Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines
Condition: Tetanus; Acellular Pertussis; Diphtheria
MeSH terms: Diphtheria
Intervention: SB213503 lot 1; SB213503 lot 2; SB213503 lot 3; Infanrix; IPOL; M-M-R II
Intervention description: SB213503 lot 1 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.; SB213503 lot 2 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.; SB213503 lot 3 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.; Infanrix vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.; IPOL vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.; M-M-R II vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: The study was conducted in an open manner except for the consistency lots of SB213503 vaccine that were double-blinded.
Enrollment: 4209.0
Sex: All
Minimum age: 4 Years
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aims of this trial are to demonstrate the consistency of three manufacturing lots of GSK
      Biologicals' DTaP-IPV candidate vaccine in terms of immunogenicity and to evaluate the
      non-inferiority of GSK Biologicals' DTaP-IPV vaccine with respect to immunogenicity and
      safety compared to the control vaccines (separate injections of GSK Biologicals' DTaP vaccine
      [Infanrix] and Aventis Pasteur's IPV vaccine [IPOL]) when administered as a 5th dose of DTaP
      and a 4th dose of inactivated poliovirus vaccine in subjects 4 to 6 years of age. Vaccines
      will be co-administered with the second dose of M-M-RII, which is recommended at this age.
      Concomitant administration of a US-licensed influenza vaccine will be allowed according to
      seasonal availability of vaccine and at the discretion of the investigator.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female child between and including 4 and 6 years of age at the time of
             vaccination.

          -  Free of obvious health problems as established by medical history and brief medical
             evaluation before entering into the study.

          -  Received 4 doses of Infanrix and 3 doses of IPOL during the first 2 years of life.

          -  Vaccination against measles, mumps, and rubella in the second year of life.

          -  Subjects whom the investigator believed would comply with the requirements of the
             protocol.

          -  Written informed consent obtained before study entry from the parent(s) or guardian(s)
             of the subject.

        Exclusion criteria:

          -  Use of any investigational or non-registered drug or vaccine other than the study
             vaccines within 30 days preceding the administration of study vaccines, or planned use
             during the study period.

          -  History of previous or intercurrent diphtheria, tetanus, pertussis, polio, measles,
             mumps, or rubella disease, or of vaccination against these diseases given after the
             second year of life.

          -  Known exposure to diphtheria, tetanus, pertussis, or polio, prior to vaccination.

          -  Poliovirus vaccination with one or more doses of OPV vaccine.

          -  Administration or planned administration of a vaccine not foreseen by the study
             protocol within 30 days of study vaccination and ending at Day 30.

          -  Chronic administration or administration of immunosuppressants or other immune
             modifying drugs within six months prior to study vaccination or planned administration
             during the study period ending at Day 30.

          -  Administration of immunoglobulins and/or any blood products within three months prior
             to study vaccination or planned administration during the study period ending at Day
             30.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus infection.

          -  History of seizures or progressive neurological disorder, including infantile spasms,
             uncontrolled epilepsy or progressive encephalopathy.

          -  Major congenital defects or serious chronic illness.

          -  Acute disease at the time of enrollment.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine(s), including allergic reactions to 2-phenoxyethanol, formaldehyde,
             neomycin, polymyxin B, streptomycin, gelatin, and/or latex.

          -  History of anaphylactic reaction to egg proteins or previous doses of the vaccine(s).

          -  Encephalopathy within 7 days of administration of previous dose of Infanrix.

          -  Fever ≥ 40.5°C or 104.9°F (rectal temperature) (39.5°C or 103.1°F, oral/axillary)
             within 48 hours of previous dose of Infanrix not due to another identifiable cause.

          -  Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of
             previous dose of Infanrix.

          -  Persistent, severe, inconsolable screaming or crying lasting ≥ 3 hours which occurred
             within 48 hours of administration of previous dose of Infanrix.

          -  Thrombocytopenia following a previous dose of M-M-RII or its component vaccines.

          -  Inability to contact a parent/guardian of the subject by telephone.

          -  Blood dyscrasias (including current thrombocytopenia), leukemia, lymphomas or other
             malignant neoplasms affecting the bone marrow or lymphatic systems.

          -  Family history of congenital or hereditary immunodeficiency, unless the immune
             competence of the subject was demonstrated.