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

NCT01830855 | Completed Phase 3 Results DMC

• 3 other identifiers: B19710096108A1-30012010-023873-20
• Study Type: interventional
• Target: 3,596
• Locations: 8 countries
• Sites: 99

Brief Summary

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.

Conditions

Meningococcal Vaccine

Outcome Measures

Primary Outcomes (38)

• 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) 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) 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 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 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 First Vaccination

  Within 30 days after first 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 Third Vaccination

  Within 30 days after third 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 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 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 (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 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 Outcomes (11)

• 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

  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

  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

  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

  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

  One month after second Bivalent rLP2086 vaccination

Study Arms (4)

rLP2086 lot 1

EXPERIMENTAL

Biological: rLP2086

rLP2086 lot 2

EXPERIMENTAL

Biological: rLP2086

rLP2086 lot 3

EXPERIMENTAL

Biological: rLP2086

Control

ACTIVE COMPARATOR

Havrix (HAV) and Saline

Biological: Havrix (HAV); Biological: Saline

Interventions

rLP2086 BIOLOGICAL

0.5 mL dose, given at 0, 2 and 6 months (lot 1)

rLP2086 lot 1

Havrix (HAV) BIOLOGICAL

0.5 mL dose or 1.0 mL dose dependent on age given at month 0 and 6.

Control

Saline BIOLOGICAL

0.5 mL dose of sterile normal saline for injection.

Control

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female subject aged \>=10 and \<19 years at the time of enrollment.
• Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
• Negative urine pregnancy test for all female subjects.

You may not qualify if:

• Previous vaccination with any meningococcal serogroup B vaccine.
• Subjects who have received prior HAV vaccination.
• 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.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (99)

Birmingham Pediatric Associates, PC

Birmingham, Alabama, 35205, United States

Location

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

Southeastern Pediatrics

Dothan, Alabama, 36305, United States

Location

Harrisburg Family Medical Center

Harrisburg, Arkansas, 72432, United States

Location

The Children's Clinic of Jonesboro, P.A.

Jonesboro, Arkansas, 72401, United States

Location

Arkansas Pediatric Clinic

Little Rock, Arkansas, 72205, United States

Location

California Research Foundation

San Diego, California, 92103-6204, United States

Location

Colorado Springs Health Partners/Clinical Research Advantage, Inc.

Colorado Springs, Colorado, 80922, United States

Location

Aga Clinical Trials

Hialeah, Florida, 33012, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Accelovance

Melbourne, Florida, 32934, United States

Location

Accelovance

Melbourne, Florida, 32935, United States

Location

North Georgia Clinical Research Center

Dalton, Georgia, 30721, United States

Location

Northern Illinois Research Associates

DeKalb, Illinois, 60115, United States

Location

Northpoint Pediatrics

Indianapolis, Indiana, 46256, United States

Location

Accelovance, Inc.

Mishawaka, Indiana, 46545, United States

Location

Optimal Research, LLC

Mishawaka, Indiana, 46545, United States

Location

Nassim, McMonigle, Mescia & Associates

New Albany, Indiana, 47150, United States

Location

Augusta Family Practice

Augusta, Kansas, 67010, United States

Location

Heartland Research Associates, LLC

Augusta, Kansas, 67010, United States

Location

Heartland Research Associates, LLC

Newton, Kansas, 67114, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67205, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, 40004, United States

Location

Bluegrass Clinical Research, Inc.

Louisville, Kentucky, 40291, United States

Location

Central Kentucky Research Associates, Inc.

Mount Sterling, Kentucky, 40353, United States

Location

Mt. Sterling Pediatrics

Mount Sterling, Kentucky, 40353, United States

Location

Pedia Research, LLC

Owensboro, Kentucky, 42301, United States

Location

David B. Ware, MD

Eunice, Louisiana, 70535, United States

Location

Horizon Research Group of Opelousas, LLC

Eunice, Louisiana, 70535, United States

Location

ACC Pediatric Research

Haughton, Louisiana, 71037, United States

Location

Benchmark Research

Metairie, Louisiana, 70006, United States

Location

Southwestern Medical Clinic Lakeland HealthCare Affiliate

Niles, Michigan, 49120, United States

Location

Allina Health Bandana Square Clinic

Saint Paul, Minnesota, 55108, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

Bellevue Urgent Care

Bellevue, Nebraska, 68005, United States

Location

Pioneer Clinical Research, LLC

Bellevue, Nebraska, 68005, United States

Location

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

Meridian Clinical Research, Llc

Omaha, Nebraska, 68134, United States

Location

Winthrop Division of Pediatric Infectious Diseases

Mineola, New York, 11501, United States

Location

Winthrop Pediatric Associates

Mineola, New York, 11501, United States

Location

Winthrop University Pharmacy

Mineola, New York, 11501, United States

Location

Winthrop-University Hospital - Clinical Trials Center

Mineola, New York, 11501, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

Asheboro Research Associates

Asheboro, North Carolina, 27203, United States

Location

Cary Pediatric Center

Cary, North Carolina, 27518, United States

Location

Capitol Pediatrics & Adolescent Center PLLC

Raleigh, North Carolina, 27609, United States

Location

Dr. Shelly David Senders, MD Inc. dba Senders Pediatrics

Cleveland, Ohio, 44121, United States

Location

Dayton Clinical Research

Dayton, Ohio, 45406, United States

Location

Ohio Pediatric Research Association

Dayton, Ohio, 45414, United States

Location

Ohio Pediatrics, Inc.

