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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Trial Summary
Trial Overview
Inclusion Criteria

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
sites
Advances In Health, Inc.
Houston, Texas 77030
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Clinical Research Associates of Tidewater
400 Gresham Dr
Norfolk, Virginia 23507
757-627-7446
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Norfolk, VA
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Jean Brown Research
1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
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Clinical Trials of Texas, Inc.
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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San Antonio, TX
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Omega Medical Research
400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
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Warwick, RI
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Heartland Research Associates, LLC
1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Wichita, KS
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Benchmark Research
Austin, Texas
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The Office of Dr. Roberta Braun, MD
Austin, Texas 78705
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Kentucky Pediatric/ Adult Research
Bardstown, Kentucky 40004
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Bardstown, KY
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Preferred Primary Care Physicians, Inc.
Carnegie, Pennsylvania 15106
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Carnegie, PA
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Cary Pediatric Center, P.A.
Cary, North Carolina 27518
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Cary, NC
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Radiant Research
Chandler, Arizona 85225
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Chandler, AZ
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Charleston Pediatrics, PA
198 Rutledge Avenue
Charleston, South Carolina 29403
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Pediatric Associates of Charlottesville, LLC
Charlottesville, Virginia 22901
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West Office - Pediatric Associates of Charlottesville
Charlottesville, Virginia 22903
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North Office - Pediatric Associates of Charlottesville
Charlottesville, Virginia 22911
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Cincinnati Children's Hospital Medical Center (CCHMC)
Cincinnati, Ohio 45229
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Cincinnati, OH
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Senders Pediatrics
Cleveland, Ohio 44221
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Rapid Medical Research, Inc.
Cleveland, Ohio 44122
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Lynn Institute of the Rockies
Colorado Springs, Colorado 80907
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Colorado Springs Family Practice
2960 North Circle Drive
Colorado Springs, Colorado 80909
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Richard K. Ohnmacht, MD
Cranston, Rhode Island 02920
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West Coast Clinical Trials, LLC
Cypress, California 90630
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Cypress, CA
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Coastal Clinical Research Inc.
Daphne, Alabama 36526
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Daphne, AL
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Duke University Medical Center - Duke Health Center
Durham, North Carolina 27704
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Durham, NC
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Durham Pediatrics
Durham, North Carolina 27704
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Durham, NC
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Duke Health Center
Durham, North Carolina 27704
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Liberty Family Practice
Erie, Pennsylvania 16508
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Erie, PA
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Innovis Health, LLC dba Essentia Health South University Clinic
Fargo, North Dakota 58103
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Fargo, ND
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Clinical Research Center of Nevada
Henderson, Nevada 89015
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Pediatric Healthcare of Northwest Houston
Houston, Texas 77070
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Texas Center for Drug Development, P.A.
Houston, Texas
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Pediatric Care Medical Group, Inc
Huntington Beach, California
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Northpoint Pediatrics
Indianapolis, Indiana 46256
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Indianapolis, IN
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The Children'S Clinic of Jonesboro, P.A.
Jonesboro, Arkansas 72401
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The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri 64114
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Clinical Research Center of Nevada, LLC
Las Vegas, Nevada 89104
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University of Texas Medical Branch Pediatric Specialty Center
League City, Texas 77573
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Central Kentucky Research Associates, Inc.
Lexington, Kentucky 40509
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Lexington, KY
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Midwest Children'S Health Research Institute
Lincoln, Nebraska 68504
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Lincoln, NE
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Arkansas Pediatric Clinic
Little Rock, Arkansas 72205
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Brownsboro Park Pediatrics
Louisville, Kentucky 40207
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Bluegrass Clinical Research
Louisville, Kentucky 40291
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Pediatrics & Adolescent Medicine, Pa
Marietta, Georgia 30062
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Marietta, GA
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Advanced Clinical Research, Inc.
Meridian, Idaho 83642
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Meridian, ID
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Miami Research Associates
Miami, Florida
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Monroe Clinic
Monroe, Wisconsin 53566
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Monroe, WI
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Loma Linda University Health Care - Moreno Valley Pediatrics
Moreno Valley, California 92557
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Moreno Valley, CA
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Coastal Carolina Research Center
Mount Pleasant, South Carolina 29464
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PMG Research of Charleston, LLC
Mount Pleasant, South Carolina 29464
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Murray Pediatrics
Murray, Utah 84107
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Clinical Research Associates
Nashville, Tennessee 37203
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Lynn Institute of Norman (LION)
Norman, Oklahoma 73069
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Norman, OK
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Lynn Health Science Institute
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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Quality Clinical Research, Inc.
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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Bayview Research Group, LLC
Paramount, California 90723
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Paramount, CA
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Center for Clinical Trials, LLC.
Paramount, California 90723
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PMG Research of Raleigh, LLC
Raleigh, North Carolina 27609
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Wake Internal Medicine Consultants, Inc.
Raleigh, North Carolina 27612
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Wake Research Associates, LLC
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 Clinical Research Inc.
Rochester, New York 14609
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Mercy Health Research
Saint Louis, Missouri 63141
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Sundance Clinical Research, LLC
Saint Louis, Missouri 63141
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Allina Health Bandana Square Clinic
Saint Paul, Minnesota 55108
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Aspen Medical Group / Odyssey Research
Saint Paul, Minnesota 55108
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Benchmark Research
San Angelo, Texas 76904
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First Steps Pediatrics
San Antonio, Texas 78229
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Radiant Research, Inc
San Antonio, Texas
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California Research Foundation
San Diego, California 92103
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Pennridge Pediatric Associates
Sellersville, Pennsylvania 18960
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Sellersville, PA
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Clinical Research Atlanta
Stockbridge, Georgia 30281
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SUNY Upstate Medical University
750 East Adams Street
Syracuse, New York 13210
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Pediatric Healthcare of Northwest Houston
Tomball, Texas 77375
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Oklahoma State University - Center for Health Sciences - Pediatric Research Houston Center
Tulsa, Oklahoma 74127
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Tulsa, OK
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Oklahoma State University - Center for Health Sciences Houston Parke Physicians
Tulsa, Oklahoma 74127
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Bayview Research Group
Valley Village, California 91607
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The Vancouver Clinic
Vancouver, Washington 98664
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Vancouver, WA
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Advanced Pediatrics
Vienna, Virginia 22180
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Vienna, VA
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Pediatrics and Adolescent Medicine
Woodstock, Georgia 30189
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Woodstock, GA
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