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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2499

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 6, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 6, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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