AzTrials
AzTrials

Meningococcal VaccinePhase 3NCT01830855

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 study testing rLP2086, Havrix (HAV) and Saline in people with Meningococcal Vaccine, run by Pfizer at 99 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 10 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Meningococcal Vaccine
What is being tested?
rLP2086, Havrix (HAV) and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,596 participants
Where
99 sitesin 8 countries
Study dates
Apr 2013to Apr 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 9Show fewer
  • 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.

Trial locations and contacts

99 sites in 8 countries.

99 sites in 8 countries

United States62 sites

  • Asheboro Research Associates

    Asheboro, North Carolina, 27203

  • Augusta Family Practice

    Augusta, Kansas, 67010

  • Heartland Research Associates, LLC

    Augusta, Kansas, 67010

  • Kentucky Pediatric/Adult Research

    Bardstown, Kentucky, 40004

  • Bellevue Urgent Care

    Bellevue, Nebraska, 68005

  • Pioneer Clinical Research, LLC

    Bellevue, Nebraska, 68005

  • Birmingham Pediatric Associates, PC

    Birmingham, Alabama, 35205

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama, 35235

  • Cary Pediatric Center

    Cary, North Carolina, 27518

  • Pediatric Research of Charlottesville, LLC

    Charlottesville, Virginia, 22902

  • Pediatric Research of Charlottesville

    Charlottesville, Virginia, 22902

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

    Cleveland, Ohio, 44121

  • Colorado Springs Health Partners/Clinical Research Advantage, Inc.

    Colorado Springs, Colorado, 80922

  • North Georgia Clinical Research Center

    Dalton, Georgia, 30721

  • Dayton Clinical Research

    Dayton, Ohio, 45406

  • Ohio Pediatric Research Association

    Dayton, Ohio, 45414

  • Ohio Pediatrics, Inc.

    Dayton, Ohio, 45414

  • Northern Illinois Research Associates

    DeKalb, Illinois, 60115

  • Southeastern Pediatrics

    Dothan, Alabama, 36305

  • Liberty Family Practice

    Erie, Pennsylvania, 16508

  • David B. Ware, MD

    Eunice, Louisiana, 70535

  • Horizon Research Group of Opelousas, LLC

    Eunice, Louisiana, 70535

  • Harrisburg Family Medical Center

    Harrisburg, Arkansas, 72432

  • ACC Pediatric Research

    Haughton, Louisiana, 71037

  • Aga Clinical Trials

    Hialeah, Florida, 33012

  • Northpoint Pediatrics

    Indianapolis, Indiana, 46256

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

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

    Jonesboro, Arkansas, 72401

  • Holston Medical Group - Suite 3B

    Kingsport, Tennessee, 37660

  • Holston Medical Group Laboratory

    Kingsport, Tennessee, 37660

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Cumberland Pediatrics Associates

    Lebanon, Tennessee, 37087

  • Arkansas Pediatric Clinic

    Little Rock, Arkansas, 72205

  • Bluegrass Clinical Research, Inc.

    Louisville, Kentucky, 40291

  • Accelovance

    Melbourne, Florida, 32934

  • Accelovance

    Melbourne, Florida, 32935

  • Benchmark Research

    Metairie, Louisiana, 70006

  • Winthrop Division of Pediatric Infectious Diseases

    Mineola, New York, 11501

  • Winthrop Pediatric Associates

    Mineola, New York, 11501

  • Winthrop University Pharmacy

    Mineola, New York, 11501

  • Winthrop-University Hospital - Clinical Trials Center

    Mineola, New York, 11501

  • Accelovance, Inc.

    Mishawaka, Indiana, 46545

  • Optimal Research, LLC

    Mishawaka, Indiana, 46545

  • Central Kentucky Research Associates, Inc.

    Mount Sterling, Kentucky, 40353

  • Mt. Sterling Pediatrics

    Mount Sterling, Kentucky, 40353

  • Nassim, McMonigle, Mescia & Associates

    New Albany, Indiana, 47150

  • Heartland Research Associates, LLC

    Newton, Kansas, 67114

  • Southwestern Medical Clinic Lakeland HealthCare Affiliate

    Niles, Michigan, 49120

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • Meridian Clinical Research, Llc

    Omaha, Nebraska, 68134

  • Pedia Research, LLC

    Owensboro, Kentucky, 42301

  • Capitol Pediatrics & Adolescent Center PLLC

    Raleigh, North Carolina, 27609

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609

  • Allina Health Bandana Square Clinic

    Saint Paul, Minnesota, 55108

  • California Research Foundation

    San Diego, California, 92103-6204

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141

  • Preferred Primary Care Physicians, Inc.

