A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to Gardasil and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 11 and 17



Status:Completed
Conditions:Vaccines
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:11 - 17
Updated:12/21/2018
Start Date:September 28, 2011
End Date:July 6, 2013

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A Phase 2, Randomized, Active-controlled, Observer-blinded Trial, To Assess The Safety, Tolerability, And Immunogenicity Of Gardasil (Registered) (Hpv) Vaccine And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged >=11 To <18 Years

This is a clinical study to assess the safety, tolerance and immunogenic response to Gardasil
(human papilloma virus (HPV)) and rLP2086 vaccine. Healthy male and female subjects will be
randomized into 1 of 3 groups; the trial will be an observer-blinded study to the injection
being given; and, vaccinated with either Gardasil and rLP2086 concomitantly, rLP2086 and
saline concomitantly, or Gardasil and saline concomitantly. The subjects are adolescent
children between the ages of 11 and 17 years old.


Inclusion Criteria:

- Male or female subjects from 11 to 17 years old at the time of they start the study.

- Subject must be healthy which will be determined by obtaining subject's medical
history, receiving a physical examination and by judgment of the investigator.

Exclusion Criteria:

- Previous vaccination with any meningococcal serogroup B vaccine.

- Previous vaccination with any HPV vaccine.

- Contraindication to vaccination with Gardasil or any HPV vaccine.
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79
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Saint Louis, Missouri 63141
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Saint Louis, MO
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400 Gresham Dr
Norfolk, Virginia 23507
757-627-7446
2336
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1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
1182
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
2559
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Warwick, RI
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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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Carnegie, Pennsylvania 15106
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Cary, North Carolina 27518
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Chandler, Arizona 85225
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198 Rutledge Avenue
Charleston, South Carolina 29403
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Charlottesville, Virginia 22901
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Cincinnati, OH
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Cleveland, Ohio 44221
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Cleveland, Ohio 44122
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Colorado Springs, Colorado 80907
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2960 North Circle Drive
Colorado Springs, Colorado 80909
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Cranston, Rhode Island 02920
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Cypress, California 90630
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Daphne, Alabama 36526
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Durham, NC
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Durham, North Carolina 27704
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Durham, North Carolina 27704
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Erie, Pennsylvania 16508
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Fargo, ND
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Henderson, Nevada 89015
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Henderson, NV
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Houston, Texas 77030
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Huntington Beach, California
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Indianapolis, Indiana 46256
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Jonesboro, Arkansas 72401
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Kansas City, Missouri 64114
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Las Vegas, Nevada 89104
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Lexington, Kentucky 40509
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Lincoln, NE
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Little Rock, Arkansas 72205
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Louisville, Kentucky 40207
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Louisville, Kentucky 40291
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Marietta, Georgia 30062
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Meridian, Idaho 83642
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Miami, Florida
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Monroe, Wisconsin 53566
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Moreno Valley, CA
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Mount Pleasant, South Carolina 29464
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Mount Pleasant, South Carolina 29464
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Murray, Utah 84107
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Nashville, Tennessee 37203
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Norman, Oklahoma 73069
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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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10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
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Paramount, California 90723
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Paramount, California 90723
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Raleigh, North Carolina 27609
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Raleigh, North Carolina 27612
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Rochester, New York 14609
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Saint Louis, Missouri 63141
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Saint Paul, Minnesota 55108
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Saint Paul, Minnesota 55108
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San Angelo, Texas 76904
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San Antonio, Texas 78229
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San Antonio, Texas
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San Diego, California 92103
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Sellersville, Pennsylvania 18960
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Stockbridge, Georgia 30281
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750 East Adams Street
Syracuse, New York 13210
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Tomball, TX
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Valley Village, California 91607
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Vancouver, Washington 98664
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Vienna, Virginia 22180
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Woodstock, Georgia 30189
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