NCT00874549

Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines in Subjects ≥ 56 Years

A Safety and Immunogenicity Evaluation of a Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) and a Meningococcal Polysaccharide Vaccine Groups A, C, Y, and W-135 Combined (Menomune® - A/C/Y/W-135) in Subjects 56 Years of Age or Older

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 56 Years
• Healthy volunteers: Accepted

Summary

Safety: To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination with either Menactra® vaccine or Menomune® vaccine. Immunogenicity: To evaluate the immune response to serogroups A, C, Y, and W-135 in each of the four study groups.

Conditions

• Meningococcal Infections
• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide	0.5 mL, Subcutaneous
BIOLOGICAL	Menactra®: Polysaccharide Diphtheria Toxoid Conjugate	0.5 mL, Intramuscular
BIOLOGICAL	Menactra®: Polysaccharide Diphtheria Toxoid Conjugate	0.5 mL. Intramuscular
BIOLOGICAL	Menactra®: Polysaccharide Diphtheria Toxoid Conjugate	0.5 mL, Intramuscular

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-01-01
• Completion: 2008-10-01
• First posted: 2009-04-02
• Last updated: 2013-09-20
• Results posted: 2010-03-25

Locations

6 sites across 1 country: United States