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

Vaccines Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461993
• Other study ID #: B1971011
• Secondary ID: 6108A1-2007
• Status: Completed
• Phase: Phase 2
• Start date: September 28, 2011
• Est. completion date: July 6, 2013

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2499
• Est. completion date: July 6, 2013
• Est. primary completion date: July 6, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Meningococcal Vaccines
• Vaccines

Intervention

Biological:
• rLP2086 and Gardasil
Gardasil vaccine and rLP2086 injection will be given to the subject concomitantly in Group 1 at Months 0, 2 and 6.
• rLP2086
Injections of rLP2086 and saline will be given to the subject concomitantly in Group 2 at Months 0, 2 and 6.
• Gardasil
Injections of saline and Gardasil vaccine will be given to the subject concomitantly in Group 3 at Months 0, 2 and 6.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens		1 month after Vaccination 3
Primary	Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]		1 month after Vaccination 3
Primary	Percentage of Participants With at Least One Adverse Event (AE)		Vaccination 1 up to 1 month after Vaccination 3
Secondary	Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)		1 month after Vaccination 3
Secondary	Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants		Before vaccination 1
Secondary	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
Secondary	Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level		Before Vaccination 1, 1 month after Vaccination 2, 3
Secondary	Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)		Before Vaccination 1, 1 month after Vaccination 2, 3