Last updated: 07/17/2024 16:51:36
Evaluation of the long-term persistence of immunity to hepatitis B, in adolescents vaccinated in infancy with Engerix™-B Kinder
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody concentrations equal to or above the cut off value.
Timeframe: One month after the challenge dose (Month 1)
Secondary outcomes:
Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody concentrations equal to or above the cut off value.
Timeframe: Before (Day 0) and one month after the challenge dose (Month 1)
Antibody titers against hepatitis B virus
Timeframe: 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.
Timeframe: Prior to vaccination with the challenge dose
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Timeframe: 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.
Timeframe: During the 4-day (Days 0-3) follow-up period after the challenge dose
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Timeframe: During the 31-day (Days 0-30) follow-up period after the challenge dose
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
Timeframe: During the entire study period (Day 0 to Month 1)
Interventions:
Biological/vaccine: Engerix™-B Kinder
Enrollment:
303
Observational study model:
Not applicable
Primary completion date:
2014-21-02
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
SKF103860
Collaborators
Not applicable
Study date(s)
July 2013 to February 2014
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
15 - 16 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
- 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.
Subject’s parent(s)/guardians who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Exclusion criteria:
- 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.
- 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.
Child in care.
Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
Trial location(s)
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
Status
Study Complete
Location
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
Status
Study Complete
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
Status
Study Complete
Location
GSK Investigational Site
Tuttlingen, Baden-Wuerttemberg, Germany, 78532
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2014-21-02
Actual study completion date
2014-21-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
IPD for this study will be made available via the Clinical Study Data Request site.
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