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36-Month Post Marketing Surveillance and Analysis of Menactra in 2-10 Year Olds

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00728260
First received: May 7, 2008
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

To describe and characterize safety-related events occurring after vaccination with the Menactra vaccine.


Condition Intervention
Meningitis
Meningococcemia
 Biological: Meningococcal polysaccharide diphtheria toxoid conjugate

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-licensure Safety Surveillance Study of Routine Use of Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Recipients 2 to 10 Years of Age.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To describe and characterize safety-related events occurring after vaccination with the Menactra vaccine. [ Time Frame: 0-30 and 31-60 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]

Enrollment: 1906
Study Start Date: July 2008
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Study Group
Vaccination according to routine clinical practice. (IM)
 Biological: Meningococcal polysaccharide diphtheria toxoid conjugate
0.5 mL, IM
Other Name: Menactra®

  Eligibility

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

2-10 years of age at the time of vaccination

Criteria

Inclusion Criteria:

  • 2-10 years of age inclusive at the time of receipt of Menactra vaccine during the study period.

Exclusion Criteria:

  • None.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728260

Locations
United States, California
Oakland, California, United States, 94612
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi pasteur Inc.
  More Information

No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00728260     History of Changes
Other Study ID Numbers: MTA38
Study First Received: May 7, 2008
Last Updated: April 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Meningitis
Meningococcemia
Neisseria meningitidis

Additional relevant MeSH terms:
Meningitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013