Evaluation of Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Boostrix Vaccine Administered as a Booster Dose in Healthy Russian Subjects
Condition: Diphtheria-Tetanus-acellular Pertussis Vaccines
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Intervention: Boostrix
Intervention description: One dose administered intramuscularly in the deltoid muscle of the non-dominant arm in dTap group.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: The treatment allocation would be non-randomised and stratified by age into four strata [4-9 years (children), 10-17 years (adolescents), 18-64 (adults) years and ≥65 years (elderly population)].
Enrollment: 448.0
Sex: All
Minimum age: 4 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Pertussis; Tetanus; Immunogenicity

Summary:

      Diphtheria, tetanus and pertussis are common causes of diseases worldwide, with significant
      morbidity and mortality. The purpose of this study is to assess the immunogenicity, safety
      and reactogenicity of a single dose of GlaxoSmithKline (GSK) Biologicals' Boostrix vaccine,
      administered as a booster dose in healthy Russian subjects. An equal number of subjects are
      expected to be recruited in the following age categories: 4-9 years (children), 10-17 years
      (adolescents), 18-64 years (adults) and ≥65 years (elderly population). By receiving the
      Boostrix vaccine, the subjects could be protected against diphtheria, tetanus and pertussis
      diseases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects or subjects' parent(s)/adoptive parent(s) who, in the opinion of the
             investigator, can and will comply with the requirements of the protocol.

          -  A male or female four years of age and older.

          -  Written informed consent obtained from the subject/from the parent(s)/adoptive
             parent(s) of the subject prior to performing any study specific procedure.

          -  Written informed assent obtained from subjects aged 14 years to <18 years.

          -  Healthy subjects as established by medical history and physical examination before
             entering into the study.

          -  Children 4-7 years of age with documented previous diphtheria, tetanus and pertussis
             vaccination (primary series and first booster) as per local recommendation prior to
             study enrolment, but should have not received any further diphtheria-tetanus
             containing booster planned at 6-7 years of age as per local recommendations or any
             other diphtheria, tetanus and pertussis containing vaccine.

          -  Subjects eight years of age and older who can report previous diphtheria, tetanus with
             or without pertussis vaccination - documented or to the best of their/subjects'
             parent(s)/subjects' adoptive parent(s) knowledge - and did not receive an additional
             diphtheria, tetanus with or without pertussis vaccination within five years prior to
             enrolment in the study will be enrolled.

          -  Female subjects of non-childbearing potential may be enrolled in the study.

               -  Non-childbearing potential is defined as pre-menarche, current tubal ligation,
                  hysterectomy, ovariectomy or post-menopause.

          -  Female subjects of childbearing potential may be enrolled in the study, if the
             subject:

               -  has practiced adequate contraception within 30 days prior to vaccination, and

               -  has a negative pregnancy test on the day of vaccination, and

               -  has agreed to continue adequate contraception during the entire treatment period
                  and for 1 month after completion of the vaccination.

        Exclusion Criteria:

          -  Child in care

          -  Use of any investigational or non-registered product other than the study vaccine
             within 30 days preceding the dose of study vaccine, or planned use during the study
             period.

          -  History of previous or intercurrent diphtheria, tetanus or pertussis diseases since
             birth in subjects four to seven years of age.

          -  History of previous or intercurrent diphtheria, tetanus or pertussis diseases within 5
             years prior to enrolment in subjects aged eight years and above.

          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants
             or other immune-modifying drugs within six months prior to the vaccine dose. For
             corticosteroids, this will mean prednisone ≥ 20 mg/day (for adult subjects, ≥18 years
             of age) or ≥ 0.5 mg/kg/day (for paediatric subjects, aged 4-17 years), or equivalent.
             Inhaled and topical steroids are allowed

          -  Administration of long-acting immune-modifying drugs at any time during the study
             period.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             within the period starting 30 days before and ending 30 days after the dose of vaccine
             with the exception of inactivated influenza vaccine which can be given at any time
             during the study conduct as per the Summary of Product Characteristics (SPC) and
             according to the local governmental recommendations.

          -  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 vaccine/product (pharmaceutical product or device).

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Family history of congenital or hereditary immunodeficiency.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine.

          -  Hypersensitivity to latex.

          -  History of encephalopathy after administration of a previous dose of pertussis vaccine
             that could not be attributed 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 stabilised.

          -  Acute disease and/or fever at the time of enrolment.

               -  Fever is defined as temperature ≥38.0°C. The preferred location for measuring
                  temperature in this study will be the axilla.

               -  Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory
                  infection) without fever may, be enrolled at the discretion of the investigator.

          -  Acute or chronic, clinically significant uncontrolled pulmonary, cardiovascular,
             hepatic or renal functional abnormality, as determined by physical examination and/or
             laboratory screening tests.

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the dose of study vaccine or planned administration during the study period.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions during the study conduct.

          -  Any medical condition that, in the opinion of the investigator, might interfere with
             the evaluations required by the study.

          -  Any medical condition that in the judgment of the investigator would make
             intramuscular injection unsafe.