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Clinical Trial Summary

GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV) vaccine in several countries. In view of its registration in the Philippines, the present study will collect data on the safety of the vaccine in the local target population as per the Bureau of Food and Drugs Directive.


Clinical Trial Description

The protocol was amended to reflect a change in the prescribing information. The age of the infants was changed from 6 - 14 weeks to at least 6 weeks at the time of the first vaccination. This protocol posting has been amended in order to comply with FDA AA. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00353366
Study type Observational
Source GlaxoSmithKline
Contact
Status Completed
Phase
Start date November 16, 2006
Completion date July 17, 2010

See also
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