Immunogenicity and Safety of Booster Dose of BoostrixTM Polio Vaccine in Previously Boosted Adults

This is an interventional prevention trial for Acellular Pertussis focused on measuring BoostrixTM Polio, dTpa-IPV, booster Read More

Inclusion Criteria:

• Subjects who the investigator believes can and will comply with the requirements of the protocol.
• Male or female subjects who have received vaccine in study NCT01277705.
• Written informed consent obtained from the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Female subjects of non-childbearing potential may be enrolled in the study.

• Female subjects of childbearing potential may be enrolled in the study and receive the booster vaccine, if the subject:

  • practices/has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • agrees to continue adequate contraception during the entire booster epoch.

Exclusion Criteria:

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of the 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.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Previous booster vaccination against diphtheria, tetanus, pertussis or poliovirus since the dose received in study NCT01277705. In Germany, previous dose of a monovalent vaccine against pertussis is allowed for subjects in the Group C.
• History of diphtheria, tetanus, pertussis or poliomyelitis diseases following the receipt of booster dose in study NCT01277705.
• Any confirmed or suspected immunosuppressive or immunodeficiency condition based on medical history and physical examination.
• 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 seven 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 within 48 hours of vaccination,
  • convulsions with or without fever, occurring within 3 days of vaccination.
• Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
• Acute disease and/or fever at the time of enrolment.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.