NCT01732627

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

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered in Subjects 56 Years of Age and Older

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 56 Years
• Healthy volunteers: Accepted

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.

Detailed description

All participants received a single dose of their assigned vaccine on Day 0. They were assessed for immunogenicity on Day 0 and Day 30, and monitored for safety throughout the study.

Conditions

• Meningitis
• Meningococcal Meningitis
• Meningococcal Infections
• Invasive Meningococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine	0.5 milliliter (mL), Intramuscular (IM)
BIOLOGICAL	Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 Combined	0.5 mL, Subcutaneous (SC)

Timeline

• Start date: 2012-11-12
• Primary completion: 2013-01-17
• Completion: 2013-01-17
• First posted: 2012-11-26
• Last updated: 2022-04-04
• Results posted: 2020-06-09

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study