A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants
NCT ID: NCT00474526
Last Updated: 2014-03-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
4545 participants
INTERVENTIONAL
2007-03-31
2009-11-30
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
NONE
Study Groups
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US1A (MenACWY-CRM + Infant Vaccines)
Received vaccines:
MenACWY: 2, 4, 6, and 12 months
DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months
Pneumococcal, HAV, and MMR-V: 12 months
Meningococcal ACWY Conjugate Vaccine
DTaP-IPV-HBV
Hib
Rotavirus
Pneumococcal 7-valent Conjugate Vaccine
HAV
MMR-V
US1B (MenACWY-CRM + Infant Vaccines)
Received vaccines:
MenACWY: 2, 4, 6, and 13 months
DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months
Pneumococcal, HAV, and MMR-V: 12 months
Meningococcal ACWY Conjugate Vaccine
DTaP-IPV-HBV
Hib
Rotavirus
Pneumococcal 7-valent Conjugate Vaccine
HAV
MMR-V
US2 (Infant Vaccines Only)
Received vaccines:
MenACWY: 12 and 15 months
DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months
Pneumococcal, HAV, and MMR-V: 12 months
Meningococcal ACWY Conjugate Vaccine
DTaP-IPV-HBV
Hib
Rotavirus
Pneumococcal 7-valent Conjugate Vaccine
HAV
MMR-V
US3 (MenACWY-CRM + Infant Vaccines)
Received vaccines:
MenACWY: 2, 4, 6, and 12 months
DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months
Pneumococcal, HAV, and MMR-V: 12 months
Meningococcal ACWY Conjugate Vaccine
DTaP-IPV-HBV
Hib
Rotavirus
Pneumococcal 7-valent Conjugate Vaccine
HAV
MMR-V
US4A (Infant Vaccines Only)
Received vaccines:
MenACWY: 12 and 15 months
DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months
Pneumococcal, HAV, and MMR-V: 12 months
Meningococcal ACWY Conjugate Vaccine
DTaP-IPV-HBV
Hib
Rotavirus
HAV
MMR-V
US4B (Infant Vaccines Only)
Received vaccines:
MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months
Pneumococcal, HAV, and MMR-V: 12 months
Meningococcal ACWY Conjugate Vaccine
DTaP-IPV-HBV
Hib
Rotavirus
Pneumococcal 7-valent Conjugate Vaccine
HAV
MMR-V
US4C (Infant Vaccines Only)
Received vaccines:
MenACWY: 18 months
DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months
Pneumococcal, HAV, and MMR-V: 12 months
Meningococcal ACWY Conjugate Vaccine
DTaP-IPV-HBV
Hib
Rotavirus
Pneumococcal 7-valent Conjugate Vaccine
HAV
MMR-V
LA1A (MenACWY-CRM + Infant Vaccines)
Received vaccines:
MenACWY: 2, 6, and 12 months
DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
Meningococcal ACWY Conjugate Vaccine
DTaP-IPV-HBV
Hib
Rotavirus
Pneumococcal 7-valent Conjugate Vaccine
HAV
MMR-V
LA1B (MenACWY-CRM + Infant Vaccines)
Received vaccines:
MenACWY: 2, 6, and 13 months
DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months
Pneumococcal, HAV, and MMR-V: 12 months
Meningococcal ACWY Conjugate Vaccine
DTaP-IPV-HBV
Hib
Rotavirus
Pneumococcal 7-valent Conjugate Vaccine
HAV
MMR-V
LA2 (Infant Vaccines Only)
Received vaccines:
MenACWY: 12 and 15 months
DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months
Pneumococcal, HAV, and MMR-V: 12 months
Meningococcal ACWY Conjugate Vaccine
DTaP-IPV-HBV
Hib
Rotavirus
Pneumococcal 7-valent Conjugate Vaccine
HAV
MMR-V
LA3A (MenACWY-CRM + Infant Vaccines)
Received vaccines:
MenACWY: 2, 4, 6, and 16 months
DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months
DTaP, Hib: 16 months
Pneumococcal, HAV, and MMR-V: 12 months
