NCT07003984 · Bavarian Nordic
A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.
What this study is about
The goal of this multi-center, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment study is to evaluate the safety and immunogenicity of CHIKV VLP Vaccine in children 2 to \<12 years of age.
View original scientific description
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 2 to \<12 years of age.
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
Primary outcome measures
Safety Endpoint 3: Incidence of AESI, MAAEs, and SAEs
Time frame: From vaccination through the end of the trial, planned to be Day 732 for study completers.
Incidence of adverse events of special interest (AESIs; defined as new onset or worsening arthralgia that is medically attended), medically attended adverse events (MAAEs), and serious adverse events (SAEs) through end of the trial.
Primary Immunogenicity Endpoint: Day 22 anti-CHIKV SNA seroresponse rate in seronegative children
Time frame: Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.
Day 22 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in baseline seronegative children 1 to \<12 years of age in the immunogenicity evaluable population.
Safety Endpoint 2: Incidence of unsolicited AEs through Day 29
Time frame: From vaccination on Day 1 through Day 29, 28 days after vaccination with CHIKV VLP vaccine or placebo.
Incidence of unsolicited adverse events (AEs) through Day 29.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Males or females between 2 and \<12 years of age at Day 1 (day of vaccination). 2. In general good health, in the opinion of the investigator, based on medical history and physical examination. 3. 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. 4. 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
Where
- Fountain Valley, California
- Washington D.C., District of Columbia
- Miami, Florida
- Omaha, Nebraska
- Cincinnati, Ohio
- Beaumont, Texas
- West Jordan, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 24, 2026 · Source of record for eligibility and locations