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

NCT07003984 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2026-03-24

No results posted yet for this 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.

Conditions

  • Chikungunya Virus

Interventions

BIOLOGICAL

CHIKV VLP vaccine

CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2%

BIOLOGICAL

Placebo

Placebo is comprised of formulation buffer

Sponsors & Collaborators

  • Bavarian Nordic

    lead INDUSTRY

Principal Investigators

  • Patrick Ajiboye, MD · Bavarian Nordic A/S

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-05
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • Philippines
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07003984 on ClinicalTrials.gov