Hepatitis B Antibody Persistence and Immune Response to Hepatitis B Vaccine Challenge in Previously Vaccinated Children

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.