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

Meningococcal Meningitis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00874549
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1/Phase 2
Start date October 2007
Completion date October 2008
View Details
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