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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00480324 |
This study is undertaken to provide the regulatory authorities in Japan with immunogenicity, efficacy, safety and reactogenicity data of GSK Biologicals' HRV vaccine, given as a 2-dose primary vaccination, in healthy Japanese infants aged approximately 2 months at the time of the first dose and previously uninfected with HRV. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Condition | Intervention | Phase |
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Gastroenteritis Caused by Rotavirus |
Biological: Rotarix Biological: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy, Safety, Reactogenicity and Immunogenicity Study of the Lyophilised Formulation of Rotarix Vaccine in Healthy Japanese Infants |
Estimated Enrollment: | 765 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Experimental |
Biological: Rotarix
Two-dose oral vaccination.
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Group B: Placebo Comparator |
Biological: Placebo
Two-dose oral administration.
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DTPa and HBV vaccines are allowed to be co-administered along with Rotarix vaccine/Placebo.
Ages Eligible for Study: | 6 Weeks to 14 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Isabelle Harpigny ) |
Study ID Numbers: | 107625 |
Study First Received: | May 29, 2007 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00480324 History of Changes |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Digestive System Diseases Gastrointestinal Diseases Healthy Gastroenteritis |
Digestive System Diseases Gastrointestinal Diseases Gastroenteritis |