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A Phase 1 Randomized, Observer-Blinded,Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Recombinant Respiratory Syncytial Virus F Protein Particle Vaccine in Healthy Adults
A Phase 1, Randomized, Placebo-Controlled, Observer-Blinded, Escalating Dose-Ranging Study to Assess the Safety, and immunogenicity of 6 different recombinant RSV-F formulations in healthy adults (18 to 49 years of age). Study Objectives: Primary: * To assess and compare the safety, reactogenicity, and tolerability of 6 RSV-F protein particle vaccine formulations. Secondary: * To assess and compare the immunogenicity (neutralizing antibody and total anti-F antibody) of the 6 RSV-F protein particle vaccine formulations * To confirm the "dose sparing" and "value added" effects of the aluminum phosphate adjuvant
Details
| Lead sponsor | Novavax |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 150 |
| Start date | 2010-12 |
| Completion | 2011-12 |
Conditions
- Respiratory Syncytial Virus Infections
Interventions
- RSV-F Particle Vaccine
- RSV-F Particle Vaccine
- RSV-F Particle Vaccine
- RSV-F Particle Vaccine
- Placebo
- RSV-F Particle Vaccine
- RSV-F Particle Vaccine
Primary outcomes
- To assess and compare the safety, reactogenicity, and tolerability of 6 RSV-F protein particle vaccine formulations. — Day 60 (2 months)
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
Countries
United States