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Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia

NCT03602053 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2020-12-19

Study results available
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Summary

The study is being conducted to evaluate and compare the immunogenicity of ROTAVAC® and ROTAVAC 5D 28 days after the last dose of the vaccine, when administered to infants in a three-dose schedule at 6, 10 and 14 weeks of age.

The study will also assess the reactogenicity of the vaccine 7 days after each vaccination and safety from first vaccination up to 4 weeks after the last vaccination with ROTAVAC® and ROTAVAC 5D, and of Rotarix® when administered to infants in a two-dose schedule at 6 and 10 weeks of age.

Conditions

Interventions

BIOLOGICAL

ROTAVAC®

0.5 ml of the vaccine will be administered orally thrice at 6, 10 and 14 weeks of age.

BIOLOGICAL

ROTAVAC 5D

0.5 ml of the vaccine will be administered orally thrice at 6, 10 and 14 weeks of age.

BIOLOGICAL

Rotarix®

1.5 ml of the liquid vaccine will be administered orally twice at 6 and 10 weeks of age.

Sponsors & Collaborators

  • PATH

    collaborator OTHER

  • Christian Medical College, Vellore, India

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • Bharat Biotech International Limited

    collaborator INDUSTRY

  • Centre for Infectious Disease Research in Zambia

    lead OTHER

Principal Investigators

  • Niraj Rathi, MD · PATH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-22
Primary Completion
2019-10-04
Completion
2019-10-04

Countries

  • Zambia

Study Locations

More Related Trials

Entities

Diseases

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 NCT03602053 on ClinicalTrials.gov