneumococcal vaccine (FLU + PV) is met if lower limit of the 2-sided 95% confidence interval (CI) of postvaccination (Day 22) Geometric Mean Titer ratio (FLU+PV/FLU) is greater than 0.5.
| Arm | Type | Description |
|---|---|---|
| cTIV | EXPERIMENTAL | Cell culture derived seasonal trivalent influenza vaccine (cTIV) |
| eTIV_a | ACTIVE_COMPARATOR | Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) |
| FLU (cTIV or eTIV_a) | EXPERIMENTAL | Cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a). |
| FLU (cTIV or eTIV_a) + PV | ACTIVE_COMPARATOR | 23-valent Pneumococcal vaccine (PV) concomitantly administered with cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a). |
| Name | Type | Description |
|---|---|---|
| Cell culture derived seasonal trivalent influenza vaccine (cTIV) | BIOLOGICAL | cell cultured trivalent influenza vaccine (cTIV) vaccine administered as 0.5 mL single dose in the deltoid muscle, preferably of the non-dominant arm. |
| Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a). | BIOLOGICAL | egg based trivalent influenza vaccine (eTIV\_a) administered as 0.5 mL single dose in the deltoid muscle, preferably of the non-dominant arm. |
| cTIV or eTIV_a | BIOLOGICAL | 0.5 mL, Single dose of either cell cultured trivalent influenza vaccine (cTIV) or egg based trivalent influenza vaccine eTIV\_a administered. |
| cTIV+PV OR eTIV_a+PV | BIOLOGICAL | 0.5 mL, Single dose of either cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) administered concomitantly with 23-valent pneumococcal polysaccharide vaccine (PV). |
Inclusion Criteria: * participation in the V58P4 study * mentally competent to understand the nature, the scope and the consequences of the study * able and willing to give written informed consent prior to study entry * available for all the visits scheduled in the study Exclusion Criteria: * re...
cTIV or eTIV_a is an investigational influenza vaccine being studied for the prevention of influenza. It is a monoclonal antibody modality, though it is being evaluated as a vaccine in a Phase 3 clinical trial. The study enrolled adults and elderly participants to assess safety and tolerability.
cTIV or eTIV_a is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.
cTIV or eTIV_a is in Phase 3 clinical development. It is an investigational influenza vaccine and has not been approved by regulatory authorities. The Phase 3 trial has been completed, with results expected to inform further development and potential regulatory submissions.
cTIV or eTIV_a has one completed Phase 3 clinical trial registered under NCT00579345. This study, titled 'Second Extension Study to Evaluate Safety and Tolerability of Influenza Vaccines in Adults and Elderly, and to Evaluate Immunogenicity and Concomitant Vaccination With Pneumococcal Vaccine in a Subgroup,' enrolled 1,522 participants in Poland.
cTIV and eTIV_a are two names used for the same investigational influenza vaccine. The drug is referred to by both names in clinical development contexts. This naming convention may reflect different formulations or presentations of the vaccine being studied.