NCT00139347

Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants

A Multi-country & Multi-center Study to Assess the Efficacy, Immunogenicity & Safety of Two Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6,360 (planned)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

The main objectives of this study is 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.

Detailed description

The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-12 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine EPI vaccinations are given at the discretion of the investigator and according to local National Plans of Immunisation schedule in each participating country.

Conditions

• Infections, Rotavirus

Interventions

Type	Name	Description
BIOLOGICAL	2-dose oral live attenuated G1P[8] human rotavirus vaccine

Timeline

• Start date: 2003-12-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2005-08-31
• Last updated: 2016-10-28

Locations

17 sites across 6 countries: Argentina, Brazil, Colombia, Dominican Republic, Honduras, Panama