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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00254995 |
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 ™) |
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
|
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Past receipt of Menactra vaccine
Inclusion Criteria:
Exclusion Criteria:
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 |
Health Authority: | United States: Food and Drug Administration |
Meningitis, Meningococcal |
Central Nervous System Infections Central Nervous System Diseases Diphtheria Meningitis |
Nervous System Diseases |