Vaccine Efficacy ag Rotavirus Diarrhoea; Vaccine Given w Routine Childhood Vaccinations in Healthy African Infants - Full Text View

Purpose

The primary objective of this study is to determine if the GSK Biologicals' HRV vaccine (pooled HRV groups) given concomitantly with routine EPI vaccinations can prevent severe rotavirus gastroenteritis (≥11 on the 20-point Vesikari scoring system [Ruuska, 1990]) caused by the circulating wild-type RV strains during the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 5.

The primary objective will be reached if the lower limit of the of the 95% confidence interval (CI) on vaccine efficacy is >0%.

Condition	Intervention	Phase
Prophylaxis Rotavirus	Biological: Rotavirus	Phase III

MedlinePlus related topics:

Gastroenteritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Vaccine efficacy against severe rotavirus gastroenteritis (≥11 on the 20-point Vesikari scoring system) at one year of age.

Secondary Outcome Measures:

Vaccine efficacy against hospitalisation and/or supervised re-hydration therapy (= to WHO plan B or C) in a medical facility, vaccine efficacy against circulating RV serotypes, efficacy against any RV GE, efficacy against severe GE, reactogenicity

Estimated Enrollment:	5670
Study Start Date:	October 2005
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Detailed Description:

The study will have three groups: Group HRV 3-Dose, Group HRV 2-Dose and Group Placebo. Three-dose immunisation will be administered in healthy infants at approximately 6, 10, and 14 weeks of age. Routine EPI vaccinations will be administered concomitantly with the study vaccines. This study will also evaluate immunogenicity and safety relative to the placebo.

Eligibility

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

Criteria

Inclusion criteria:

Healthy infants with birth weight >2000 g, between 5 and 10 weeks of age at first study vaccination

Exclusion criteria:

History of allergic disease
Any confirmed or suspected immunosuppressive or immunodeficient condition
Clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator
Had not received treatment prohibited by the protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241644

Locations


Malawi, Blantyre
	Ndirande Health Center
	Ndirande, Blantyre, Malawi

South Africa

	Republic of South Africa, South Africa

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	Clinical Trials	GlaxoSmithKline

More Information

Responsible Party:	GSK Biologicals ( Isabelle Harpigny )
Study ID Numbers:	102248
First Received:	October 18, 2005
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00241644
Health Authority:	South Africa: Medicines Control Council

Study placed in the following topic categories:

Diarrhea

Healthy

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00241644