Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:10 - 18
Updated:9/14/2018
Start Date:May 2014
End Date:February 2015

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A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.

Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single
dose of MenACWY vaccine.


Inclusion Criteria:

- Adolescents from 10-18 years of age, generally in good health, and available for all
study visits, who/whose legally acceptable representative has given written informed
consent at the time of enrollment.

- Female subjects of childbearing potential must have a negative urine pregnancy test.

Exclusion Criteria:

- Serious, acute, or chronic illnesses. Previous or suspected disease caused by N.
meningitidis. Previous immunization with any meningococcal vaccine.

- Exposure to individuals with clinically proven meningococcal disease or clinical
bacterial meningitis without further microbiologic characterization.
We found this trial at
8
sites
Melbourne, Florida 32935
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Melbourne, FL
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Wichita, KS
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Cleveland, Ohio 44221
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Cleveland, OH
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Huntsville, Alabama 35802
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Huntsville, AL
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Jonesboro, Arkansas 72401
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Jonesboro, AR
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Louisville, Kentucky 40291
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Louisville, KY
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Newton, Kansas 67114
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Newton, KS
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Omaha, Nebraska 68134
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Omaha, NE
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