NCT00353366

To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination

Open, Multicentric, Post-marketing Surveillance Study to Evaluate Safety and Reactogenicity of GSK Bio's Live Attenuated Oral Human Rotavirus (HRV) Vaccine, Rotarix When Administered According to Prescribing Information, in Filipino Subjects Aged at Least 6 Weeks of Age at the Time of First Vaccination

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,439 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 24 Weeks
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Infections, Rotavirus
• Rotavirus Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	Rotarix	Two doses of the oral vaccine
OTHER	Data collection	Safety evaluation: recording of adverse events by using diary cards and by non-leading questioning.

Timeline

• Start date: 2006-11-16
• Primary completion: 2010-03-31
• Completion: 2010-07-17
• First posted: 2006-07-18
• Last updated: 2021-03-16
• Results posted: 2011-08-03

Locations

18 sites across 1 country: Philippines