NCT00382772

A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine).

Study to Evaluate Clinical Consistency of the Liquid Formulation of GSK Biologicals' HRV Vaccine and to Evaluate Liquid Formulation Compared to Lyophilised Formulation of the HRV Vaccine Administered as a Two-dose Primary Vaccination.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (planned)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 11 Weeks – 17 Weeks
• Healthy volunteers: Accepted

Summary

The aim of this this study is to evaluate the lot-to-lot consistency of the liquid formulation of GSK Biologicals' HRV vaccine and to evaluate the liquid formulation compared to the lyophilised formulation of GSK Biologicals' HRV vaccine when administered concomitantly with a combination childhood vaccine.

Conditions

• Infections, Rotavirus

Interventions

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

Timeline

• Start date: 2006-11-01
• Primary completion: 2007-04-01
• Completion: 2007-08-01
• First posted: 2006-10-02
• Last updated: 2016-11-04

Locations

12 sites across 1 country: Finland