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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
NCT00728260 |
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Date of registration:
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07/05/2008 |
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Primary sponsor: |
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Public title:
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36-Month Post Marketing Surveillance and Analysis of Menactra in 2-10 Year Olds
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Scientific title:
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Post-licensure Safety Surveillance Study of Routine Use of Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Recipients 2 to 10 Years of Age. |
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Date of first enrolment:
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July 2008 |
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Target sample size:
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1906 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00728260 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi pasteur Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 2-10 years of age inclusive at the time of receipt of Menactra vaccine during the
study period.
Exclusion Criteria:
- None.
Age minimum:
2 Years
Age maximum:
10 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Meningitis
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Meningococcemia
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Intervention(s)
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Biological: Meningococcal polysaccharide diphtheria toxoid conjugate
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Primary Outcome(s)
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To describe and characterize safety-related events occurring after vaccination with the Menactra vaccine.
[Time Frame: 0-30 and 31-60 days post-vaccination and entire study duration]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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