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To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines

NCT00140686 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3994

Last updated 2017-03-23

No results posted yet for this study

Summary

The main objectives of this study is to determine vaccine efficacy against any rotavirus (RV) gastroenteritis (GE) during the first efficacy period.

Conditions

  • Infections, Rotavirus

Interventions

BIOLOGICAL

Rotavirus (vaccine)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2006-08-31
Completion
2006-08-31

Countries

  • Czechia
  • Finland
  • France
  • Germany
  • Italy
  • Spain

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 NCT00140686 on ClinicalTrials.gov