Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.
Condition: Tetanus; Acellular Pertussis; Diphtheria; Diphtheria-Tetanus-acellular Pertussis Vaccines
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Tetany
Intervention: Boostrix®; Decavac™
Intervention description: Intramuscular, single dose.; Intramuscular, single dose.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1332.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Boostrix®; adults

Summary:

      This phase IIIb, observer-blind study will evaluate the immunogenicity and safety of GSK
      Biologicals' Boostrix® vaccine in adults (extending indication) aged 65 years or older.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that can and will comply with the requirements
             of the protocol should be enrolled in the study.

          -  Males or females 65 years of age and older at the time of study entry.

          -  Free of an acute aggravation of the health status as established by medical history
             and medical history and clinical examination before entering into the study.

          -  Written informed consent from all subjects.

        Exclusion Criteria:

          -  Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.

          -  Administration of a Tdap vaccine at any time prior to study entry.

          -  History of diphtheria and/or tetanus and/or pertussis disease.

          -  Use of any investigational or non-registered drug or vaccine other than the study
             vaccines within 30 days preceding vaccination, or planned use during the entire study
             period.

          -  Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or
             4 weeks (for live vaccines) prior to enrolment in this study, with the exception of
             influenza, vaccine, which may be administered at any time up to or during the study
             period, including the day of study vaccination.

          -  Planned administration of any vaccine not foreseen by the study protocol up to 30 days
             following vaccination, with the exception of influenza, vaccine, which may be
             administered at any time up to or during the study period, including the day of study
             vaccination. Pneumococcal and zoster vaccines can be administered at the discretion of
             the investigator when the subject comes back at Visit 2.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to vaccination or planned administration during the study period.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination.

          -  History of serious allergic reaction following any other tetanus toxoid, diphtheria
             toxoid or pertussis-containing vaccine or any component of the study vaccines.

          -  History of encephalopathy within seven days of administration of a previous booster
             dose of pertussis vaccine that is not attributable to another identifiable cause.

          -  Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy:
             pertussis vaccine should not be administered to individuals with these conditions
             until a treatment regimen has been established and the condition has stabilized.

          -  Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by clinical evaluation or pre-existing
             laboratory screening tests.

          -  Acute disease at the time of vaccination.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding vaccination, or planned administration during the study period.

          -  Any medical condition that, in the opinion of the investigator, might interfere with
             the evaluations required by the study.