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

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

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.

Study Overview

• Status: Completed
• Conditions: Vaccines; Meningococcal Vaccines
• Intervention / Treatment: Biological: rLP2086 + MCV4 + Tdap; Biological: MCV4 + Tdap + saline; Biological: rLP2086 + saline

• Study Type: Interventional
• Enrollment (Actual): 2648
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Radiant Research, Inc.
    • Daphne, Alabama, United States, 36526
      • Costal Clinical Research, Inc.
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Radiant Research, Inc.
    • Chandler, Arizona, United States, 85224
      • Clinical Research Advantage Inc/ East Valley Family Physicians, PLC
    • Mesa, Arizona, United States, 85203
      • Clinical Research Advantage, Inc./Mesa Family Medical Center, PC
    • Mesa, Arizona, United States, 85213
      • Clinical Research Advantage, Inc./Desert
    • Tucson, Arizona, United States, 85712
      • Radiant Research, Inc.
    • Tucson, Arizona, United States, 85710
      • Radiant Research, Inc.
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • The Children's Clinic of Jonesboro, PA
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Pediatric Clinic
  • California
    • Fresno, California, United States, 93726
      • Kaiser Permanente Fresno
    • Hayward, California, United States, 94545
      • Kaiser Permanente Hayward
    • Huntington Beach, California, United States, 92647
      • Pediatric Care Medical Group
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Loma Linda, California, United States, 92350
      • Loma Linda University
    • Loma Linda, California, United States, 92354
      • Loma Linda University Health Care Pediatric Clinic
    • Moreno Valley, California, United States, 92557
      • Loma Linda University Health Care - Moreno Valley Pediatrics
    • Paramount, California, United States, 90723
      • Bayview Research Group, LLC
    • Paramount, California, United States, 90723
      • Center for Clinical Trials, LLC
    • Sacramento, California, United States, 95815
      • Kaiser Permanente Sacramento
    • San Diego, California, United States, 92103
      • California Research Foundation
    • Valley Village, California, United States, 91607
      • Bayview Research Group, LLC
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Lynn Institute of the Rockies
    • Colorado Springs, Colorado, United States, 80909
      • Colorado Springs Family Practice
    • Denver, Colorado, United States, 80239
      • Radiant Research, Inc.
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Norwich Pediatric Group, P.C.
  • Florida
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University School of Medicine
    • Atlanta, Georgia, United States, 30322
      • Emory University School of Medicine Department of Pediatrics
    • Atlanta, Georgia, United States, 30342
      • Radiant Research, Inc
    • Dalton, Georgia, United States, 30721
      • North Georgia Clinical Research Center dba Whites Pediatrics
    • Marietta, Georgia, United States, 30062
      • Pediatrics and Adolescent Medicine, PA
    • Woodstock, Georgia, United States, 30189
      • Pediatrics and Adolescent Medicine
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Advanced Clinical Research
  • Illinois
    • DeKalb, Illinois, United States, 60115
      • Northern Illinois Research Associates
  • Iowa
    • Council Bluffs, Iowa, United States, 51503
      • Clinical Research Advantage, Inc./ Ridge Family Practice, PC
  • Kansas
    • Augusta, Kansas, United States, 67010
      • Heartland Research Associates, LLC
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates, LLC
    • Wichita, Kansas, United States, 67208
      • Via Christi Clinic, P.A.
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Kentucky Pediatric/Adult Research
    • Louisville, Kentucky, United States, 40207
      • Brownsboro Park Pediatrics
    • Louisville, Kentucky, United States, 40291
      • Bluegrass Clinical Research, Inc.
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Pediatrics: Children and Youth Project
  • Michigan
    • Stevensville, Michigan, United States, 49127
      • Southwestern Medical Clinic Lakeland HealthCare Affiliate
  • Minnesota
    • Saint Paul, Minnesota, United States, 55108
      • Allina Health Bandana Square Clinic
    • Saint Paul, Minnesota, United States, 55108
      • Aspen Medical Group/ Odyssey Research
    • Saint Paul, Minnesota, United States, 55108
      • Aspen Medical Group
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • The Center for Pharmaceutical Research, PC
    • Saint Louis, Missouri, United States, 63141
      • Mercy Health Research
    • Saint Louis, Missouri, United States, 63141
      • Sundance Clinical Research, LLC
    • Saint Louis, Missouri, United States, 63104
      • Saint Louis University
    • Saint Louis, Missouri, United States, 63141
      • Radiant Research, Inc.
  • Nebraska
    • Fremont, Nebraska, United States, 68025
      • Clinical Research Advantage, Inc. / Prairie Fields Family Medicine, PC
    • Lincoln, Nebraska, United States, 68504
      • Midwest Children's Health Research Institute