Dayton, Ohio, 45414, United States

Location

Liberty Family Practice

Erie, Pennsylvania, 16508, United States

Location

Preferred Primary Care Physicians, Inc.

Uniontown, Pennsylvania, 15401, United States

Location

PEAK Research, LLC

Upper Saint Clair, Pennsylvania, 15241, United States

Location

Holston Medical Group - Suite 3B

Kingsport, Tennessee, 37660, United States

Location

Holston Medical Group Laboratory

Kingsport, Tennessee, 37660, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

Cumberland Pediatrics Associates

Lebanon, Tennessee, 37087, United States

Location

Pediatric Research of Charlottesville, LLC

Charlottesville, Virginia, 22902, United States

Location

Pediatric Research of Charlottesville

Charlottesville, Virginia, 22902, United States

Location

Advanced Pediatrics

Vienna, Virginia, 22180, United States

Location

The Vancouver Clinic

Vancouver, Washington, 98664, United States

Location

Medicor Research Inc.

Greater Sudbury, Ontario, P3E 1H5, Canada

Location

Dr. Hartley Garfield Medicine Professional Corporation

Toronto, Ontario, M5G 1N8, Canada

Location

Clinique Medicale St-Louis (recherche) Inc.

Québec, Quebec, G1W 4R4, Canada

Location

ALPHA Recherche Clinique

Québec, Quebec, G3K 2P8, Canada

Location

Diex Research Sherbrooke Inc.

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Ordinace praktickeho lekare pro deti a dorost

Brandýs nad Labem-Stará Boleslav, 25001, Czechia

Location

Fakultni nemocnice Hradec Kralove, Klinika infekcnich nemoci,Centrum ockovani a cestovni mediciny

Hradec Králové, 500 05, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Hradec Králové, 50002, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Jindřichův Hradec, 37701, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Odolena Voda, 25070, Czechia

Location

MUDr. Elena Adamkova

Pardubice, 53002, Czechia

Location

Zdravotnicke stredisko Dubina v.o.s.

Pardubice, 53012, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Prague, 16000, Czechia

Location

Helsinki East Vaccine Research Clinic

Helsinki, 00930, Finland

Location

Jarvenpaa Vaccine Research Clinic

Jarvenpaa, 04400, Finland

Location

Oulu Vaccine Research Clinic

Oulu, 90220, Finland

Location

Vantaa East Vaccine Research Clinic

Vantaa, 01300, Finland

Location

Central Laboratory and Vaccination Centre, Stiftung Juliusspital

Würzburg, Bavaria, 97070, Germany

Location

Kinderarztpraxis Dr. Thomas Adelt

Bramsche, 49565, Germany

Location

Gemeinschaftspraxis für Kinder- und Jugendmedizin Dres. Behre, Burgert, Günkel

Kehl, 77694, Germany

Location

UOC di Pediatria 1

Milan, Milano, 20122, Italy

Location

Servizio di Igiene e Sanita Pubblica

Sassari, Sassari, 07100, Italy

Location

Dipartimento di Scienze della Salute

Genova, 16132, Italy

Location

Azienda Sanitaria Provinciale di Ragusa

Ragusa, 97100, Italy

Location

Azienda Ospedaliero Universitaria di Sassari

Sassari, 07100, Italy

Location

oddzial Neuroinfekcji i Neurologii Dzieciecel, Krakowski Szpital Specjalistyczny im.J ana Pawla II

Krakow, Malopolska, 31-202, Poland

Location

Wojewodzka Poradnia Szczepien Ochronnych

Krakow, Malopolska, 31-202, Poland

Location

Prywatny Gabinet Lekarski dr n med. Jerzy Brzostek

Dębica, 39-200, Poland

Location

NZOZ Praktyka Lekarza Rodzinnego lek.med. Agata Slawin

Kiełczów, 55-093, Poland

Location

NZOZ Praktyka Lekarza Rodzinnego Eskulap Sp.z o.o.

Lublin, 20-044, Poland

Location

NZOZ Praktyka Lekarza Rodzinnego Eskulap Sp.z o.o. ul.

Lunlin, 20-044, Poland

Location

NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska

Siemianowice Śląskie, 41-103, Poland

Location

NZOZ Praktyka Lekarza Rodzinnego Beata Stecka

Wroclaw, 50-452, Poland

Location

NIHR Wellcome Trust Clinical Research Facility

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

University of Bristol, Clinical Research and Imaging Centre

Bristol, BS2 8DX, United Kingdom

Location

St. George's University of London**

London, SW17 ORE, United Kingdom

Location

Oxford Vaccine Group, University of Oxford

Oxford, OX3 7LE, United Kingdom

Location

Related Publications (4)

• 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: 35164991 DERIVED

• 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.

  PMID: 32700260 DERIVED

• 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.

  PMID: 32681472 DERIVED

• 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.

  PMID: 29236639 DERIVED

Related Links

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

MeSH Terms

Interventions

factor H-binding protein, Neisseria meningitidis; Hepatitis A Vaccines; Sodium Chloride

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2013
• First Posted: April 12, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 14, 2016
• Results First Posted: June 14, 2016

Record last verified: 2016-05

Locations

DE (3); CA (5); PL (8); CZ (8); GB (4); US (62); IT (5); FI (4)