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A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants

NCT00197210 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10708

Last updated 2016-11-04

No results posted yet for this study

Summary

The main objectives of this study are to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until two years of age and to determine the safety of GSK Biologicals' HRV vaccine with respect to definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose.

Conditions

  • Infections, Rotavirus

Interventions

BIOLOGICAL

Rotavirus

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Companies

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 NCT00197210 on ClinicalTrials.gov