Trials / Recruiting
RecruitingNCT07003984
A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.
A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children 1 to <12 Years of Age
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 720 (estimated)
- Sponsor
- Bavarian Nordic · Industry
- Sex
- All
- Age
- 1 Year – 11 Years
- Healthy volunteers
- Accepted
Summary
The goal of this multi-center, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity of CHIKV VLP Vaccine in children 1 to \<12 years of age.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CHIKV VLP vaccine | CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2% |
| BIOLOGICAL | Placebo | Placebo is comprised of formulation buffer |
Timeline
- Start date
- 2025-06-05
- Primary completion
- 2028-12-01
- Completion
- 2028-12-01
- First posted
- 2025-06-04
- Last updated
- 2026-03-24
Locations
15 sites across 3 countries: United States, Philippines, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07003984. Inclusion in this directory is not an endorsement.