Immunogenicity and Safety of Booster Dose of BoostrixTM Polio Vaccine in Previously Boosted Adults
Condition: Acellular Pertussis; Poliomyelitis; Diphtheria; Tetanus
MeSH terms: Diphtheria; Poliomyelitis
Intervention: BoostrixTM Polio
Intervention description: Single dose, intramuscular administration.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 212.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: BoostrixTM Polio; dTpa-IPV; booster

Summary:

      This study will evaluate the persistence of immune response against diphtheria, tetanus,
      pertussis and poliomyelitis in healthy adults, 10 years after a booster dose, and also assess
      the immunogenicity and safety of another booster dose of BoostrixTM Polio.
    

Eligibility criteria:

        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.