Status:
COMPLETED
Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief Summary
This study was conducted to evaluate the lot-to-lot consistency of three lots of HBV-MPL vaccine and to compare their safety and immunogenicity with that of Engerix™-B.
Detailed Description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Eligibility Criteria
Inclusion
- A male or female aged ≥ 15 years at the time of the first vaccination. In Centre 103 (Germany) and Centre 1 (Netherlands), only subjects ≥ 18 years will be enrolled.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the subject and/or from the parent or guardian of the subject.
- If the subject was a female, she was of non-childbearing potential, if of childbearing potential, she was abstinent or used adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination
Exclusion
- Use of any investigational or non-registered drug or vaccine other than the study vaccine (s) during the study period or within 30 days preceding the first dose of study vaccine.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
- Previous vaccination against hepatitis B.
- History of non-response to previous hepatitis B vaccination.
- Known exposure to hepatitis B within the past 6 weeks.
- History of hepatitis B infection.
- Confirmed human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrollment.
- Hepatomegaly, right upper quadrant abdominal pain or tenderness.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
- Pregnant or lactating female
Key Trial Info
Start Date :
April 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1303 Patients enrolled
Trial Details
Trial ID
NCT00696917
Start Date
April 1 1999
Last Update
June 13 2008
Active Locations (7)
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1
GSK Clinical Trials Call Center
Parkville, Victoria, Australia, 3052
2
GSK Clinical Trials Call Center
Hradec Kralové, Czechia
3
GSK Clinical Trials Call Center
München, Germany
4
GSK Clinical Trials Call Center
Bari, Italy