A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:10/14/2017
Start Date:March 2007
End Date:November 2009

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A Phase 3, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY
conjugate vaccine when administered with routine infant vaccinations to healthy infants.


Inclusion Criteria:

- Healthy term 2-month-old infants for whom a parent/legal representative has given
written informed consent.

Exclusion Criteria:

- Subjects with a previous or suspected disease caused by Neisseria meningitidis,
Corynebacterium diphtheriae, Clostridium tetani, Poliovirus, Hepatitis B, Haemophilus
influenzae type b (Hib), Pneumococcus or Bordetella pertussis; previous immunization
with a meningococcal vaccine or vaccine containing meningococcal antigen(s) or prior
vaccination with Diptheria, Tetanus, Pertussis (acellular or whole cell), inactivated
polio vaccineIPV or oral polio vaccineOPV, H. influenzae type b (Hib) or Pneumococcus;
who have had household contact with and/or intimate exposure to an individual with
laboratory confirmed N. meningitidis (serogroups A, C, W-135, or Y), B. pertussis,
Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth; Any
serious acute, chronic or progressive disease
We found this trial at
54
sites
Latrobe, Pennsylvania 15650
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1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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Akron, OH
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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1925 W. Mountain View Ave.
Longmont, Colorado 80501
303-776-8718
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Longmont, CO
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Alvear 1439 PB Dpto, rio IV, Cordoba, Cordoba
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Alvear 1439 PB Dpto, rio IV, Cordoba,
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200 Forbes Street
Annapolis, Maryland 21401
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Aurora, Colorado 80045
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Baltimore, Maryland 21201
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Baltimore, MD
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Bardstown, Kentucky 40004
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4000 Pine Lane Southeast
Bessemer, Alabama 35022
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Bessemer, AL
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Birmingham, Alabama 35235
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Birmingham, AL
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200 Riverhill Business Park
Birmingham, Alabama 35242
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Birmingham, AL
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Boardman, OH
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1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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Boston, MA
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813 Washington Avenue
Carnegie, Pennsylvania 15106
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Carnegie, PA
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Chicago, Illinois 60614
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Chicago, IL
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2054 South Green Road
Cleveland, Ohio 44118
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Cleveland, OH
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Dallas, Texas 75010
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Downey, California 90241
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Downey, CA
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Erie, Pennsylvania 16505
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Erie, PA
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851 Middle Street
Fall River, Massachusetts 02724
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1475 Taney Avenue
Frederick, Maryland 21702
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Frederick, MD
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110 North Main Street
Greenville, Pennsylvania 16125
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Greenville, PA
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Grove City, Pennsylvania 16127
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270 Main Street
Harleyville, Pennsylvania 19438
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Houston, Texas 77030
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Houston, TX
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Layton, Utah 84041
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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Madison, Tennessee 37115
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411 22nd Avenue
Monroe, Wisconsin 53566
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Monroe, WI
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160 West Germantown Pike
Norristown, Pennsylvania 19401
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Norristown, PA
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Oakland, California 94611
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2500 California Plaza
Omaha, Nebraska 68102
(402) 280-2700
Creighton University Creighton University, located in Omaha, Neb., offers a top-ranked education in the Jesuit...
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4825 Dodge Street
Omaha, Nebraska 68132
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716 West 800 North
Orem, Utah 84057
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Paramount, California 90723
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Paramount, CA
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6308 Forbes Avenue
Pittsburgh, Pennsylvania 15217
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Pittsburgh, Pennsylvania 15220
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Pittsburgh, Pennsylvania 15227
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1200 Brooks Lane
Pittsburgh, Pennsylvania 15236
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Pittsburgh, Pennsylvania 15241
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Pleasanton, California 94566
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Richmond, California 94801
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Richmond, CA
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1077 Rydal Road
Rydal, Pennsylvania 19046
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Rydal, PA
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Salt Lake City, Utah 84109
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San Francisco, California 94115
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Santa Clara, California 95051
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Santa Clara, CA
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Sellersville, Pennsylvania 18960
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South Jordan, Utah 84095
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Temple, Texas 76508
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Temple, TX
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1000 West Carson Street
Torrence, California 90502
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Uniontown, Pennsylvania 15401
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6000 Brooktree Road
Wexford, Pennsylvania 15090
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