Rotavirus Gastroenteritis Clinical Trial
Official title:
A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-country and Multi-center Study to Assess the Efficacy and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants.
This Year 3 extension of the main study rota-028, 029 or 030 is conducted to evaluate
vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during third year of
life in infants previously vaccinated with human rotavirus (HRV) vaccine or placebo in the
following schedules:
at 3 and 4 months of age in study rota-028; at 2 and 4 months of age in study rota-029 or
rota-030.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
Note that no new subjects will be recruited in this extension phase studies.
The expected total enrolment for the primary studies was as follows:
rota-028: 5700 rota-029: 3018 rota-030: 1102
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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