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

This study is currently recruiting participants.

Verified by Sanofi-Aventis, January 2009

Sponsored by:	Sanofi-Aventis
Information provided by:	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

MedlinePlus related topics: Meningitis

Drug Information available for: Meningococcal Vaccines

Study Type:	Observational
Study Design:	Case-Only, Prospective

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	20000
Study Start Date:	July 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Vaccination according to routine clinical practice. (IM)	Biological: Meningococcal polysaccharide diphtheria toxoid conjugate 0.5 mL, IM

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

Contacts

Contact: Public Registry Sanofi Pasteur

Locations

United States, California
	Recruiting
Oakland, California, United States, 94612

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Monitor

Sanofi pasteur Inc.

More Information

Responsible Party:	Sanofi Pasteur, Inc. ( Medical Director )
Study ID Numbers:	MTA38
Study First Received:	May 7, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00728260
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Meningitis
Meningococcemia
Neisseria meningitidis

Study placed in the following topic categories:

Meningococcemia
Central Nervous System Infections
Central Nervous System Diseases
Neisseria meningitidis
Meningitis

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 13, 2009