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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00396630 |
The aim of this study is to explore horizontal transmission of the HRV vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Condition | Intervention | Phase |
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Rotavirus Gastroenteritis |
Biological: Rotarix Biological: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Phase IIIb, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family. |
Enrollment: | 200 |
Study Start Date: | January 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group B: Placebo Comparator |
Biological: Placebo
Two-dose oral administration.
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Group A: Experimental |
Biological: Rotarix
Two-dose oral vaccination.
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This is a Phase 3b study. Three doses of Infanrix® hexa will be administered to all subjects at the discretion of the investigator.
One complimentary dose of Rotarix will be administered to all infants enrolled in this study (both study groups) who are aged less than 6 months at Visit 3 (Week 13) as a benefit to the placebo group for participation in the study.
The study will be conducted in a double-blind manner with respect to Rotarix and placebo administered at Visit 1 and Visit 2. The parents/guardians of the subjects will know that within each pair of twins, one subject will receive the Rotarix vaccine and one subject will receive the placebo.
The study will be open label with respect to administration of the Rotarix vaccine dose given at Visit 3 to all subjects in each group who are aged less than 6 months.
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 ( Study Director ) |
Study ID Numbers: | 106260 |
Study First Received: | November 6, 2006 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00396630 |
Health Authority: | Dominican Republic: Secretaria de Estado de Salud Pública y Asistencia Social (SESPAS); United States: Food and Drug Administration |
rotavirus Gastroenteritis HRV vaccine Shedding Transmission |
Digestive System Diseases Gastrointestinal Diseases Gastroenteritis |