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Study of Two Doses of Menactra® or One Dose of Monovalent Meningococcal Group C Vaccine With Routine Immunizations

Meningitis Clinical Trial

Official title:
Safety and Immunogenicity of Two Doses of Menactra® (Meningococcal [Groups A, C, Y, and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) or One Dose of Monovalent Meningococcal Group C Conjugate Vaccine Administered Concomitantly With Routine Immunizations Between 12 and 18 Months of Age in Canada

Clinical Trial Summary

The purpose for this study is to demonstrate the safety and immunogenicity of two doses of Menactra® administered between 12 and 18 months of age and concomitantly with routine immunization with two different provincial schedule

Primary Objectives:

- To describe the immunogenicity of Menactra® administered concomitantly with routine immunizations at 12 and 18 months in naïve or Menjugate-primed (MenC-primed) infants (measured by serum bactericidal assay using baby rabbit complement [SBA-BR])

- To describe the immunogenicity of MenC administered concomitantly with routine immunizations at 12 months of age (measured by SBA-BR)

Secondary Objectives:

Safety

- To describe the safety profile of Menactra® and MenC vaccines after each dose when given concomitantly with routine immunization.

Immunogenicity

- To describe the immunogenicity of both vaccines using serum bactericidal assay using human complement [SBA-HC]

- To describe the immunogenicity of Pediacel administered at 18 months.

Clinical Trial Description

Participants depending on their groups will receive either two doses of Menactra vaccine concomitantly with the routinely recommended vaccines or one dose of MenC vaccine concomitantly with the routinely recommended vaccines and will be monitored for safety and immunogenicity. The duration of each subject's participation in the trial will be approximately 7 months. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01359449
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date May 2011
Completion date November 2012
View Details
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