Clinical trial NCT01461993: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vaccines
Meningococcal Vaccines
Keywords: vaccine
rLP2086
Gardasil
HPV
meningitis B
N. meningitidis serogroup B
adolescents
single-blind
Meningococcal Vaccines
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-10-28
Enrollment: 2499
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens
timeFrame: 1 month after Vaccination 3
measure: Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]
timeFrame: 1 month after Vaccination 3
measure: Percentage of Participants With at Least One Adverse Event (AE)
timeFrame: Vaccination 1 up to 1 month after Vaccination 3
Secondary outcomes:
measure: Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)
timeFrame: 1 month after Vaccination 3
measure: Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants
timeFrame: Before vaccination 1
measure: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
timeFrame: Before vaccination 1, 1 month after vaccination (Vac) 2, 3
measure: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
timeFrame: Before Vaccination 1, 1 month after Vaccination 2, 3
measure: Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)
timeFrame: Before Vaccination 1, 1 month after Vaccination 2, 3
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Coastal Clinical Research Inc.
state: Alabama
city: Chandler
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Jonesboro
country: United States
facility: The Children's Clinic of Jonesboro, PA
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Pediatric Clinic
state: Arkansas
city: Cypress
country: United States
facility: West Coast Clinical Trials, LLC
state: California
city: Huntington Beach
country: United States
facility: Pediatric Care Medical Group
state: California
city: Moreno Valley
country: United States
facility: Loma Linda University Health Care - Moreno Valley Pediatrics
state: California
city: Paramount
country: United States
facility: Bayview Research Group, LLC
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: Valley Village
country: United States
facility: Bayview Research Group, LLC
state: California
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Family Practice
state: Colorado
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Marietta
country: United States
facility: Pediatrics and Adolescent Medicine, PA
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Woodstock
country: United States
facility: Pediatrics and Adolescent Medicine
state: Georgia
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Indianapolis
country: United States
facility: Northpoint Pediatrics, LLC
state: Indiana
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research
state: Kentucky
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Louisville
country: United States
facility: Brownsboro Park Pediatrics
state: Kentucky
city: Louisville
country: United States
facility: Bluegrass Clinical Research, Inc.
state: Kentucky
city: Saint Paul
country: United States
facility: Allina Health Bandana Square Clinic
state: Minnesota
city: Saint Paul
country: United States
facility: Aspen Medical Group / Odyssey Research
state: Minnesota
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research, PC
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Henderson
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Henderson
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Cary
country: United States
facility: Cary Pediatric Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center - Duke Health Center
state: North Carolina
city: Durham
country: United States
facility: Durham Pediatrics
state: North Carolina
city: Durham
country: United States
facility: Duke Health Center
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh, LLC
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh, LLC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Internal Medicine Consultants, Inc
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Fargo
country: United States
facility: Innovis Health, LLC dba Essentia Health South University Clinic
state: North Dakota
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center (CCHMC)
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center (CCHMC)
state: Ohio
city: Cleveland
country: United States
facility: Senders Pediatrics
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman (LION)
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma State University - Center for Health Sciences - Pediatric Research Houston Center
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma State University - Center for Health Sciences Houston Parke Physicians
state: Oklahoma
city: Carnegie
country: United States
facility: Preferred Primary Care Physicians, Inc.
state: Pennsylvania
city: Erie
country: United States
facility: Liberty Family Practice
state: Pennsylvania
city: Sellersville
country: United States
facility: Pennridge Pediatric Associates
state: Pennsylvania
city: Cranston
country: United States
facility: Richard K. Ohnmacht, MD
state: Rhode Island
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Charleston
country: United States
facility: Charleston Pediatrics
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Mount Pleasant
country: United States
facility: PMG Research of Charleston
state: South Carolina
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Austin
country: United States
facility: The Office of Dr. Roberta Braun, MD
state: Texas
city: Houston
country: United States
facility: Advances In Health, Inc.
state: Texas
city: Houston
country: United States
facility: Pediatric Healthcare of Northwest Houston
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: League City
country: United States
facility: University of Texas Medical Branch Pediatric Specialty Center
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials Of Texas, Inc
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: San Antonio
country: United States
facility: First Steps Pediatrics
state: Texas
city: San Antonio
country: United States
facility: Radiant Research, Inc.
state: Texas
city: Tomball
country: United States
facility: Pediatric Healthcare of Northwest Houston, PA
state: Texas
city: Tomball
country: United States
facility: Pediatric Healthcare of Northwest Houston
state: Texas
city: Murray
country: United States
facility: Murray Pediatrics
state: Utah
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: Charlottesville
country: United States
facility: Pediatric Associates of Charlottesville
state: Virginia
city: Charlottesville
country: United States
facility: West Office - Pediatric Associates of Charlottesville
state: Virginia
city: Charlottesville
country: United States
facility: North Office - Pediatric Associates of Charlottesville
state: Virginia
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
city: Vienna
country: United States
facility: Advanced Pediatrics
state: Virginia
city: Vancouver
country: United States
facility: The Vancouver Clinic
state: Washington
city: Vancouver
country: United States
facility: The Vancouver Clinic
state: Washington
city: Monroe
country: United States
facility: Monroe Clinic
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.