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
2 other identifiers
interventional
2,648
1 country
117
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2011
117 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2011
CompletedStudy Start
First participant enrolled
September 28, 2011
CompletedFirst Posted
Study publicly available on registry
October 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2014
CompletedResults Posted
Study results publicly available
May 25, 2015
CompletedDecember 20, 2018
November 1, 2018
2.6 years
September 28, 2011
May 7, 2015
November 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (5)
Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens
1 Month after Vaccination 1
Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens
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
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)
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
Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3
Other Outcomes (3)
Immunogloblulin G (IgG) Measured by GMC
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)
Vaccination phase (baseline up to 1 month after Vaccination 3); Follow-up phase (from 1 month up to 6 months after Vaccination 3)
Study Arms (3)
MCV4 + Tdap+ rLP2086
ACTIVE COMPARATORGroup 1 - MCV4 + Tdap + rLP2086
MCV4 + Tdap + saline
ACTIVE COMPARATORGroup 2, MCV4 + Tdap+ saline
Saline + saline + rLP2086
PLACEBO COMPARATORGroup 3- rLP2086 + saline
Interventions
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.
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.
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (117)
Radiant Research, Inc.
Birmingham, Alabama, 35209, United States
Costal Clinical Research, Inc.
Daphne, Alabama, 36526, United States
Clinical Research Advantage Inc/ East Valley Family Physicians, PLC
Chandler, Arizona, 85224, United States
Radiant Research, Inc.
Chandler, Arizona, 85224, United States
Clinical Research Advantage, Inc./Mesa Family Medical Center, PC
Mesa, Arizona, 85203, United States
Clinical Research Advantage, Inc./Desert
Mesa, Arizona, 85213, United States
Radiant Research, Inc.
Tucson, Arizona, 85710, United States
Radiant Research, Inc.
Tucson, Arizona, 85712, United States
The Children's Clinic of Jonesboro, PA
Jonesboro, Arkansas, 72401, United States
Arkansas Pediatric Clinic
Little Rock, Arkansas, 72205, United States
Kaiser Permanente Fresno
Fresno, California, 93726, United States
Kaiser Permanente Hayward
Hayward, California, 94545, United States
Pediatric Care Medical Group
Huntington Beach, California, 92647, United States
Loma Linda University
Loma Linda, California, 92350, United States
Loma Linda University Health Care Pediatric Clinic
Loma Linda, California, 92354, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Loma Linda University Health Care - Moreno Valley Pediatrics
Moreno Valley, California, 92557, United States
Bayview Research Group, LLC
Paramount, California, 90723, United States
Center for Clinical Trials, LLC
Paramount, California, 90723, United States
Kaiser Permanente Sacramento
Sacramento, California, 95815, United States
California Research Foundation
San Diego, California, 92103, United States
Bayview Research Group, LLC
Valley Village, California, 91607, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80907, United States
Colorado Springs Family Practice
Colorado Springs, Colorado, 80909, United States
Radiant Research, Inc.
Denver, Colorado, 80239, United States
Norwich Pediatric Group, P.C.
Norwich, Connecticut, 06360, United States
University of South Florida
Tampa, Florida, 33606, United States
Emory University School of Medicine Department of Pediatrics
Atlanta, Georgia, 30322, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Radiant Research, Inc
Atlanta, Georgia, 30342, United States
North Georgia Clinical Research Center dba Whites Pediatrics
Dalton, Georgia, 30721, United States
Pediatrics and Adolescent Medicine, PA
Marietta, Georgia, 30062, United States
Pediatrics and Adolescent Medicine
Woodstock, Georgia, 30189, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
Northern Illinois Research Associates
DeKalb, Illinois, 60115, United States
Clinical Research Advantage, Inc./ Ridge Family Practice, PC
Council Bluffs, Iowa, 51503, United States
Heartland Research Associates, LLC
Augusta, Kansas, 67010, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Via Christi Clinic, P.A.
Wichita, Kansas, 67208, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004, United States
University of Louisville Pediatrics: Children and Youth Project
Louisville, Kentucky, 40202, United States
Brownsboro Park Pediatrics
Louisville, Kentucky, 40207, United States
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, 40291, United States
Southwestern Medical Clinic Lakeland Healthcare Affiliate
Stevensville, Michigan, 49127, United States
Allina Health Bandana Square Clinic
Saint Paul, Minnesota, 55108, United States
Aspen Medical Group/ Odyssey Research
Saint Paul, Minnesota, 55108, United States
Aspen Medical Group
Saint Paul, Minnesota, 55108, United States
The Center for Pharmaceutical Research, PC
Kansas City, Missouri, 64114, United States
Saint Louis University
St Louis, Missouri, 63104, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Radiant Research, Inc.
