Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa

NCT00383903 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 472

Last updated 2016-09-15

No results posted yet for this study

Summary

The purpose of this study is to determine the appropriate regimen of GSK HRV vaccine for concomitant administration with EPI vaccines to infants in South Africa.

Conditions

  • Infections, Rotavirus

Interventions

BIOLOGICAL

HRV vaccine

Two or three oral doses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Weeks
Max Age
10 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2004-09-30
Completion
2004-09-30

Countries

  • South Africa

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 NCT00383903 on ClinicalTrials.gov