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...
Quadrivalent VLP Vaccine is an investigational vaccine being developed for the prevention of influenza. It is designed to provide protection against four strains of the influenza virus. The vaccine is currently in clinical development and has not been approved by regulatory authorities.
Quadrivalent VLP Vaccine is being developed by Novavax, Inc., a biotechnology company traded on the NASDAQ under the ticker symbol NVAX. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy in preventing influenza.
Quadrivalent VLP Vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not yet received regulatory approval. The Phase 2 trial has been completed, and the vaccine is not currently in active clinical trials.
Quadrivalent VLP Vaccine has been studied in one completed Phase 2 clinical trial, identified as NCT02307851. This was a dose-ranging study conducted in the United States involving 400 healthy young adults aged 18 years and older. The trial was randomized, double-blind, and active-controlled.
Quadrivalent VLP Vaccine is a specific type of quadrivalent influenza vaccine that uses virus-like particles (VLPs) to target four influenza strains. It is being developed by Novavax and is distinct from other quadrivalent influenza vaccines that may use different technologies, such as inactivated or recombinant proteins.