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RECRUITING
NCT07003984
PHASE3

A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.

Sponsor: Bavarian Nordic

View on ClinicalTrials.gov

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

Interventions

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

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