Actively Recruiting

Phase 3
Age: 1Year - 11Years
All Genders
Healthy Volunteers
NCT07003984

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

Led by Bavarian Nordic · Updated on 2026-03-24

720

Participants Needed

15

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 1Year - 11Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Males or females between 1 and less than 12 years of age on the day of vaccination
  • Body weight of at least 6.5 kg
  • Generally in good health based on medical history and physical exam
  • Able and willing to provide informed assent; caregiver able and willing to provide informed consent
  • Able and willing to complete scheduled visits and follow study procedures
Not Eligible

You will not qualify if you...

  • Participation or planned participation in another investigational study within 30 days before vaccination and during the study
  • Current acute illness, with or without fever
  • Current or recent chikungunya virus infection based on specific tests (for participants in the Philippines)
  • Known or suspected allergy or anaphylaxis to vaccine components
  • Known congenital or acquired immune deficiency or immunosuppressive condition
  • Use of systemic immunomodulatory or immunosuppressive medications within 180 days prior to screening through Day 22
  • Receipt or planned receipt of immunoglobulin within 180 days prior to screening through study duration
  • Receipt or planned receipt of certain vaccines within specified timeframes before and after vaccination
  • Known infection with HIV, hepatitis C, or hepatitis B virus (except certain antibody-positive cases)
  • Bleeding disorder or recent use of anticoagulants contraindicating intramuscular vaccination
  • Receipt or planned receipt of blood products within 90 days before vaccination through study duration
  • Onset of menarche prior to vaccination
  • Planned medical or surgical procedure that could affect participation
  • Immediate family members of study staff, employees, contractors, or those with financial interest in the study
  • Any other medical condition that could affect participation or study conduct, including severe malnutrition

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

ARK Clinical Research, LLC

Fountain Valley, California, United States, 92708

Actively Recruiting

2

Emerson Clinical Research Institute- DC

Washington D.C., District of Columbia, United States, 20009

Actively Recruiting

3

Acevedo Clinical Research

Miami, Florida, United States, 33142

Actively Recruiting

4

Hope Research Network

Miami, Florida, United States, 33166

Actively Recruiting

5

Velocity Clinical Research-Omaha

Omaha, Nebraska, United States, 68134

Actively Recruiting

6

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

7

KidCare Pediatrics

Beaumont, Texas, United States, 77706

Actively Recruiting

8

Velocity Clinical Research - Salt Lake City

West Jordan, Utah, United States, 84088

Actively Recruiting

9

CARE CT Group Inc.

Dasmariñas, Cavite, Philippines, 4114

Actively Recruiting

10

HIMC Research and Development on Medical Sciences

Imus, Cavite, Philippines, 4103

Actively Recruiting

11

Silang Specialist Medical Center

Silang, Cavite, Philippines, 4118

Actively Recruiting

12

University of Perpetual Help DALTA Medical Center, Biomedical Research Institute

Las Piñas, National Capital Region, Philippines, 1740

Not Yet Recruiting

13

Institute of Child Health and Human Development, University of the Philippines

Manila, National Capital Region, Philippines, 1000

Actively Recruiting

14

University of the Philippines-Philippine General Hospital

Manila, Philippines, 100

Not Yet Recruiting

15

CMRC Headlands LLC

San Juan, Puerto Rico, Puerto Rico, 918

Actively Recruiting

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Research Team

P

Priya Uppin

CONTACT

F

Faye Cross

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

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