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

NCT01352845 | Completed Phase 3 Results DMC

• 3 other identifiers: B19710166108A1-20042009-014492-46
• Study Type: interventional
• Target: 3,301
• Locations: 6 countries
• Sites: 58

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (37)

• 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 Outcomes (10)

• 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

Study Arms (2)

rLP2086

EXPERIMENTAL

Biological: rLP2086

Control

PLACEBO COMPARATOR

Steril normal saline solution

Other: Placebo

Interventions

rLP2086 BIOLOGICAL

0.5 mL dose, given at 0, 2 and 6 months

rLP2086

Placebo OTHER

0.5 mL dose, given at 0, 2 and 6 months

Control

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subject aged \>=18 and \<26 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 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 (58)

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

Clinical Research Advantage, Inc./Desert Clinical Research, LLC

Mesa, Arizona, 85213, United States

Location

Clinical Research Advantage, Inc./ Fiel Family and Sports Medicine, PC

Tempe, Arizona, 85282, United States

Location

Clinical Research Advantage, Inc./ Fiel Family and Sports Medicine, PC

Tempe, Arizona, 85283, United States

Location

Anaheim Clinical Trials LLC

Anaheim, California, 92801, United States

Location

eStudySite

La Mesa, California, 91942, United States

Location

Benchmark Research

Sacramento, California, 95822, United States

Location

Broward Research Group

Hollyood, Florida, 33024, United States

Location

Altus Research Inc.

Lake Worth, Florida, 33461, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Johnson County Clin-Trials, Inc.

Lenexa, Kansas, 66219, United States

Location

Benchmark Research

Metairie, Louisiana, 70006, United States

Location

Milford Emergency Associates, Inc.

Milford, Massachusetts, 01757, United States

Location

The Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Bellevue Urgent Care

Bellevue, Nebraska, 68005, United States

Location

Meridian Clinical Research

Bellevue, Nebraska, 68005, United States

Location

Pioneer Clinical Research, LLC

Bellevue, Nebraska, 68005, United States

Location

Meridian Clinical Research,

Omaha, Nebraska, 68134, United States

Location

Central New York Clinical Research

Manlius, New York, 13104, United States

Location

PMG Research of Raleigh, LLC

Raleigh, North Carolina, 27609, United States

Location

Community Research

Cincinnati, Ohio, 45227, United States

Location

Rapid Medical Research, Inc.

Cleveland, Ohio, 44122, United States

Location

Rapid Medical Research

Cleveland, Ohio, 44122, United States

Location

PEAK Research, LLC

Upper Saint Clair, Pennsylvania, 15241, United States

Location

Coastal Medical

East Greenwich, Rhode Island, 02818, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Meridian Clinical Research

Dakota Dunes, South Dakota, 57049, United States

Location

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

Texas Center for Drug Development, Inc.

Houston, Texas, 77081, United States

Location

Research Across America

Katy, Texas, 77450, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

Premier Clinical Research

Spokane, Washington, 99204-4880, United States

Location

Dr. Calvin Powell Professional Medical Corporation

Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada

Location

Canadian Center for Vaccinology - IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Milestone Research

London, Ontario, N5W 6A2, Canada

Location

London Road Diagnostic Clinic and Medical Centre

Sarnia, Ontario, N7T 4X3, Canada

Location

Devonshire Clinical Research Inc.

Woodstock, Ontario, N4S 5P5, Canada

Location

McGill University Health Centre - Vaccine Study Centre

Pierrefonds, Quebec, H9H 4Y6, Canada

Location

Centre hospitalier universitaire de Québec

Québec, Quebec, G1E 7G9, Canada

Location

Pro-Recherche Inc.

Saint Romuald, Quebec, G6W 5M6, Canada

Location

Clinique Medicale St-Louis Inc.

Sainte-Foy, Québec, Quebec, G1W 4R4, Canada

Location

Aarhus Universitetshospital Skejby

Aarhus N, 8200, Denmark

Location

Espoo Vaccine Research Clinic

Espoo, 02230, Finland

Location

Helsinki South Vaccine Research Clinic

Helsinki, 00100, Finland

Location

Kokkola Vaccine Research Clinic

Kokkola, 67100, Finland

Location

Seinäjoki Vaccine Research Clinic

Seinäjoki, 60100, Finland

Location

NZOZ Centrum Medyczne Graniczna Sp. z o.o.

Katowice, 40-018, Poland

Location

Specjalistyczna Poradnia Medyczna Przyladek Zdrowia

Krakow, 30-438, Poland

Location

NZOZ Salmed s.c.

Łęczna, 21-010, Poland

Location

CAP Balenya

Balenya, Barcelona, 08550, Spain

Location

CAP Centelles

Centelles, Barcelona, 08540, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

CAP El Remei

Vic, Barcelona, 08500, Spain

Location

FOM (Fundacion Oftalmologica del Mediterraneo) - FISABIO

Valencia, Valencia, 46015, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

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

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: May 11, 2011
• First Posted: May 12, 2011
• Study Start: May 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 23, 2016
• Results First Posted: February 23, 2016

Record last verified: 2016-01

Locations

CA (9); ES (6); FI (4); PL (3); DK (1); US (35)