Hepatitis MedDRA version: 14.1 Level: PT Classification code 10019731 Term: Hepatitis B System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Engerix™-B Kinder
Product Name: Engerix™-B Kinder
Product Code: SB103860
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: HEPATITIS B SURFACE ANTIGEN
Other descriptive n
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A male or female between, and including, 15 and 16 years of age (from and including the 15th birthday up to but excluding the 17th birthday) at the time of the vaccination. Healthy subjects as established by medical history and clinical examination before entering into the study. Documented evidence of previous vaccination with three consecutive doses of Engerix™-B Kinder in Germany: with the first two doses received by 9 months of age and the third dose received by 18 months of age (up to but excluding the first day of the 10th and 19th month, respectively). Written informed consent obtained from the parent(s)/LAR(s) of the subject. Written informed assent obtained from the subject in addition to the informed consent signed by the parent(s)/LAR(s). Are the trial subjects under 18? yes Number of subjects for this age range: 300 F.1.2 Adults (18-64 years) no 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: •Child in care. •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period. •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone >= 20 mg/day, or equivalent. Inhaled and topical steroids are allowed. •Previous hepatitis B vaccination since administration of the third dose of Engerix™-B Kinder. •History of hepatitis B disease. •Administration of a vaccine not foreseen by the study protocol within the period starting 30 days before study vaccine dose, or planned administration during the study period. •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 vaccine/product (pharmaceutical product or device). •History of any reaction or hypersensitivity 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 and/or fever at the time of enrolment. -Fever is defined as temperature >= 37.5°C for oral, axillary or tympanic route, or >= 38.0°C on rectal route. The preferred route for recording temperature in this study will be axillary. -Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. •Administration of immunoglobulins and/or any blood products within the 3 months preceding the study vaccine dose or planned administration during the study period. •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 anti-HBs antibody response to a challenge dose of Engerix-B Kinder in subjects 15-16 years of age vaccinated with three doses of Engerix-B Kinder in infancy.;Secondary Objective: To assess the persistence of anti-HBs antibodies in subjects 15-16 years of age vaccinated with three doses of Engerix-B Kinder in infancy. To evaluate the safety and reactogenicity of challenge dose of Engerix-B Kinder in terms of solicited symptoms, unsolicited symptoms and serious adverse events (SAEs);Primary end point(s): Evaluation of anti-HBs immune status in terms of antibody concentrations.;Timepoint(s) of evaluation of this end point: One month after the challenge dose (Month 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of anti-HBs immune status in terms of antibody concentrations. Occurrence of solicited local and general symptoms Occurrence of unsolicited adverse events Occurrence of serious adverse events (SAEs);Timepoint(s) of evaluation of this end point: Anti-HBs immune status: Before (Day 0) and one month after the challenge dose (Month 1). Solicited local and general symptoms: During the 4-day (Days 0-3) follow-up period after the challenge dose unsolicited symptoms: During the 31-day (Days 0-30) follow-up period after the challenge dose SAEs: After challenge dose, up to study end (Month 1) | — |
Countries
Germany
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed