Immunogenicity and Safety of BoostrixTM Using a New Syringe in 10 to 15-year Old Adolescents
Condition: Diphtheria; Tetanus; Acellular Pertussis
MeSH terms: Diphtheria
Intervention: Boostrix TM (new syringe presentation); Boostrix TM (previous syringe presentation)
Intervention description: Single dose, intramuscular administration in a new syringe presentation; Single dose, intramuscular administration in previous syringe presentation
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 671.0
Sex: All
Minimum age: 10 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: dTpa; Boostrix

Summary:

      The purpose of the study is to compare the immunogenicity and safety of a booster dose of
      BoostrixTM administered in a new syringe presentation to that of BoostrixTM administered in
      the previous syringe presentation in healthy adolescents aged 10-15 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject's parent(s)/Legally Acceptable Representative(s) and subjects who the
             investigator believes can and are willing to comply with the requirements of the
             protocol.

          -  A male or female between 10 and 15 years of age at the time of booster vaccination.

          -  Prior to protocol amendment 2, subjects who have previously received 5 doses of
             diphtheria-tetanus-pertussis vaccine (whole cell/acellular [w/a]) as part of primary
             and booster vaccination, in line with local recommendations.

          -  After protocol amendment 2, subjects who have previously received 6 doses of either
             DT(P) (w/a)/ dTpa vaccine as part of primary and booster vaccination, in line with
             local recommendations.

          -  Healthy subjects as determined by the investigator based on medical history and
             clinical examination before entering into the study.

          -  Written informed consent to be obtained before study entry from the parent(s)/ Legally
             Acceptable Representative(s) of the subject.

          -  Written informed assent to be obtained from the subject in addition to the informed
             consent signed by the parent(s)/ Legally Acceptable Representative(s), if required by
             local regulations.

          -  Female subjects of non-childbearing potential may be enrolled in the study.

          -  Female subjects of childbearing potential may be enrolled in the study, if the
             subject:

               -  has a negative pregnancy test on the day of vaccination,

               -  if sexually active, has practiced adequate contraception for 30 days prior to
                  vaccination, and has agreed to continue adequate contraception during the entire
                  treatment period and for 2 months after booster vaccination.

        Exclusion Criteria:

          -  Child in care.

          -  Use of any investigational or non-registered product other than the study vaccine
             within 30 days preceding the booster dose of 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.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             within 30 days of the booster dose of vaccine - with the exception of influenza
             vaccine which is allowed up to 7 days before the study vaccine dose, or planned in the
             period ≥ 7 days after the study vaccine dose.

          -  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.

          -  A history of previous or intercurrent diphtheria, tetanus or pertussis disease.

          -  A history of vaccination against these diseases since the 5th or the 6th dose of
             DT(P)/dT(pa). For subjects who have received the 6th dose of the diphtheria, tetanus
             and/or pertussis containing vaccine, the interval between the last DT(P)/dT(pa)
             vaccination and the administration of the study vaccine should be at least 18 months.

          -  Occurrence of any of the following adverse event after a previous administration of a
             Boostrix vaccine :

               -  known hypersensitivity to any component of the vaccine, or have shown signs of
                  hypersensitivity after previous administration of diphtheria, tetanus or
                  pertussis vaccines,

               -  encephalopathy of unknown aetiology occurring within 7 days following previous
                  vaccination with pertussis-containing vaccine,

               -  transient thrombocytopenia or neurological complications following an earlier
                  immunisation against diphtheria and/or tetanus.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine.

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the first dose of study vaccine 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, if applicable.