Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination.

This Protocol Posting has been updated in order to comply with FDA AA, Sep 2007.

Inclusion criteria

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
• Subjects who have received dTpa vaccine or Td and pa vaccines in study 263855/004.
• A male or female subject, recruited 10 years after booster vaccination in study 263855/004.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must use adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.
• Written informed consent obtained from the subject.

Exclusion criteria

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
• Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination or planned administration during the active 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.
• Previous booster vaccination against tetanus, diphtheria or pertussis since the last dose received in study 263855/004.
• History of documented diphtheria, tetanus, or pertussis diseases.
• Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
• Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
• Occurrence of any of the following adverse event after a previous administration of a DTP vaccine :

• hypersensitivity reaction to any component of the vaccine,
• encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine,
• fever >= 40°C within 48 hours of vaccination not due to another identifiable cause,
• collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination,
• convulsions with or without fever, occurring within 3 days of vaccination.
• Acute disease at the time of enrolment.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after completion of the vaccination series.