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

NCT04566484 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 3210

Last updated 2025-06-22

No results posted yet for this study

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.

Conditions

  • Chikungunya

Interventions

DRUG

BBV87 Chikungunya vaccine

BBV87 Chikungunya vaccine is a whole virus inactivated vaccine formulated with 0.25 mg aluminum (as aluminum hydroxide) per single human dose.

DRUG

Normal Saline

Normal saline is the placebo

Sponsors & Collaborators

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Sushant Sahastrabuddhe, MBBS, MPH · Director, Chikungunya Program,International Vaccine Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2022-07-19
Completion
2025-05-31

Countries

  • Colombia
  • Costa Rica
  • Guatemala
  • Panama
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04566484 on ClinicalTrials.gov