NCT01847430CompletedPhase 4
Long-term Persistence of Hepatitis B Antibodies and Immune Response to a Challenge Dose of GSK Biologicals' Hepatitis B Virus Vaccine, Engerix™-B Kinder (SKF103860), in 15-16 Years Old Adolescents, Vaccinated in Infancy With Engerix™-B Kinder
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 303
- Locations
- 10
- Primary Endpoint
- Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut Off Value.
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
HBV Group
Experimental
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.
Intervention: Engerix™-B Kinder (Biological)
Outcomes
Primary Outcomes
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut Off Value.
Time Frame: One month after the challenge dose (Month 1)
The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).
Secondary Outcomes
- Number of Subjects Reporting Unsolicited Adverse Events (AEs).(During the 31-day (Days 0-30) follow-up period after the challenge dose)
- Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut Off Value.(Before (Day 0) and one month after the challenge dose (Month 1))
- Antibody Titers Against Hepatitis B Virus(Before (Day 0) and one month (Month 1) after the challenge dose)
- Number of Subjects With an Anamnestic Response to the Challenge Dose in Relation to Their Pre Vaccination Status.(Prior to vaccination with the challenge dose)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.(During the 4-day (Days 0-3) follow-up period after the challenge dose)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.(During the 4-day (Days 0-3) follow-up period after the challenge dose)
- Number of Subjects Reporting Any Serious Adverse Events (SAEs).(During the entire study period (Day 0 to Month 1))
Investigators
Study Sites (10)
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