Safety and Immune Response of Different Pediatric Combination Vaccines.
Condition: Diphtheria; Polio; Pertussis
MeSH terms: Whooping Cough; Diphtheria
Intervention: DAPTACEL®. (DTaP), IPOL®., and ActHIB®.; Pentacel®: DTaP-IPV/Hib combined; DTaP-IPV and ActHIB®; Pentacel®: DTaP-IPV/Hib combined
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2167.0
Sex: All
Minimum age: 42 Days
Maximum age: 89 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pertussis; Whooping cough; Filamentous Haemagglutinin; Fimbriae Types 2 and 3;; Pertactin; Diphtheria; Tetanus; Poliovirus Types 1, 2, and 3.

Summary:

      The overall aim of the study is to corroborate that a schedule consisting of 3 doses of
      Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of
      Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3
      doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus
      vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged ≥ 42 days and ≤ 89 days on the day of inclusion

          -  Born at full term of pregnancy (≥ 36 weeks)

          -  Informed consent form signed by the parent(s) or other legally authorized
             representative(s) before the 1st study related procedure

          -  Vaccination with a hepatitis B vaccine at least 30 days before inclusion

          -  Able to attend all scheduled visits and to comply with all trial procedures(i.e.,
             access to a phone)

          -  Provide blood sample prior to Dose 1

          -  Parent or legal representative willing to take rectal temperatures after each
             vaccination.

        Exclusion Criteria:

          -  Participation in another clinical trial in the 4 weeks preceding the (first)trial
             vaccination

          -  Planned participation in another clinical trial during the present trial period

          -  Personal or immediate family history of congenital or acquired immunodeficiency,
             immunosuppressive therapy such as long-term systemic corticosteroids therapy

          -  Known or suspected systemic hypersensitivity to any of the vaccine components or
             history of a life-threatening reaction to a vaccine containing the same substances as
             the trial vaccine(s)

          -  Chronic illness that could interfere with trial conduct or completion

          -  Received blood or blood-derived products since birth

          -  Any vaccination in the 2 weeks preceding the first trial vaccination or planned in the
             4 weeks after any trial vaccination. Flu vaccine could be administered only 2 weeks
             after any trial vaccination

          -  Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis-
             (DTwP) based combination vaccines, Haemophilus influenzae type b (Hib)-conjugate,
             poliovirus, or pneumococcal conjugate vaccines

          -  Coagulation disorder contraindicating intramuscular (IM) vaccination

          -  Clinically significant findings on review of systems (determined by investigator or
             sub-investigator to be sufficient for exclusion)

          -  Developmental delay or neurological disorder

          -  Any condition which, in the opinion of the investigator, would interfere with the
             evaluation of the vaccine or pose a health risk to the subject.