Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years
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-HBs antibody titres < 10 mIU/ml at previous timepoint. The study also
 evaluated the effect of a booster dose of the vaccine (Month 42) after primary vaccination.
Inclusion Criteria:

 -  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 Criteria:

 -  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.