Status:
COMPLETED
Long-Term Follow-Up Studies at Year 6, 7, 8, 9, 10: 2 Formulations of Combined Hepatitis A/B Vaccine Compared in Subjects Aged 12-15 Years
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Hepatitis A
Eligibility:
All Genders
12-15 years
Phase:
PHASE3
Brief Summary
To evaluate the persistence of anti-hepatitis A virus (anti-HAV) and anti-hepatitis B surface antigen (anti-HBs) antibodies up to 6, 7, 8, 9 and 10 years after administration of the first dose of the ...
Detailed Description
Open, randomized, long-term antibody persistence studies. Immune persistence was compared between subjects who received one of the two formulations of GlaxoSmithKline Biologicals' combined hepatitis A...
Eligibility Criteria
Inclusion
- Healthy male and female volunteers vaccinated in study HAB-084.
- Written informed consent obtained from the subject before the blood sampling visit of each year.
Exclusion
- • none
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2004
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT00197119
Start Date
May 1 2004
End Date
June 1 2004
Last Update
April 20 2017
Active Locations (2)
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1
GSK Investigational Site
Brussels, Belgium, 1200
2
GSK Investigational Site
Hradec Králové, Czechia, 500 03