Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RSV-F Particle Vaccine · 1 trial · 1 indication
This primary outcome will be evaluated through an assessment of the following parameters: * Immediate AEs * Solicited AEs * All SAEs and SNMCs * Vital signs * Laboratory Assessments
| Arm | Type | Description |
|---|---|---|
| A: Dose 1 + adjuvant | EXPERIMENTAL | - |
| B: Dose 2 + adjuvant | EXPERIMENTAL | - |
| C: Dose 3 + adjuvant | EXPERIMENTAL | - |
| D: Dose 3 alone | EXPERIMENTAL | - |
| E: Placebo control | PLACEBO_COMPARATOR | - |
| F: Dose 4 alone | EXPERIMENTAL | - |
| G: Dose 4 +adjuvant | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| RSV-F Particle Vaccine | BIOLOGICAL | Dose 1 + adjuvant / dose; Day 0 and Day 30 |
| Placebo | BIOLOGICAL | Placebo; Day 0 and Day 30 |
Inclusion Criteria: * Male or female aged 18 to 49 years inclusive * Ability to provide written informed consent to participate * Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations at baseline * Females are required to fulfill o...
The RSV-F Particle Vaccine is an investigational vaccine developed by Novavax, Inc. for the prevention of respiratory syncytial virus infections. It is a vaccine modality that has completed a Phase 1 clinical trial. It is not an approved product and remains in clinical development.
The RSV-F Particle Vaccine is being developed for the prevention of respiratory syncytial virus infections, an infectious disease of the respiratory tract. Its only recorded clinical study enrolled healthy adult volunteers aged 18 years and older in the United States.
The RSV-F Particle Vaccine is developed by Novavax, Inc., which trades on the Nasdaq under the ticker NVAX. Novavax is the sponsor of the vaccine's clinical program for respiratory syncytial virus infections.
The RSV-F Particle Vaccine is in Phase 1 development. Its single clinical trial, NCT01290419, has been completed, and no trials are currently active. The vaccine is investigational and has not been approved by the FDA.
The RSV-F Particle Vaccine has been studied in one completed Phase 1 trial, NCT01290419, titled Safety Study of Respiratory Syncytial Virus (RSV)-Fusion (F) Protein Particle Vaccine. The trial enrolled 150 healthy adult volunteers in the United States and used a randomized, double-blind, placebo-controlled design.