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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00385320 |
The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.
Condition | Intervention | Phase |
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Rotavirus Gastroenteritis |
Biological: HRV vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | To Assess the Efficacy, Immuno & Safety of 2 Doses of GSK HRV Vaccine at Different Virus Concentrations in Healthy Infants Aged 2 Months & Previously Uninfected With HRV, Concurrently Given With DTPw-HBV, Hib. |
Ages Eligible for Study: | 6 Weeks to 12 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Brazil, Pará | |
GSK Clinical Trials Call Center | |
Belém, Pará, Brazil | |
Mexico | |
GSK Clinical Trials Call Center | |
Tlalpan, Mexico | |
Venezuela | |
GSK Clinical Trials Call Center | |
Valencia, Venezuela |
Study Director: | Clinical Trials | GlaxoSmithKline |
Study ID Numbers: | 444563/006 |
Study First Received: | October 6, 2006 |
Last Updated: | October 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00385320 History of Changes |
Health Authority: | Brazil: National Health Surveillance Agency |
Virus Diseases Digestive System Diseases Gastrointestinal Diseases Healthy Gastroenteritis |
Digestive System Diseases Gastrointestinal Diseases Gastroenteritis |