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Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Dose ranging |
| 2 | EXPERIMENTAL | Dose ranging |
| Arm 1 | OTHER | Dose ranging |
| Arm 2 | OTHER | Dose ranging |
| Name | Type | Description |
|---|---|---|
| Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine | BIOLOGICAL | High dose group and low dose group of adjuvanted vaccines |
Inclusion Criteria: * Healthy Japanese aged 6 months to 19 years Exclusion Criteria: * History of anaphylaxis, serious vaccine reactions, hypersensitivity to vaccine viral proteins or excipients * Administration of adjuvanted influenza vaccine or suspected influenza disease within 3 month prior t...
Top 6 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 1 | PHASE3 | mRNA-1018-H5 |
| 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 |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | Flu/COVID-19 mRNA combination vaccine |
It is an investigational vaccine developed by Novartis AG for protection against swine-origin influenza A H1N1 virus. The vaccine is cell-derived, inactivated, monovalent, and subunit-based, and it includes an adjuvant. It was studied in Phase 2 clinical trials in Japanese adult and pediatric subjects.
The vaccine is intended for immunization against swine-origin influenza A H1N1 virus, also known as the 2009 pandemic H1N1 strain. Its clinical program evaluated it in healthy adult and pediatric volunteers in Japan to assess dose-ranging and immune response against this specific influenza subtype.
Novartis AG, which trades under the ticker NVS, is the developer of this vaccine. The company sponsored the Phase 2 clinical trials conducted in Japan in adult and pediatric populations.
The vaccine is in Phase 2 development. Two Phase 2 trials have been completed: one in Japanese adults and one in Japanese pediatric subjects. No active trials are ongoing, and the vaccine is not approved for use.
The vaccine was studied in two completed Phase 2 trials. NCT00996138 was a single-blind, dose-ranging study in Japanese adults aged 29 years and older, enrolling 200 participants. NCT01000207 was a single-blind, dose-ranging study in Japanese pediatric subjects aged 6 months and older, enrolling 123 participants.