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
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      -  Investigational groups: 3, each receive one of 3 lots of DTaP-IPV vaccine.

        -  Control: US-licensed DTaP (Infanrix) + US-licensed IPV (IPOL) vaccines administered in
           separate injections.

        -  Two study visits one month apart for a subset of subjects (Safety and Immunogenicity
           subset) with a blood draw at each visit. All other subjects will have one visit.

        -  A telephone contact 4-6 days after vaccination for all subjects, a telephone contact
           31-38 days after vaccination for the Safety only subset and a telephone contact for all
           subjects during the extended safety follow-up phase (5 months following the active
           phase).
    

Intervention name(s): SB213503 lot 1; SB213503 lot 2; SB213503 lot 3; Infanrix; IPOL; M-M-R II
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 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.
Other intervention name(s): GSK Biologicals combined diphteria, tetanus, acellular pertussis and inactivated poliovirus lot 1 vaccine; GSK Biologicals combined diphteria, tetanus, acellular pertussis and inactivated poliovirus lot 2 vaccine; GSK Biologicals combined diphteria, tetanus, acellular pertussis and inactivated poliovirus lot 3 vaccine; GSK Biologicals combined diphteria, tetanus, acellular pertussis vaccine; Aventis Pasteur inactivated poliovirus vaccine; Merck and Company licensed combined measles-mumps-rubella vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention