RecruitingPhase 3NCT07003984

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

Sponsor

Bavarian Nordic

Enrollment

720 participants

Start Date

Jun 5, 2025

Study Type

INTERVENTIONAL

Conditions

Chikungunya Virus

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

Min Age: 1 YearMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called CHIKV VLP vaccine and a biological treatment called Placebo for people with chikungunya virus. The study is currently recruiting participants at 15 locations. People eligible for this study include aged 1 Year to 11 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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, 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

View Full Details on ClinicalTrials.gov

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NCT07003984