Seamless Controlled Trial To Evaluate Safety And Immunogenicity of Chikungunya Vaccine in LatinAmerica and Asia
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This study has a Phase II with part A and part B and a Phase III with part C. This Adaptive
seamless design will prospectively include planned modifications and incorporate both dose
selection (parts A and B) and confirmation of the selected dose (part C) based on the
accumulation of subjects' data within the entire study period as shown below. Part C will be
randomized for immunogenicity subset and will be open label for safety cohort. The
participants assigned to the control group from all parts (i.e, Part A, B and C) will be
continuously followed up from the enrollment until the end of the study.