Actively Recruiting

Phase 3
Age: 1Year - 11Years
All Genders
Healthy Volunteers
ID07003984

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

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

720

Participants Needed

15

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the safety and immune response of the CHIKV VLP vaccine in children aged 1 to under 12 years. This Phase 3 randomized, double-blind, placebo-controlled trial aims to evaluate how well the vaccine works and its safety profile in young children against Chikungunya virus infection. Participants will be randomly assigned to one of four groups: two active vaccine groups and two placebo groups. The CHIKV VLP vaccine contains chikungunya virus-like particles combined with an aluminum hydroxide adjuvant. The study includes multiple visits for vaccination and follow-up, with immune responses measured at several time points including Days 15, 22, 183, 366, and 732 after vaccination. Safety is monitored throughout via reports of adverse events and serious events. Children in the study will attend scheduled visits to receive the vaccine or placebo and undergo assessments including blood tests to measure immune response. Researchers will track any side effects from vaccination up to two years after the first dose. The main outcomes focus on immune response by Day 22 and safety events throughout the study. Participants' health and adherence to study visits will be closely monitored during the entire trial period, which lasts up to approximately two years.

CONDITIONS

Brief 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 at Day 1 (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 and caregiver able to provide informed consent
  • Able and willing to complete all scheduled visits and study procedures
Not Eligible

You will not qualify if you...

  • Participation or planned participation in an investigational clinical study within 30 days before Day 1 and during the study
  • Current acute illness, with or without fever
  • Current or recent CHIKV infection indicated by rapid diagnostic test (in the Philippines only)
  • Known allergy or anaphylaxis to any component of the investigational product
  • Known congenital or acquired immunodeficiency or immunosuppressive condition
  • Use of systemic immunomodulatory or immunosuppressive medications from 180 days prior to screening through Day 22
  • Receipt or planned receipt of immunoglobulin from 180 days prior to screening through the study
  • Recent administration or planned administration of licensed live vaccines or other vaccines near study vaccination
  • Known infection with HIV, hepatitis B, or hepatitis C (with exceptions)
  • Bleeding disorder or recent use of anticoagulants contraindicating intramuscular vaccination
  • Receipt or planned receipt of blood products from 90 days before Day 1 through the study
  • Onset of menarche prior to study vaccination
  • Planned medical or surgical procedure that could affect participation
  • Immediate family member of investigator or study employee with direct involvement
  • Any other medical condition that could adversely impact participation or study conduct according to investigator opinion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day

Participants receive a single vaccination with either the CHIKV VLP vaccine or placebo.

1 vaccination visit (in-person)

Follow-up

Duration - Up to 732 days

Participants are monitored for safety and immunogenicity after vaccination, including multiple blood draws and health assessments.

Approximately 8 visits over 2 years (in-person)

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

F

Faye Cross

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

Frequently Asked Questions

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Published Research Related To This Trial

Safety and immunogenicity of PXVX0317, an aluminium hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial.

Sean R Bennett, James M McCarty, Roshan Ramanathan...

https://pubmed.ncbi.nlm.nih.gov/35709798

Chikungunya virus virus-like particle vaccine is well tolerated and immunogenic in chikungunya seropositive individuals.

James M McCarty, Lisa Bedell, Jason Mendy...

https://pubmed.ncbi.nlm.nih.gov/37690874

Chikungunya virus virus-like particle vaccine safety and immunogenicity in adolescents and adults in the USA: a phase 3, randomised, double-blind, placebo-controlled trial.

Jason S Richardson, Deborah M Anderson, Jason Mendy...

https://pubmed.ncbi.nlm.nih.gov/40158526