Hepatitis B vaccine challenge dose given to subjects, 17 to 21 years of age, to evaluate immune memory to Hepatitis B antigen, approximately 6 years after priming with Hepatitis B vaccine.
Conditions
Interventions
Trade Name: Engerix B
Product Name: Engerix B
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Hepatitis B virus surface antigen recombinant (S protein) adsorbed
Concentration unit:
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for the follow-up visit) should be enrolled in the study. A male or female who received the complete primary vaccination course of hepatitis B vaccine (Engerix™-B), in the HBV-280 primary study. Written informed consent obtained from the subject and/or parent/guardian of 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, i.e. have a current tubal ligation, hysterectomy, and ovariectomy or be post-menopausal, 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 the hepatitis B challenge dose. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the hepatitis B vaccine challenge dose, 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. (For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) 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 an additional dose of hepatitis B vaccine outside the context of the study between the primary vaccination course and the hepatitis B challenge vaccination 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 (pharmaceutical product or device). History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). Acute disease at the time of enrolment. [Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral temperature <37.5°C (99.5°F) /axillary temperature <37.5°C (99.5°F).] Acute or chronic, clinically significant 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 (one month). Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the immune response to a challenge dose of hepatitis B vaccine administered in subjects who previously received a complete hepatitis B primary vaccination course, 72 to 78 months ago.;Secondary Objective: To evaluate the immunogenicity of a challenge dose of hepatitis B vaccine. To evaluate safety and reactogenicity of a challenge dose of hepatitis B vaccine in terms of: - solicited symptoms occurring during the 4-day (Day 0 to Day 3) follow-up period. - unsolicited symptoms occurring during the 31-day (Day 0 to Day 30) follow-up period. - serious adverse events during the entire study period. ;Primary end point(s): To assess the immune response to a challenge dose of hepatitis B vaccine administered in subjects who previously received a complete hepatitis B primary vaccination course, 72 to 78 months ago. | — |
Countries
Belgium
Outcome results
None listed