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VaccinesPhase 2NCT01461993

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 study testing rLP2086 and Gardasil, rLP2086 and Gardasil in people with Vaccines and Meningococcal Vaccines, run by Pfizer at 87 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 11 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Vaccines, Meningococcal Vaccines
What is being tested?
rLP2086 and Gardasil, rLP2086 and Gardasil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,499 participants
Where
87 sitesUnited States
Study dates
28 Sep 2011to 6 Jul 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • Previous vaccination with any meningococcal serogroup B vaccine.
  • Previous vaccination with any HPV vaccine.
  • Contraindication to vaccination with Gardasil or any HPV vaccine.

Trial locations and contacts

87 sites in 1 country.

87 sites in 1 country

United States87 sites

  • Benchmark Research

    Austin, Texas, 78705

  • The Office of Dr. Roberta Braun, MD

    Austin, Texas, 78705

  • Kentucky Pediatric/Adult Research

    Bardstown, Kentucky, 40004

  • Preferred Primary Care Physicians, Inc.

    Carnegie, Pennsylvania, 15106

  • Cary Pediatric Center

    Cary, North Carolina, 27518

  • Radiant Research, Inc.

    Chandler, Arizona, 85224

  • Charleston Pediatrics

    Charleston, South Carolina, 29401

  • Pediatric Associates of Charlottesville

    Charlottesville, Virginia, 22902

  • West Office - Pediatric Associates of Charlottesville

    Charlottesville, Virginia, 22903

  • North Office - Pediatric Associates of Charlottesville

    Charlottesville, Virginia, 22911

  • Cincinnati Children's Hospital Medical Center (CCHMC)

    Cincinnati, Ohio, 45206

  • Cincinnati Children's Hospital Medical Center (CCHMC)

    Cincinnati, Ohio, 45229-3039

  • Senders Pediatrics

    Cleveland, Ohio, 44121

  • Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

  • Lynn Institute of the Rockies

    Colorado Springs, Colorado, 80907

  • Colorado Springs Family Practice

    Colorado Springs, Colorado, 80909

  • Richard K. Ohnmacht, MD

    Cranston, Rhode Island, 02920

  • West Coast Clinical Trials, LLC

    Cypress, California, 90630

  • Coastal Clinical Research Inc.

    Daphne, Alabama, 36526

  • Duke University Medical Center - Duke Health Center

    Durham, North Carolina, 27704

  • Durham Pediatrics

    Durham, North Carolina, 27704

  • Duke Health Center

    Durham, North Carolina, 27705

  • Liberty Family Practice

    Erie, Pennsylvania, 16508

  • Innovis Health, LLC dba Essentia Health South University Clinic

    Fargo, North Dakota, 58103

  • Clinical Research Center of Nevada

    Henderson, Nevada, 89014

  • Clinical Research Center of Nevada

    Henderson, Nevada, 89105

  • Advances In Health, Inc.

    Houston, Texas, 77030

  • Pediatric Healthcare of Northwest Houston

    Houston, Texas, 77070

  • Texas Center for Drug Development, Inc.

    Houston, Texas, 77081

  • Pediatric Care Medical Group

    Huntington Beach, California, 92647

  • Northpoint Pediatrics, LLC

    Indianapolis, Indiana, 46256

  • The Children's Clinic of Jonesboro, PA

    Jonesboro, Arkansas, 72401

  • The Center for Pharmaceutical Research, PC

    Kansas City, Missouri, 64114

  • Clinical Research Center of Nevada

    Las Vegas, Nevada, 89105

  • University of Texas Medical Branch Pediatric Specialty Center

    League City, Texas, 77573

  • Central Kentucky Research Associates, Inc.

    Lexington, Kentucky, 40509

  • Midwest Children's Health Research Institute

    Lincoln, Nebraska, 68504

  • Arkansas Pediatric Clinic

    Little Rock, Arkansas, 72205

  • Brownsboro Park Pediatrics

    Louisville, Kentucky, 40207

  • Bluegrass Clinical Research, Inc.

    Louisville, Kentucky, 40291

  • Pediatrics and Adolescent Medicine, PA

    Marietta, Georgia, 30062

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • Miami Research Associates

    Miami, Florida, 33143

  • Monroe Clinic

    Monroe, Wisconsin, 53566

  • Loma Linda University Health Care - Moreno Valley Pediatrics

    Moreno Valley, California, 92557

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • PMG Research of Charleston

    Mt. Pleasant, South Carolina, 29464

  • Murray Pediatrics

    Murray, Utah, 84107

  • Clinical Research Associates, Inc.

    Nashville, Tennessee, 37203

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia, 23507

  • Lynn Institute of Norman (LION)

    Norman, Oklahoma, 73069

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Quality Clinical Research, Inc.

