Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants

NCT00938327 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 332

Last updated 2018-01-02

Study results available
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Summary

This post marketing surveillance will evaluate reactogenicity and safety data of human rotavirus vaccine when administered to healthy infants according to the Prescribing Information in India.

Conditions

  • Infections, Rotavirus

Interventions

BIOLOGICAL

Rotarix™

Two doses of oral vaccine.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
6 Weeks
Max Age
167 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-03
Primary Completion
2010-02-20
Completion
2010-04-23

Countries

  • India

Study Locations

More Related Trials

Entities

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 NCT00938327 on ClinicalTrials.gov