RecruitingChikungunya Virus
A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.
Eligible age
1–11 yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Bavarian Nordic
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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:
Where it's recruiting
California
Fountain Valley
District of Columbia
Washington D.C.
Florida
Miami
Nebraska
Omaha
Ohio
Cincinnati
Texas
Beaumont
Utah
West Jordan
Source: ClinicalTrials.gov · NCT07003984 · last updated 2026-03-24