Seamless Controlled Trial To Evaluate Safety And Immunogenicity of Chikungunya Vaccine in LatinAmerica and Asia

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.

Timeline

Start

2021-08-01

Primary completion

2022-07-19

Completion

2025-05-31

Outcome

Outcome not reported

Stopped: “The founder has decided to discontinue the study for Part C. This decision is not related to any safety concerns, adverse event findings or manufacturing process changes. There were multiple delays in initiating part C”

Drugs

Indications