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A Study to Evaluate Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of Engerix™-B Kinder Challenge Dose, in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa During Infancy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2016 by GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: June 9, 2016
Last updated: July 6, 2016
Last verified: July 2016
The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 14-15 years who were vaccinated with four doses of Infanrix™-Hexa in the first two years of life and to assess the anamnestic response, immunogenicity, safety and reactogenicity of a single challenge dose of the hepatitis B vaccine Engerix™-B Kinder.

Condition Intervention Phase
Hepatitis B
Biological: Engerix™-B Kinder
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine, Engerix™-B Kinder (SKF103860) Challenge Dose, in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa (SB217744) During Infancy

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-Hepatitis B (HB)s antibody concentrations [ Time Frame: One month after the single challenge dose of Hepatitis B Virus (HBV) vaccine ] [ Designated as safety issue: No ]
    The Anti-HBs cut-off to be assessed is ≥100 milli-international units (mIU/ml)

Secondary Outcome Measures:
  • Anti-HBs antibody concentrations [ Time Frame: Before the challenge dose of HBV vaccine (Day 0) ] [ Designated as safety issue: No ]
    The Anti-HBs cut-offs to be assessed are ≥ 10 mIU/ml, ≥ 100 mIU/ml and anti-HBs antibody geometric mean concentrations (GMCs)

  • Anamnestic response to the single challenge dose of HBV vaccines [ Time Frame: One month after the single challenge dose of Engerix-B Kinder vaccine ] [ Designated as safety issue: No ]
    The Anti-HBs amnestic response cut-off to be assessed iss ≥ 10 mIU/ml

  • Number of subjects with solicited local and general symptoms [ Time Frame: Within 4 days (Day 0 - Day 3) after the vaccination ] [ Designated as safety issue: No ]
    Occurrence of each solicited local and general symptom

  • Number of subjects with unsolicited adverse events [ Time Frame: Within 31 days (Day 0 - Day 30) after the vaccination ] [ Designated as safety issue: No ]
    Occurrence of unsolicited Adverse Events (AEs) after the single challenge dose of HBV vaccine

  • Number of subjects with serious adverse events [ Time Frame: From Day 0 to Day 31 ] [ Designated as safety issue: No ]
    Occurrence of serious adverse events after the single challenge dose of HBV vaccine up to study end

Estimated Enrollment: 300
Study Start Date: August 2016
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HBV Group
Subjects will receive a single challenge dose of Engerix™-B Kinder.
Biological: Engerix™-B Kinder
Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 14-15 years of age.


Ages Eligible for Study:   14 Years to 15 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.
  • In addition to the informed consent that will be signed by the parents/LAR(s), written informed assent of the subject will be sought.
  • A male or female between the ages of 14 to 15 at the time of vaccination.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Subjects with documented evidence of previous vaccination with four consecutive doses of Infanrix hexa as part of routine vaccination in Germany: three doses of primary vaccination received by 9 months of age and one booster dose received between 11 and 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 or ovariectomy.
  • 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 series.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the dose of study vaccine, or planned use during the study period.
  • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
  • Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
  • Administration of long-acting immune-modifying drugs at any time during the study period.
  • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and ending 30 days after the dose of HBV vaccine administration with the exception of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, which can be given as part of routine vaccination practice. Seasonal or pandemic influenza vaccine can be given at any time during the study, and according to the Summary of Product Characteristics and national recommendations.
  • 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).
  • Evidence of previous hepatitis B booster vaccination since administration of the fourth dose of Infanrix hexa booster in the second year of life.
  • History of or intercurrent hepatitis B disease.
  • Hepatitis B vaccination at birth.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness including thrombocytopenia and bleeding disorders.
  • History of any neurological disorders or seizures.
  • 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 for rectal route.
    • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Administration of immunoglobulins and/or any blood products during the period starting 3 months before the dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02798952

Contact: US GSK Clinical Trials Call Center 877-379-3718

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT02798952     History of Changes
Other Study ID Numbers: 106794  2015-003391-74 
Study First Received: June 9, 2016
Last Updated: July 6, 2016
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:
Hepatitis B antibodies
Challenge dose
Engerix B Kinder
Infanrix hexa

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Hepatitis B Antibodies
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Immunologic Factors
Physiological Effects of Drugs processed this record on September 23, 2016