Status:
COMPLETED
To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Rotavirus Vaccines
Eligibility:
All Genders
6-24 years
Brief 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 da...
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 protoco...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- A Filipino male or female aged at least 6 weeks at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
Exclusion
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Any history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract.
- Any contraindications as stated in the Prescribing Information.
Key Trial Info
Start Date :
November 16 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 17 2010
Estimated Enrollment :
1439 Patients enrolled
Trial Details
Trial ID
NCT00353366
Start Date
November 16 2006
End Date
July 17 2010
Last Update
March 16 2021
Active Locations (18)
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1
GSK Investigational Site
Alabang, Muntinlupa City, Philippines, 1780
2
GSK Investigational Site
Binangonan, Rizal, Philippines
3
GSK Investigational Site
Cainta, Rizal, Philippines
4
GSK Investigational Site
City of Muntinlupa, Philippines, 1780