A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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-u