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Clinical Trials in the USA / NCT07003984
Recruiting Phase 3

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

NCT07003984 · tracked via the Priya Life Science USA tracker
Sponsor
Bavarian Nordic
Phase
Phase 3
Started
2025-06-05
Last updated
2026-03-24

Condition(s) studied

Chikungunya Virus

Investigational drug(s) / intervention(s)

CHIKV VLP vaccinePlacebo

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

Study 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

Sex
ALL
Min age
1 Year
Max age
11 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Males or females between 1 and \<12 years of age at Day 1 (day of vaccination). Note: Screening should only occur in the active/open cohorts. Please see Section 6.1 for details 2. Body weight ≥6.5 kg. 3. In general good health, in the opinion of the investigator, based on medical history and physical examination. 4. Able and willing to provide informed assent for study participation and primary caregiver is able and willing to provide informed consent for study participation, in accordance with the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) determination and applicable federal and local regulations and guidelines. 5. Able and willing to complete all scheduled visits and comply with all study procedures. Exclusion Criteria: 1. Participation or planned participation in an investigational clinical study (eg, vaccine, drug) within 30 days before Day 1 and for the duration of the study. Note: Participation in an observational study or follow-up phase of a study may be allowed; these instances should be discussed with the sponsor's medical monitor and written agreement obtained prior to enrollment. 2. Current acute illness, with or without fever. 3. Current or recent CHIKV infection indicated by positive immunoglobulin M (IgM) and negative immunoglobulin G (IgG) rapid diagnostic test (RDT) results at screening in the Philippines only; participants in the US will not be tested using the RDT. 4. History of any known or suspected allergy or history of anaphylaxis to any component of the investigational product. 5. History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to vaccination. 6. Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications from 180 days prior to screening through Day 22. Note: Systemic corticosteroid use at a dose or equivalent dose of 20 mg or greater (≥0.5 mg/kg for children \<40 kg) of prednisone for 14 consecutive days or more within 90 days of screening through Day 22 is exclusionary. The use of inhaled, intranasal, topical, or ocular steroids is allowed. 7. Receipt or anticipated receipt of immunoglobulin from 180 days prior to screening through the duration of the study. 8. Any administration or planned administration of: * A licensed live attenuated vaccine within 28 days before administration of investigational product and until Visit 2 (Day 15 or 22, as applicable) has occurred. * Other licensed (not live) vaccine within 14 days before administration of investigational product and until Visit 2 (Day 15 or 22, as applicable) has occurred. * Another licensed or investigational CHIKV vaccine. 9. Known infection with human immunodeficiency virus, hepatitis C virus (HCV), or hepatitis B virus. Note: Positive anti-HCV antibodies and negative HCV polymerase chain reaction would NOT be exclusionary. Polymerase chain reaction testing will not be performed as part of this protocol. 10. Bleeding disorder or receipt of anticoagulants in the 21 days before Day 1, contraindicating intramuscular vaccination, as judged by the investigator. 11. Receipt or anticipated receipt of blood products from 90 days before Day 1 through the duration of the study. 12. Onset of menarche prior to study vaccination. 13. Planned medical or surgical procedure that could adversely impact the participant's participation or the conduct of the study. 14. Identified as an immediate family member of the investigator or employee with direct involvement in the study. Bavarian Nordic staff members and their families, contractors, agents, business partners, and anyone with a financial interest in the outcome of the study. 15. Any other medical condition, including severe malnutrition, that, in the opinion of the investigator, could adversely impact the participant's participation or conduct of the study.

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
ARK Clinical Research, LLC Fountain Valley California Recruiting
Emerson Clinical Research Institute- DC Washington D.C. District of Columbia Recruiting
Acevedo Clinical Research Miami Florida Recruiting
Hope Research Network Miami Florida Recruiting
Velocity Clinical Research-Omaha Omaha Nebraska Recruiting
Cincinnati Children's Hospital Medical Center Cincinnati Ohio Recruiting
KidCare Pediatrics Beaumont Texas Recruiting
Velocity Clinical Research - Salt Lake City West Jordan Utah Recruiting
CARE CT Group Inc. Dasmariñas Cavite Recruiting
HIMC Research and Development on Medical Sciences Imus Cavite Recruiting
Silang Specialist Medical Center Silang Cavite Recruiting
University of Perpetual Help DALTA Medical Center, Biomedical Research Institute Las Piñas National Capital Region Not Yet Recruiting
Institute of Child Health and Human Development, University of the Philippines Manila National Capital Region Recruiting
University of the Philippines-Philippine General Hospital Manila Philippines Not Yet Recruiting
CMRC Headlands LLC San Juan Puerto Rico Recruiting

More Bavarian Nordic trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07003984 on ClinicalTrials.gov ↗ ← All trials in the USA