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Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac in Healthy Infants in Vietnam

NCT04596696 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2020-10-23

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 Gastroenteritis

Interventions

BIOLOGICAL

Rotavac

Rotavac Is a monovalent vaccine containing suspension of live attenuated rotavirus 116E strain, a naturally occurring reassortant strain G9P\[11\], containing one bovine rotavirus gene P\[11\] and 10 human rotavirus genes prepared in Vero cells administered orally at 6, 10 and 14 weeks of age.

Sponsors & Collaborators

  • Bharat Biotech International Limited

    lead INDUSTRY

Principal Investigators

  • Dr Krishana Mohan, MD · Bharat Biotech International Limited

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
2017-12-20
Primary Completion
2018-12-30
Completion
2019-06-30

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 NCT04596696 on ClinicalTrials.gov