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
sites
Mount Pleasant, South Carolina 29464
2187
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from 91732
Mount Pleasant, SC
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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...
2176
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DeLand, FL
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
1182
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from 91732
San Antonio, TX
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
1186
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from 91732
Wichita, KS
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Austin, Texas
1212
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Austin, TX
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Bardstown, Kentucky 40004
1829
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Bardstown, KY
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Binghamton, New York 13901
2330
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Binghamton, NY
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52 Medical Plaza Drive
Birmingham, Alabama 35205
1792
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Birmingham, AL
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2013
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Bristol, TN
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Bristol, Tennessee 37620
2013
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Bristol, TN
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Burke, Virginia 22015
2268
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Burke, VA
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198 Rutledge Avenue
Charleston, South Carolina 29403
2184
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Charleston, SC
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Charlottesville, Virginia 22902
2208
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Charlottesville, VA
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Cincinnati, Ohio 45219
1879
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Cincinnati, OH
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Cleveland, Ohio 44122
2041
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Cleveland, OH
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Columbus, Ohio 43213
1967
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Columbus, OH
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Dakota Dunes, South Dakota 57049
1299
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Dakota Dunes, SD
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1897
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Dayton, OH
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559
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Draper, UT
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Endwell, New York 13760
2324
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Endwell, NY
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Erie, Pennsylvania 16508
2116
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Erie, PA
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1511
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Eunice, LA
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Fort Worth, Texas 76104
1195
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Fort Worth, TX
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Fort Worth, Texas 76104
1195
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Fort Worth, TX
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Fort Worth, Texas 76135
1195
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Fort Worth, TX
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4625 Boat Club Road
Fort Worth, Texas 76135
1188
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Fort Worth, TX
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362
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Fountain Hills, AZ
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1276
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Fremont, NE
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Harrisburg, Arkansas 72432
1546
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Harrisburg, AR
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Haughton, Louisiana 71037
1415
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Haughton, LA
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Huntsville, Alabama 35802
1787
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Huntsville, AL
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Jindrichuv Hradec,
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Jupiter, Florida 33458
2295
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Jupiter, FL
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Kingsport, Tennessee 37660
1995
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Kingsport, TN
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Melbourne, Florida 32934
2231
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Melbourne, FL
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Mount Pleasant, South Carolina 29464
2188
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Mount Pleasant, SC
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Nashville, Tennessee 37203
1762
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Nashville, TN
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Newton, Kansas 67114
1183
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Newton, KS
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Norfolk, Nebraska 68701
1243
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Norfolk, NE
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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...
1164
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Oklahoma City, OK
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Omaha, Nebraska 68134
1295
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Omaha, NE
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Peoria, Illinois 64614
1618
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Peoria, IL
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Plano, Texas 75093
1227
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Plano, TX
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Raleigh, North Carolina 27609
2218
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Raleigh, NC
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Rochester, New York 14609
2245
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Rochester, NY
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572
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Salt Lake City, UT
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565
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Salt Lake City, UT
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San Diego, California 92103
103
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San Diego, CA
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San Diego, California 92117
106
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San Diego, CA
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Santa Clara, California 95051
316
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Santa Clara, CA
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Savannah, Georgia 31406
2132
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Savannah, GA
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558
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South Jordan, UT
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Tempe, Arizona 85283
352
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Tempe, AZ
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