drugset / Trial / NCT01732627

Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older

NCT01732627

Phase 2 Completed 301 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupOpen-labelPrevention

Summary

Primary objectives: * To describe the antibody responses to meningococcal serogroups A, C, Y, and W 135, measured by serum bactericidal assay using human complement (hSBA) and baby rabbit complement (rSBA), induced by a single dose of Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein (MenACYW) Conjugate vaccine or Menomune® - A/C/Y/W 135. * To describe the safety profile of a single dose of MenACYW Conjugate vaccine or Menomune® - A/C/Y/W 135.

Timeline

Start
2012-11-12
Primary completion
2013-01-17
Completion
2013-01-17

Drugs

EvaluationDrugModalityDoseRoute
Comparator MPSV4 Vaccine 0.5 ml Subcutaneous
Subject MenACYW-TT Vaccine 0.5 ml Intramuscular