Evaluation of the Long-term Persistence of Immunity to Hepatitis B, in Adolescents Vaccinated in Infancy With Engerix™-B Kinder

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Hepatitis B

Treatments: Biological: Engerix™-B Kinder

Study type: Interventional

Funder types: Industry

Identifiers

NCT01847430

2012-003950-10 (EudraCT Number)

116722

Details and patient eligibility

About

The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 15-16 years who were vaccinated with Engerix™-B Kinder in infancy. The study will also assess the immune response to a challenge dose of Engerix™-B Kinder in these subjects.

Full description

This MDD has been updated following the Protocol Amendment 1, dated 20 June 2013.

The Protocol was amended because GSK replaced its in-house Enzyme-Linked ImmunoSorbent Assay (ELISA) that was used to measure anti-HBs (antibodies to Hepatitis B surface antigen) antibody concentrations with ChemiLuminescence ImmunoAssay (CLIA).

Additionally, the threshold level of prednisone was modified to reflect the dosage normally prescribed to adolescents.

Enrollment: 303 patients

Sex: All

Ages: 15 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject's parent(s)/guardians who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.

• A male or female between, and including, 15 and 16 years of age at the time of the vaccination.

• 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).

• 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.

• Female subjects of non-childbearing potential may be enrolled in the study.

  • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.

• Female subjects of childbearing potential may be enrolled in the study, if the subject:

  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination.

Exclusion criteria

• Child in care.

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

• Chronic administration 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.

• 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.

• Acute disease and/or fever at the time of enrollment.

  • 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 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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303 participants in 1 patient group

HBV Group

Experimental group

Description:

Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Engerix™-B Kinder