NCT00329745

Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)

A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-country and Multi-center Study to Assess the Efficacy and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,687 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 2 Years – 3 Years
• Healthy volunteers: Accepted

Summary

This Year 3 extension of the main study rota-028, 029 or 030 is conducted to evaluate vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during third year of life in infants previously vaccinated with human rotavirus (HRV) vaccine or placebo in the following schedules: at 3 and 4 months of age in study rota-028; at 2 and 4 months of age in study rota-029 or rota-030. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

Note that no new subjects will be recruited in this extension phase studies. The expected total enrolment for the primary studies was as follows: rota-028: 5700 rota-029: 3018 rota-030: 1102

Conditions

• Infections, Rotavirus

Interventions

Type	Name	Description
BIOLOGICAL	Rotarix™	Oral administration, 2 doses
BIOLOGICAL	Placebo	Oral administration, 2 doses

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2006-05-25
• Last updated: 2016-12-09
• Results posted: 2009-10-14

Locations

4 sites across 1 country: Singapore