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A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants.

NCT00140673 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 63227

Last updated 2019-12-30

No results posted yet for this study

Summary

The main objectives of this study are: 1) In a subset (N = 20 000), to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age. 2) In all subjects (N = 60 000), 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
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2003-08-05
Completion
2005-10-20

Countries

  • Argentina
  • Brazil
  • Chile
  • Colombia
  • Dominican Republic
  • Finland
  • Honduras
  • Mexico
  • Nicaragua
  • Panama
  • Peru
  • Venezuela

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 NCT00140673 on ClinicalTrials.gov