Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:2 - 10
Updated:4/21/2016
Start Date:March 2008
End Date:October 2009

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A Phase 3, Randomized, Observer-blind, Multi-Center Study to Compare the Safety and Immunogenicity of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Conjugate Vaccine Administered to Healthy Children 2-10 Years of Age

To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given
to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein
conjugate vaccine.


Inclusion Criteria:

- healthy 2-10 years of age children, inclusive and for whom, after the nature of the
study has been explained, the parent or legal guardian has provided written informed
consent

- 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:

- whose parent or legal guardian is unwilling or unable to give written informed
consent

- 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
We found this trial at
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1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
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1925 W. Mountain View Ave.
Longmont, Colorado 80501
303-776-8718
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3191 South 3300 East
Salt Lake City, Utah 84109
801-487-2072
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Aurora, Colorado 80012
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Bardstown, Kentucky 40004
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Bentonville, Arkansas 72712
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Centennial, Colorado 80112
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Cleveland, Ohio 44121
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Clinton, Utah 84015
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Downey, California 90241
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, North Carolina 27704
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Durham, North Carolina 27704
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Erie, Pennsylvania 16505
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Fargo, North Dakota 58103
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Fort Worth, Texas 76135
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39400 Paseo Padre Parkway
Fremont, California 94538
(510) 248-3000
Kaiser Permanente - Fremont You can rely on Kaiser Permanente for quality care, delivered with...
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Fresno, California 93720
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Greenville, Pennsylvania 16125
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Gresham, Oregon 97030
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Grove City, Pennsylvania 16127
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Hayward, California 94545
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Jackson, Tennessee 38305
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Latrobe, Pennsylvania 15650
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Layton, Utah 84041
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Little Rock, Arkansas 72205
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Metairie, Louisiana 70006
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Murray, Utah 84107
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Oakland, California 94611
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Omaha, Nebraska 68134
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Pittsburg, Pennsylvania 15241
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Pittsburgh, Pennsylvania 15218
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Pittsburgh, Pennsylvania 15227
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Pittsburgh, Pennsylvania 15241
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Pleasanton, California 94566
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Rochester, New York 14618
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San Angelo, Texas 76904
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San Francisco, California 94115
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San Jose, California 94538
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South Jordan, Utah 84095
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Spokane, Washington 99204
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Spokane, Washington 99218
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Springfield, Kentucky 40004
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St. Louis, Missouri 63117
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Surrey, British Columbia
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Thornton, Colorado 80233
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Uniontown, Pennsylvania 15401
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Upper St. Clair, Pennsylvania 15241
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Westminister, Colorado 80234
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Wexford, Pennsylvania 15090
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