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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
2,499
Gardasil vaccine and rLP2086 injection will be given to the subject concomitantly in Group 1 at Months 0, 2 and 6.
Injections of rLP2086 and saline will be given to the subject concomitantly in Group 2 at Months 0, 2 and 6.
Injections of saline and Gardasil vaccine will be given to the subject concomitantly in Group 3 at Months 0, 2 and 6.
Coastal Clinical Research Inc.
Daphne, Alabama, United States
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
Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens
Time frame: 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
Percentage of Participants With at Least One Adverse Event (AE)
Time frame: Vaccination 1 up to 1 month after Vaccination 3
Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)
Time frame: 1 month after Vaccination 3
Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants
Time frame: 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
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
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)
Time frame: Before Vaccination 1, 1 month after Vaccination 2, 3
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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
...and 77 more locations