At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra® and Meningococcal Group C Conjugate vaccine: MenC for Meningitis and Meningococcal Infection. Completed, enrolled 123 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
0.5 mL, Intramuscular
0.5 mL, Intramuscular