drugset / Trial / NCT06007183
Long-term Follow-up Study to Evaluate Safety and Immunogenicity of PXVX0317 Single or Booster Vaccination
RandomizedParallel-groupTriple-blindPrevention
Summary
The purpose of this phase 3 multicenter, randomized, double-blind, placebo-controlled rollover study is to evaluate the safety and long-term immunogenicity of CHIKV VLP vaccine in adult and adolescent participants and to evaluate CHIKV VLP booster vaccine induced serum neutralizing antibody (SNA) response at 3, 4, or 5 years post-initial CHIKV VLP vaccination.
Timeline
- Start
- 2023-08-30
- Primary completion
- 2028-04
- Completion
- 2028-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CHIKV VLP vaccine | Vaccine | 0.8 ml | Intramuscular |
| Comparator | CHIKV VLP vaccine | Vaccine | 40 mg | Intramuscular |