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NCT00874549 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Meningococcal Infections and Meningococcal Meningitis, sponsored by Sanofi Pasteur, a Sanofi Company.

Completed
Registry status
Phase 1
Development phase
216
Enrollment target
6
Study locations

NCT00874549: Completed Phase 1 study of Meningococcal Infections and Meningococcal Meningitis, sponsored by Sanofi Pasteur, a Sanofi Company.

NCT00874549 is a Phase 1 study of Meningococcal Infections and Meningococcal Meningitis that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 216 participants, below the 767-participant average among 4 other Meningococcal Infections trials with a reported enrollment target (72% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00874549, a Phase 1 study of Meningococcal Infections and Meningococcal Meningitis, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.

COMPLETED
Registry status
Phase 1
Development phase
216 participants
Enrollment target
6
Study locations

Study 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.

Primary Outcome

Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.

Interventions

  • BIOLOGICAL Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide
  • BIOLOGICAL Menactra®: Polysaccharide Diphtheria Toxoid Conjugate

Study Locations (6)

Washington

  • - Seattle
  • - Spokane

Arizona

  • - Scottsdale

Kentucky

  • - Bardstown

New Mexico

  • - Albuquerque

Utah

  • - West Jordon

Trial Details

FieldValue
Enrollment Target 216 participants
Start Date 2007-10
Est. Completion 2008-10
Phase Phase 1
Sanofi Pasteur, a Sanofi Company

153 total trials

What the finished NCT00874549 record still lists

NCT00874549 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, below the 767-participant average among 4 other Meningococcal Infections trials with a reported enrollment target (72% lower).

The record links to 2 conditions, with Meningococcal Infections appearing as the primary indexed condition, and to 2 interventions - of which Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide is the first listed.

NCT00874549 lists 6 locations in 5 states (Washington, Arizona, Kentucky).

Frequently Asked Questions

What is clinical trial NCT00874549 about?

NCT00874549 is a clinical study titled "Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines in Subjects ≥ 56 Years". 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...

What is the current status of trial NCT00874549?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 216 participants. The study started on 2007-10. Estimated completion is 2008-10.

What conditions does trial NCT00874549 study?

This clinical trial studies the following conditions: Meningococcal Infections, Meningococcal Meningitis.

What interventions are being tested in trial NCT00874549?

The interventions under investigation include: Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide (BIOLOGICAL), Menactra®: Polysaccharide Diphtheria Toxoid Conjugate (BIOLOGICAL).

Who is sponsoring clinical trial NCT00874549?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00874549 being conducted?

This trial has 6 study locations across Arizona, Kentucky, New Mexico, Utah, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00874549, the US trial registry maintained by the National Library of Medicine. NCT00874549 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.