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.
We found this trial at
79
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Raleigh, North Carolina 27612
1068
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Raleigh, NC
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400 Gresham Dr
Norfolk, Virginia 23507
757-627-7446
1181
mi
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Norfolk, VA
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1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
777
mi
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Salt Lake City, UT
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
570
mi
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San Antonio, TX
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
1420
mi
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Warwick, RI
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
32
mi
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Wichita, KS
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Austin, Texas
517
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Austin, TX
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Austin, TX
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Bardstown, Kentucky 40004
674
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Bardstown, KY
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Carnegie, Pennsylvania 15106
967
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Carnegie, PA
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Cary, North Carolina 27518
1061
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Cary, NC
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Chandler, Arizona 85225
844
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Chandler, AZ
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198 Rutledge Avenue
Charleston, South Carolina 29403
1062
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Charleston, SC
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Charlottesville, Virginia 22901
1053
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Charlottesville, VA
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727
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Cincinnati, OH
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Cleveland, Ohio 44221
901
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Cleveland, Ohio 44122
903
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Cleveland, OH
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Colorado Springs, Colorado 80907
386
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2960 North Circle Drive
Colorado Springs, Colorado 80909
385
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Colorado Springs, CO
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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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1051
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Durham, NC
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Durham, North Carolina 27704
1052
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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
953
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Henderson, NV
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Houston, Texas 77030
569
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Houston, TX
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569
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Houston, TX
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569
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Houston, TX
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Huntington Beach, California
1163
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Indianapolis, Indiana 46256
652
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Indianapolis, IN
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Jonesboro, Arkansas 72401
416
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Jonesboro, AR
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Kansas City, Missouri 64114
193
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Kansas City, MO
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Las Vegas, Nevada 89104
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Las Vegas, NV
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League City, TX
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Lexington, Kentucky 40509
731
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Lexington, KY
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222
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Lincoln, NE
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Little Rock, Arkansas 72205
369
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Louisville, Kentucky 40207
663
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Louisville, KY
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Louisville, Kentucky 40291
667
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Marietta, Georgia 30062
790
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Marietta, GA
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Meridian, Idaho 83642
1050
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Miami, Florida
1322
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Miami, FL
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Monroe, Wisconsin 53566
546
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Monroe, WI
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1116
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Moreno Valley, CA
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Mount Pleasant, South Carolina 29464
1067
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Mount Pleasant, SC
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Mount Pleasant, South Carolina 29464
1065
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Murray, Utah 84107
778
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Murray, UT
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Nashville, Tennessee 37203
618
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Norman, Oklahoma 73069
175
mi
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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...
158
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Oklahoma City, OK
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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...
260
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Omaha, NE
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Paramount, California 90723
1167
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Paramount, California 90723
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Raleigh, North Carolina 27609
1068
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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...
1064
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Rochester, New York 14609
1122
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Saint Louis, Missouri 63141
403
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Saint Louis, Missouri 63141
403
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Saint Paul, Minnesota 55108
553
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Saint Paul, Minnesota 55108
553
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San Angelo, Texas 76904
467
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San Antonio, Texas 78229
576
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San Antonio, Texas
576
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San Diego, California 92103
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Sellersville, Pennsylvania 18960
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Stockbridge, Georgia 30281
815
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750 East Adams Street
Syracuse, New York 13210
1193
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543
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Tomball, TX
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Tulsa, OK
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Valley Village, California 91607
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Vancouver, Washington 98664
1381
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Vienna, Virginia 22180
1115
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Woodstock, Georgia 30189
784
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