A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.
ConditionChikungunya Virus
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-11
SponsorBavarian Nordic
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CHIKV VLP vaccine
- Placebo
Treatment groups
720 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov