A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years. (B1971016)

A Phase 3, Randomized, Placebo-controlled, Observer-blinded, Trial To Assess The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine When Administered As A 3-dose Regimen In Healthy Young Adults Aged >=18 To <26 Years

This study is looking at a new vaccine that might prevent meningococcal disease, and will study the immune response elicited by this vaccine when given to healthy young adults. The study will also look at the safety of the new vaccine as well as how it is tolerated.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: rLP2086; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 3301
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1E 7G9
    • Centre Hospitalier Universitaire de Quebec
  • Newfoundland and Labrador
    • Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
      • Dr. Calvin Powell Professional Medical Corporation
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • Canadian Center for Vaccinology - IWK Health Centre
  • Ontario
    • London, Ontario, Canada, N5W 6A2
      • Milestone Research
    • Sarnia, Ontario, Canada, N7T 4X3
      • London Road Diagnostic Clinic and Medical Centre
    • Woodstock, Ontario, Canada, N4S 5P5
      • Devonshire Clinical Research Inc.
  • Quebec
    • Pierrefonds, Quebec, Canada, H9H 4Y6
      • McGill University Health Centre - Vaccine Study Centre
    • Sainte-Foy, Québec, Quebec, Canada, G1W 4R4
      • Clinique Medicale St-Louis Inc.
    • St-Romuald, Quebec, Canada, G6W 5M6
      • Pro-Recherche Inc.
• Denmark
  • Aarhus N, Denmark, 8200
    • Aarhus Universitetshospital Skejby
• Finland
  • Espoo, Finland, 02230
    • Espoo Vaccine Research Clinic
  • Helsinki, Finland, 00100
    • Helsinki South Vaccine Research Clinic
  • Kokkola, Finland, 67100
    • Kokkola Vaccine Research Clinic
  • Seinäjoki, Finland, 60100
    • Seinäjoki Vaccine Research Clinic
• Poland
  • Katowice, Poland, 40-018
    • NZOZ Centrum Medyczne Graniczna Sp. z o.o.
  • Krakow, Poland, 30-438
    • Specjalistyczna Poradnia Medyczna Przylądek Zdrowia
  • Leczna, Poland, 21-010
    • NZOZ Salmed s.c.
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic de Barcelona
  • Valencia, Spain, 46015
    • FOM (Fundacion Oftalmologica del Mediterraneo) - FISABIO
  • Barcelona
    • Balenya, Barcelona, Spain, 08550
      • CAP Balenyà
    • Centelles, Barcelona, Spain, 08540
      • CAP Centelles
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge
    • Vic, Barcelona, Spain, 08500
      • CAP El Remei
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research, Inc.
  • Arizona
    • Mesa, Arizona, United States, 85213
      • Clinical Research Advantage, Inc./Desert Clinical Research, LLC
    • Tempe, Arizona, United States, 85282
      • Clinical Research Advantage, Inc./ Fiel Family and Sports Medicine, PC
    • Tempe, Arizona, United States, 85283
      • Clinical Research Advantage, Inc./ Fiel Family and Sports Medicine, PC
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials Llc
    • La Mesa, California, United States, 91942
      • eStudySite
    • Sacramento, California, United States, 95822
      • Benchmark Research
  • Florida
    • Hollyood, Florida, United States, 33024
      • Broward Research Group
    • Lake Worth, Florida, United States, 33461
      • Altus Research Inc.
    • South Miami, Florida, United States, 33143
      • Miami Research Associates
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Johnson County Clin-Trials, Inc.
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Benchmark Research
  • Massachusetts
    • Milford, Massachusetts, United States, 01757
      • Milford Emergency Associates, Inc.
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • The Center for Pharmaceutical Research
  • Nebraska
    • Bellevue, Nebraska, United States, 68005
      • Meridian Clinical Research
    • Bellevue, Nebraska, United States, 68005
      • Pioneer Clinical Research, LLC
    • Bellevue, Nebraska, United States, 68005
      • Bellevue Urgent Care
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research,
  • New York
    • Manlius, New York, United States, 13104
      • Central New York Clinical Research
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • PMG Research of Raleigh, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Community Research
    • Cleveland, Ohio, United States, 44122
      • Rapid Medical Research
    • Cleveland, Ohio, United States, 44122
      • Rapid Medical Research, Inc.
  • Pennsylvania
    • Upper St. Clair, Pennsylvania, United States, 15241
      • PEAK Research, LLC
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Coastal Medical
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research
  • South Carolina
    • Mt. Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
  • South Dakota
    • Dakota Dunes, South Dakota, United States, 57049
      • Meridian Clinical Research
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates, Inc.
  • Texas
    • Dallas, Texas, United States, 75234
      • Research Across America
    • Houston, Texas, United States, 77081
      • Texas Center for Drug Development, Inc.
    • Katy, Texas, United States, 77450
      • Research Across America
  • Utah
    • West Jordan, Utah, United States, 84088
      • Advanced Clinical Research
  • Washington
    • Spokane, Washington, United States, 99204-4880
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female subject aged >=18 and <26 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 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rLP2086	Biological: rLP2086; 0.5 mL dose, given at 0, 2 and 6 months
Placebo Comparator: Control; Steril normal saline solution	Other: Placebo; 0.5 mL dose, given at 0, 2 and 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1	Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point. This outcome measure was planned to be analyzed for Group 1 only.	One month after third bivalent rLP2086 vaccination
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination		Within 7 days after first vaccination
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination		Within 7 days after second vaccination
Percentage of Participants Reporting Pre-specified 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		Within 7 days after first vaccination
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination		Within 7 days after second vaccination
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination		Within 7 days after 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 (AE) Within 30 Days After Any Vaccination		Within 30 days after any vaccination
Percentage of Participants With at Least 1 Adverse Event (AE) 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) 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 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) 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 Reporting at Least 1 Medically Attended Adverse Event 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		Within 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 the third vaccination
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination		Within 30 minutes after first vaccination
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination		Within 30 minutes after second vaccination
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Third Vaccination		Within 30 minutes after third vaccination
Number of Days Participants 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 >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: 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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: 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: 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: 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: Group 1		One month after second Bivalent rLP2086 vaccination
Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1		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 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1	Results for PMB80[A22] 1:16, PMB2001[A56] 1:8, PMB2948[B24] 1:8 and PMB2707[B44] 1:8 are reported under secondary endpoint 'Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1'.	Before Vaccination (Vac) 1, 1 Month after Vac 2, 3
hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1		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 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 Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1		One month after third bivalent rLP2086 vaccination

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: May 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: May 11, 2011
• First Submitted That Met QC Criteria: May 11, 2011
• First Posted (Estimate): May 12, 2011

Study Record Updates

• Last Update Posted (Estimate): February 23, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: B1971016; 6108A1-2004 (Other Identifier: Alias Study Number); 2009-014492-46 (EudraCT Number)