Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Quadrivalent VLP Vaccine · 1 trial · 1 indication
Derived/calculated endpoints based on: Seroconversion rate (SCR) Seroprotection rate (SPR) Geometric mean titer (GMT) Geometric mean ratio (GMR)
Number and percentage of subjects with solicited local and systemic adverse events over the seven days post-injections; all adverse events (including adverse changes in clinical laboratory parameters) over 21 days post-injections; and Medically Attended Events (MAEs), Serious Adverse Events (SAEs), and Significant New medical Conditions (SNMCs) through six months.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Quadrivalent VLP vaccine, low dose, intramuscular injection (0.5mL) |
| Group B | EXPERIMENTAL | Quadrivalent VLP vaccine, high dose, intramuscular injection (0.5mL) |
| Group C | EXPERIMENTAL | Quadrivalent VLP vaccine, medium dose, intramuscular injection (0.5mL) |
| Group D | ACTIVE_COMPARATOR | Comparator TIV, intramuscular injection (0.5mL) |
| Name | Type | Description |
|---|---|---|
| Quadrivalent VLP Vaccine | BIOLOGICAL | - |
| Comparator TIV | BIOLOGICAL | - |
Inclusion Criteria: 1. Healthy adult male or female, 18-49 years of age 2. Willing and able to give informed consent prior to study enrollment 3. Able to comply with study requirements 4. Women of child-bearing potential must have a negative urine pregnancy test at vaccination, will be advised thro...
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 Quadrivalent VLP Vaccine is an investigational influenza vaccine developed by Novavax, Inc. It is a virus-like particle (VLP) vaccine designed to protect against influenza, also known as the flu. It is intended for use in young adults and has been studied in a Phase 2 clinical trial.
The Quadrivalent VLP Vaccine is being developed for the prevention of influenza. It targets the flu in young adults aged 18 years and older. The vaccine is investigational and has been evaluated in a completed Phase 2 dose-ranging study.
The Quadrivalent VLP Vaccine is developed by Novavax, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol NVAX. Novavax specializes in vaccine development using its virus-like particle technology platform.
The Quadrivalent VLP Vaccine is in Phase 2 development. It has completed one Phase 2 clinical trial, a dose-ranging study in young adults. It is an investigational vaccine and is not approved by the FDA.
The Quadrivalent VLP Vaccine has been studied in one completed Phase 2 clinical trial, NCT02307851, titled "Quadrivalent Influenza VLP Vaccine Dose Ranging Study in Young Adults." The trial enrolled 400 participants in the United States and was randomized, double-blind, and active-controlled.