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

Sanofi Pasteur, a Sanofi Company · 2011
ClinicalTrials.gov · Datasets · License: Public Domain · 2011
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meningitis
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.
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