Immunogenicity and Safety of GSK Biologicals' Boostrix Polio Vaccine in 3 and 4-year-old Children
Condition: Acellular Pertussis; Poliomyelitis; Tetanus; Diphtheria
MeSH terms: Diphtheria; Poliomyelitis
Intervention: Boostrix PolioTM; RepevaxTM; PriorixTM
Intervention description: Single dose, intramuscular administration.; Single dose, intramuscular administration.; Single dose, intramuscular or subcutaneous administration.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 387.0
Sex: All
Minimum age: 3 Years
Maximum age: 4 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: MMR; dTpa-IPV; Boostrix Polio; Repevax; Priorix

Summary:

      The purpose of the study is to compare the immunogenicity and safety of a booster dose of
      BoostrixTM Polio to that of Sanofi Pasteur MSD's RepevaxTM, when co-administered with a
      second dose of PriorixTM, in healthy 3 and 4-year-old children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parent(s)/Legally Acceptable
             Representative(s) (LAR) can and will comply with the requirements of the protocol
             should be enrolled in the study.

          -  A male or female child of 3 or 4 years of age at the time of booster vaccination (up
             to, but excluding 5 years of age).

          -  Subjects who have received a complete three-dose primary vaccination with
             diphtheria-tetanus-acellular pertussis (DTPa) vaccine and inactivated poliovirus (IPV)
             vaccine in the first six months of life, in line with recommendations in the United
             Kingdom (UK).

          -  Subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine
             within the second year of life, in line with recommendations in the UK.

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject at the time
             of enrolment.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

          -  Child in care.

          -  Use of any investigational or non-registered product other than the study vaccine(s)
             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 vaccine dose.

          -  Administration of a vaccine not foreseen by the study protocol within 30 days prior to
             vaccination, or planned administration during the study period, with the exception of
             inactivated influenza vaccine.

          -  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, pertussis, poliomyelitis
             since primary vaccination in the first year of life.

          -  Previous measles, mumps and/or rubella second dose vaccination.

          -  Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis,
             measles, mumps and/or rubella disease.

          -  Known exposure to measles, mumps and/or rubella within 30 days prior to study start.

          -  Any confirmed or suspected immunosuppressive or immunodeficiency 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 immunoglobulin 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.

          -  Occurrence of any of the following adverse events 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 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 and/or fever at the time of enrolment or within 24 hours of study
             vaccine administration.