RecruitingPhase 3

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

United States720 participantsStarted 2025-06-05

Plain-language 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.

Who can participate

Age range1 Year – 11 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. Body weight ≥6.5 kg.
✓. In general good health, in the opinion of the investigator, based on medical history and physical examination.
✓. 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.
✓. Able and willing to complete all scheduled visits and comply with all study procedures.

Exclusion criteria

✕. 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.
✕. Current acute illness, with or without fever.
✕. 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.
✕. History of any known or suspected allergy or history of anaphylaxis to any component of the investigational product.
✕. History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to vaccination.
✕. 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.
✕. Receipt or anticipated receipt of immunoglobulin from 180 days prior to screening through the duration of the study.
✕. Any administration or planned administration of:

What they're measuring

Safety Endpoint 3: Incidence of AESI, MAAEs, and SAEs

Timeframe: From vaccination through the end of the trial, planned to be Day 732 for study completers.

Primary Immunogenicity Endpoint: Day 22 anti-CHIKV SNA seroresponse rate in seronegative children

Timeframe: Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.

Safety Endpoint 2: Incidence of unsolicited AEs through Day 29

Timeframe: From vaccination on Day 1 through Day 29, 28 days after vaccination with CHIKV VLP vaccine or placebo.

Trial details

NCT IDNCT07003984

SponsorBavarian Nordic

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12

Contact for this trial

Priya Uppin

844-422-8274 info@bavarian-nordic.com

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