Status:
COMPLETED
Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
32-3 years
Phase:
PHASE3
Brief Summary
To assess the long-term efficacy and safety of the subjects during the third year after priming with 2 doses of GSK Biologicals' oral live attenuated HRV vaccine (Rotarix) in the primary vaccination s...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- A male or female who has completed the second year efficacy follow-up of the primary vaccination study in Finland.
- Written informed consent obtained from the parent or guardian of the subject.
Exclusion
Key Trial Info
Start Date :
February 12 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2007
Estimated Enrollment :
1613 Patients enrolled
Trial Details
Trial ID
NCT00420316
Start Date
February 12 2007
End Date
August 8 2007
Last Update
August 28 2018
Active Locations (15)
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1
GSK Investigational Site
Espoo, Finland, 02100
2
GSK Investigational Site
Helsinki, Finland, 00100
3
GSK Investigational Site
Helsinki, Finland, 00930
4
GSK Investigational Site
Jarvenpaa, Finland, 04400