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Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® in Healthy Infants Aged Between 6-8 Weeks in Vietnam

NCT03367559 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2019-03-25

No results posted yet for this study

Summary

An open label study to evaluate immunogenicity, safety, and reactogenicity of Rotavac® (live attenuated oral rotavirus vaccine) as a 3-dose series in healthy infants aged between 6 weeks and 8 weeks in Vietnam.

Conditions

  • Rotavirus Infections

Interventions

BIOLOGICAL

ROTAVAC®

Rotavac® is in frozen form and is thawed till fully liquid prior to administration.

Sponsors & Collaborators

  • Bharat Biotech International Limited

    collaborator INDUSTRY

  • Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-02-08
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • Vietnam

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 NCT03367559 on ClinicalTrials.gov