Descriptive, Post-Marketing, Passive Surveillance Safety Study of Menactra Vaccine

This study is enrolling participants by invitation only.

First Received: November 15, 2005 Last Updated: February 12, 2008 History of Changes

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00254995

Purpose

To further characterize the vaccine safety profile and to identify any signals of potentially vaccine-related AEs not detected during pre-licensure studies.

Condition	Intervention	Phase
Meningitis	Biological: None administered in this study	Phase IV

Study Type:	Observational
Study Design:	Cohort
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 ™)

Resource links provided by NLM:

MedlinePlus related topics: Meningitis

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	20000
Study Start Date:	July 2005
Estimated Study Completion Date:	December 2008

Groups/Cohorts	Assigned Interventions
1	Biological: None administered in this study N/A in this study

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Past receipt of Menactra vaccine

Criteria

Inclusion Criteria:

Receipt of Menactra vaccine during the study period.

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254995

Locations

United States, California

Oakland, California, United States, 94612

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Clinical Trials

sanofi pasteur

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi Pasteur, Inc. ( Medical Monitor )
Study ID Numbers:	MTA30, MTA30
Study First Received:	November 15, 2005
Last Updated:	February 12, 2008
ClinicalTrials.gov Identifier:	NCT00254995 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Meningitis,
Meningococcal

Study placed in the following topic categories:

Central Nervous System Infections
Central Nervous System Diseases
Diphtheria
Meningitis

Additional relevant MeSH terms:

Central Nervous System Infections
Nervous System Diseases
Central Nervous System Diseases
Meningitis

ClinicalTrials.gov processed this record on September 02, 2009