Status:
COMPLETED
Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Hepatitis A
Eligibility:
All Genders
12-15 years
Phase:
PHASE3
Brief Summary
To evaluate the persistence of immune response 5 years and 6 years after the first vaccine dose.
Detailed Description
Open, randomised, long-term antibody persistence studies, conducted in 2 centers. Immune persistence was compared between subjects who received two doses of GSK Biologicals combined hepatitis A and he...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subjects who received GSK Biologicals' combined hepatitis A and B vaccine in the primary study (HAB-082). Subjects were aged 12 to 15 years at the time of the first vaccination.
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT00197171
Start Date
September 1 2003
End Date
December 1 2003
Last Update
September 7 2016
Active Locations (2)
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1
GSK Investigational Site
Paramatta, New South Wales, Australia, 2124
2
GSK Investigational Site
Melbourne, Victoria, Australia, 3001