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
  Purpose

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.


Condition Intervention Phase
Meningitis
Biological: None administered in this study
Phase 4

Study Type: Observational
Study Design: Observational Model: 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:


Further study details as provided by Sanofi:

Estimated Enrollment: 20000
Study Start Date: July 2005
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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
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: NCT00254995

Locations
United States, California
Oakland, California, United States, 94612
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00254995     History of Changes
Other Study ID Numbers: MTA30, MTA30
Study First Received: November 15, 2005
Last Updated: February 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Meningitis,
Meningococcal

Additional relevant MeSH terms:
Meningitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 16, 2014