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
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 April 16, 2014