Status:
COMPLETED
Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
13-20 years
Phase:
PHASE3
Brief Summary
To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months after the first dose of the hepatitis B primary vaccination course. Subjects were aged 11 to 15 years at the ...
Detailed Description
All subjects who participated in the primary study, in which they received either 2 or 3 doses of GSK Biologicals hepatitis B vaccine, and who consented to participate in the long-term follow-up at Mo...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subjects have participated in primary study HBV-280
- Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood-sampling visit of each year
Exclusion
Key Trial Info
Start Date :
April 21 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2008
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT00343915
Start Date
April 21 2004
End Date
January 10 2008
Last Update
June 10 2019
Active Locations (4)
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1
GSK Investigational Site
Sydney, New South Wales, Australia
2
GSK Investigational Site
Brussels, Belgium, 1200
3
GSK Investigational Site
Wilrijk, Belgium, 2610
4
GSK Investigational Site
Kyiv, Ukraine, 03038