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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00254995
First received: November 15, 2005
Last updated: February 14, 2013
Last verified: February 2013

November 15, 2005
February 14, 2013
July 2005
May 2013   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00254995 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Descriptive, Post-marketing, Passive Surveillance Safety Study of Menactra Vaccine
Post-licensure Safety Surveillance Study of Routine Use of Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra ™)

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

Not Provided
Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample

Past receipt of Menactra vaccine

Meningitis
Biological: None administered in this study
N/A in this study
1
Intervention: Biological: None administered in this study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20000
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Receipt of Menactra vaccine during the study period.

Exclusion Criteria:

  • None
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00254995
MTA30, MTA30
No
Sanofi
Sanofi
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc.
Sanofi
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP