Trial to Assess Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:10 - 18
Updated:4/21/2016
Start Date:August 2014
End Date:March 2016

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A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine Administered at Different Schedules Compared to Novartis Meningococcal Group B Vaccine, in Healthy Adolescents

The main purposes for conducting the study are firstly to assess immunological
non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to
healthy adolescents 10 to 18 years of age, to those of the licensed rMenB+OMV vaccine
(Bexsero™) in terms of hSBA GMTs at one month after the second vaccination, secondly to give
the flexibility for the national vaccination program by showing the safety and
immunogenicity of MenABCWY administrated according to four different vaccination schedules
and additionally to evaluate a potential benefit of the 3-dose vaccination series.


Inclusion Criteria:

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

2. Individuals of who the investigator believes can and will comply with the
requirements of the protocol (e.g. use of an eDiary, return for follow-up visits,
available for phone contacts).

3. Female subjects of childbearing potential must have a negative urine preganancy test.

Exclusion Criteria:

1. Serious, acute, or chronic illness. Previous or suspected disease caused by N.
meningitidis. Previous immunization with any menincococcal or Hepatitis A vaccines.

2. Exposure to individuals with clicically proven meningococcal disease or clinical
bacterial meningitis without further microbiologic characteriszation.
We found this trial at
17
sites
Omaha, Nebraska 68144
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Omaha, NE
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Augusta, Kansas 67010
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Augusta, KS
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Bellevue, Nebraska 68123
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Bellevue, NE
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Binghamton, New York 13901
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Binghamton, NY
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Charleston, South Carolina 29407
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Charleston, SC
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Cleveland, Ohio 44109
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Cleveland, OH
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Dayton, Ohio 45402
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Dayton, OH
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Espoo,
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Hialeah, Florida 33012
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Hialeah, FL
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Jonesboro, Arkansas 72401
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Jonesboro, AR
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Melbourne, Florida 32901
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Melbourne, FL
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Miami, Florida 33136
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Miami, FL
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Mt Pleasant, South Carolina 29464
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Mt Pleasant, SC
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Niles, Michigan 49120
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Niles, MI
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Raleigh, North Carolina 27609
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Raleigh, NC
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Saint Paul, Minnesota 55102
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Saint Paul, MN
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Spokane, Washington 99202
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Spokane, WA
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