Bacterial Infections Clinical Trial
Official title:
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
n/a
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