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