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

NCT00874549 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2013-09-20

Study results available
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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

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

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
56 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-01-31
Completion
2008-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00874549 on ClinicalTrials.gov