Safety and Immune Response of Different Pediatric Combination Vaccines.

• Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. [ Time Frame: 30 Days post-dose 3 vaccination ] [ Designated as safety issue: No ]
  Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer > LLOQ; or a pre-dose 1 titer > LLOQ and post-dose 3 titer ≥ pre-dose 1 titer.
• Percentage of Participants With a Four-fold Rise in Pertusis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) [ Time Frame: 30 Days post-dose 3 vaccination ] [ Designated as safety issue: No ]
• Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. [ Time Frame: 30 Days post-dose 3 vaccination. ] [ Designated as safety issue: No ]

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®.

• Diphtheria
• Polio
• Pertussis

• Biological: DAPTACEL®. (DTaP), IPOL®., and ActHIB®.
  0.5 mL, Intramuscular
  Other Names:

  • DAPTACEL®
  • IPOL®
  • ActHIB®
• Biological: Pentacel®: DTaP-IPV/Hib combined
  0.5 mL, Intramuscular
  Other Name: Pentacel®
• Biological: DTaP-IPV and ActHIB®
  0.5 mL, Intramuscular
  Other Name: ActHIB®

• Experimental: Study Group 1: DAPTACEL®, ActHIB®, and IPOL®
  Participants will receive 3 doses of DAPTACEL®, ActHIB®, and IPOL® at Months 2, 4, and 6, respectively
  Intervention: Biological: DAPTACEL®. (DTaP), IPOL®., and ActHIB®.
• Experimental: Study Group 2: Pentacel®
  Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively
  Intervention: Biological: Pentacel®: DTaP-IPV/Hib combined
• Experimental: Study Group 3: DTaP-IPV and ActHIB®
  Participants will receive 3 doses of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively
  Intervention: Biological: DTaP-IPV and ActHIB®
• Experimental: Study Group 4: Pentacel®
  Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively
  Intervention: Biological: Pentacel®: DTaP-IPV/Hib combined

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.