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

A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Lot Consistency, Safety, Tolerability, And Immunogenicity Of A Meningococcal Serogroup B Bivalent Rlp2086 Vaccine In Healthy Subjects Aged >/=10 To <19 Years

This study is looking at a new vaccine that might prevent meningococcal disease, and will study whether healthy adolescent subjects receiving different lots of vaccine respond in a similar way. The study will also look at the safety of the new vaccine as well as how it is tolerated.

Study Overview

• Status: Completed
• Conditions: Meningococcal Vaccine
• Intervention / Treatment: Biological: rLP2086; Biological: rLP2086; Biological: rLP2086; Biological: Havrix (HAV); Biological: Saline

• Study Type: Interventional
• Enrollment (Actual): 3596
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G3K 2P8
    • ALPHA Recherche Clinique
  • Quebec, Canada, G1W 4R4
    • Clinique Medicale St-Louis (recherche) Inc.
  • Ontario
    • Sudbury, Ontario, Canada, P3E 1H5
      • Medicor Research Inc.
    • Toronto, Ontario, Canada, M5G 1N8
      • Dr. Hartley Garfield Medicine Professional Corporation
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 1Z1
      • Diex Research Sherbrooke Inc.
• Czech Republic
  • Brandys nad Labem - Stara Boleslav, Czech Republic, 25001
    • Ordinace praktického lékaře pro děti a dorost
  • Hradec Kralove, Czech Republic, 500 05
    • Fakultni nemocnice Hradec Kralove, Klinika infekcnich nemoci,Centrum ockovani a cestovni mediciny
  • Hradec Kralove, Czech Republic, 50002
    • Ordinace praktického lékaře pro děti a dorost
  • Jindrichuv Hradec, Czech Republic, 37701
    • Ordinace praktického lékaře pro děti a dorost
  • Odolena Voda, Czech Republic, 25070
    • Ordinace praktického lékaře pro děti a dorost
  • Pardubice, Czech Republic, 53002
    • MUDr. Elena Adamkova
  • Pardubice, Czech Republic, 53012
    • Zdravotnicke stredisko Dubina v.o.s.
  • Praha 6, Czech Republic, 16000
    • Ordinace praktického lékaře pro děti a dorost
• Finland
  • Helsinki, Finland, 00930
    • Helsinki East Vaccine Research Clinic
  • Jarvenpaa, Finland, 04400
    • Järvenpää Vaccine Research Clinic
  • Oulu, Finland, 90220
    • Oulu Vaccine Research Clinic
  • Vantaa, Finland, 01300
    • Vantaa East Vaccine Research Clinic
• Germany
  • Bramsche, Germany, 49565
    • Kinderarztpraxis Dr. Thomas Adelt
  • Kehl, Germany, 77694
    • Gemeinschaftspraxis für Kinder- und Jugendmedizin Dres. Behre, Burgert, Günkel
  • Bavaria
    • Wuerzburg, Bavaria, Germany, 97070
      • Central Laboratory and Vaccination Centre, Stiftung Juliusspital
• Italy
  • Genova, Italy, 16132
    • Dipartimento di Scienze della Salute
  • Milano, Italy, 20122
    • UOC di Pediatria 1
  • Ragusa, Italy, 97100
    • Azienda Sanitaria Provinciale di Ragusa
  • Sassari, Italy, 07100
    • Azienda Ospedaliero Universitaria di Sassari
  • Sassari, Italy, 07100
    • Servizio di Igiene e Sanita Pubblica
• Poland
  • Debica, Poland, 39-200
    • Prywatny Gabinet Lekarski dr n med. Jerzy Brzostek
  • Kielczow, Poland, 55-093
    • NZOZ Praktyka Lekarza Rodzinnego lek.med. Agata Slawin
  • Lublin, Poland, 20-044
    • NZOZ Praktyka Lekarza Rodzinnego Eskulap Sp.z o.o.
  • Lunlin, Poland, 20-044
    • NZOZ Praktyka Lekarza Rodzinnego Eskulap Sp.z o.o. ul.
  • Siemianowice Slaskie, Poland, 41-103
    • NZLA Michalkowice Jarosz i partnerzy Spolka Lekarska
  • Wroclaw, Poland, 50-452
    • NZOZ Praktyka Lekarza Rodzinnego Beata Stecka
  • Malopolska
    • Krakow, Malopolska, Poland, 31-202
      • oddzial Neuroinfekcji i Neurologii Dzieciecel, Krakowski Szpital Specjalistyczny im.J ana Pawla II
    • Krakow, Malopolska, Poland, 31-202
      • Wojewodzka Poradnia Szczepien Ochronnych
• United Kingdom
  • Bristol, United Kingdom, BS2 8DX
    • University of Bristol, Clinical Research and Imaging Centre
  • London, United Kingdom, SW17 ORE
    • St. George's University of London**
  • Oxford, United Kingdom, OX3 7LE
    • Oxford Vaccine Group, University of Oxford
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • NIHR Wellcome Trust Clinical Research Facility
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics, LLC
    • Birmingham, Alabama, United States, 35205
      • Birmingham Pediatric Associates, PC
    • Dothan, Alabama, United States, 36305
      • Southeastern Pediatrics
  • Arkansas
    • Harrisburg, Arkansas, United States, 72432
      • Harrisburg Family Medical Center
    • Jonesboro, Arkansas, United States, 72401
      • The Children's Clinic of Jonesboro, P.A.
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Pediatric Clinic
  • California
    • San Diego, California, United States, 92103-6204
      • California Research Foundation
  • Colorado
