Status:
COMPLETED
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief Summary
Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years
Eligibility Criteria
Inclusion
- A male or female \> = 15 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject/ from the parents or guardians of the subject.
- Seronegative for anti-HBs antibodies, anti-HBc antibodies \& Hepatitis B Surface antigen (HBsAg).
- If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.
- Pre-haemodialysis patient\* or a patient on haemodialysis.
Exclusion
- Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
- Previous vaccination against hepatitis B.
- History of hepatitis B infection.
- Known exposure to hepatitis B virus within 6 weeks. Pregnant or lactating female
- Clinically abnormal ALT/AST values (\> 3 times normal values)
Key Trial Info
Start Date :
December 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2000
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00383227
Start Date
December 1 1999
End Date
November 1 2000
Last Update
September 16 2016
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