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Meningitis, MeningococcalPhase 3NCT01352793

A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

A Phase 3 study testing rLP2086 vaccine in people with Meningitis, Meningococcal, run by Pfizer at 86 sites in 12 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

A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2. Read more about this study

Who is it for?
Ages 10 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Meningitis, Meningococcal
What is being tested?
rLP2086 vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,715 participants
Where
86 sitesin 12 countries
Study dates
Nov 2012to Sep 2014
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 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy subjects aged 10 to 25 years.

Who cannot join

  • Previous vaccination with Hepatitis A virus vaccine
  • Previous vaccination with investigational meningococcal B vaccine
  • History of culture-proven N. meningitidis serogroup B disease
  • Any neuroinflammatory or autoimmune condition
  • Any immune defect that would prevent an effective response to the study vaccine

Trial locations and contacts

86 sites in 12 countries.

86 sites in 12 countries

United States39 sites

  • Benchmark Research

    Austin, Texas, 78705

  • Tekton Research

    Austin, Texas, 78745

  • Kentucky Pediatric/Adult Research

    Bardstown, Kentucky, 40004

  • PMG Research of Bristol

    Bristol, Tennessee, 37620

  • PI-Coor Clinical Research, LLC

    Burke, Virginia, 22015

  • Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC

    Chandler, Arizona, 85224

  • Clinical Research Advantage, Inc/ East Valley Family Physicians, PLC

    Chandler, Arizona, 85224

  • Pediatric Research of Charlottesville

    Charlottesville, Virginia, 22902

  • Rapid Medical Research. Inc.

    Cleveland, Ohio, 44122

  • Clinical Research Advantage,Inc/Ridge Family Practice

    Council Bluffs, Iowa, 51503

  • Research Across America

    Dallas, Texas, 75234

  • Ohio Pediatric Research Association

    Dayton, Ohio, 45414

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • Benchmark Research

    Fort Worth, Texas, 76135

  • Clinical Research Advantage, Inc./ Pediatric Partners, LLC Additional Site-No IP

    Fremont, Nebraska, 68025

  • Prairie Fields Family Medicine/Clinical Research Advantage

    Fremont, Nebraska, 68025

  • Harrisburg Family Medical Center

    Harrisburg, Arkansas, 72432

  • West Houston Clinical Research Service

    Houston, Texas, 77055

  • Accelovance,Inc.

    Huntsville, Alabama, 35802

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Research Across America

    Katy, Texas, 77450

  • Optimal Research, LLC

    Melbourne, Florida, 32934

  • Accelovance

    Melbourne, Florida, 32935

  • Accelovance,Inc.

    Mishawaka, Indiana, 46545

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609

  • J. Lewis Research, Inc. - Foothill Family Clinic

    Salt Lake City, Utah, 84109

  • J. Lewis Research, Inc. / Foothill Family Clinic South

    Salt Lake City, Utah, 84121

  • Jean Brown Research

    Salt Lake City, Utah, 84124

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Accelovance. Inc

    San Diego, California, 92108

  • Benchmark Research

    San Francisco, California, 94102

  • J. Lewis Research, Inc. - Jordan River Family Medicine

    South Jordan, Utah, 84095

  • Miami Research Associates

    South Miami, Florida, 33143

  • Cassidy Medical Group/Clinical Research Advantage

    Tempe, Arizona, 85282

  • Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC

    Tempe, Arizona, 85282

  • Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC Administrative/Mailing Address