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research, Inc.
    • Omaha, Nebraska, United States, 68131
      • Creighton Pediatric Infectious Diseases Creighton University Medical Center
  • Nevada
    • Henderson, Nevada, United States, 89014
      • Clinical Research Center of Nevada
    • Las Vegas, Nevada, United States, 89105
      • Clinical Research Center of Nevada
  • New York
    • East Syracuse, New York, United States, 13057
      • Child Health Care Associates
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Duke University Medical Center - Duke Health Center
    • Durham, North Carolina, United States, 27704
      • Durham Pediatrics
    • Durham, North Carolina, United States, 27705
      • Duke Health Center
    • Raleigh, North Carolina, United States, 27609
      • PMG Research of Raleigh, LLC
    • Raleigh, North Carolina, United States, 27612
      • PMG Research of Raleigh, LLC
    • Raleigh, North Carolina, United States, 27609
      • PMG Research of Raleigh, LLC -
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Odyssey Research
    • Fargo, North Dakota, United States, 58103
      • Innovis Health
  • Ohio
    • Akron, Ohio, United States, 44311
      • Radiant Research, Inc
    • Cincinnati, Ohio, United States, 45206
      • Cincinnati Center for Clinical Research, Satellite Site - Clinic
    • Cincinnati, Ohio, United States, 45229-3039
      • Cincinnati Childrens Hospital Medical Center Gamble Program for Clinical Studies
    • Cleveland, Ohio, United States, 44122
      • Rapid Medical Research, Inc.
    • Cleveland, Ohio, United States, 44121
      • Senders Pediatrics
    • Cleveland, Ohio, United States, 44121
      • Dr. Shelly David Senders, MD Inc. dba Senders Pediatrics
    • Columbus, Ohio, United States, 43212
      • Radiant Research
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Association
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatrics, Inc.
    • Huber Heights, Ohio, United States, 45424
      • Ohio Pediatrics, Inc.
    • Kettering, Ohio, United States, 45420
      • Ohio Pediatric Research
  • Oklahoma
    • El Reno, Oklahoma, United States, 73036
      • Christopher Brad Redden, ARNP Healthcare One Urgent Care and Family Practice
    • Norman, Oklahoma, United States, 73069
      • Lynn Institute of Norman (LION)
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Tulsa, Oklahoma, United States, 74127
      • Oklahoma State University - Center for Health Sciences - Pediatric Research
  • Rhode Island
    • Cranston, Rhode Island, United States, 02920
      • Office of Richard Ohnmacht
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Radiant Research, Inc.
    • Charleston, South Carolina, United States, 29401
      • Charleston Pediatrics
    • Mount Pleasant, South Carolina, United States, 29464
      • PMG Research of Charleson
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Pmg Research of Bristol
    • Bristol, Tennessee, United States, 37620
      • Internal Medicine & Pediatric Associates of Bristol, PC
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates, Inc.
  • Texas
    • Austin, Texas, United States, 78745
      • Tekton Research, Inc.
    • Dallas, Texas, United States, 75231
      • Radiant Research, Inc.
    • Houston, Texas, United States, 77081
      • Texas Center for Drug Development, Inc.
    • Houston, Texas, United States, 77055
      • West Houston Clinical Research Service
    • Houston, Texas, United States, 77070
      • Pediatric Healthcare of Northwest Houston
    • Houston, Texas, United States, 77030
      • Advances in Health Research, Inc
    • Houston, Texas, United States, 77065
      • Pediatric Healthcare of Northwest Houston
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
    • San Antonio, Texas, United States, 78229
      • Radiant Research, Inc.
    • San Antonio, Texas, United States, 78212
      • Child Care Associates
    • San Antonio, Texas, United States, 78254
      • First Steps Pediatrics
    • Tomball, Texas, United States, 77375
      • Pediatric Healthcare of Northwest Houston, PA
    • Tomball, Texas, United States, 77375
      • Pediatric Healthcare of Northwest Houston
  • Utah
    • Murray, Utah, United States, 84123
      • Radiant Research, Inc.
    • Salt Lake City, Utah, United States, 84124
      • Jean Brown Research
    • Salt Lake City, Utah, United States, 84109
      • J. Lewis Resarch Incorporated, Foothill Family Clinic
    • Salt Lake City, Utah, United States, 84121
      • J. Lewis Research Inc. - Foothill Family Clinic South
    • South Jordan, Utah, United States, 84095
      • J. Lewis Research, Inc. - Jordan River Family Medicine
    • West Jordan, Utah, United States, 84088
      • Advanced Clinical Research
  • Virginia
    • Burke, Virginia, United States, 22015
      • PI-Coor Clinical Research, LLC
    • Charlottesville, Virginia, United States, 22902
      • Pediatric Associates of Charlottesville, PLC
    • Charlottesville, Virginia, United States, 22903
      • Pediatric Associates of Charlottesville, PLC - West Satellite
    • Charlottesville, Virginia, United States, 22911
      • Pediatric Associates of Charlottesville, PLC - North Satellite
  • Washington
    • Vancouver, Washington, United States, 98664
      • The Vancouver Clinic
