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A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.
Sponsor: 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.
Official title: 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
Key Details
Gender
All
Age Range
1 Year - 11 Years
Study Type
INTERVENTIONAL
Enrollment
720
Start Date
2025-06-05
Completion Date
2028-12
Last Updated
2026-03-24
Healthy Volunteers
Yes
Conditions
Interventions
CHIKV VLP vaccine
CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2%
Placebo
Placebo is comprised of formulation buffer
Locations (15)
ARK Clinical Research, LLC
Fountain Valley, California, United States
Emerson Clinical Research Institute- DC
Washington D.C., District of Columbia, United States
Acevedo Clinical Research
Miami, Florida, United States
Hope Research Network
Miami, Florida, United States
Velocity Clinical Research-Omaha
Omaha, Nebraska, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
KidCare Pediatrics
Beaumont, Texas, United States
Velocity Clinical Research - Salt Lake City
West Jordan, Utah, United States
CARE CT Group Inc.
Dasmariñas, Cavite, Philippines
HIMC Research and Development on Medical Sciences
Imus, Cavite, Philippines
Silang Specialist Medical Center
Silang, Cavite, Philippines
University of Perpetual Help DALTA Medical Center, Biomedical Research Institute
Las Piñas, National Capital Region, Philippines
Institute of Child Health and Human Development, University of the Philippines
Manila, National Capital Region, Philippines
University of the Philippines-Philippine General Hospital
Manila, Philippines
CMRC Headlands LLC
San Juan, Puerto Rico, Puerto Rico