Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination in Study NCT01267058
Condition: Acellular Pertussis; Tetanus; Diphtheria; Diphtheria-Tetanus-acellular Pertussis Vaccines
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Tetany
Intervention: Boostrix™
Intervention description: Intramuscular injection, 1 dose
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 203.0
Sex: All
Minimum age: 28 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in
      adults 10 years after previous booster vaccination with dTpa in a previous clinical study
      (NCT01267058). Only subjects who received the booster vaccination in a previous clinical
      study are eligible for participation in this study. The Protocol Posting has been updated in
      order to comply with the FDA Amendment Act, Sep 2007.

      No new recruitment will be performed in this booster phase (see inclusion criteria).
    

Eligibility criteria:

        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 263855/002 .

          -  A male or female subject, recruited 10 years (+/- 9 months) after booster vaccination
             in study 263855/002.

          -  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 be abstinent or have used adequate contraceptive
             precautions for 30 days prior to vaccination, have a negative pregnancy test and must
             agree to continue such precautions for two months after completion of booster
             vaccination.

          -  Written informed consent obtained from the subject.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine within 30 days preceding the booster dose of study vaccine, or planned
             use during the study period.

          -  Chronic administration (defined as more than 14 days) 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 diphtheria, tetanus or pertussis since the last
             dose received in study 263855/002

          -  History of 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 (axillary temperature)
             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.

          -  Acute disease at the time of enrolment.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.