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
Persistence of anti-HBs antibodies at Month 24, 30 and 36 in subjects who had completed primary vaccination was evaluated. The anamnestic response to a booster dose was evaluated in subjects with anti...
Eligibility Criteria
Inclusion
- Subjects were to have completed primary vaccination course. 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.
- If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she was to be abstinent or use 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 within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Pregnant or lactating female.
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
January 1 2004
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00383591
Start Date
March 1 2002
End Date
January 1 2004
Last Update
March 23 2017
Active Locations (5)
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1
GSK Investigational Site
Hradec Králové, Czechia, 500 01
2
GSK Investigational Site
Bandar Tun Razak, Cheras, Malaysia, 56000
3
GSK Investigational Site
Barcelona, Spain, 08036
4
GSK Investigational Site
Madrid, Spain, 28046