A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.
NCT ID: NCT03135834
Last Updated: 2023-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1610 participants
INTERVENTIONAL
2017-04-24
2022-10-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 1 (ACWY Naive subjects, MenABCWY/Saline)
ACWY Naive subjects, MenABCWY/Saline
MenABCWY
N meningitidis group A, B, C, W, and Y vaccine
Saline
Placebo
Group 2 (ACWY Naive subjects, rLP2086/MenACWY-CRM)
ACWY Naive subjects, rLP2086/MenACWY-CRM
rLP2086
Bivalent recombinant lipoprotein 2086 vaccine
MenACWY-CRM
meningococcal group A, C, W-135, and Y conjugate vaccine
Group 3 (ACWY Experienced subjects, MenABCWY/Saline)
ACWY Experienced subjects, MenABCWY/Saline
MenABCWY
N meningitidis group A, B, C, W, and Y vaccine
Saline
Placebo
Group 4 (ACWY Experienced subjects, rLP2086/MenACWY-CRM)
ACWY Experienced subjects, rLP2086/MenACWY-CRM
rLP2086
Bivalent recombinant lipoprotein 2086 vaccine
MenACWY-CRM
meningococcal group A, C, W-135, and Y conjugate vaccine
Interventions
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MenABCWY
N meningitidis group A, B, C, W, and Y vaccine
Saline
Placebo
rLP2086
Bivalent recombinant lipoprotein 2086 vaccine
MenACWY-CRM
meningococcal group A, C, W-135, and Y conjugate vaccine
Eligibility Criteria
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Inclusion Criteria
* Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
* Negative urine pregnancy test for all female subjects.
* Subjects who have not received, or who have received no more than 1 prior dose within the past 4 years, of a vaccine containing 1 or more ACWY serogroup
Exclusion Criteria
* Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
* 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 in the United States with terminal complement deficiency are excluded from participation in this study.
* Significant neurological disorder or history of seizure (excluding simple febrile seizure).
* Current chronic use of systemic antibiotics.
* Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
* Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
10 Years
25 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Optimal Research, LLC
Huntsville, Alabama, United States
Synexus Clinical Research US, Inc./Fountain Hills Family Practice, P.C.
Fountain Hills, Arizona, United States
Clinical Research Consortium
Tempe, Arizona, United States
Harrisburg Family Medical Center
Harrisburg, Arkansas, United States
Paradigm Clinical Research Centers, Inc.
La Mesa, California, United States
California Research Foundation
San Diego, California, United States
Kaiser Permanente Santa Clara
Santa Clara, California, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Health Awareness, Inc.
Jupiter, Florida, United States
Optimal Research, LLC
Melbourne, Florida, United States
Meridian Clinical Research LLC
Savannah, Georgia, United States
Optimal Research
Peoria, Illinois, United States
Meridian Clinical Research
Sioux City, Iowa, United States
Alliance for Multispecialty Research, LLC
Newton, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Alliance For Multispecialty Research (AMR)
Wichita, Kansas, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States
Horizon Research Group of Opelousas, LLC
Eunice, Louisiana, United States
ACC Pediatric Research
Haughton, Louisiana, United States
Methodist Physicians Clinic/CCT Research
Fremont, Nebraska, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Meridian Clinical Research, LLC
Binghamton, New York, United States
United Medical Associates
Binghamton, New York, United States
Meridian Clinical Research, LLC
Binghamton, New York, United States
United Medical Associates
Binghamton, New York, United States
Regional Clinical Research, Inc
Endwell, New York, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Meridian Clinical Research, LLC
Vestal, New York, United States
Regional Clinical Research, Inc
Vestal, New York, United States
Capitol Pediatrics & Adolescent Center PLLC
Raleigh, North Carolina, United States
Meridian Clinical Research, LLC
Cincinnati, Ohio, United States
Velocity Clinical Research, Inc.
Cleveland, Ohio, United States
Aventiv Research Inc.
Columbus, Ohio, United States
Ohio Pediatric Research Association, Inc.
Dayton, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Liberty Family Practice
Erie, Pennsylvania, United States
Charleston Pediatrics, PA
Charleston, South Carolina, United States
PMG Research of Charleston, LLC
Mt. Pleasant, South Carolina, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Internal Medicine and Pediatric Associates of Bristol, PC
Bristol, Tennessee, United States
PMG Research of Bristol, LLC
Bristol, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Benchmark Research
Austin, Texas, United States
Texas Health Care, PLLC
Fort Worth, Texas, United States
Ventavia Research Group, LLC
Fort Worth, Texas, United States
Benchmark Research
Fort Worth, Texas, United States
Acrc Trials
Plano, Texas, United States
North Texas Family Medicine
Plano, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
J. Lewis Research Inc. / Foothill Family Clinic Draper
Draper, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Jordan River Family Medicine
South Jordan, Utah, United States
PI-Coor Clinical Research, LLC
Burke, Virginia, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, United States
Ordinace praktickeho lekare pro deti a dorost
Jindřichův Hradec, , Czechia
MEDICENTRUM 6 s.r.o. - Ordinace praktickeho lekare pro deti a dorost
Prague, , Czechia
Espoo Vaccine Research Clinic
Espoo, , Finland
Helsinki South Vaccine Research Clinic
Helsinki, , Finland
Helsinki East Vaccine Research Clinic
Helsinki, , Finland
Jarvenpaa Vaccine Research Clinic
Järvenpää, , Finland
Kokkola Vaccine Research Clinic
Kokkola, , Finland
Oulu Vaccine Research Clinic
Oulu, , Finland
Pori Vaccine Research Clinic
Pori, , Finland
Seinajoki Vaccine Research Clinic
Seinäjoki, , Finland
Tampere Vaccine Research Clinic
Tampere, , Finland
Turku Vaccine Research Clinic
Turku, , Finland
Jerzy Brzostek Prywatny Gabinet Lekarski
Dębica, , Poland
Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska
Krakow, , Poland
Oddzial Pediatrii i Neurologii Dzieciecej, Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, , Poland
Countries
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References
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Peterson J, Drazan D, Moughan B, Maguire JD, Zolotas L, Maansson R, O'Neill R, Peyrani P, Jodar L, Gruber WC, Anderson AS, Beeslaar J. Randomized trial showing persistence of hSBA titers elicited by a pentavalent meningococcal MenABCWY vaccine for up to 4 years following a primary series and safety and immunogenicity of a booster dose. Vaccine. 2025 Jan 1;43(Pt 1):126469. doi: 10.1016/j.vaccine.2024.126469. Epub 2024 Nov 8.
Peterson J, Drazan D, Czajka H, Maguire J, Pregaldien JL, Seppa I, Maansson R, O'Neill R, Balmer P, Jodar L, Jansen KU, Anderson AS, Perez JL, Beeslaar J. Immunogenicity and safety of a pentavalent meningococcal ABCWY vaccine in adolescents and young adults: an observer-blind, active-controlled, randomised trial. Lancet Infect Dis. 2023 Dec;23(12):1370-1382. doi: 10.1016/S1473-3099(23)00191-3. Epub 2023 Aug 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2016-004421-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1971057
Identifier Type: -
Identifier Source: org_study_id
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