A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years.
NCT ID: NCT01352845
Last Updated: 2016-02-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3301 participants
INTERVENTIONAL
2013-05-31
2015-02-28
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
rLP2086
0.5 mL dose, given at 0, 2 and 6 months
Control
Steril normal saline solution
Placebo
0.5 mL dose, given at 0, 2 and 6 months
Interventions
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rLP2086
0.5 mL dose, given at 0, 2 and 6 months
Placebo
0.5 mL dose, given at 0, 2 and 6 months
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 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.
3. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
4. 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.
5. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
6. Current chronic use of systemic antibiotics.
7. Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
8. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
18 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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Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Clinical Research Advantage, Inc./Desert Clinical Research, LLC
Mesa, Arizona, United States
Clinical Research Advantage, Inc./ Fiel Family and Sports Medicine, PC
Tempe, Arizona, United States
Clinical Research Advantage, Inc./ Fiel Family and Sports Medicine, PC
Tempe, Arizona, United States
Anaheim Clinical Trials LLC
Anaheim, California, United States
eStudySite
La Mesa, California, United States
Benchmark Research
Sacramento, California, United States
Broward Research Group
Hollyood, Florida, United States
Altus Research Inc.
Lake Worth, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Johnson County Clin-Trials, Inc.
Lenexa, Kansas, United States
Benchmark Research
Metairie, Louisiana, United States
Milford Emergency Associates, Inc.
Milford, Massachusetts, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, United States
Bellevue Urgent Care
Bellevue, Nebraska, United States
Meridian Clinical Research
Bellevue, Nebraska, United States
Pioneer Clinical Research, LLC
Bellevue, Nebraska, United States
Meridian Clinical Research,
Omaha, Nebraska, United States
Central New York Clinical Research
Manlius, New York, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, United States
Community Research
Cincinnati, Ohio, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, United States
Rapid Medical Research
Cleveland, Ohio, United States
PEAK Research, LLC
Upper Saint Clair, Pennsylvania, United States
Coastal Medical
East Greenwich, Rhode Island, United States
Omega Medical Research
Warwick, Rhode Island, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Meridian Clinical Research
Dakota Dunes, South Dakota, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Research Across America
Dallas, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
Research Across America
Katy, Texas, United States
Advanced Clinical Research
West Jordan, Utah, United States
Premier Clinical Research
Spokane, Washington, United States
Dr. Calvin Powell Professional Medical Corporation
Bay Roberts, Newfoundland and Labrador, Canada
Canadian Center for Vaccinology - IWK Health Centre
Halifax, Nova Scotia, Canada
Milestone Research
London, Ontario, Canada
London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario, Canada
Devonshire Clinical Research Inc.
Woodstock, Ontario, Canada
McGill University Health Centre - Vaccine Study Centre
Pierrefonds, Quebec, Canada
Centre hospitalier universitaire de Québec
Québec, Quebec, Canada
Pro-Recherche Inc.
Saint Romuald, Quebec, Canada
Clinique Medicale St-Louis Inc.
Sainte-Foy, Québec, Quebec, Canada
Aarhus Universitetshospital Skejby
Aarhus N, , Denmark
Espoo Vaccine Research Clinic
Espoo, , Finland
Helsinki South Vaccine Research Clinic
Helsinki, , Finland
Kokkola Vaccine Research Clinic
Kokkola, , Finland
Seinäjoki Vaccine Research Clinic
Seinäjoki, , Finland
NZOZ Centrum Medyczne Graniczna Sp. z o.o.
Katowice, , Poland
Specjalistyczna Poradnia Medyczna Przyladek Zdrowia
Krakow, , Poland
NZOZ Salmed s.c.
Łęczna, , Poland
CAP Balenya
Balenya, Barcelona, Spain
CAP Centelles
Centelles, Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
CAP El Remei
Vic, Barcelona, Spain
FOM (Fundacion Oftalmologica del Mediterraneo) - FISABIO
Valencia, Valencia, Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
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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6108A1-2004
Identifier Type: OTHER
Identifier Source: secondary_id
2009-014492-46
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1971016
Identifier Type: -
Identifier Source: org_study_id
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