A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.



Status:Recruiting
Conditions:Vaccines
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:10 - 25
Updated:9/9/2018
Start Date:April 24, 2017
End Date:January 18, 2023
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A Phase 3, Randomized, Active-controlled, Observer-blinded Study To Assess The Immunogenicity, Safety, And Tolerability Of Bivalent Rlp2086 When Administered As A 2-dose Regimen And A First-in-human Study To Describe The Immunogenicity, Safety, And Tolerability Of A Bivalent Rlp2086-Containing Pentavalent Vaccine (Menabcwy) In Healthy Subjects>=10 To <26 Years Of Age

This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a
0-,6- month schedule. This trial is also studyng safety and immunogenicity of a meningococcal
pentavalent vaccine.


Inclusion Criteria:

- Male or female subject aged >=10 and <26 years at the time of enrollment.

- Healthy subject as determined by medical history, physical examination, and judgment
of the investigator.

- Negative urine pregnancy test for all female subjects.

- Subjects who have not received, or who have received no more than 1 prior dose within
the past 4 years, of a vaccine containing 1 or more ACWY serogroup

Exclusion Criteria:

- Previous vaccination with any meningococcal serogroup B or purely polysaccaride
(nonconjugate) meningococcal vaccine.

- Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving
allergen immunotherapy with a licensed product and are not on stable maintenance
doses.

- A known or suspected defect of the immune system that would prevent an immune response
to the vaccine, such as subjects with congenital or acquired defects in B cell
function, those receiving chronic systemic (oral, intravenous, or intramuscular)
corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the
United States with terminal complement deficiency are excluded from participation in
this study.

- Significant neurological disorder or history of seizure (excluding simple febrile
seizure).

- Current chronic use of systemic antibiotics.

- Received any investigational vaccines, drugs, or devices within 28 days before
administration of the first study vaccination.

- Any neuroinflammatory or autoimmune condition, including, but not limited to,
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
We found this trial at
53
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Harrisburg, Arkansas 72432
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Austin, Texas
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Bardstown, Kentucky 40004
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Binghamton, New York 13901
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52 Medical Plaza Drive
Birmingham, Alabama 35205
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Bristol, Tennessee 37620
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Burke, Virginia 22015
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198 Rutledge Avenue
Charleston, South Carolina 29403
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Charlottesville, Virginia 22902
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Cincinnati, Ohio 45219
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Cleveland, Ohio 44122
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Columbus, Ohio 43213
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Dakota Dunes, South Dakota 57049
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Dayton, OH
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Endwell, New York 13760
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Erie, Pennsylvania 16508
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Fort Worth, Texas 76104
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Fort Worth, Texas 76104
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Fort Worth, Texas 76135
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4625 Boat Club Road
Fort Worth, Texas 76135
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Fountain Hills, AZ
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Haughton, Louisiana 71037
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Huntsville, Alabama 35802
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Jindrichuv Hradec,
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Jupiter, Florida 33458
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Kingsport, Tennessee 37660
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Melbourne, Florida 32934
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Mount Pleasant, South Carolina 29464
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Mount Pleasant, South Carolina 29464
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Nashville, Tennessee 37203
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Newton, Kansas 67114
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Norfolk, Nebraska 68701
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Omaha, Nebraska 68134
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Peoria, Illinois 64614
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Plano, Texas 75093
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Raleigh, North Carolina 27609
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Rochester, New York 14609
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San Diego, California 92103
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San Diego, California 92117
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Santa Clara, California 95051
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Savannah, Georgia 31406
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Tempe, Arizona 85283
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