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

Phase 3

Completed

• Conditions: Infections, Rotavirus

• Registration Number: NCT00382772
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-29
• Study First Submitted QC: 2006-09-29
• Study First Posted: 2006-10-02
• Study Start: 2006-11
• Primary Completion: 2007-04
• Study Completion: 2007-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Healthy infants birth weigh >2000 g, 11 -17 weeks old at Dose 1 with written informed consent.

Read More

Exclusion Criteria

• Allergic reaction to vaccine components; clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol; immunocompromised.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Demonstrate lot-to-lot consistency of HRV vaccine liquid formulation and non-inferiority of liquid formulation versus the lyophilised formulation of the HRV vaccine.

Secondary Outcome Measures

Name	Time	Method
Assess lot-to-lot consistency in terms of reactogenicity and assess safety of HRV vaccines.

Trial Locations

Locations (1)

GSK Investigational Site; 🇫🇮 Vantaa, Finland