drugset / Trial / NCT06007183

Long-term Follow-up Study to Evaluate Safety and Immunogenicity of PXVX0317 Single or Booster Vaccination

NCT06007183 ↗

Phase 3 Active not recruiting 800 enrolled Bavarian Nordic
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

EvaluationDrugModalityDoseRoute
Comparator CHIKV VLP vaccine Vaccine 0.8 ml Intramuscular
Comparator CHIKV VLP vaccine Vaccine 40 mg Intramuscular

Indications