Year 2 Extension for Efficacy Follow-up in Subjects Vaccinated in Study Rota-037 - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00598468

Purpose

This Year 2 extension of the main study rota-037 is conducted to evaluate vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during second year of life in infants previously vaccinated with HRV vaccine or placebo in study rota-037. In addition to the WHO, Rotavirus Vaccine Program LLC (RVP)was also a collaborator for this study.

Condition	Intervention	Phase
Rotavirus Gastroenteritis	Biological: Rotarix	Phase III

MedlinePlus related topics: Gastroenteritis

Drug Information available for: RotaTeq

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Multi-Center Study to Assess Efficacy, Safety & 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:

not applicable for this phase [ Time Frame: not applicable for this phase ]

Secondary Outcome Measures:

Occurrence of severe RV GE caused by the circulating wild-type RV strains [ Time Frame: During the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 7, and from Visit 6 to Visit 7 ]
Occurrence of hospitalisation and/or supervised re-hydration therapy in a medical facility for RV GE caused by the circulating wild-type RV strains [ Time Frame: During the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 7, and from Visit 6 to Visit 7 ]
Occurrence of severe RV GE caused by the circulating wild-type RV strains of G1 serotype [ Time Frame: During the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 7, and from Visit 6 to Visit 7 ]
Occurrence of severe RV GE caused by the circulating wild-type RV strains of non-G1 serotype [ Time Frame: During the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 7, and from Visit 6 to Visit 7 ]

Estimated Enrollment:	3113
Study Start Date:	October 2007
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Live attenuated human rotavirus vaccine

Eligibility

Ages Eligible for Study:	1 Year to 2 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects with supplemental informed consent from parent/guardian for participation in the 2nd year efficacy follow-up were eligible to participate in the Year 2 extension study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598468

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Locations

Malawi
GSK Investigational Site	Recruiting
Ndirande, Blantyre, Malawi, 3
GSK Investigational Site	Recruiting
Limbe, Blantyre, Malawi, 3
GSK Investigational Site	Recruiting
Bangwe, Blantyre, Malawi, 3
GSK Investigational Site	Recruiting
Zingwanga, Blantyre, Malawi, 3
South Africa
GSK Investigational Site	Completed
Shoshanguve, South Africa
GSK Investigational Site	Completed
Brits, South Africa, 0250
GSK Investigational Site	Completed
Diepkloof, Soweto, South Africa
GSK Investigational Site	Completed
Eldorado Park Ext 9, Soweto, South Africa
GSK Investigational Site	Completed
Ga-Rankuwa, South Africa, 0208
GSK Investigational Site	Completed
Mamelodi East, South Africa

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	111274
Study First Received:	January 10, 2008
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00598468
Health Authority:	South Africa: Medicines Control Council

Keywords provided by GlaxoSmithKline:

rotavirus,
diarrhoea,
HRV vaccine

Study placed in the following topic categories:

Digestive System Diseases
Diarrhea
Gastrointestinal Diseases
Healthy
Gastroenteritis

ClinicalTrials.gov processed this record on January 16, 2009