Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa

Phase 2

Completed

• Conditions: Infections, Rotavirus

• Registration Number: NCT00383903
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to determine the appropriate regimen of GSK HRV vaccine for concomitant administration with EPI vaccines to infants in South Africa.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2004-09
• Study Completion: 2004-09
• Study First Submitted: 2006-10-03
• Study First Submitted QC: 2006-10-03
• Study First Posted: 2006-10-04
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 472

Inclusion Criteria

• Healthy infants born after a normal gestation period (>=36 weeks), between 5 and 10 weeks of age at Dose 1 with confirmed negative HIV status of the subject's mother.
• Written informed consent was obtained from the parent/guardian of the subject before study entry.

Exclusion Criteria

• History of allergic disease/polio disease,
• Confirmed or suspected immunosuppressive or immunodeficient condition,
• Clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator,
• Received treatment prohibited by the protocol.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Seroconversion after HRV vaccination

Secondary Outcome Measures

Name	Time	Method
shedding, serum anti-rota IgA antibody concentrations, anti-polio 1, 2 and 3 seroprotection rates, reactogenicity, safety

Trial Locations

Locations (1)

GSK Investigational Site; 🇿🇦 Sunnyside, Pretoria, South Africa