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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014