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

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00383903

Purpose

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.

Condition	Intervention	Phase
Rotavirus Gastroenteritis	Biological: Oral live attenuated HRV vaccine	Phase II

MedlinePlus related topics: Gastroenteritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study of the Safety, Reactogenicity and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants (Approximately 5-10 Weeks Old) in South Africa

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Seroconversion after HRV vaccination

Secondary Outcome Measures:

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

Estimated Enrollment:	475
Study Start Date:	September 2003

Eligibility

Ages Eligible for Study:	5 Weeks to 10 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383903

Locations

South Africa
GSK Investigational Site
Sunnyside, Pretoria, South Africa, 2
GSK Investigational Site
Brits, South Africa, 0250
GSK Investigational Site
Pretoria, South Africa, 2
GSK Investigational Site
Pretoria North, South Africa, 2
GSK Investigational Site
Rooihuiskraal, South Africa, 0145
GSK Investigational Site
Ga-Rankuwa, South Africa, 0208

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	444563/013
Study First Received:	October 3, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00383903
Health Authority:	South Africa: Medicines Control Council

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Healthy
Gastroenteritis

ClinicalTrials.gov processed this record on January 16, 2009