In this study, subjects who received primary neonatal vaccination with hepatitis B vaccine
at 0, 1, 2, 12 months, 20 years ago in the 103860/272 primary study will be evaluated for
immunological memory to hepatitis B vaccine via assessment of the response to a vaccine
challenge dose.
Inclusion Criteria:
- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol should be enrolled in the study.
- A male or female adult who received the complete neonatal primary vaccination course
of hepatitis B vaccine (Engerix™-B), in the 103860/272 primary study approximately 20
years earlier.
- Documented level of anti-HBs antibody concentrations < 100 milli-international units
per milliliter (mIU/ml) at the previous long-term time-point for which serological
results are available for that subject.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before
entering into the study.
- If the subject is female, she must be of non-childbearing potential or if she is of
childbearing potential, she must practice adequate contraception for 30 days prior to
vaccination, have a negative pregnancy test and continue such precautions for 2
months after completion of the hepatitis B challenge dose.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within six months prior to the hepatitis B vaccine challenge
dose.
- Planned administration/ administration of a vaccine not foreseen by the study
protocol during the period starting from 30 days before the hepatitis B vaccine
challenge dose and ending 30 days after.
- Subjects who received a booster dose of hepatitis B vaccine outside the context of
this study between the long-term time-point at the documented level of anti-HBs
antibody concentrations and the current challenge dose study visit.
- Concurrently participating in another clinical study, at any time during the study
period, in which the subject has been or will be exposed to an investigational or a
non-investigational product.
- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
human immunodeficiency virus (HIV) infection.
- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by physical examination or laboratory screening
tests.
- Administration of immunoglobulins and/or any blood products within the three months
preceding the hepatitis B vaccine challenge dose or planned administration during the
study period.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive
precautions.