St Louis, Missouri, 63141, United States
Sundance Clinical Research, LLC
St Louis, Missouri, 63141, United States
Clinical Research Advantage, Inc. / Prairie Fields Family Medicine, PC
Fremont, Nebraska, 68025, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68504, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Creighton Pediatric Infectious Diseases Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Clinical Research Center of Nevada
Henderson, Nevada, 89014, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89105, United States
Child Health Care Associates
East Syracuse, New York, 13057, United States
Duke University Medical Center - Duke Health Center
Durham, North Carolina, 27704, United States
Durham Pediatrics
Durham, North Carolina, 27704, United States
Duke Health Center
Durham, North Carolina, 27705, United States
PMG Research of Raleigh, LLC -
Raleigh, North Carolina, 27609, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27612, United States
Innovis Health
Fargo, North Dakota, 58103, United States
Odyssey Research
Fargo, North Dakota, 58104, United States
Radiant Research, Inc
Akron, Ohio, 44311, United States
Cincinnati Center for Clinical Research, Satellite Site - Clinic
Cincinnati, Ohio, 45206, United States
Cincinnati Childrens Hospital Medical Center Gamble Program for Clinical Studies
Cincinnati, Ohio, 45229-3039, United States
Dr. Shelly David Senders, MD Inc. dba Senders Pediatrics
Cleveland, Ohio, 44121, United States
Senders Pediatrics
Cleveland, Ohio, 44121, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
Radiant Research
Columbus, Ohio, 43212, United States
Ohio Pediatric Research Association
Dayton, Ohio, 45414, United States
Ohio Pediatrics, Inc.
Dayton, Ohio, 45414, United States
Ohio Pediatrics, Inc.
Huber Heights, Ohio, 45424, United States
Ohio Pediatric Research
Kettering, Ohio, 45420, United States
Christopher Brad Redden, ARNP Healthcare One Urgent Care and Family Practice
El Reno, Oklahoma, 73036, United States
Lynn Institute of Norman (LION)
Norman, Oklahoma, 73069, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Oklahoma State University - Center for Health Sciences - Pediatric Research
Tulsa, Oklahoma, 74127, United States
Office of Richard Ohnmacht
Cranston, Rhode Island, 02920, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Radiant Research, Inc.
Anderson, South Carolina, 29621, United States
Charleston Pediatrics
Charleston, South Carolina, 29401, United States
PMG Research of Charleson
Mt. Pleasant, South Carolina, 29464, United States
Internal Medicine & Pediatric Associates of Bristol, PC
Bristol, Tennessee, 37620, United States
PMG Research of Bristol
Bristol, Tennessee, 37620, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203, United States
Tekton Research, Inc.
Austin, Texas, 78745, United States
Radiant Research, Inc.
Dallas, Texas, 75231, United States
Advances in Health Research, Inc
Houston, Texas, 77030, United States
West Houston Clinical Research Service
Houston, Texas, 77055, United States
Pediatric Healthcare of Northwest Houston
Houston, Texas, 77065, United States
Pediatric Healthcare of Northwest Houston
Houston, Texas, 77070, United States
Texas Center for Drug Development, Inc.
Houston, Texas, 77081, United States
Child Care Associates
San Antonio, Texas, 78212, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Radiant Research, Inc.
San Antonio, Texas, 78229, United States
First Steps Pediatrics
San Antonio, Texas, 78254, United States
Pediatric Healthcare of Northwest Houston, PA
Tomball, Texas, 77375, United States
Pediatric Healthcare of Northwest Houston
Tomball, Texas, 77375, United States
Radiant Research, Inc.
Murray, Utah, 84123, United States
J. Lewis Resarch Incorporated, Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
J. Lewis Research Inc. - Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
Jean Brown Research
Salt Lake City, Utah, 84124, United States
J. Lewis Research, Inc. - Jordan River Family Medicine
South Jordan, Utah, 84095, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
PI-Coor Clinical Research, LLC
Burke, Virginia, 22015, United States
Pediatric Associates of Charlottesville, PLC
Charlottesville, Virginia, 22902, United States
Pediatric Associates of Charlottesville, PLC - West Satellite
Charlottesville, Virginia, 22903, United States
Pediatric Associates of Charlottesville, PLC - North Satellite
Charlottesville, Virginia, 22911, United States
The Vancouver Clinic
Vancouver, Washington, 98664, United States
The Vancouver Clinic
Vancouver, Washington, 98686, United States
Gundersen Clinic, LTD
La Crosse, Wisconsin, 54601, United States
Monroe Clinic
Monroe, Wisconsin, 53566, United States
Related Publications (2)
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.
PMID: 35164991DERIVEDBeeslaar 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.
PMID: 32681472DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2011
First Posted
October 28, 2011
Study Start
September 28, 2011
Primary Completion
May 8, 2014
Study Completion
May 8, 2014
Last Updated
December 20, 2018
Results First Posted
May 25, 2015
Record last verified: 2018-11