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

Completed · Phase 2

Conditions studied: Vaccines, Meningococcal Vaccines

In brief

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.

Key facts

Study ID

NCT01461993

Run by

Pfizer

People needed

2499

Starts

2011-09-28

Expected to finish

2013-07-06

Last updated by the study team

2018-12-19

Who can join

Age: 11 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Radiant Research, Inc. — Chandler, Arizona, United States
• The Children's Clinic of Jonesboro, PA — Jonesboro, Arkansas, United States
• Arkansas Pediatric Clinic — Little Rock, Arkansas, United States
• West Coast Clinical Trials, LLC — Cypress, California, United States
• Pediatric Care Medical Group — Huntington Beach, California, United States
• Loma Linda University Health Care - Moreno Valley Pediatrics — Moreno Valley, California, United States
• Bayview Research Group, LLC — Paramount, California, United States
• Center for Clinical Trials, LLC — Paramount, California, United States
• California Research Foundation — San Diego, California, United States
• Bayview Research Group, LLC — Valley Village, California, United States
• Lynn Institute of the Rockies — Colorado Springs, Colorado, United States
• Colorado Springs Family Practice — Colorado Springs, Colorado, United States
• Miami Research Associates — Miami, Florida, 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
• Advanced Clinical Research — Meridian, Idaho, United States
• Northpoint Pediatrics, LLC — Indianapolis, Indiana, United States
• Heartland Research Associates, LLC — Wichita, Kansas, 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
• Allina Health Bandana Square Clinic — Saint Paul, Minnesota, United States
• Coastal Clinical Research Inc. — Daphne, Alabama, United States

Full record on ClinicalTrials.gov

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