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

November 30, 2018 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2499

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Daphne, Alabama, United States, 36526
        • Coastal Clinical Research Inc.
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Radiant Research, Inc.
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • The Children's Clinic of Jonesboro, PA
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Pediatric Clinic
    • California
      • Cypress, California, United States, 90630
        • West Coast Clinical Trials, Llc
      • Huntington Beach, California, United States, 92647
        • Pediatric Care Medical Group
      • Moreno Valley, California, United States, 92557
        • Loma Linda University Health Care - Moreno Valley Pediatrics
      • Paramount, California, United States, 90723
        • Bayview Research Group, LLC
      • Paramount, California, United States, 90723
        • Center for Clinical Trials, LLC
      • San Diego, California, United States, 92103
        • California Research Foundation
      • Valley Village, California, United States, 91607
        • Bayview Research Group, LLC
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Lynn Institute of the Rockies
      • Colorado Springs, Colorado, United States, 80909
        • Colorado Springs Family Practice
    • Florida
      • Miami, Florida, United States, 33143
        • Miami Research Associates
    • Georgia
      • Marietta, Georgia, United States, 30062
        • Pediatrics and Adolescent Medicine, PA
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Atlanta
      • Woodstock, Georgia, United States, 30189
        • Pediatrics and Adolescent Medicine
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Northpoint Pediatrics, LLC
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates, LLC
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Kentucky Pediatric/Adult Research
      • Lexington, Kentucky, United States, 40509
        • Central Kentucky Research Associates, Inc.
      • Louisville, Kentucky, United States, 40207
        • Brownsboro Park Pediatrics
      • Louisville, Kentucky, United States, 40291
        • Bluegrass Clinical Research, Inc.
    • Minnesota
      • Saint Paul, Minnesota, United States, 55108
        • Allina Health Bandana Square Clinic
      • Saint Paul, Minnesota, United States, 55108
        • Aspen Medical Group / Odyssey Research
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • The Center for Pharmaceutical Research, PC
      • Saint Louis, Missouri, United States, 63141
        • Mercy Health Research
      • Saint Louis, Missouri, United States, 63141
        • Sundance Clinical Research, LLC
      • Saint Louis, Missouri, United States, 63141
        • Sundance Clinical Research
    • Nebraska
      • Lincoln, Nebraska, United States, 68504
        • Midwest Children's Health Research Institute
      • Omaha, Nebraska, United States, 68114
        • Quality Clinical Research, Inc.
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Clinical Research Center of Nevada
      • Henderson, Nevada, United States, 89105
        • Clinical Research Center of Nevada
      • Las Vegas, Nevada, United States, 89105
        • Clinical Research Center of Nevada
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, Inc.
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Cary Pediatric Center
      • Durham, North Carolina, United States, 27704
        • Duke University Medical Center - Duke Health Center
      • Durham, North Carolina, United States, 27704
        • Durham Pediatrics
      • Durham, North Carolina, United States, 27705
        • Duke Health Center
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
      • Raleigh, North Carolina, United States, 27609
        • PMG Research of Raleigh, LLC
      • Raleigh, North Carolina, United States, 27612
        • Wake Internal Medicine Consultants, Inc
      • Raleigh, North Carolina, United States, 27612
        • PMG Research of Raleigh, LLC
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Innovis Health, LLC dba Essentia Health South University Clinic
    • Ohio
      • Cincinnati, Ohio, United States, 45206
        • Cincinnati Children's Hospital Medical Center (CCHMC)
      • Cincinnati, Ohio, United States, 45229-3039
        • Cincinnati Children's Hospital Medical Center (CCHMC)
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research, Inc.
      • Cleveland, Ohio, United States, 44121
        • Senders Pediatrics
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Lynn Institute of Norman (LION)
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
      • Tulsa, Oklahoma, United States, 74127
        • Oklahoma State University - Center for Health Sciences - Pediatric Research Houston Center
      • Tulsa, Oklahoma, United States, 74127
        • Oklahoma State University - Center for Health Sciences Houston Parke Physicians
