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Clinical Trial to Evaluate the Immunogenicity of Chikungunya Vaccine

NCT04603131 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-10-28

No results posted yet for this study

Summary

Chikungunya vaccine is an inactivated virus vaccine. There will be three study arms and subjects will be vaccinated in a dose escalation manner.In each arm, vaccine will be administered on Day 1, Day 29, and Day 57. Vaccine will be administered through intramuscular route.

Conditions

  • Chikungunya

Interventions

BIOLOGICAL

Inactivated Chikungunya virus vaccine 20 mcg

3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57

BIOLOGICAL

Inactivated Chikungunya virus vaccine 30 mcg

3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57

BIOLOGICAL

Inactivated Chikungunya virus vaccine 10 mcg

3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57

BIOLOGICAL

Placebo

3 doses of Placebo administered intramuscularly on Day 0, 29 and 57

Sponsors & Collaborators

  • Bharat Biotech International Limited

    lead INDUSTRY

Principal Investigators

  • Krishna Mohan, PHD · Bharat Biotech International Limited

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-17
Primary Completion
2018-01-30
Completion
2018-07-30

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

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 NCT04603131 on ClinicalTrials.gov