Assessing the 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 - 19
Updated:9/26/2018
Start Date:December 1, 2014
End Date:June 11, 2015

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A Phase 2b, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of the 3rd Dose of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.

This is extension of the V102_16 study (NCT02140762). V102_16E1 is designed to assess the
effectiveness of a 3-dose vaccination series of MenABCWY, administered according to 0, 2, 6
month schedule, against the same panel of endemic US N. meningitidis serogroup B strains, as
measured by enc-hSBA assay. The subjects who completed the parent V102_16 study will be
invited at the time of their last study visit to participate in this extension study.


Inclusion Criteria:

- Adolescents who completed V102_16 study and received the study vaccines as assigned in
the protocol (either two doses of the MenABCWY or one dose each of MenACWY and
Placebo).

Exclusion Criteria:

- Serious, acute, or chronic illnesses. Previous or suspected disease caused by N.
meningitidis.

- History of any meningococcal vaccine administration other than vaccination given in
the parent V102_16 protocol.
We found this trial at
8
sites
Cleveland, Ohio 44195
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Cleveland, OH
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Huntsville, Alabama 35801
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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 40202
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Louisville, KY
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Melbourne, Florida 32935
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Melbourne, FL
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Newton, Kansas 67114
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Newton, KS
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Omaha, Nebraska 68131
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Omaha, NE
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Wichita, Kansas 67207
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from
Wichita, KS
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