    • Pennsylvania
      • Carnegie, Pennsylvania, United States, 15106
        • Preferred Primary Care Physicians, Inc.
      • Erie, Pennsylvania, United States, 16508
        • Liberty Family Practice
      • Sellersville, Pennsylvania, United States, 18960
        • Pennridge Pediatric Associates
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • Richard K. Ohnmacht, MD
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Charleston Pediatrics
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
      • Mount Pleasant, South Carolina, United States, 29464
        • PMG Research of Charleston
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates, Inc.
    • Texas
      • Austin, Texas, United States, 78705
        • Benchmark Research
      • Austin, Texas, United States, 78705
        • The Office of Dr. Roberta Braun, MD
      • Houston, Texas, United States, 77081
        • Texas Center for Drug Development, Inc.
      • Houston, Texas, United States, 77030
        • Advances In Health, Inc.
      • Houston, Texas, United States, 77070
        • Pediatric Healthcare of Northwest Houston
      • League City, Texas, United States, 77573
        • University of Texas Medical Branch Pediatric Specialty Center
      • San Angelo, Texas, United States, 76904
        • Benchmark Research
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc
      • San Antonio, Texas, United States, 78229
        • Radiant Research, Inc.
      • San Antonio, Texas, United States, 78229
        • First Steps Pediatrics
      • Tomball, Texas, United States, 77375
        • Pediatric Healthcare of Northwest Houston, PA
      • Tomball, Texas, United States, 77375
        • Pediatric Healthcare of Northwest Houston
    • Utah
      • Murray, Utah, United States, 84107
        • Murray Pediatrics
      • Salt Lake City, Utah, United States, 84124
        • Jean Brown Research
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • Pediatric Associates of Charlottesville
      • Charlottesville, Virginia, United States, 22903
        • West Office - Pediatric Associates of Charlottesville
      • Charlottesville, Virginia, United States, 22911
        • North Office - Pediatric Associates of Charlottesville
      • Norfolk, Virginia, United States, 23507
        • Clinical Research Associates of Tidewater
      • Vienna, Virginia, United States, 22180
        • Advanced Pediatrics
    • Washington
      • Vancouver, Washington, United States, 98664
        • The Vancouver Clinic
      • Vancouver, Washington, United States, 98686
        • The Vancouver Clinic
    • Wisconsin
      • Monroe, Wisconsin, United States, 53566
        • Monroe Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
rLP2086 + Gardasil
Biological: rLP2086 and Gardasil
Gardasil vaccine and rLP2086 injection will be given to the subject concomitantly in Group 1 at Months 0, 2 and 6.
Placebo Comparator: Group 2
rLP2086 and saline
Biological: rLP2086
Injections of rLP2086 and saline will be given to the subject concomitantly in Group 2 at Months 0, 2 and 6.
Active Comparator: Group 3
Saline + Gardasil
Biological: Gardasil
Injections of saline and Gardasil vaccine will be given to the subject concomitantly in Group 3 at Months 0, 2 and 6.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With at Least One Adverse Event (AE)
Time Frame: Vaccination 1 up to 1 month after Vaccination 3
Vaccination 1 up to 1 month after Vaccination 3
Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens
Time Frame: 1 month after Vaccination 3
1 month after Vaccination 3
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]
Time Frame: 1 month after Vaccination 3
1 month after Vaccination 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)
Time Frame: 1 month after Vaccination 3
1 month after Vaccination 3
Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants
Time Frame: Before vaccination 1
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)
Time Frame: Before vaccination 1, 1 month after vaccination (Vac) 2, 3
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
Time Frame: Before Vaccination 1, 1 month after Vaccination 2, 3
Before Vaccination 1, 1 month after Vaccination 2, 3
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)
Time Frame: Before Vaccination 1, 1 month after Vaccination 2, 3
Before Vaccination 1, 1 month after Vaccination 2, 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2011

Primary Completion (Actual)

July 6, 2013

Study Completion (Actual)

July 6, 2013

Study Registration Dates

First Submitted

September 28, 2011

First Submitted That Met QC Criteria

October 26, 2011

First Posted (Estimate)

October 28, 2011

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

November 30, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B1971011
  • 6108A1-2007 (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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