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
Bavarian Nordic
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.
Eligibility
- Age range
- 1–11 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Males or females between 1 and \<12 years of age at Day 1 (day of vaccination). Note: Screening should only occur in the active/open cohorts. Please see Section 6.1 for details 2. Body weight ≥6.5 kg. 3. In general good health, in the opinion of the investigator, based on medical history and physical examination. 4. Able and willing to provide informed assent for study participation and primary caregiver is able and willing to provide informed consent for study participation, in accordance with the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) dete…
Interventions
- BiologicalCHIKV VLP vaccine
CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2%
- BiologicalPlacebo
Placebo is comprised of formulation buffer
Locations (15)
- ARK Clinical Research, LLCFountain Valley, California
- Emerson Clinical Research Institute- DCWashington D.C., District of Columbia
- Acevedo Clinical ResearchMiami, Florida
- Hope Research NetworkMiami, Florida
- Velocity Clinical Research-OmahaOmaha, Nebraska
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio