A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years
NCT ID: NCT01830855
Last Updated: 2016-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3596 participants
INTERVENTIONAL
2013-04-30
2015-04-30
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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rLP2086 lot 1
rLP2086
0.5 mL dose, given at 0, 2 and 6 months (lot 1)
rLP2086 lot 2
rLP2086
0.5 mL dose, given at 0, 2 and 6 months (lot 2)
rLP2086 lot 3
rLP2086
0.5 mL dose, given at 0, 2 and 6 months (lot 3)
Control
Havrix (HAV) and Saline
Havrix (HAV)
0.5 mL dose or 1.0 mL dose dependent on age given at month 0 and 6.
Saline
0.5 mL dose of sterile normal saline for injection.
Interventions
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rLP2086
0.5 mL dose, given at 0, 2 and 6 months (lot 1)
rLP2086
0.5 mL dose, given at 0, 2 and 6 months (lot 2)
rLP2086
0.5 mL dose, given at 0, 2 and 6 months (lot 3)
Havrix (HAV)
0.5 mL dose or 1.0 mL dose dependent on age given at month 0 and 6.
Saline
0.5 mL dose of sterile normal saline for injection.
Eligibility Criteria
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Inclusion Criteria
2. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
3. Negative urine pregnancy test for all female subjects.
Exclusion Criteria
2. Subjects who have received prior HAV vaccination.
3. Subjects who are scheduled to receive 1 or more doses of an HPV vaccine as part of a 3-dose series during the period between Visit 1 and 28 days after the second vaccination.
4. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
5. 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.
6. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
7. Current chronic use of systemic antibiotics.
8. Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
9. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
10 Years
18 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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Birmingham Pediatric Associates, PC
Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Southeastern Pediatrics
Dothan, Alabama, United States
Harrisburg Family Medical Center
Harrisburg, Arkansas, United States
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, United States
Arkansas Pediatric Clinic
Little Rock, Arkansas, United States
California Research Foundation
San Diego, California, United States
Colorado Springs Health Partners/Clinical Research Advantage, Inc.
Colorado Springs, Colorado, United States
Aga Clinical Trials
Hialeah, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Accelovance
Melbourne, Florida, United States
Accelovance
Melbourne, Florida, United States
North Georgia Clinical Research Center
Dalton, Georgia, United States
Northern Illinois Research Associates
DeKalb, Illinois, United States
Northpoint Pediatrics
Indianapolis, Indiana, United States
Accelovance, Inc.
Mishawaka, Indiana, United States
Optimal Research, LLC
Mishawaka, Indiana, United States
Nassim, McMonigle, Mescia & Associates
New Albany, Indiana, United States
Augusta Family Practice
Augusta, Kansas, United States
Heartland Research Associates, LLC
Augusta, Kansas, United States
Heartland Research Associates, LLC
Newton, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, United States
Central Kentucky Research Associates, Inc.
Mount Sterling, Kentucky, United States
Mt. Sterling Pediatrics
Mount Sterling, Kentucky, United States
Pedia Research, LLC
Owensboro, Kentucky, United States
David B. Ware, MD
Eunice, Louisiana, United States
Horizon Research Group of Opelousas, LLC
Eunice, Louisiana, United States
ACC Pediatric Research
Haughton, Louisiana, United States
Benchmark Research
Metairie, Louisiana, United States
Southwestern Medical Clinic Lakeland HealthCare Affiliate
Niles, Michigan, United States
Allina Health Bandana Square Clinic
Saint Paul, Minnesota, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Bellevue Urgent Care
Bellevue, Nebraska, United States
Pioneer Clinical Research, LLC
Bellevue, Nebraska, United States
Creighton University Medical Center
Omaha, Nebraska, United States
Meridian Clinical Research, Llc
Omaha, Nebraska, United States
Winthrop Division of Pediatric Infectious Diseases
Mineola, New York, United States
Winthrop Pediatric Associates
Mineola, New York, United States
Winthrop University Pharmacy
Mineola, New York, United States
Winthrop-University Hospital - Clinical Trials Center
Mineola, New York, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Asheboro Research Associates
Asheboro, North Carolina, United States
Cary Pediatric Center
Cary, North Carolina, United States
Capitol Pediatrics & Adolescent Center PLLC
Raleigh, North Carolina, United States
Dr. Shelly David Senders, MD Inc. dba Senders Pediatrics
Cleveland, Ohio, United States
Dayton Clinical Research
Dayton, Ohio, United States
Ohio Pediatric Research Association
Dayton, Ohio, United States
Ohio Pediatrics, Inc.
Dayton, Ohio, United States
Liberty Family Practice
Erie, Pennsylvania, United States
Preferred Primary Care Physicians, Inc.
Uniontown, Pennsylvania, United States
PEAK Research, LLC
Upper Saint Clair, Pennsylvania, United States
Holston Medical Group - Suite 3B
Kingsport, Tennessee, United States
Holston Medical Group Laboratory
Kingsport, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Cumberland Pediatrics Associates
Lebanon, Tennessee, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, United States
Pediatric Research of Charlottesville
Charlottesville, Virginia, United States
Advanced Pediatrics
Vienna, Virginia, United States
The Vancouver Clinic
Vancouver, Washington, United States
Medicor Research Inc.
Greater Sudbury, Ontario, Canada
Dr. Hartley Garfield Medicine Professional Corporation
Toronto, Ontario, Canada
Clinique Medicale St-Louis (recherche) Inc.
Québec, Quebec, Canada
ALPHA Recherche Clinique
Québec, Quebec, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Ordinace praktickeho lekare pro deti a dorost
Brandýs nad Labem-Stará Boleslav, , Czechia
Fakultni nemocnice Hradec Kralove, Klinika infekcnich nemoci,Centrum ockovani a cestovni mediciny
Hradec Králové, , Czechia
Ordinace praktickeho lekare pro deti a dorost
Hradec Králové, , Czechia
Ordinace praktickeho lekare pro deti a dorost
Jindřichův Hradec, , Czechia
Ordinace praktickeho lekare pro deti a dorost
Odolena Voda, , Czechia
MUDr. Elena Adamkova
Pardubice, , Czechia
Zdravotnicke stredisko Dubina v.o.s.
Pardubice, , Czechia
Ordinace praktickeho lekare pro deti a dorost
Prague, , Czechia
Helsinki East Vaccine Research Clinic
Helsinki, , Finland
Jarvenpaa Vaccine Research Clinic
Järvenpää, , Finland
Oulu Vaccine Research Clinic
Oulu, , Finland
Vantaa East Vaccine Research Clinic
Vantaa, , Finland
Central Laboratory and Vaccination Centre, Stiftung Juliusspital
Würzburg, Bavaria, Germany
Kinderarztpraxis Dr. Thomas Adelt
Bramsche, , Germany
Gemeinschaftspraxis für Kinder- und Jugendmedizin Dres. Behre, Burgert, Günkel
Kehl, , Germany
UOC di Pediatria 1
Milan, Milano, Italy
Servizio di Igiene e Sanita Pubblica
Sassari, Sassari, Italy
Dipartimento di Scienze della Salute
Genova, , Italy
Azienda Sanitaria Provinciale di Ragusa
Ragusa, , Italy
Azienda Ospedaliero Universitaria di Sassari
Sassari, , Italy
oddzial Neuroinfekcji i Neurologii Dzieciecel, Krakowski Szpital Specjalistyczny im.J ana Pawla II
Krakow, Malopolska, Poland
Wojewodzka Poradnia Szczepien Ochronnych
Krakow, Malopolska, Poland
Prywatny Gabinet Lekarski dr n med. Jerzy Brzostek
Dębica, , Poland
NZOZ Praktyka Lekarza Rodzinnego lek.med. Agata Slawin
Kiełczów, , Poland
NZOZ Praktyka Lekarza Rodzinnego Eskulap Sp.z o.o.
Lublin, , Poland
NZOZ Praktyka Lekarza Rodzinnego Eskulap Sp.z o.o. ul.
Lunlin, , Poland
NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska
Siemianowice Śląskie, , Poland
NZOZ Praktyka Lekarza Rodzinnego Beata Stecka
Wroclaw, , Poland
NIHR Wellcome Trust Clinical Research Facility
Southampton, Hampshire, United Kingdom
University of Bristol, Clinical Research and Imaging Centre
Bristol, , United Kingdom
St. George's University of London**
London, , United Kingdom
Oxford Vaccine Group, University of Oxford
Oxford, , United Kingdom
Countries
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References
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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, Absalon J, Anderson AS, Eiden JJ, Balmer P, Harris SL, Jones TR, O'Neill RE, Pregaldien JL, Radley D, Maansson R, Ginis J, Srivastava A, Perez JL. MenB-FHbp Vaccine Protects Against Diverse Meningococcal Strains in Adolescents and Young Adults: Post Hoc Analysis of Two Phase 3 Studies. Infect Dis Ther. 2020 Sep;9(3):641-656. doi: 10.1007/s40121-020-00319-0. Epub 2020 Jul 22.
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.
Ostergaard L, Vesikari T, Absalon J, Beeslaar J, Ward BJ, Senders S, Eiden JJ, Jansen KU, Anderson AS, York LJ, Jones TR, Harris SL, O'Neill R, Radley D, Maansson R, Pregaldien JL, Ginis J, Staerke NB, Perez JL; B1971009 and B1971016 Trial Investigators. A Bivalent Meningococcal B Vaccine in Adolescents and Young Adults. N Engl J Med. 2017 Dec 14;377(24):2349-2362. doi: 10.1056/NEJMoa1614474.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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6108A1-3001
Identifier Type: OTHER
Identifier Source: secondary_id
2010-023873-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1971009
Identifier Type: -
Identifier Source: org_study_id
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