    • Colorado Springs, Colorado, United States, 80922
      • Colorado Springs Health Partners/Clinical Research Advantage, Inc.
  • Florida
    • Hialeah, Florida, United States, 33012
      • AGA Clinical Trials
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Melbourne, Florida, United States, 32935
      • Accelovance
    • Melbourne, Florida, United States, 32934
      • Accelovance
  • Georgia
    • Dalton, Georgia, United States, 30721
      • North Georgia Clinical Research Center
  • Illinois
    • DeKalb, Illinois, United States, 60115
      • Northern Illinois Research Associates
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Northpoint Pediatrics
    • Mishawaka, Indiana, United States, 46545
      • Accelovance, Inc.
    • Mishawaka, Indiana, United States, 46545
      • Optimal Research, LLC
    • New Albany, Indiana, United States, 47150
      • Nassim, McMonigle, Mescia & Associates
  • Kansas
    • Augusta, Kansas, United States, 67010
      • Heartland Research Associates, LLC
    • Augusta, Kansas, United States, 67010
      • Augusta Family Practice
    • Newton, Kansas, United States, 67114
      • Heartland Research Associates, LLC
    • Wichita, Kansas, United States, 67205
      • Heartland Research Associates, LLC
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates, LLC
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Kentucky Pediatric/Adult Research
    • Louisville, Kentucky, United States, 40291
      • Bluegrass Clinical Research, Inc.
    • MT. Sterling, Kentucky, United States, 40353
      • Central Kentucky Research Associates, Inc.
    • Mt. Sterling, Kentucky, United States, 40353
      • Mt. Sterling Pediatrics
    • Owensboro, Kentucky, United States, 42301
      • Pedia Research, LLC
  • Louisiana
    • Eunice, Louisiana, United States, 70535
      • Horizon Research Group of Opelousas, LLC
    • Eunice, Louisiana, United States, 70535
      • David B. Ware, MD
    • Haughton, Louisiana, United States, 71037
      • ACC Pediatric Research
    • Metairie, Louisiana, United States, 70006
      • Benchmark Research
  • Michigan
    • Niles, Michigan, United States, 49120
      • Southwestern Medical Clinic Lakeland HealthCare Affiliate
  • Minnesota
    • Saint Paul, Minnesota, United States, 55108
      • Allina Health Bandana Square Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Sundance Clinical Research, LLC
  • Nebraska
    • Bellevue, Nebraska, United States, 68005
      • Pioneer Clinical Research, LLC
    • Bellevue, Nebraska, United States, 68005
      • Bellevue Urgent Care
    • Omaha, Nebraska, United States, 68131
      • Creighton University Medical Center
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research, LLC
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop Pediatric Associates
    • Mineola, New York, United States, 11501
      • Winthrop Division of Pediatric Infectious Diseases
    • Mineola, New York, United States, 11501
      • Winthrop University Pharmacy
    • Mineola, New York, United States, 11501
      • Winthrop-University Hospital - Clinical Trials Center
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc.
  • North Carolina
    • Asheboro, North Carolina, United States, 27203
      • Asheboro Research Associates
    • Cary, North Carolina, United States, 27518
      • Cary Pediatric Center
    • Raleigh, North Carolina, United States, 27609
      • Capitol Pediatrics & Adolescent Center PLLC
  • Ohio
    • Cleveland, Ohio, United States, 44121
      • Dr. Shelly David Senders, MD Inc. dba Senders Pediatrics
    • Dayton, Ohio, United States, 45406
      • Dayton Clinical Research
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Association
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatrics, Inc.
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16508
      • Liberty Family Practice
    • Uniontown, Pennsylvania, United States, 15401
      • Preferred Primary Care Physicians, Inc.
    • Upper St. Clair, Pennsylvania, United States, 15241
      • PEAK Research, LLC
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group - Suite 3B
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group Laboratory
    • Lebanon, Tennessee, United States, 37087
      • Cumberland Pediatrics Associates
  • Virginia
    • Charlottesville, Virginia, United States, 22902
      • Pediatric Research of Charlottesville, LLC
    • Charlottesville, Virginia, United States, 22902
      • Pediatric Research of Charlottesville
    • Vienna, Virginia, United States, 22180
      • Advanced Pediatrics
  • Washington
    • Vancouver, Washington, United States, 98664
      • The Vancouver Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female subject aged >=10 and <19 years at the time of enrollment.
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:

