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

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01839188
Study type	Interventional
Source	MCM Vaccines B.V.
Contact
Status	Completed
Phase	Phase 3
Start date	May 1, 2013
Completion date	March 19, 2014

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