Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children.
Condition: Acellular Pertussis; Tetanus; Diphtheria; Poliomyelitis
MeSH terms: Diphtheria; Poliomyelitis
Intervention: Boostrix Polio™ 711866; Priorix Tetra TM 208136; Tetravac TM
Intervention description: Single dose, intramuscular administration.; Single dose, subcutaneously.; Single dose, intramuscular administration.
Intervention MeSH terms: Pentetic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 303.0
Sex: All
Minimum age: 5 Years
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Boostrix Polio; dTpa-IPV

Summary:

      This phase 3b study will compare the immunogenicity and reactogenicity of the dTpa-IPV
      vaccine to that of a DTPa-IPV vaccine when administered as a booster dose in healthy children
      5-6 years of age who have received three primary vaccination doses of DTPa-based vaccine
      according to the "3-5-11" month schedule recommended in Italy.

      In this study, MMRV vaccine will also be co-administered to all children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female child of 5 and 6 years of age at the time of vaccination.

          -  Subjects who received a complete 3-dose vaccination with a DTPa-based combined vaccine
             according to a 3-5-11 month schedule in line with recommendations in Italy.

          -  Subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine
             in the second year of life, in line with recommendations in Italy.

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol should be enrolled in the study.

          -  Written informed consent obtained from the parent or guardian of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccine(s)
             within 30 days preceding the first 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.

          -  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 tetanus, diphtheria, pertussis and/or
             poliomyelitis since vaccination in the first two years of life.

          -  Previous measles, mumps, rubella and/or varicella second dose vaccination.

          -  Known history of diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps,
             rubella and/or varicella disease.

          -  Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to
             study start.

          -  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 immunoglobulin and/or any blood products within the three months
             preceding vaccination 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 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.

          -  Residence in the same household as a person high risk for varicella

          -  The following condition is temporary or self-limiting, and a subject may be vaccinated
             once the condition has resolved if no other exclusion criteria is met:

               -  Current febrile illness or axillary temperature ≥ 38.5 ºC or other moderate to
                  severe illness within 24 hours of study vaccine administration.