Clinical trial NCT01461980: A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age
Official title: A Phase 2, Randomized, Active-controlled, Observer-blinded Trial, To Assess The Safety, Tolerability, And Immunogenicity Of Mcv4, Tdap Vaccine And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged > = 10 To <13 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vaccines
Meningococcal Vaccines
Keywords: vaccine
rLP2086
MCV4
Tdap
meningitis B
N. meningitidis serogroup B
adolescents
observer-blind
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-10-28
Enrollment: 2648
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
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 MCV4(quadrivalent meningococcal polysaccharide conjugate, meningococcal serogroups A,C,Y, and W135), Tdap (diphtheria, tetanus, and acellular pertussis), and bivalent rLP2086 vaccine. Healthy male and female subjects, between the ages of 10 to 12 years old, will be randomized into 1 of 3 groups. The subjects, investigators, site staff and sponsor will be blinded to all injections given throughout the study. An unblinded administrator will be responsible to administer the vaccinations to all subjects and will be unblinded to the subject randomization in order to determine which subjects were in randomized to group 3 so they may receive their catch-up vaccinations of MCV4 and Tdap. A final telephone contact will be conducted with all subjects 6-months post their last vaccination to obtain safety information.


Eligibility criteria: Inclusion Criteria:

* Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (and a legally authorized representative) has been informed of all pertinent aspects of the study.
* Parent /legally authorized representative and subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
* Male or female subject aged greater than or equal to 10 and \<13 years at the time of enrollment.
* Available for the entire study period and can be reached by telephone.
* Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
* Has received full series (5-dose series is preferred, 4-dose catch up series is allowed) of diphtheria, tetanus and pertussis (whole cell or acellular) vaccines per country specific recommendations applicable at the time of receipt.
* Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study.

Exclusion Criteria:

* Previous vaccination with any meningococcal serogroup B vaccine.
* Vaccination with any diphtheria, tetanus or pertussis vaccine within 5 years of the first study vaccination.
* Previous vaccination with any MCV4 vaccine.
* A previous anaphylactic reaction to any vaccine or vaccine-related component.
* Contraindication to vaccination with MCV4 and/or Tdap vaccine.
* Subjects receiving any allergen immunotherapy with a non-licensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
* A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects with terminal complement deficiency may not be included.
* History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoea.
* Significant neurological disorder or history of seizure (excluding simple febrile seizure).
* Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination.
* Current chronic use of systemic antibiotics.
* Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

