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Safety and Immunogenicity of BBV121

NCT04478656 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-10-22

No results posted yet for this study

Summary

To evaluate the safety, tolerability, and immunogenicity of two-doses of three-sequentially escalating cohort (2.5 µg, 5 µg and 10 µg) of BBV121 (purified inactivated adsorbed Zika virus vaccine) compared with Placebo (Alum). The investigational product is administered intramuscularly on Day 0 and 28 with safety and immunogenicity testing on Day 0, 28 and 56, and Month 6, 9 and 12

Conditions

  • Zika Virus Infection

Interventions

BIOLOGICAL

BBV121

BBV121 or Placebo are administered intramuscularly in deltoid region on Day 0 and 28

Sponsors & Collaborators

  • Bharat Biotech International Limited

    lead INDUSTRY

Principal Investigators

  • Sudhakar Bangera · Bharat Biotech International Limited

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-06-03
Primary Completion
2017-11-15
Completion
2018-11-15

Countries

  • India

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 NCT04478656 on ClinicalTrials.gov