Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mammalian cell based flu vaccine · 1 trial · 2 indications
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following two doses of either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.
Safety was assessed as the number of subjects who reported unsolicited adverse events following vaccination with either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.
Safety was assessed as the number of subjects who reported serious adverse events (SAEs), medically attended AEs and new onset of chronic diseases (NOCD) in subjects aged ≥4 To ≤17 Years.
| Arm | Type | Description |
|---|---|---|
| TIVc | EXPERIMENTAL | Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status. |
| TIVf | ACTIVE_COMPARATOR | Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status. |
| Name | Type | Description |
|---|---|---|
| Mammalian cell based flu vaccine | BIOLOGICAL | - |
| Egg based flu vaccine | BIOLOGICAL | - |
Inclusion Criteria: \- Healthy subjects 4-17 years of age Exclusion Criteria: * Subjects who are not healthy, * Subjects who are pregnant or breast feeding, * Subjects with a history of severe allergic reaction or allergic to any of the vaccine components.
Mammalian cell based flu vaccine is an investigational vaccine being developed for the prevention of influenza. It is designed to protect against seasonal flu, which is caused by influenza viruses. The vaccine is currently in Phase 3 clinical development and has been studied in a clinical trial involving children and adolescents.
Mammalian cell based flu vaccine is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is publicly traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and efficacy of this vaccine for influenza prevention.
Mammalian cell based flu vaccine is currently in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the vaccine is being studied for its safety and effectiveness in preventing influenza.
Mammalian cell based flu vaccine has been studied in one completed Phase 3 clinical trial with the identifier NCT01857206. This trial evaluated the safety of two trivalent influenza vaccines in children and adolescents aged 4 to 17 years. The study enrolled 2055 participants across the United States, Australia, New Zealand, Philippines, and Thailand.
Mammalian cell based flu vaccine is a vaccine that works by stimulating the immune system to produce antibodies against influenza viruses. It is produced using mammalian cell culture technology, which allows for the growth of influenza viruses in a controlled environment. This approach is used to create vaccines that can elicit a protective immune response.