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

This study is ongoing, but not recruiting participants.

First Received on May 7, 2008. Last Updated on March 27, 2012 History of Changes

Sponsor:	Sanofi-Aventis
Information provided by (Responsible Party):	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00728260

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:

MedlinePlus related topics: Diphtheria Meningitis

Drug Information available for: Diphtheria vaccine Meningococcal Vaccines

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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:	November 2012
Primary Completion Date:	October 2010 (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

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:

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-Aventis

Investigators

Study Director:

Medical Monitor

Sanofi pasteur Inc.

More Information

No publications provided

Responsible Party:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00728260 History of Changes
Other Study ID Numbers:	MTA38
Study First Received:	May 7, 2008
Last Updated:	March 27, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

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 23, 2012