Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
NCT ID: NCT00616421
Last Updated: 2016-02-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2907 participants
INTERVENTIONAL
2008-03-31
2009-10-31
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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MenACWY-CRM (1 dose)
1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study day 1.
MenACWY-CRM
1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly
Licensed polysaccharide vaccine
1 injection of a licensed meningococcal MenACWY polysaccharide-protein conjugate vaccine administered by intramuscular (IM) injection on study day 1
Licensed meningococcal ACWY vaccine
1 injection of the licensed meningococcal ACWY was administered intramuscularly
MenACWY-CRM (2 doses)
2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study days 1 and 61.
MenACWY-CRM
2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age
Interventions
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MenACWY-CRM
1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly
MenACWY-CRM
2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age
Licensed meningococcal ACWY vaccine
1 injection of the licensed meningococcal ACWY was administered intramuscularly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* who are available for all visits and telephone calls scheduled for the study
* who are up-to-date with age-appropriate routine childhood vaccinations
Exclusion Criteria
* who had a previous or suspected disease caused by N. meningitidis;
* who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
* who have received any investigational agents or vaccines within 90 days prior to enrollment
* who have any serious acute, chronic or progressive disease
* who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome
* who have a history of anaphylaxis, serious vaccine reactions
* who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from
* who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
* who have Down's syndrome or other known cytogenic disorders
2 Years
10 Years
ALL
Yes
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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Children's Investigational Reserach Program
Bentonville, Arkansas, United States
Arkansas Pediatric Research Group
Little Rock, Arkansas, United States
Premier Health Research Center
Downey, California, United States
Kaiser Permanente - Fremont
Fremont, California, United States
Kaiser Permanente - Fresno
Fresno, California, United States
Kaiser Permanente - Hayward
Hayward, California, United States
Kaiser Permanente - Oakland
Oakland, California, United States
Kaiser Permanente - Pleasanton
Pleasanton, California, United States
Kaiser Permanente - San Francisco
San Francisco, California, United States
Kaiser Permanente - San Jose
San Jose, California, United States
Kaiser Permanente - Aurora
Aurora, Colorado, United States
1st Allergy & Clinical Research
Centennial, Colorado, United States
Longmont Medical Research Network
Longmont, Colorado, United States
1st Allergy & Clinical Research
Thornton, Colorado, United States
Kaiser Permanente - Westminister
Westminister, Colorado, United States
Kentucky Pediatric Research Center
Bardstown, Kentucky, United States
Physicians to Children & Adolescents
Springfield, Kentucky, United States
Benchmark Research
Metairie, Louisiana, United States
St. Louis University School of Medicine
St Louis, Missouri, United States
Meridian Clinical Research LLC
Omaha, Nebraska, United States
Legacy Pediatrics
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Durham Pediatrics
Durham, North Carolina, United States
Regional Pediatric Associates PA
Durham, North Carolina, United States
Odyssey Research
Fargo, North Dakota, United States
Dr. Senders and Associates
Cleveland, Ohio, United States
Calcagno Research & Development
Gresham, Oregon, United States
Children's Health Care - West
Erie, Pennsylvania, United States
University Of Pittsburgh Medical Center
Greenville, Pennsylvania, United States
Family Healthcare Partners
Grove City, Pennsylvania, United States
Pediatric Associates of Latrobe
Latrobe, Pennsylvania, United States
Pediatric Alliance PC
Pittsburgh, Pennsylvania, United States
Pediatric Alliance PC
Pittsburgh, Pennsylvania, United States
South Hills Pediatrics
Pittsburgh, Pennsylvania, United States
Pediatric Alliance PC
Pittsburgh, Pennsylvania, United States
Primary Physicians Research Inc.
Pittsburgh, Pennsylvania, United States
Primary Physicians Research Inc.
Pittsburgh, Pennsylvania, United States
Laurel Pediatrics
Uniontown, Pennsylvania, United States
Family Practice Medical Associates South
Upper Saint Clair, Pennsylvania, United States
Children's Community Pediatrics
Wexford, Pennsylvania, United States
Jackson Clinic Professional Association
Jackson, Tennessee, United States
Benchmark Research Ft. Worth
Fort Worth, Texas, United States
Benchmark Research San Angelo
San Angelo, Texas, United States
Jean Brown Research
Clinton, Utah, United States
Wee Care Pediatrics
Layton, Utah, United States
Cottonwood Pediatrics
Murray, Utah, United States
J. Lewis Research Inc.
Salt Lake City, Utah, United States
J. Lewis Research Inc.
Salt Lake City, Utah, United States
Jean Brown Research
Salt Lake City, Utah, United States
Copperview Medical Center
South Jordan, Utah, United States
Rockwood Clinic
Spokane, Washington, United States
Rockwood Clinic North
Spokane, Washington, United States
TASC Research Services Inc.
Surrey, British Columbia, Canada
Manitoba Clinic
Winnipeg, Manitoba, Canada
Clinical Trials Research Center
Halifax, Nova Scotia, Canada
Colchester Regional Hospital
Truro, Nova Scotia, Canada
Albion Finch Medical Centre
Etobicoke, Ontario, Canada
Medicor Research Inc.
Greater Sudbury, Ontario, Canada
Children's Hospital of Western Ontario
London, Ontario, Canada
SKDS Research In.
Newmarket, Ontario, Canada
Herridge Community Health Clinic
Ottawa, Ontario, Canada
Sarnia Institute of Clinical Research
Sarnia, Ontario, Canada
Resolve Research Solutions
Toronto, Ontario, Canada
Resolve Research Solutions
Toronto, Ontario, Canada
Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Commonwealth Medical Clinic
Mount Pearl, , Canada
White Hills Medical Clinic
St. John's, , Canada
Countries
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References
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Halperin SA, Gupta A, Jeanfreau R, Klein NP, Reisinger K, Walter E, Bedell L, Gill C, Dull PM. Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Vaccine. 2010 Nov 23;28(50):7865-72. doi: 10.1016/j.vaccine.2010.09.092. Epub 2010 Oct 29.
Other Identifiers
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11278
Identifier Type: -
Identifier Source: secondary_id
V59P20
Identifier Type: -
Identifier Source: org_study_id
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