    Uniontown, Pennsylvania, 15401

  • PEAK Research, LLC

    Upper Saint Clair, Pennsylvania, 15241

  • The Vancouver Clinic

    Vancouver, Washington, 98664

  • Advanced Pediatrics

    Vienna, Virginia, 22180

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67205

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

Other trials in United States

Czechia8 sites

  • Ordinace praktickeho lekare pro deti a dorost

    Brandýs nad Labem-Stará Boleslav, 25001

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

    Hradec Králové, 500 05

  • Ordinace praktickeho lekare pro deti a dorost

    Hradec Králové, 50002

  • Ordinace praktickeho lekare pro deti a dorost

    Jindřichův Hradec, 37701

  • Ordinace praktickeho lekare pro deti a dorost

    Odolena Voda, 25070

  • MUDr. Elena Adamkova

    Pardubice, 53002

  • Zdravotnicke stredisko Dubina v.o.s.

    Pardubice, 53012

  • Ordinace praktickeho lekare pro deti a dorost

    Prague, 16000

Other trials in Czechia

Poland8 sites

  • Prywatny Gabinet Lekarski dr n med. Jerzy Brzostek

    Dębica, 39-200

  • NZOZ Praktyka Lekarza Rodzinnego lek.med. Agata Slawin

    Kiełczów, 55-093

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

    Krakow, Malopolska, 31-202

  • Wojewodzka Poradnia Szczepien Ochronnych

    Krakow, Malopolska, 31-202

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

    Lublin, 20-044

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

    Lunlin, 20-044

  • NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska

    Siemianowice Śląskie, 41-103

  • NZOZ Praktyka Lekarza Rodzinnego Beata Stecka

    Wroclaw, 50-452

Other trials in Poland

Canada5 sites

  • Medicor Research Inc.

    Greater Sudbury, Ontario, P3E 1H5

  • Clinique Medicale St-Louis (recherche) Inc.

    Québec, Quebec, G1W 4R4

  • ALPHA Recherche Clinique

    Québec, Quebec, G3K 2P8

  • Diex Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1H 1Z1

  • Dr. Hartley Garfield Medicine Professional Corporation

    Toronto, Ontario, M5G 1N8

Other trials in Canada

Italy5 sites

  • Dipartimento di Scienze della Salute

    Genova, 16132

  • UOC di Pediatria 1

    Milan, Milano, 20122

  • Azienda Sanitaria Provinciale di Ragusa

    Ragusa, 97100

  • Servizio di Igiene e Sanita Pubblica

    Sassari, Sassari, 07100

  • Azienda Ospedaliero Universitaria di Sassari

    Sassari, 07100

Other trials in Italy

Finland4 sites

  • Helsinki East Vaccine Research Clinic

    Helsinki, 00930

  • Jarvenpaa Vaccine Research Clinic

    Jarvenpaa, 04400

  • Oulu Vaccine Research Clinic

    Oulu, 90220

  • Vantaa East Vaccine Research Clinic

    Vantaa, 01300

Other trials in Finland

United Kingdom4 sites

  • University of Bristol, Clinical Research and Imaging Centre

    Bristol, BS2 8DX

  • St. George's University of London**

    London, SW17 ORE

  • Oxford Vaccine Group, University of Oxford

    Oxford, OX3 7LE

  • NIHR Wellcome Trust Clinical Research Facility

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

Germany3 sites

  • Kinderarztpraxis Dr. Thomas Adelt

    Bramsche, 49565

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

    Kehl, 77694

  • Central Laboratory and Vaccination Centre, Stiftung Juliusspital

    Würzburg, Bavaria, 97070

Other trials in Germany

About this study

Official title: 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.

Being tested
rLP2086, Havrix (HAV), Saline

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rLP2086Biological

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

  • rLP2086Biological

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

  • rLP2086Biological

    0.5 mL dose, given at 0, 2 and 6 months (lot 3)

  • Havrix (HAV)Biological

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

  • SalineBiological

    0.5 mL dose of sterile normal saline for injection.

Study groups in NCT01830855
Study groupRoleWhat they receive
rLP2086 lot 1ExperimentalNot described
Receives: Biological: rLP2086
rLP2086 lot 2ExperimentalNot described
Receives: Biological: rLP2086
rLP2086 lot 3ExperimentalNot described
Receives: Biological: rLP2086
ControlActive comparatorHavrix (HAV) and Saline
Receives: Biological: Havrix (HAV); Biological: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: One month after third bivalent rLP2086 vaccination

  2. hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine

    Measured: One month after third bivalent rLP2086 vaccination

  3. Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination

    Measured: Within 7 Days after first vaccination

  4. Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination

    Measured: Within 7 Days after second vaccination

  5. Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination

    Measured: Within 7 Days after third vaccination

  6. 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.

