Spanish Mixed HEXA/PENTA/HEXA Schedule (V419-010)

A Phase 3 Open-label Study to Evaluate the Immunogenicity and Safety of a Mixed (HEXA/PENTA/HEXA) Primary Series Schedule That Includes V419 (PR5I) at 2 and 6 Months of Age and Pediacel at 4 Months of Age.

To evaluate the immune response and the safety of a primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age

Primary objectives

• To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B (HB) one month after completion of the mixed schedule
• To demonstrate that the mixed schedule induces acceptable responses for Haemophilus influenzae type b (Hib) one month after completion of the mixed schedule

Secondary objectives

• To describe the antibody response to all PR5I antigens one month after completion of the mixed schedule
• To describe the antibody response to meningococcal serogroup C (MCC) conjugate vaccine one month after the second dose of MenC vaccine
• To describe the safety profile after each dose of study vaccines administered

Inclusion Criteria:

• Healthy infant 46 to 74 days (both inclusive)
• Documented receipt of only one dose of monovalent hepatitis B vaccine within the 3 days after birth
• Parent(s)/legal representative able to comply with the study procedures

Exclusion Criteria:

• Participation in any study with an investigational compound or device since birth
• History of congenital or acquired immunodeficiency
• Chronic illness that could interfere with study conduct or completion
• Hypersensitivity to any of the study vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines
• Contraindication to Pediacel®, NeisVac-C®, Prevenar 13®, and RotaTeq®
• History or maternal history of HBsAg seropositivity
• Coagulation disorder that contraindicate intramuscular injection
• History of vaccination with a Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acelullar or whole-cell), poliovirus, meningococcal serogroup C conjugate, pneumococcal conjugate containing vaccine(s)
• History of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, or serogroup C meningococcal infection
• Receipt of immune globulin, blood or blood-derived products since birth
• Receipt of systemic corticosteroids for more than 14 consecutive days within one month of the study start
• Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study