Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:2 - 10
Updated:2/8/2019
Start Date:October 7, 2012
End Date:May 30, 2014

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A Phase 3b, Randomized, Observer-Blind, Placebo-Controlled Multi-Center Study Comparing Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine, Administered to Healthy Children 2 to 10 Years of Age.

This study was designed to conduct a comparative trial to further evaluate the safety,
immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine,
given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2
through 10 years of age.


Inclusion Criteria:

- Healthy children, 2 to 10 years of age who have up to date routine childhood
vaccination, according to U.S. ACIP recommendations

Exclusion Criteria:

1. Unwilling or unable to give written informed assent or consent to participate in the
study.

2. Perceived to be unreliable or unavailable for the duration of the study period.

3. Previous confirmed or suspected disease caused by N. meningitidis.

4. Previously immunized with a meningococcal vaccine (licensed or investigational).

5. Receipt of any investigational or non-registered product within 30 days prior to
enrolment or who expect to receive an investigational drug or vaccine prior to the
completion of the study.

6. Receipt or plan to receive any vaccines within 30 days before and after administration
of each dose of the study vaccine.

(certain exceptions influenza vaccines apply)

7. Significant acute infection within the 7 days prior to enrolment or body temperature
of 38°C or greater within 3 days prior to enrolment.

8. Previous serious acute, chronic or progressive disease, epilepsy or any progressive
neurological disease or history of Guillain-Barre syndrome.

9. History of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine
components

10. Impairment/alteration of immune function, either congenital or acquired or resulting
from (for example):

- receipt of immunosuppressive therapy,

- receipt of immunostimulants,

- receipt of parenteral immunoglobulin preparation, blood products, and/or plasma
derivatives.

11. Known bleeding diathesis, or any condition that may be associated with a prolonged
bleeding time.
We found this trial at
21
sites
Austin, Texas 78705
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Austin, TX
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Bellevue, Nebraska 68123
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Bellevue, NE
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Birmingham, Alabama 35249
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Birmingham, AL
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Cleveland, Ohio 44195
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Cleveland, OH
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Council Bluffs, Iowa 51503
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Council Bluffs, IA
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Fort Worth, Texas 76104
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Fort Worth, TX
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Fremont, Nebraska 68025
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Fremont, NE
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Johnson City, New York 13790
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Johnson City, NY
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Lake Mary, Florida 32736
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Lake Mary, FL
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Louisville, Kentucky 40202
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Louisville, KY
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Marietta, Georgia 30060
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Marietta, GA
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Metairie, Louisiana 70006
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Metairie, LA
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New Albany, Indiana 47150
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New Albany, IN
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Niles, Michigan 49120
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Niles, MI
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Omaha, Nebraska 68131
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Omaha, NE
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Sacramento, California 95815
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Sacramento, CA
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South Euclid, Ohio 44121
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South Euclid, OH
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Stevensville, Michigan 49127
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Stevensville, MI
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Vestal, New York 13850
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Vestal, NY
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West Jordan, Utah 84088
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West Jordan, UT
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Woodstock, Georgia 30189
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Woodstock, GA
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