NCT00140686

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

A Multi-country & Multi-center Study to Assess the Efficacy, Safety & Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,994 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 14 Weeks
• Healthy volunteers: Accepted

Summary

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

Detailed description

The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-14 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	Rotavirus (vaccine)

Timeline

• Start date: 2004-09-01
• Primary completion: 2006-08-01
• Completion: 2006-08-01
• First posted: 2005-09-01
• Last updated: 2017-03-23

Locations

101 sites across 6 countries: Czechia, Finland, France, Germany, Italy, Spain