Evaluation of Antibody Persistence and Immune Memory Against the Hepatitis B Antigen in Previously Vaccinated Children
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Engerix™-B
Intervention description: Intramuscular, single dose
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 185.0
Sex: All
Minimum age: 11 Years
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Persistence; challenge dose; Engerix-B; immune response

Summary:

      This study will evaluate the persistence of immunity to hepatitis B 10 to 11 years after
      vaccination with Infanrix hexa™ or Engerix™-B and also the ability to mount an immune
      response to the challenge dose of Engerix™-B.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parents/Legally acceptable
             representative) can and will comply with the requirements of the protocol should be
             enrolled in the study.

          -  A male or female aged 11-12 years at the time of study entry (from and including the
             11th birthday until and excluding the 13th birthday).

          -  Written informed consent obtained from the parent or Legally Acceptable Representative
             of the subject.

          -  Study procedures will be explained to subjects and depending on their understanding,
             optional informed assent will be sought at the discretion of the investigator.

          -  Written informed assent obtained from the subject in addition to the informed consent
             signed by the parent(s)/ Legally Acceptable Representative (s).

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Subjects who have received all three doses of Infanrix hexa or Engerix-B in the
             primary study 217744/031 (NCT01457495).

          -  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 series.

        Exclusion Criteria:

          -  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.

          -  Child in care.

          -  Use of any investigational or non-registered product drug or vaccine) other than the
             study vaccine within 30 days preceding the challenge dose of HBV vaccine, or planned
             use during the study period.

          -  Receipt of hepatitis B (containing) vaccine after vaccination in the primary study
             217744/031 (NCT01457495).

          -  History of hepatitis B disease.

          -  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 HBV
             vaccine challenge dose.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the challenge dose of HBV vaccine 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.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.

          -  Known hypersensitivity to any component of the HBV vaccine or evidence of
             hypersensitivity after previous immunisation with a vaccine containing the hepatitis B
             component.

          -  Acute disease and/or fever at the time of enrolment.

          -  Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic
             setting

          -  Subjects with a minor illness without fever may be enrolled at the discretion of the
             investigator.