1. Previous vaccination with any meningococcal serogroup B vaccine.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rLP2086 lot 1	Biological: rLP2086; 0.5 mL dose, given at 0, 2 and 6 months (lot 1); Biological: rLP2086; 0.5 mL dose, given at 0, 2 and 6 months (lot 2); Biological: rLP2086; 0.5 mL dose, given at 0, 2 and 6 months (lot 3)
Experimental: rLP2086 lot 2	Biological: rLP2086; 0.5 mL dose, given at 0, 2 and 6 months (lot 1); Biological: rLP2086; 0.5 mL dose, given at 0, 2 and 6 months (lot 2); Biological: rLP2086; 0.5 mL dose, given at 0, 2 and 6 months (lot 3)
Experimental: rLP2086 lot 3	Biological: rLP2086; 0.5 mL dose, given at 0, 2 and 6 months (lot 1); Biological: rLP2086; 0.5 mL dose, given at 0, 2 and 6 months (lot 2); Biological: rLP2086; 0.5 mL dose, given at 0, 2 and 6 months (lot 3)
Active Comparator: Control; Havrix (HAV) and Saline	Biological: Havrix (HAV); 0.5 mL dose or 1.0 mL dose dependent on age given at month 0 and 6.; Biological: Saline; 0.5 mL dose of sterile normal saline for injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination		Within 30 days after second vaccination
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination		Within 30 days after third vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination		Within 30 days after first vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination		Within 30 days after second vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination		Within 30 days after third vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination		Within 30 days after any vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase		From the first vaccination up to 1 month after the third vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period		From the first vaccination up to 6 month after the third vaccination
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination		Within 30 days after first vaccination
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination		Within 30 days after second vaccination
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination		Within 30 days after third vaccination
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination		Within 30 days after any vaccination
Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase		From the first vaccination up to 1 month after the third vaccination
Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase		From 1 month after third vaccination up to 6 months after the third vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination		Within 30 days after first vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination		Within 30 days after third vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase		From the first vaccination up to 1 month after the third vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase		From 1 month after third vaccination up to 6 months after the third vaccination
Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1	Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1,2,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point.	One month after third bivalent rLP2086 vaccination
hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine		One month after third bivalent rLP2086 vaccination
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination		Within 7 Days after first vaccination
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination		Within 7 Days after second vaccination
Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination		Within 7 Days after third vaccination
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination	Here, N signifies participants with known values reporting specific characteristic.	Within 7 Days after first vaccination
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination	Here, N signifies participants with known values reporting specific characteristic.	Within 7 Days after second vaccination
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination	Here, N signifies participants with known values reporting specific characteristic.	Within 7 Days after third vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-Up Phase		From 1 month after third vaccination up to 6 months after the third vaccination
Percentage of Participants With at Least 1 Medically Attended AE Throughout the Study Period		From the first vaccination up to 6 month after the third vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination		30 days after second vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination		Within 30 Days After any Vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period		From the first vaccination up to 6 month after the third vaccination
Percentage of Participants With at Least 1 Adverse Event (AE) WIthin 30 Days After First Vaccination		Within 30 days after first vaccination
Percentage of Participants With at Least 1 Adverse Event Within 30 Days After Any Vaccination		Within 30 Days after any vaccination
Percentage of Participants With at Least 1 Adverse Event During the Vaccination Phase		From the first vaccination up to 1 month after the third vaccination
Percentage of Participants Reporting at Least 1 Immediate AE After First Vaccination		Within 30 minutes after first vaccination
Percentage of Participants Reporting at Least 1 Immediate AE After Second Vaccination		Within 30 minutes after second vaccination
Percentage of Participants Reporting at Least 1 Immediate AE After Third Vaccination		Within 30 minutes after third vaccination
Number of Days Participant's Missed School or Work Due to AE During the Vaccination Phase		From the first vaccination up to 1 month after the third vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1	Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.	Before first vaccination, 1 month after third vaccination
Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1	Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.	Before first vaccination, 1 month after third vaccination (Vac)
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1	Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.	Before first vaccination, 1 month after third vaccination
Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination for Group 1	Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2 ,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.	Before vaccination 1, 1 Month after Vaccination 2
Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination for Group 1	Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.	One month after second Bivalent rLP2086 vaccination
Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination		One month after second, third vaccination
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination		Before vaccination (Vac) 1, 1 Month after Vac 2
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination		Before Vaccination (Vac) 1, 1 Month after Vac 2, 3
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination	Results for PMB80[A22] 1:16, PMB2001[A56] 1:8, PMB2948[B24] 1:8 and PMB2707[B44] 1:8 are reported under secondary outcome measure 'Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination.	Before Vaccination (Vac) 1, 1 Month after Vac 2, 3
Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains and for Primary Test Starins Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination		One month after third bivalent rLP2086 vaccination
Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination		One month after third bivalent rLP2086 vaccination (Vac)

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.
• 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.
• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: April 3, 2013
• First Submitted That Met QC Criteria: April 9, 2013
• First Posted (Estimate): April 12, 2013

Study Record Updates

• Last Update Posted (Estimate): June 14, 2016
• Last Update Submitted That Met QC Criteria: May 5, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: B1971009; 6108A1-3001 (Other Identifier: Alias Study Number); 2010-023873-20 (EudraCT Number)