    Measured: Within 7 Days after first vaccination

  7. 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.

    Measured: Within 7 Days after second vaccination

  8. 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.

    Measured: Within 7 Days after third vaccination

  9. Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination

    Measured: Within 30 days after first vaccination

  10. Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination

    Measured: Within 30 days after second vaccination

  11. Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination

    Measured: Within 30 days after third vaccination

  12. Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination

    Measured: Within 30 days after any vaccination

  13. Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase

    Measured: From the first vaccination up to 1 month after the third vaccination

  14. Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-Up Phase

    Measured: From 1 month after third vaccination up to 6 months after the third vaccination

  15. Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period

    Measured: From the first vaccination up to 6 month after the third vaccination

  16. Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination

    Measured: Within 30 days after first vaccination

  17. Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination

    Measured: Within 30 days after second vaccination

  18. Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination

    Measured: Within 30 days after third vaccination

  19. Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination

    Measured: Within 30 days after any vaccination

  20. Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase

    Measured: From the first vaccination up to 1 month after the third vaccination

  21. Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase

    Measured: From 1 month after third vaccination up to 6 months after the third vaccination

  22. Percentage of Participants With at Least 1 Medically Attended AE Throughout the Study Period

    Measured: From the first vaccination up to 6 month after the third vaccination

  23. Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination

    Measured: Within 30 days after first vaccination

  24. Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination

    Measured: 30 days after second vaccination

  25. Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination

    Measured: Within 30 days after third vaccination

  26. Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination

    Measured: Within 30 Days After any Vaccination

  27. Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase

    Measured: From the first vaccination up to 1 month after the third vaccination

  28. Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase

    Measured: From 1 month after third vaccination up to 6 months after the third vaccination

  29. Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period

    Measured: From the first vaccination up to 6 month after the third vaccination

  30. Percentage of Participants With at Least 1 Adverse Event (AE) WIthin 30 Days After First Vaccination

    Measured: Within 30 days after first vaccination

  31. Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination

    Measured: Within 30 days after second vaccination

  32. Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination

    Measured: Within 30 days after third vaccination

  33. Percentage of Participants With at Least 1 Adverse Event Within 30 Days After Any Vaccination

    Measured: Within 30 Days after any vaccination

  34. Percentage of Participants With at Least 1 Adverse Event During the Vaccination Phase

    Measured: From the first vaccination up to 1 month after the third vaccination

  35. Percentage of Participants Reporting at Least 1 Immediate AE After First Vaccination

    Measured: Within 30 minutes after first vaccination

  36. Percentage of Participants Reporting at Least 1 Immediate AE After Second Vaccination

    Measured: Within 30 minutes after second vaccination

  37. Percentage of Participants Reporting at Least 1 Immediate AE After Third Vaccination

    Measured: Within 30 minutes after third vaccination

  38. Number of Days Participant's Missed School or Work Due to AE During the Vaccination Phase

    Measured: From the first vaccination up to 1 month after the third vaccination

Secondary outcomes (11)

  1. 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.

    Measured: Before first vaccination, 1 month after third vaccination

  2. 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.

    Measured: Before first vaccination, 1 month after third vaccination (Vac)

  3. 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.

    Measured: Before first vaccination, 1 month after third vaccination

  4. 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.

    Measured: Before vaccination 1, 1 Month after Vaccination 2

  5. 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.

    Measured: One month after second Bivalent rLP2086 vaccination

  6. 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

    Measured: One month after second, third vaccination

  7. 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

    Measured: Before vaccination (Vac) 1, 1 Month after Vac 2

  8. Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination

    Measured: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3

  9. 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.

    Measured: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3

  10. 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

    Measured: One month after third bivalent rLP2086 vaccination

  11. 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

    Measured: One month after third bivalent rLP2086 vaccination (Vac)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,596 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01830855
Sponsor's protocol ID
B1971009
Other IDs
6108A1-3001, 2010-023873-20
Status last verified
May 2016
First submitted
3 Apr 2013
Last updated
14 Jun 2016
Data monitoring committee
Yes

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.

    PubMed 35164991

  • 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.

    PubMed 32700260

  • 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.

    PubMed 32681472

  • 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.

    PubMed 29236639

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rLP2086, Havrix (HAV) and Saline in people with Meningococcal Vaccine, run by Pfizer at 99 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, Czechia, Poland, Canada, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: One month after third bivalent rLP2086 vaccination). The study lists 38 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01830855, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2016.

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