Status:
COMPLETED
Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were Compared
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Hepatitis A
Eligibility:
All Genders
3-13 years
Phase:
PHASE3
Brief Summary
To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine....
Detailed Description
Open, randomised, self-contained, multicentric, multinational, long-term antibody persistence studies. Immune persistence was compared between subjects who received either two dose or three doses of G...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Participation in primary study
- Written informed consent obtained before each long term follow up visit.
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2004
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT00197184
Start Date
November 1 2003
End Date
March 10 2004
Last Update
August 20 2018
Active Locations (7)
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1
GSK Investigational Site
North Adelaide, South Australia, Australia, 5006
2
GSK Investigational Site
Carlton, Victoria, Australia, 3053
3
GSK Investigational Site
Brussels, Belgium, 1200
4
GSK Investigational Site
Barcelona, Spain, 08042