Meningococcal ACWY Conjugate Vaccine
DTaP-IPV-HBV
Hib
Rotavirus
Pneumococcal 7-valent Conjugate Vaccine
HAV
MMR-V
DTaP
LA3B (MenACWY-CRM + Infant Vaccines)
Received vaccines:
MenACWY: 2, 4, 6, and 17 months
DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months
DTaP, Hib: 16 months
Pneumococcal, HAV, and MMR-V: 12 months
Meningococcal ACWY Conjugate Vaccine
DTaP-IPV-HBV
Hib
Rotavirus
Pneumococcal 7-valent Conjugate Vaccine
HAV
MMR-V
DTaP
LA4 (Infant Vaccines Only)
Received vaccines:
MenACWY: 12 and 15 months
DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months
DTaP, Hib: 15 months
Pneumococcal, HAV, and MMR-V: 12 months
Meningococcal ACWY Conjugate Vaccine
DTaP-IPV-HBV
Hib
Rotavirus
Pneumococcal 7-valent Conjugate Vaccine
HAV
MMR-V
DTaP
LA5 (MenACWY-CRM + Infant Vaccines)
Received vaccines:
MenACWY: 2, 4, 6, and 12 months
DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months
Pneumococcal, HAV, and MMR-V: 12 months
Meningococcal ACWY Conjugate Vaccine
DTaP-IPV-HBV
Hib
Rotavirus
Pneumococcal 7-valent Conjugate Vaccine
HAV
MMR-V
LA6A (Infant Vaccines Only)
Received vaccines:
MenACWY: 12, and 15 months
DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months
Pneumococcal, HAV, and MMR-V: 12 months
Meningococcal ACWY Conjugate Vaccine
DTaP-IPV-HBV
Hib
Rotavirus
Pneumococcal 7-valent Conjugate Vaccine
HAV
MMR-V
LA6B (Infant Vaccines Only)
Received vaccines:
MenACWY: 13 and 15 months
DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months
Pneumococcal, HAV, and MMR-V: 12 months
Meningococcal ACWY Conjugate Vaccine
DTaP-IPV-HBV
Hib
Rotavirus
Pneumococcal 7-valent Conjugate Vaccine
HAV
MMR-V
LA6C (Infant Vaccines Only)
Received vaccines:
MenACWY: 18 months
DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months
Pneumococcal, HAV, and MMR-V: 12 months
Meningococcal ACWY Conjugate Vaccine
DTaP-IPV-HBV
Hib
Rotavirus
Pneumococcal 7-valent Conjugate Vaccine
HAV
Interventions
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Meningococcal ACWY Conjugate Vaccine
DTaP-IPV-HBV
Hib
Rotavirus
Pneumococcal 7-valent Conjugate Vaccine
HAV
MMR-V
DTaP
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2 Months
2 Months
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis - Vaccines
Role: STUDY_CHAIR
Novartis Vaccines & Diagnostics
Locations
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Growing Up Pediatrics
Bessemer, Alabama, United States
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Growing Up Pediatrics
Birmingham, Alabama, United States
Premier Health Research Center, LLC
Downey, California, United States
Kaiser Permanente Oakland
Oakland, California, United States
Kaiser Permanente Med Group - Vaccine Study Ctr
Oakland, California, United States
Center for Clinical Trials, LLC
Paramount, California, United States
Kaiser Permanente Pleasanton
Pleasanton, California, United States
Kaiser Permanente Richmond
Richmond, California, United States
Kaiser Permanente San Francisco
San Francisco, California, United States
Kaiser Permanente Santa Clara
Santa Clara, California, United States
UCLA Center for Vaccine Research
Torrence, California, United States
The Children's Hospital
Aurora, Colorado, United States
Longmont Medical Research Network
Longmont, Colorado, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Kentucky Pediatric/Adult Research Inc.
