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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.
Top 8 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE1 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
The mammalian cell based flu vaccine is an investigational influenza vaccine developed by Novartis AG. It is a trivalent influenza vaccine designed to protect against seasonal flu and was studied in children and adolescents aged 4 to 17 years. It is produced using mammalian cell culture rather than traditional egg-based manufacturing.
It is used for the prevention of influenza in children and adolescents. The Phase 3 trial evaluated its safety in participants 4 to 17 years of age across the United States, Australia, New Zealand, the Philippines, and Thailand, with fever listed among the conditions studied.
Novartis AG, which trades under the ticker NVS, is the developer of the mammalian cell based flu vaccine. The company sponsored the Phase 3 clinical trial that evaluated the vaccine in children and adolescents.
The mammalian cell based flu vaccine is in Phase 3 development. Its single registered trial, NCT01857206, has completed, and the vaccine is investigational rather than approved. The trial enrolled 2,055 participants and was active-controlled, randomized, and conducted in healthy volunteers.
The vaccine was studied in one Phase 3 trial, NCT01857206, titled Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age. The trial is completed, enrolled 2,055 participants, and was active-controlled and randomized, though not double-blind.