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Sponsor: MCM Vaccines B.V.
Conditions: Neisseria Meningitidis, Bacterial Infections, Virus Diseases
Interventions: PR5I, Pediacel®, NeisVac-C®, RotaTeq®, Prevenar 13®
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
Sex: ALL
Age: 46 Days to 76 Days
Healthy volunteers: Yes
Study type: INTERVENTIONAL
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