Hepatitis B Antibody Persistence and Immune Response to Hepatitis B Vaccine Challenge in Previously Vaccinated Children
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Engerix-B™ Kinder
Intervention description: Intramuscular, single dose
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 300.0
Sex: All
Minimum age: 7 Years
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: immune response; Engerix-B™Kinder; Persistence; challenge dose

Summary:

      This study will evaluate the persistence of immunity to hepatitis B in healthy children aged
      7 to 8 years, after previous vaccination with Infanrix hexa™ in the first two years of life,
      and also their ability to mount an immune response to the challenge dose of Engerix-B™
      Kinder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parent(s)/Legally Acceptable
             Representative(s) can and will comply with the requirements of the protocol.

          -  A male or female 7 to 8 years of age at the time of enrolment.

          -  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.

          -  Written informed consent obtained from the parents/Legally Acceptable
             Representative(s) of the subject at the time of enrolment.

          -  In addition to the informed consent that will be signed by the parent(s)/Legally
             Acceptable Representative(s), written informed assent of the subject will be sought
             when the subject is judged able to understand by the investigator.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        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.

          -  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 product.

          -  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.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             during the period starting from 30 days before and ending 30 days after the hepatitis
             B vaccine challenge dose.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding challenge dose or planned administration during the study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the challenge dose of HBV vaccine.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the hepatitis B vaccine, or evidence of hypersensitivity after previous
             immunisation with a vaccine containing the hepatitis B component.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Acute disease and/or fever at the time of enrolment.