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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00139347 |
The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age.
Condition | Intervention | Phase |
---|---|---|
Rotavirus Gastroenteritis |
Biological: 2-dose oral live attenuated G1P[8] human rotavirus vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Parallel Assignment, Efficacy Study |
Official Title: | A Multi-Country & Multi-Center Study to Assess the Efficacy, Immunogenicity & Safety of Two Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants |
Estimated Enrollment: | 6360 |
Study Start Date: | December 2003 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-12 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine EPI vaccinations are given at the discretion of the investigator and according to local National Plans of Immunisation schedule in each participating country.
Ages Eligible for Study: | 6 Weeks to 12 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Argentina | |
GSK Investigational Site | |
Cordoba, Argentina, 5000 | |
GSK Investigational Site | |
La Plata, Argentina, 1900 | |
GSK Investigational Site | |
Córdova, Argentina, 5016 | |
GSK Investigational Site | |
Mendoza, Argentina, 5500 | |
Argentina, Córdova | |
GSK Investigational Site | |
Rio Cuarto, Córdova, Argentina, 5800 | |
GSK Investigational Site | |
Colonia Caroya, Córdova, Argentina, X5223CDT | |
Argentina, Mendoza | |
GSK Investigational Site | |
Tunuyan, Mendoza, Argentina, 5560 | |
GSK Investigational Site | |
Villanueva, Mendoza, Argentina, 5521 | |
Brazil, Rio Grande Do Sul | |
GSK Investigational Site | |
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903 | |
Colombia | |
GSK Investigational Site | |
Cali Colombia, Colombia | |
GSK Investigational Site | |
Bogota, Colombia, 805 | |
GSK Investigational Site | |
Cali, Colombia | |
Dominican Republic | |
GSK Investigational Site | |
Santo Domingo, Dominican Republic | |
Dominican Republic, Sant Dom- Distrito Nacional | |
GSK Investigational Site | |
Santo Domingo, Distrito Nacional, Sant Dom- Distrito Nacional, Dominican Republic | |
Honduras | |
GSK Investigational Site | |
Comayaguela, Honduras | |
Panama | |
GSK Investigational Site | |
Panama, Panama | |
Panama, Chiriquí | |
GSK Investigational Site | |
David, Chiriquí, Panama, Panamá 937, David |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 444563/024 |
Study First Received: | August 30, 2005 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00139347 |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Digestive System Diseases Gastrointestinal Diseases Healthy Gastroenteritis |