    Omaha, Nebraska, 68114

  • Bayview Research Group, LLC

    Paramount, California, 90723

  • Center for Clinical Trials, LLC

    Paramount, California, 90723

  • PMG Research of Raleigh, LLC

    Raleigh, North Carolina, 27609

  • PMG Research of Raleigh, LLC

    Raleigh, North Carolina, 27612

  • Wake Internal Medicine Consultants, Inc

    Raleigh, North Carolina, 27612

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609

  • Rochester Clinical Research

    Rochester, New York, 14609

  • Allina Health Bandana Square Clinic

    Saint Paul, Minnesota, 55108

  • Aspen Medical Group / Odyssey Research

    Saint Paul, Minnesota, 55108

  • Jean Brown Research

    Salt Lake City, Utah, 84124

  • Benchmark Research

    San Angelo, Texas, 76904

  • Clinical Trials Of Texas, Inc

    San Antonio, Texas, 78229

  • Clinical Trials of Texas

    San Antonio, Texas, 78229

  • First Steps Pediatrics

    San Antonio, Texas, 78229

  • Radiant Research, Inc.

    San Antonio, Texas, 78229

  • California Research Foundation

    San Diego, California, 92103

  • Pennridge Pediatric Associates

    Sellersville, Pennsylvania, 18960

  • Mercy Health Research

    St Louis, Missouri, 63141

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141

  • Sundance Clinical Research

    St Louis, Missouri, 63141

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Pediatric Healthcare of Northwest Houston, PA

    Tomball, Texas, 77375

  • Pediatric Healthcare of Northwest Houston

    Tomball, Texas, 77375

  • Oklahoma State University - Center for Health Sciences - Pediatric Research Houston Center

    Tulsa, Oklahoma, 74127

  • Oklahoma State University - Center for Health Sciences Houston Parke Physicians

    Tulsa, Oklahoma, 74127

  • Bayview Research Group, LLC

    Valley Village, California, 91607

  • The Vancouver Clinic

    Vancouver, Washington, 98664

  • The Vancouver Clinic

    Vancouver, Washington, 98686

  • Advanced Pediatrics

    Vienna, Virginia, 22180

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

  • Pediatrics and Adolescent Medicine

    Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: 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.

Being tested
rLP2086 and Gardasil, rLP2086, Gardasil
Keywords
vaccine, rLP2086, Gardasil, HPV, meningitis B, N. meningitidis serogroup B, adolescents, single-blind, Meningococcal Vaccines

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rLP2086 and GardasilBiological

    Gardasil vaccine and rLP2086 injection will be given to the subject concomitantly in Group 1 at Months 0, 2 and 6.

  • rLP2086Biological

    Injections of rLP2086 and saline will be given to the subject concomitantly in Group 2 at Months 0, 2 and 6.

  • GardasilBiological

    Injections of saline and Gardasil vaccine will be given to the subject concomitantly in Group 3 at Months 0, 2 and 6.

Study groups in NCT01461993
Study groupRoleWhat they receive
Group 1Active comparatorrLP2086 + Gardasil
Receives: Biological: rLP2086 and Gardasil
Group 2Placebo comparatorrLP2086 and saline
Receives: Biological: rLP2086
Group 3Active comparatorSaline + Gardasil
Receives: Biological: Gardasil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens

    Measured: 1 month after Vaccination 3

  2. Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]

    Measured: 1 month after Vaccination 3

  3. Percentage of Participants With at Least One Adverse Event (AE)

    Measured: Vaccination 1 up to 1 month after Vaccination 3

Secondary outcomes (5)

  1. Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)

    Measured: 1 month after Vaccination 3

  2. Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants

    Measured: Before vaccination 1

  3. Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)

    Measured: Before vaccination 1, 1 month after vaccination (Vac) 2, 3

  4. Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level

    Measured: Before Vaccination 1, 1 month after Vaccination 2, 3

  5. Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)

    Measured: Before Vaccination 1, 1 month after Vaccination 2, 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2011 (estimated)
  2. Study start28 Sep 2011
  3. Primary completion6 Jul 2013
  4. Study completion6 Jul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
2,499 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01461993
Sponsor's protocol ID
B1971011
Other IDs
6108A1-2007
Status last verified
Nov 2018
First submitted
28 Sep 2011
Last updated
19 Dec 2018
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 41276263

  • Beeslaar 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.

    PubMed 35164991

  • Beeslaar 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.

    PubMed 32681472

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rLP2086 and Gardasil, rLP2086 and Gardasil in people with Vaccines and Meningococcal Vaccines, run by Pfizer at 87 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens (time frame: 1 month after Vaccination 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01461993, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.

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