Primary outcomes:
measure: Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens
timeFrame: 1 Month after Vaccination 1
measure: Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens
timeFrame: 1 Month after Vaccination 1
measure: Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens
timeFrame: 1 Month after Vaccination 1
measure: Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3
timeFrame: 1 Month after Vaccination 3
Secondary outcomes:
measure: Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens
timeFrame: 1 Month after Vaccination 1
measure: Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens
timeFrame: 1 Month after Vaccination 1
measure: Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2
timeFrame: Before Vaccination 1, 1 Month after Vaccination (Vac) 2
measure: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= 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 (Vac) 2, 3
Other outcomes:
measure: Immunogloblulin G (IgG) Measured by GMC
timeFrame: Before Vaccination 1, 1 Month after Vaccination 1
measure: Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level
timeFrame: 1 Month after Vaccination (Vac) 2, 3
measure: Percentage of Participants With at Least One Adverse Event (AE)
timeFrame: Vaccination phase (baseline up to 1 month after Vaccination 3); Follow-up phase (from 1 month up to 6 months after Vaccination 3)
Locations:
city: Birmingham
country: United States
facility: Radiant Research, Inc.
state: Alabama
city: Daphne
country: United States
facility: Costal Clinical Research, Inc.
state: Alabama
city: Chandler
country: United States
facility: Clinical Research Advantage Inc/ East Valley Family Physicians, PLC
state: Arizona
city: Chandler
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Mesa
country: United States
facility: Clinical Research Advantage, Inc./Mesa Family Medical Center, PC
state: Arizona
city: Mesa
country: United States
facility: Clinical Research Advantage, Inc./Desert
state: Arizona
city: Tucson
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Tucson
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: Fresno
country: United States
facility: Kaiser Permanente Fresno
state: California
city: Hayward
country: United States
facility: Kaiser Permanente Hayward
state: California
city: Huntington Beach
country: United States
facility: Pediatric Care Medical Group
state: California
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Health Care Pediatric Clinic
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
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: Sacramento
country: United States
facility: Kaiser Permanente Sacramento
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: Denver
country: United States
facility: Radiant Research, Inc.
state: Colorado
city: Norwich
country: United States
facility: Norwich Pediatric Group, P.C.
state: Connecticut
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine Department of Pediatrics
state: Georgia
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Atlanta
country: United States
facility: Radiant Research, Inc
state: Georgia
city: Dalton
country: United States
facility: North Georgia Clinical Research Center dba Whites Pediatrics
state: Georgia
city: Marietta
country: United States
facility: Pediatrics and Adolescent Medicine, PA
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: DeKalb
country: United States
facility: Northern Illinois Research Associates
state: Illinois
city: Council Bluffs
country: United States
facility: Clinical Research Advantage, Inc./ Ridge Family Practice, PC
state: Iowa
city: Augusta
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Via Christi Clinic, P.A.
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Pediatrics: Children and Youth Project
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: Stevensville
country: United States
facility: Southwestern Medical Clinic Lakeland Healthcare Affiliate
state: Michigan
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: Saint Paul
country: United States
facility: Aspen Medical Group
state: Minnesota
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research, PC
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Saint Louis
country: United States
facility: Radiant Research, Inc.
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Fremont
country: United States
facility: Clinical Research Advantage, Inc. / Prairie Fields Family Medicine, PC
state: Nebraska
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: Omaha
country: United States
facility: Creighton Pediatric Infectious Diseases Creighton University Medical Center
state: Nebraska
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: East Syracuse
country: United States
facility: Child Health Care Associates
state: New York
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: PMG Research of Raleigh, LLC
state: North Carolina
city: Fargo
country: United States
facility: Innovis Health
state: North Dakota
city: Fargo
country: United States
facility: Odyssey Research
state: North Dakota
city: Akron
country: United States
facility: Radiant Research, Inc
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Center for Clinical Research, Satellite Site - Clinic
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center Gamble Program for Clinical Studies
state: Ohio
city: Cleveland
country: United States
facility: Dr. Shelly David Senders, MD Inc. dba Senders Pediatrics
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: Columbus
country: United States
facility: Radiant Research
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatrics, Inc.
state: Ohio
city: Huber Heights
country: United States
facility: Ohio Pediatrics, Inc.
state: Ohio
city: Kettering
country: United States
facility: Ohio Pediatric Research
state: Ohio
city: El Reno
country: United States
facility: Christopher Brad Redden, ARNP Healthcare One Urgent Care and Family Practice
state: Oklahoma
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
state: Oklahoma
city: Cranston
country: United States
facility: Office of Richard Ohnmacht
state: Rhode Island
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Anderson
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Charleston
country: United States
facility: Charleston Pediatrics
state: South Carolina
city: Mount Pleasant
country: United States
facility: PMG Research of Charleson
state: South Carolina
city: Bristol
country: United States
facility: Internal Medicine & Pediatric Associates of Bristol, PC
state: Tennessee
city: Bristol
country: United States
facility: PMG Research of Bristol
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Austin
country: United States
facility: Tekton Research, Inc.
state: Texas
city: Dallas
country: United States
facility: Radiant Research, Inc.
state: Texas
city: Houston
country: United States
facility: Advances in Health Research, Inc
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research Service
state: Texas
city: Houston
country: United States
facility: Pediatric Healthcare of Northwest Houston
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: San Antonio
country: United States
facility: Child Care Associates
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Radiant Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: First Steps Pediatrics
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: Radiant Research, Inc.
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Resarch Incorporated, Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research Inc. - Foothill Family Clinic South
state: Utah
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: South Jordan
country: United States
facility: J. Lewis Research, Inc. - Jordan River Family Medicine
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Burke
country: United States
facility: PI-Coor Clinical Research, LLC
state: Virginia
city: Charlottesville
country: United States
facility: Pediatric Associates of Charlottesville, PLC
state: Virginia
city: Charlottesville
country: United States
facility: Pediatric Associates of Charlottesville, PLC - West Satellite
state: Virginia
city: Charlottesville
country: United States
facility: Pediatric Associates of Charlottesville, PLC - North Satellite
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: La Crosse
country: United States
facility: Gundersen Clinic, LTD
state: Wisconsin
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.