Bardstown, Kentucky, United States
Annapolis Pediatrics
Annapolis, Maryland, United States
Center for Vaccine Development
Baltimore, Maryland, United States
The Pediatric Center
Frederick, Maryland, United States
Boston University Medical Center
Boston, Massachusetts, United States
Pediatric Associates of Fall River
Fall River, Massachusetts, United States
Creighton University
Omaha, Nebraska, United States
Children's Physicians Dundee
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Montefiore Medical Center
The Bronx, New York, United States
Akron Children's Hospital
Akron, Ohio, United States
Louis P. Brine, Jr., MD, Beeghley Medical Park
Boardman, Ohio, United States
Senders Pediatric Research at Dr. Senders and Associates
Cleveland, Ohio, United States
Carnegie Pediatrics
Carnegie, Pennsylvania, United States
Children's Health Care - West
Erie, Pennsylvania, United States
UPMC/Community Medicine, Inc.
Greenville, Pennsylvania, United States
Family Healthcare Partners
Grove City, Pennsylvania, United States
Pennridge Pediatric Associates
Harleyville, Pennsylvania, United States
Pediatric Associates of Latrobe
Latrobe, Pennsylvania, United States
Pediatric Medical Associates
Norristown, Pennsylvania, United States
Squirrel Hill Office
Pittsburgh, Pennsylvania, United States
Pediatric Alliance, Greentree Division
Pittsburgh, Pennsylvania, United States
South Hills Pediatrics
Pittsburgh, Pennsylvania, United States
Pediatric Alliance, Southwestern
Pittsburgh, Pennsylvania, United States
Primary Physicians Research, Inc
Pittsburgh, Pennsylvania, United States
Pediatrics Medical Associates
Rydal, Pennsylvania, United States
Pennridge Pediatric Associates
Sellersville, Pennsylvania, United States
Laurel Pediatrics
Uniontown, Pennsylvania, United States
CCP - Pittsburgh Pediatrics
Wexford, Pennsylvania, United States
Goodlettsville Pediatrics
Madison, Tennessee, United States
Research Across America
Dallas, Texas, United States
Mercury Pharma Services
Houston, Texas, United States
Scott and White Hospital
Temple, Texas, United States
Wee Care Pediatrics
Layton, Utah, United States
Utah Valley Pediatrics - Timpanogos
Orem, Utah, United States
Foothill Family Clinic
Salt Lake City, Utah, United States
Copperview Medical Center
South Jordan, Utah, United States
Monroe Medical Foundation
Monroe, Wisconsin, United States
CEDEPAP Rio IV
Alvear 1439 PB Dpto, Rio IV, Cordoba, Córdoba Province, Argentina
Hospitales Materno Neonatal,
Castro Barros 650 - Barrio San Martin, Cordoba, Córdoba Province, Argentina
CdePAP, Centro De Desarrollo De Proyectos Avanzados Roma 1465,
Córdoba, Córdoba Province, Argentina
Hospital Regional Luis Pasteur,
Mendoza N°2152, Villa Maria, Cordoba,, Córdoba Province, Argentina
Buenos Aires, Argentina
Buenos Aires, , Argentina
Centro Estudios Infect
Scalabrini Ortiz 676, Buenos Aires, Buenos Aires,, , Argentina
Siloe
Calle 1 #50-51, Cali, Colombia
Comfenalco
Calle 6#5-42, Cali, Colombia
Hospital C H Trujillo
Calle 72U 28 F-00, Cali, Colombia
Corporation Cientifica
Ped Calle 5B5 No.37 Bis-28, Cali, Colombia
Countries
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References
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Klein NP, Reisinger KS, Johnston W, Odrljin T, Gill CJ, Bedell L, Dull P. Safety and immunogenicity of a novel quadrivalent meningococcal CRM-conjugate vaccine given concomitantly with routine vaccinations in infants. Pediatr Infect Dis J. 2012 Jan;31(1):64-71. doi: 10.1097/INF.0b013e31823dce5c.
Other Identifiers
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V59P14
Identifier Type: -
Identifier Source: org_study_id
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