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

Phase 2

Completed

Conditions: Meningococcal Vaccines
Vaccines

Interventions: Biological: Gardasil
Biological: rLP2086
Biological: rLP2086 and Gardasil

Registration Number: NCT01461993

Lead Sponsor: Pfizer

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2499

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 & Design

Study Type: INTERVENTIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 3	Gardasil	Saline + Gardasil
Group 2	rLP2086	rLP2086 and saline
Group 1	rLP2086 and Gardasil	rLP2086 + Gardasil

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants	Before vaccination 1
Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)	1 month after Vaccination 3
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

Trial Locations

Locations (78): Rapid Medical Research, Inc.
🇺🇸
Cleveland, Ohio, United States
Texas Center for Drug Development, Inc.
🇺🇸
Houston, Texas, United States
Northpoint Pediatrics, LLC
🇺🇸
Indianapolis, Indiana, United States
California Research Foundation
🇺🇸
San Diego, California, United States
Cincinnati Children's Hospital Medical Center (CCHMC)
🇺🇸
Cincinnati, Ohio, United States
Arkansas Pediatric Clinic
🇺🇸
Little Rock, Arkansas, United States
The Children's Clinic of Jonesboro, PA
🇺🇸
Jonesboro, Arkansas, United States
Loma Linda University Health Care - Moreno Valley Pediatrics
🇺🇸
Moreno Valley, California, United States
Miami Research Associates
🇺🇸
Miami, Florida, United States
Advanced Clinical Research
🇺🇸
Meridian, Idaho, United States
Midwest Children's Health Research Institute
🇺🇸
Lincoln, Nebraska, United States
Cary Pediatric Center
🇺🇸
Cary, North Carolina, United States
Innovis Health, LLC dba Essentia Health South University Clinic
🇺🇸
Fargo, North Dakota, United States
Charleston Pediatrics
🇺🇸
Charleston, South Carolina, United States
Murray Pediatrics
🇺🇸
Murray, Utah, United States
Advanced Pediatrics
🇺🇸
Vienna, Virginia, United States
Duke Health Center
🇺🇸
Durham, North Carolina, United States
Radiant Research, Inc.
🇺🇸
San Antonio, Texas, United States
Coastal Clinical Research Inc.
🇺🇸
Daphne, Alabama, United States
Pediatric Care Medical Group
🇺🇸
Huntington Beach, California, United States
Center for Clinical Trials, LLC
🇺🇸
Paramount, California, United States
West Coast Clinical Trials, LLC
🇺🇸
Cypress, California, United States
Bayview Research Group, LLC
🇺🇸
Valley Village, California, United States
Pediatrics and Adolescent Medicine, PA
🇺🇸
Marietta, Georgia, United States
Clinical Research Atlanta
🇺🇸
Stockbridge, Georgia, United States
Pediatrics and Adolescent Medicine
🇺🇸
Woodstock, Georgia, United States
Kentucky Pediatric/Adult Research
🇺🇸
Bardstown, Kentucky, United States
Central Kentucky Research Associates, Inc.
🇺🇸
Lexington, Kentucky, United States
Brownsboro Park Pediatrics
🇺🇸
Louisville, Kentucky, United States
Bluegrass Clinical Research, Inc.
🇺🇸
Louisville, Kentucky, United States
The Center for Pharmaceutical Research, PC
🇺🇸
Kansas City, Missouri, United States
Rochester Clinical Research, Inc.
🇺🇸
Rochester, New York, United States
Mercy Health Research
🇺🇸
Saint Louis, Missouri, United States
Sundance Clinical Research, LLC
🇺🇸
Saint Louis, Missouri, United States
Sundance Clinical Research
🇺🇸
Saint Louis, Missouri, United States
Duke University Medical Center - Duke Health Center
🇺🇸
Durham, North Carolina, United States
Rochester Clinical Research
🇺🇸
Rochester, New York, United States
SUNY Upstate Medical University
🇺🇸
Syracuse, New York, United States
Durham Pediatrics
🇺🇸
Durham, North Carolina, United States
Lynn Institute of Norman (LION)
🇺🇸
Norman, Oklahoma, United States
Senders Pediatrics
🇺🇸
Cleveland, Ohio, United States
PMG Research of Raleigh, LLC
🇺🇸
Raleigh, North Carolina, United States
Wake Internal Medicine Consultants, Inc
🇺🇸
Raleigh, North Carolina, United States
Preferred Primary Care Physicians, Inc.
🇺🇸
Carnegie, Pennsylvania, United States
Oklahoma State University - Center for Health Sciences - Pediatric Research Houston Center
🇺🇸
Tulsa, Oklahoma, United States
Liberty Family Practice
🇺🇸
Erie, Pennsylvania, United States
Pennridge Pediatric Associates
🇺🇸
Sellersville, Pennsylvania, United States
Pediatric Healthcare of Northwest Houston
🇺🇸
Tomball, Texas, United States
Advances In Health, Inc.
🇺🇸
Houston, Texas, United States
Omega Medical Research
🇺🇸
Warwick, Rhode Island, United States
The Office of Dr. Roberta Braun, MD
🇺🇸
Austin, Texas, United States
Richard K. Ohnmacht, MD
🇺🇸
Cranston, Rhode Island, United States
Benchmark Research
🇺🇸
San Angelo, Texas, United States
University of Texas Medical Branch Pediatric Specialty Center
🇺🇸
League City, Texas, United States
Clinical Trials Of Texas, Inc
🇺🇸
San Antonio, Texas, United States
Pediatric Healthcare of Northwest Houston, PA
🇺🇸
Tomball, Texas, United States
Clinical Trials of Texas
🇺🇸
San Antonio, Texas, United States
First Steps Pediatrics
🇺🇸
San Antonio, Texas, United States
Pediatric Associates of Charlottesville
🇺🇸
Charlottesville, Virginia, United States
West Office - Pediatric Associates of Charlottesville
🇺🇸
Charlottesville, Virginia, United States
North Office - Pediatric Associates of Charlottesville
🇺🇸
Charlottesville, Virginia, United States
Clinical Research Associates of Tidewater
🇺🇸
Norfolk, Virginia, United States
The Vancouver Clinic
🇺🇸
Vancouver, Washington, United States
Jean Brown Research
🇺🇸
Salt Lake City, Utah, United States
Colorado Springs Family Practice
🇺🇸
Colorado Springs, Colorado, United States
Heartland Research Associates, LLC
🇺🇸
Wichita, Kansas, United States
Aspen Medical Group / Odyssey Research
🇺🇸
Saint Paul, Minnesota, United States
Lynn Institute of the Rockies
🇺🇸
Colorado Springs, Colorado, United States
Allina Health Bandana Square Clinic
🇺🇸
Saint Paul, Minnesota, United States
Quality Clinical Research, Inc.
🇺🇸
Omaha, Nebraska, United States
Lynn Health Science Institute
🇺🇸
Oklahoma City, Oklahoma, United States
Oklahoma State University - Center for Health Sciences Houston Parke Physicians
🇺🇸
Tulsa, Oklahoma, United States
Wake Research Associates
🇺🇸
Raleigh, North Carolina, United States
Monroe Clinic
🇺🇸
Monroe, Wisconsin, United States
Clinical Research Center of Nevada
🇺🇸
Las Vegas, Nevada, United States
Coastal Carolina Research Center
🇺🇸
Mount Pleasant, South Carolina, United States
PMG Research of Charleston
🇺🇸
Mount Pleasant, South Carolina, United States
Clinical Research Associates, Inc.
🇺🇸
Nashville, Tennessee, United States