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
Public ClinicalTrials.gov record NCT01461993. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01461993
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 2,499 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 11 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 28, 2011 (Actual)
- Primary completion
- Jul 6, 2013 (Actual)
- Completion
- Jul 6, 2013 (Actual)
- Last update posted
- Dec 19, 2018
2011 – 2013
United States locations
- U.S. sites
- 87
- U.S. states
- 29
- U.S. cities
- 60
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Coastal Clinical Research Inc. | Daphne | Alabama | 36526 | — |
| Radiant Research, Inc. | Chandler | Arizona | 85224 | — |
| The Children's Clinic of Jonesboro, PA | Jonesboro | Arkansas | 72401 | — |
| Arkansas Pediatric Clinic | Little Rock | Arkansas | 72205 | — |
| West Coast Clinical Trials, LLC | Cypress | California | 90630 | — |
| Pediatric Care Medical Group | Huntington Beach | California | 92647 | — |
| Loma Linda University Health Care - Moreno Valley Pediatrics | Moreno Valley | California | 92557 | — |
| Bayview Research Group, LLC | Paramount | California | 90723 | — |
| Center for Clinical Trials, LLC | Paramount | California | 90723 | — |
| California Research Foundation | San Diego | California | 92103 | — |
| Bayview Research Group, LLC | Valley Village | California | 91607 | — |
| Lynn Institute of the Rockies | Colorado Springs | Colorado | 80907 | — |
| Colorado Springs Family Practice | Colorado Springs | Colorado | 80909 | — |
| Miami Research Associates | Miami | Florida | 33143 | — |
| Pediatrics and Adolescent Medicine, PA | Marietta | Georgia | 30062 | — |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | — |
| Pediatrics and Adolescent Medicine | Woodstock | Georgia | 30189 | — |
| Advanced Clinical Research | Meridian | Idaho | 83642 | — |
| Northpoint Pediatrics, LLC | Indianapolis | Indiana | 46256 | — |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | — |
| Kentucky Pediatric/Adult Research | Bardstown | Kentucky | 40004 | — |
| Central Kentucky Research Associates, Inc. | Lexington | Kentucky | 40509 | — |
| Brownsboro Park Pediatrics | Louisville | Kentucky | 40207 | — |
| Bluegrass Clinical Research, Inc. | Louisville | Kentucky | 40291 | — |
| Allina Health Bandana Square Clinic | Saint Paul | Minnesota | 55108 | — |
| Aspen Medical Group / Odyssey Research | Saint Paul | Minnesota | 55108 | — |
| The Center for Pharmaceutical Research, PC | Kansas City | Missouri | 64114 | — |
| Mercy Health Research | St Louis | Missouri | 63141 | — |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | — |
| Sundance Clinical Research | St Louis | Missouri | 63141 | — |
| Midwest Children's Health Research Institute | Lincoln | Nebraska | 68504 | — |
| Quality Clinical Research, Inc. | Omaha | Nebraska | 68114 | — |
| Clinical Research Center of Nevada | Henderson | Nevada | 89014 | — |
| Clinical Research Center of Nevada | Henderson | Nevada | 89105 | — |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89105 | — |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | — |
| Rochester Clinical Research | Rochester | New York | 14609 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Cary Pediatric Center | Cary | North Carolina | 27518 | — |
| Duke University Medical Center - Duke Health Center | Durham | North Carolina | 27704 | — |
| Durham Pediatrics | Durham | North Carolina | 27704 | — |
| Duke Health Center | Durham | North Carolina | 27705 | — |
| 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 | — |
| Innovis Health, LLC dba Essentia Health South University Clinic | Fargo | North Dakota | 58103 | — |
| 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 Norman (LION) | Norman | Oklahoma | 73069 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| 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 | — |
| Preferred Primary Care Physicians, Inc. | Carnegie | Pennsylvania | 15106 | — |
| Liberty Family Practice | Erie | Pennsylvania | 16508 | — |
| Pennridge Pediatric Associates | Sellersville | Pennsylvania | 18960 | — |
| Richard K. Ohnmacht, MD | Cranston | Rhode Island | 02920 | — |
| Omega Medical Research | Warwick | Rhode Island | 02886 | — |
| Charleston Pediatrics | Charleston | South Carolina | 29401 | — |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | — |
| PMG Research of Charleston | Mt. Pleasant | South Carolina | 29464 | — |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | — |
| Benchmark Research | Austin | Texas | 78705 | — |
| The Office of Dr. Roberta Braun, MD | Austin | Texas | 78705 | — |
| Advances In Health, Inc. | Houston | Texas | 77030 | — |
| Pediatric Healthcare of Northwest Houston | Houston | Texas | 77070 | — |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | — |
| University of Texas Medical Branch Pediatric Specialty Center | League City | Texas | 77573 | — |
| 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 | — |
| Pediatric Healthcare of Northwest Houston, PA | Tomball | Texas | 77375 | — |
| Pediatric Healthcare of Northwest Houston | Tomball | Texas | 77375 | — |
| Murray Pediatrics | Murray | Utah | 84107 | — |
| Jean Brown Research | Salt Lake City | Utah | 84124 | — |
| 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 | — |
| Clinical Research Associates of Tidewater | Norfolk | Virginia | 23507 | — |
| Advanced Pediatrics | Vienna | Virginia | 22180 | — |
| The Vancouver Clinic | Vancouver | Washington | 98664 | — |
| The Vancouver Clinic | Vancouver | Washington | 98686 | — |
| Monroe Clinic | Monroe | Wisconsin | 53566 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01461993, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 19, 2018 · Synced Oct 30, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01461993 live on ClinicalTrials.gov.