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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Infections, Rotavirus

Treatments

Biological: HRV vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00383903

444563/013

Details and patient eligibility

About

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.

Enrollment

472 patients

Sex

All

Ages

5 to 10 weeks old

Volunteers

Accepts Healthy Volunteers

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.