    • Vancouver, Washington, United States, 98686
      • The Vancouver Clinic
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Clinic, Ltd
    • Monroe, Wisconsin, United States, 53566
      • Monroe Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: MCV4 + Tdap+ rLP2086; Group 1 - MCV4 + Tdap + rLP2086	Biological: rLP2086 + MCV4 + Tdap; At visit 1, group 1 will receive MCV4 + Tdap vaccines concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 1 will receive an injection of rLP2086.
ACTIVE_COMPARATOR: MCV4 + Tdap + saline; Group 2, MCV4 + Tdap+ saline	Biological: MCV4 + Tdap + saline; At visit 1, group 2 will receive MCV4 + Tdap vaccines concomitantly with an injection of saline. At visits 3 and 5 (months 2 and 6), this group will receive a saline injection only.
PLACEBO_COMPARATOR: Saline + saline + rLP2086; Group 3- rLP2086 + saline	Biological: rLP2086 + saline; At visit 1, group 3 will receive 2 injections of saline concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 3 will receive an injection of rLP2086. Subjects randomized to this group will receive MCV4 and Tdap following their final visit blood draw (Visit 6).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens	Antibody GMCs of 2 antigens of diphtheria and tetanus toxoid were computed in International Units per milliliter (IU/mL) along with corresponding 2-sided 95 percent (%) confidence intervals (CIs). Here, 'number of participants analyzed' signifies participants with valid and determinate assay results for given antigen.	1 Month after Vaccination 1
Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens	Antibody GMCs of 4 acellular pertussis antigens (pertussis toxoid, pertussis filamentous hemagglutinin, pertussis pertactin and pertussis fimbrial agglutinogens types 2+3) were computed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL) along with corresponding 2-sided 95% CIs.	1 Month after Vaccination 1
Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens	Antibody GMTs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) were computed along with corresponding 2-sided 95% CIs.	1 Month after Vaccination 1
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3	Antibody hSBA GMTs of primary strain PMB80 [A22] and PMB2948 [B24] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.	1 Month after Vaccination 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens	Seroconversion rate for Tdap antigens was defined as greater than or equal to (>=) 4-, 2-fold rise in antibody concentration, if prevaccination antibody concentration was less than or equal to (<=), greater than (>) cutoff value, respectively. For MCV4 antigens >=4-fold rise on serum bactericidal assay using rabbit complement (rSBA) titers if baseline value >= lower limit of quantitation (LLOQ), postdose rSBA titers >=2×LLOQ if baseline value was less than (<) LLOQ. Cutoff value =0.1 IU/mL for diphtheria and tetanus, 0.9,2.9,3.0,10.6 EU/mL for pertussis toxoid, filamentous hemagglutinin, pertactin, fimbriae agglutinogens types 2 + 3, respectively.	1 Month after Vaccination 1
Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens	Participants with antibody concentration level of greater than or equal to 1.0 IU/mL for diphtheria and tetanus antigens were computed along with corresponding 2-sided 95% CIs.	1 Month after Vaccination 1
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2	Antibody hSBA of primary strain PMB80 [A22] and PMB2948 [B24] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis.	Before Vaccination 1, 1 Month after Vaccination (Vac) 2
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ)	Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 [A22] and 1:8 for PMB2948 [B24].	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	Antibody hSBA of primary strain PMB80 [A22] and PMB2948 [B24] with hSBA titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 were computed along with corresponding 2-sided 95% CIs.	Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogloblulin G (IgG) Measured by GMC	IgG GMCs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) of participants were computed along with corresponding 2-sided 95% CIs. CIs were back transformations of confidence levels based on Student t distribution for mean logarithm of titers.	Before Vaccination 1, 1 Month after Vaccination 1
Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level		1 Month after Vaccination (Vac) 2, 3
Percentage of Participants With at Least One Adverse Event (AE)	An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.	Vaccination phase (baseline up to 1 month after Vaccination 3); Follow-up phase (from 1 month up to 6 months after Vaccination 3)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 28, 2011
• Primary Completion (ACTUAL): May 8, 2014
• Study Completion (ACTUAL): May 8, 2014

Study Registration Dates

• First Submitted: September 28, 2011
• First Submitted That Met QC Criteria: October 26, 2011
• First Posted (ESTIMATE): October 28, 2011

Study Record Updates

• Last Update Posted (ACTUAL): December 20, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: vaccine; adolescents; Tdap; rLP2086; meningitis B; N. meningitidis serogroup B; MCV4; observer-blind
• Other Study ID Numbers: B1971015; 6108A1-2005 (OTHER: Alias Study Number)