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
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Engerix-B Kinder
Intervention description: 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.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 302.0
Sex: All
Minimum age: 14 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis B antibodies; Safety; Challenge dose; Persistence; Engerix B Kinder; Infanrix hexa; Immunogenicity; Adolescents

Summary:

      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.
    

Eligibility criteria:

        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.