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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00140686 |
Purpose
The main objectives of this study is to determine vaccine efficacy against any rotavirus (RV) gastroenteritis (GE) during the first efficacy period.
| Condition | Intervention | Phase |
|---|---|---|
|
Rotavirus |
Biological: Rotavirus (vaccine) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multi-Country & Multi-Center Study to Assess the Efficacy, Safety & Immunogenicity of 2 Doses of GSK Biologicals’ Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in co-Administration With Specific Childhood Vaccines |
| Estimated Enrollment: | 3930 |
| Study Start Date: | September 2004 |
Eligibility| Ages Eligible for Study: | 6 Weeks to 14 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
More Information
| Study ID Numbers: | 102247/036 |
| Study First Received: | August 31, 2005 |
| Last Updated: | February 12, 2007 |
| ClinicalTrials.gov Identifier: | NCT00140686 History of Changes |
| Health Authority: | Finland: National Agency for Medicines |