A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults
NCT ID: NCT00450437
Last Updated: 2015-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3539 participants
INTERVENTIONAL
2007-03-31
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Licensed Meningococcal Vaccine
Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine
Meningococcal ACWY Conjugate vaccine
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Novartis MenACWY Conjugate Vaccine
Novartis meningococcal ACWY conjugate Vaccine
MenACWY CRM
One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
Interventions
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MenACWY CRM
One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
Meningococcal ACWY Conjugate vaccine
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
* previous or suspected disease caused by N. meningitidis
* Any serious acute, chronic or progressive disease
* Pregnant or breastfeeding
11 Years
55 Years
ALL
No
Sponsors
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Novartis Vaccines
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Vaccines and Diagnostics
Role: STUDY_DIRECTOR
Novartis
Locations
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Bardstown, Kentucky, United States
Annapolis, Maryland, United States
Baltimore, Maryland, United States
Frederick, Maryland, United States
Boston, Massachusetts, United States
Fall River, Massachusetts, United States
Lebanon, New Hampshire, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
South Euclid, Ohio, United States
Carnegie, Pennsylvania, United States
Erie, Pennsylvania, United States
Greenville, Pennsylvania, United States
Grove City, Pennsylvania, United States
Harleyville, Pennsylvania, United States
Jefferson Borough, Pennsylvania, United States
Latrobe, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Birmingham, Alabama, United States
Tuscaloosa, Alabama, United States
Fremont, California, United States
Fresno, California, United States
Hayward, California, United States
Oakland, California, United States
Roseville, California, United States
Sacramento, California, United States
San Jose, California, United States
Denver, Colorado, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Woodstock, Georgia, United States
Chicago, Illinois, United States
Uniontown, Pennsylvania, United States
Upper Saint Clair, Pennsylvania, United States
Washington, Pennsylvania, United States
Wexford, Pennsylvania, United States
Galveston, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Countries
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References
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Jackson LA, Baxter R, Reisinger K, Karsten A, Shah J, Bedell L, Dull PM; V59P13 Study Group. Phase III comparison of an investigational quadrivalent meningococcal conjugate vaccine with the licensed meningococcal ACWY conjugate vaccine in adolescents. Clin Infect Dis. 2009 Jul 1;49(1):e1-10. doi: 10.1086/599117.
Reisinger KS, Baxter R, Block SL, Shah J, Bedell L, Dull PM. Quadrivalent meningococcal vaccination of adults: phase III comparison of an investigational conjugate vaccine, MenACWY-CRM, with the licensed vaccine, Menactra. Clin Vaccine Immunol. 2009 Dec;16(12):1810-5. doi: 10.1128/CVI.00207-09. Epub 2009 Oct 7.
Other Identifiers
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V59P13
Identifier Type: -
Identifier Source: org_study_id
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