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
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
2 other identifiers
interventional
2,499
1 country
87
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2011
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2011
CompletedStudy Start
First participant enrolled
September 28, 2011
CompletedFirst Posted
Study publicly available on registry
October 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2013
CompletedResults Posted
Study results publicly available
November 26, 2014
CompletedDecember 19, 2018
November 1, 2018
1.8 years
September 28, 2011
November 21, 2014
November 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens
1 month after Vaccination 3
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]
1 month after Vaccination 3
Percentage of Participants With at Least One Adverse Event (AE)
Vaccination 1 up to 1 month after Vaccination 3
Secondary Outcomes (5)
Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)
1 month after Vaccination 3
Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants
Before vaccination 1
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
Before vaccination 1, 1 month after vaccination (Vac) 2, 3
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Vaccination 1, 1 month after Vaccination 2, 3
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)
Before Vaccination 1, 1 month after Vaccination 2, 3
Study Arms (3)
Group 1
ACTIVE COMPARATORrLP2086 + Gardasil
Group 2
PLACEBO COMPARATORrLP2086 and saline
Group 3
ACTIVE COMPARATORSaline + Gardasil
Interventions
Gardasil vaccine and rLP2086 injection will be given to the subject concomitantly in Group 1 at Months 0, 2 and 6.
Injections of rLP2086 and saline will be given to the subject concomitantly in Group 2 at Months 0, 2 and 6.
Injections of saline and Gardasil vaccine will be given to the subject concomitantly in Group 3 at Months 0, 2 and 6.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Previous vaccination with any meningococcal serogroup B vaccine.
- Previous vaccination with any HPV vaccine.
- Contraindication to vaccination with Gardasil or any HPV vaccine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (87)
Coastal Clinical Research Inc.
Daphne, Alabama, 36526, United States
Radiant Research, Inc.
Chandler, Arizona, 85224, United States
The Children's Clinic of Jonesboro, PA
Jonesboro, Arkansas, 72401, United States
Arkansas Pediatric Clinic
Little Rock, Arkansas, 72205, United States
West Coast Clinical Trials, LLC
Cypress, California, 90630, United States
Pediatric Care Medical Group
Huntington Beach, California, 92647, United States
Loma Linda University Health Care - Moreno Valley Pediatrics
Moreno Valley, California, 92557, United States
Bayview Research Group, LLC
Paramount, California, 90723, United States
Center for Clinical Trials, LLC
Paramount, California, 90723, United States
California Research Foundation
San Diego, California, 92103, United States
Bayview Research Group, LLC
Valley Village, California, 91607, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80907, United States
Colorado Springs Family Practice
Colorado Springs, Colorado, 80909, United States
Miami Research Associates
Miami, Florida, 33143, United States
Pediatrics and Adolescent Medicine, PA
Marietta, Georgia, 30062, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Pediatrics and Adolescent Medicine
Woodstock, Georgia, 30189, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
Northpoint Pediatrics, LLC
Indianapolis, Indiana, 46256, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509, United States
Brownsboro Park Pediatrics
Louisville, Kentucky, 40207, United States
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, 40291, United States
Allina Health Bandana Square Clinic
Saint Paul, Minnesota, 55108, United States
Aspen Medical Group / Odyssey Research
Saint Paul, Minnesota, 55108, United States
The Center for Pharmaceutical Research, PC
Kansas City, Missouri, 64114, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Sundance Clinical Research, LLC
St Louis, Missouri, 63141, United States
Sundance Clinical Research
St Louis, Missouri, 63141, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68504, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Clinical Research Center of Nevada
Henderson, Nevada, 89014, United States
Clinical Research Center of Nevada
Henderson, Nevada, 89105, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89105, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Cary Pediatric Center
Cary, North Carolina, 27518, United States
Duke University Medical Center - Duke Health Center
Durham, North Carolina, 27704, United States
Durham Pediatrics
Durham, North Carolina, 27704, United States
Duke Health Center
Durham, North Carolina, 27705, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27612, United States
Wake Internal Medicine Consultants, Inc
Raleigh, North Carolina, 27612, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Innovis Health, LLC dba Essentia Health South University Clinic
Fargo, North Dakota, 58103, United States
Cincinnati Children's Hospital Medical Center (CCHMC)
Cincinnati, Ohio, 45206, United States
Cincinnati Children's Hospital Medical Center (CCHMC)
Cincinnati, Ohio, 45229-3039, United States
Senders Pediatrics
Cleveland, Ohio, 44121, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
Lynn Institute of Norman (LION)
Norman, Oklahoma, 73069, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Oklahoma State University - Center for Health Sciences - Pediatric Research Houston Center
Tulsa, Oklahoma, 74127, United States
Oklahoma State University - Center for Health Sciences Houston Parke Physicians
Tulsa, Oklahoma, 74127, United States
Preferred Primary Care Physicians, Inc.
Carnegie, Pennsylvania, 15106, United States
Liberty Family Practice
Erie, Pennsylvania, 16508, United States
Pennridge Pediatric Associates
Sellersville, Pennsylvania, 18960, United States
Richard K. Ohnmacht, MD
Cranston, Rhode Island, 02920, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Charleston Pediatrics
Charleston, South Carolina, 29401, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
PMG Research of Charleston
Mt. Pleasant, South Carolina, 29464, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203, United States
Benchmark Research
Austin, Texas, 78705, United States
The Office of Dr. Roberta Braun, MD
Austin, Texas, 78705, United States
Advances In Health, Inc.
Houston, Texas, 77030, United States
Pediatric Healthcare of Northwest Houston
Houston, Texas, 77070, United States
Texas Center for Drug Development, Inc.
Houston, Texas, 77081, United States
University of Texas Medical Branch Pediatric Specialty Center
League City, Texas, 77573, United States
Benchmark Research
San Angelo, Texas, 76904, United States
Clinical Trials Of Texas, Inc
San Antonio, Texas, 78229, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
First Steps Pediatrics
San Antonio, Texas, 78229, United States
Radiant Research, Inc.
San Antonio, Texas, 78229, United States
Pediatric Healthcare of Northwest Houston, PA
Tomball, Texas, 77375, United States
Pediatric Healthcare of Northwest Houston
Tomball, Texas, 77375, United States
Murray Pediatrics
Murray, Utah, 84107, United States
Jean Brown Research
Salt Lake City, Utah, 84124, United States
Pediatric Associates of Charlottesville
Charlottesville, Virginia, 22902, United States
West Office - Pediatric Associates of Charlottesville
Charlottesville, Virginia, 22903, United States
North Office - Pediatric Associates of Charlottesville
Charlottesville, Virginia, 22911, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
Advanced Pediatrics
Vienna, Virginia, 22180, United States
The Vancouver Clinic
Vancouver, Washington, 98664, United States
The Vancouver Clinic
Vancouver, Washington, 98686, United States
Monroe Clinic
Monroe, Wisconsin, 53566, United States
Related Publications (3)
Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
PMID: 41276263DERIVEDBeeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.
PMID: 35164991DERIVEDBeeslaar J, Peyrani P, Absalon J, Maguire J, Eiden J, Balmer P, Maansson R, Perez JL. Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data. Infect Dis Ther. 2020 Sep;9(3):625-639. doi: 10.1007/s40121-020-00322-5. Epub 2020 Jul 17.
PMID: 32681472DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2011
First Posted
October 28, 2011
Study Start
September 28, 2011
Primary Completion
July 6, 2013
Study Completion
July 6, 2013
Last Updated
December 19, 2018
Results First Posted
November 26, 2014
Record last verified: 2018-11