Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine
NCT ID: NCT00862277
Last Updated: 2016-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
763 participants
OBSERVATIONAL
2008-12-31
2009-12-31
Brief Summary
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Detailed Description
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No vaccine will be administered in this study.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Group 1: Menactra® from Previous Studies
Subjects previously received only one dose of meningococcal vaccine, Menactra® in Study MTA04, MTA12, MTA19, or MTA21.
Menactra®
0.5 mL, Intramuscular (from a previous study)
Group 2: Menomune® from Previous Study
Subjects previously received only one dose of meningococcal vaccine, Menomune® in Study MTA04
Menomune®
0.5 mL, Intramuscular (from a previous study)
Group 3: Control
Meningococcal vaccine-naive age matched subjects
No interventions assigned to this group
Interventions
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Menactra®
0.5 mL, Intramuscular (from a previous study)
Menomune®
0.5 mL, Intramuscular (from a previous study)
Eligibility Criteria
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Inclusion Criteria
* For subjects aged \< 18 years: Informed consent form signed and dated by the subject and the subject's parent/legal guardian
* Subject (and parent/legal guardian if subject is \< 18 years of age) able to attend the scheduled visit and comply with all trial procedures
* For Group 1: Previously received only one dose of meningococcal vaccine (Menactra®, received in Study MTA04, MTA12, MTA19, or MTA21)
* For Group 2: Previously received only one dose of meningococcal vaccine (Menomune®, received in Study MTA04)
* For Group 3: Aged 14 through 27 years and never received any meningococcal vaccine
Exclusion Criteria
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy \> 2 weeks
* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
* Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
* Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune responses
* Known Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C seropositivity
* History of invasive meningococcal disease (confirmed either clinically, serologically, or microbiologically)
* For Groups 1 and 2: Previous vaccination (including booster) against meningococcal disease, with the exception of the Menactra® or Menomune® vaccination received in trial MTA04, MTA12, MTA19, or MTA21
* Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
* Received oral or injected antibiotic therapy within the 72 hours prior to the blood draw (temporary criteria)
14 Years
27 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Little Rock, Arkansas, United States
Fountain Valley, California, United States
Marietta, Georgia, United States
Martinez, Georgia, United States
Woodstock, Georgia, United States
Bardstown, Kentucky, United States
Omaha, Nebraska, United States
Austintown, Ohio, United States
Cleveland, Ohio, United States
Erie, Pennsylvania, United States
Greenville, Pennsylvania, United States
Harleysville, Pennsylvania, United States
Latrobe, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Wexford, Pennsylvania, United States
Kingsport, Tennessee, United States
Spokane, Washington, United States
Spokane, Washington, United States
Countries
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Related Links
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Related Info
Other Identifiers
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MTA64
Identifier Type: -
Identifier Source: org_study_id
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