An open, phase IV, single-group, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B (HBV) vaccine challenge in adolescents 12-13 years of age who were vaccinated in infancy with GSK Biologicals’ HBV vaccine (Engerix™-B). - HBV-318

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2009-012117-21-DE
• Date of registration: 15/07/2009
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: An open, phase IV, single-group, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B (HBV) vaccine challenge in adolescents 12-13 years of age who were vaccinated in infancy with GSK Biologicals’ HBV vaccine (Engerix™-B). - HBV-318
• Scientific title: An open, phase IV, single-group, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B (HBV) vaccine challenge in adolescents 12-13 years of age who were vaccinated in infancy with GSK Biologicals’ HBV vaccine (Engerix™-B). - HBV-318
• Date of first enrolment: 29/09/2009
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012117-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects who the investigator believes that their parent(s)/ LAR(s) can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study.

A male or female of 12 to 13 years of age (from and including the 12th birthday up to but excluding the 14th birthday) at the time of enrolment.

With documented evidence of previous vaccination with three consecutive doses of Engerix-B 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) or LAR(s) of the subject at the time of enrolment.

Written informed assent obtained from the subject (the study purpose and procedures will be explained to the subject by appropriately trained personnel) in addition to the informed consent signed by the parent(s)/LAR(s).

Healthy subjects as established by medical history and clinical examination before entering into the study.

Female subjects of non-childbearing potential (defined as pre-menarche) may be enrolled in the study.


Females of childbearing potential (i.e. who have reached menarche) at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or to use adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant®, DepoProvera®, contraceptive skin patch or cervical ring) for one month prior to vaccination. Subjects are required to agree to continue such precautions for two months after vaccination.

Are the trial subjects under 18? yes
Number of subjects for this age range:
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:
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).

Evidence of previous hepatitis B booster vaccination since administration of the third dose of Engerix-B vaccine.

History of hepatitis B disease.

Hepatitis B vaccination at birth.

Adolescents living in institutional care.

Planned administration /administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before HBV vaccine challenge and ending 30 days after.

Administration of immunoglobulins and/or any blood products within the three months preceding HBV vaccine challenge or planned administration 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 HBV vaccine challenge. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).

Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the challenge dose of study vaccine, or planned use during the study period.

Pregnant or lactating female.

Female planning to become pregnant or planning to discontinue contraceptive precautions.

Known hypersensitivity to any component of the HBV vaccine or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component.

Acute disease and/or fever at the time of enrolment.
Fever is defined as temperature = 37.5°C (99.5°F) on oral, axillary or tympanic setting.
Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Antibody persistence and hepatitis B vaccine challenge in adolescents aged 12-13 years, vaccinated in infancy with three doses of GSK Biologicals’ HBV vaccine in routine practice.

Intervention(s)

Trade Name: Engerix-B Kinder
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Recombinant Hepatitis B surface antigen
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Main Objective: To assess the anti-HBs antibody response to a challenge dose of HBV vaccine (Engerix-B Kinder) in subjects 12-13 years of age, vaccinated with three doses of Engerix-B in infancy.

Primary end point(s): Anti-HBs antibody concentrations one month after the challenge dose of HBV vaccine.
Percentage of subjects with anti-HBs antibody concentrations = 100 mIU/ml.

Secondary Objective: To assess the persistence of anti-HBs antibodies in subjects, 12-13 years of age, vaccinated with three doses of Engerix-B in infancy.

To evaluate the safety and reactogenicity of a challenge dose of HBV vaccine (Engerix-B Kinder) in terms of solicited symptoms, unsolicited symptoms and serious adverse events (SAEs).

Secondary ID(s)

112682