    Tempe, Arizona, 85282

  • Cassidy Medical Group/Clinical Research Advantage

    Vista, California, 92083

  • Advanced Clinical Research

    West Jordan, Utah, 84088

Other trials in United States

Poland10 sites

  • Prywatny Gabinet Lekarski Dr.n.med.Jerzy Brzostek

    Dębica, 39-200

  • Krakowski Szpital Specjalistyczny im Jana Pawla II

    Krakow, Poland, 31-202

  • Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska

    Krakow, 31-302

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny

    Lubartów, 21-100

  • NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak

    Oborniki Śląskie, 55-120

  • Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu

    Poznan, 61-709

  • NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska

    Siemianowice Śląskie, 41-103

  • NZOZ Nasz Lekarz

    Torun, 87-100

  • Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny

    Trzebnica, 55-100

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

    Wroclaw, 50-345

Other trials in Poland

Czechia6 sites

  • Ordinace praktickeho lekare pro deti a dorost

    Jindřichův Hradec, 377 01

  • Samostatna ordinace praktickeho lekare pro deti a dorost

    Jindřichův Hradec, 377 01

  • Samostatna ordinace praktickeho lekare pro deti a dorost

    Jindřichův Hradec, 37701

  • Ordinace praktickeho lekare pro deti a dorost

    Pilsen, 30138

  • Ordinace praktickeho lekare pro deti a dorost

    Prague, 120 00

  • Prakticky Lekar Pro Deti a Mladez

    Týnec nad Sázavou, 257 41

Other trials in Czechia

Australia5 sites

  • Australian Clinical Research Network

    Maroubra, New South Wales, 2035

  • Vaccinology and Immunology Research Trials Unit (VIRTU), Discipline of Paediatrics

    North Adelaide, South Australia, 5006

  • AusTrials Pty Ltd

    Sherwood, Queensland, 4075

  • Telethon Institute for Child Health Research

    Subiaco, 6008

  • The Children's Hospital at Westmead

    Westmead, New South Wales, 2145

Other trials in Australia

Chile5 sites

  • Cesfam Dr. Jose Symon Ojeda

    Conchalí, Santiago Metropolitan, 8550442

  • Hospital Clinico de la Pontificia Universidad Catolica de Chile/

    Santiago, Santiago Metropolitan, 8330034

  • Centro de Estudios de Vacunas, CESFAM Gabriela Mistral

    Santiago, Santiago Metropolitan, 886000

  • Hospital Luis Calvo Mackenna

    Santiago, 7500539

  • Centro De Investigacion Clinica Del Sur

    Temuco, Araucania, 4781156

Other trials in Chile

Lithuania5 sites

  • JSC "InMedica"

    Kaunas, 48259

  • Saules Family Medicine Centre

    Kaunas, LT-49449

  • Kaunas Clinical Hospital, Public Institution, Clinic of Infectious Diseases

    Kaunas, LT47116

  • LITHUANIAN HEALTH SCIENCE UNIVERSITY HOSPITAL, CLINIC of FAMILY MEDICINE

    Kaunas, LT50009

  • Centro poliklinika, Public Institution

    Vilnius, LT01117

Other trials in Lithuania

Estonia4 sites

  • Eraarst Kersti Veidrik Ou

    Rakvere, 44316

  • Innomedica OU

    Tallinn, 10117

  • Merekivi Perearstid OU

    Tallinn, 10617

  • Merelahe Family Doctors Centre

    Tallinn, 10617

Other trials in Estonia

Germany4 sites

  • Clinical Trial Center North

    Hamburg, 20246

  • Clinical Trial Center North GmbH & Co.KG

    Hamburg, 20251

  • Bernhard Nocht Centre for Clinical Trials (BNCCT)

    Hamburg, 20359

  • Juliusspital Wuerzburg

    Würzburg, 97070

Other trials in Germany

Finland3 sites

  • Pori Vaccine Research Clinic

    Pori, 28100

  • Tampere Vaccine Research Clinic

    Tampere, 33100

  • Turku Vaccine Research Clinic

    Turku, 20520

Other trials in Finland

Spain2 sites

  • Instituto Hispalense de Pediatria

    Seville, Sevilla, 41014

  • Clinicas Universitarias. Universidad Catolica de Valencia San Vicente Martir

    Valencia, Valencia, 46001

Other trials in Spain

Sweden2 sites

  • Vaccinenheten Barn- och ungdomsmedicinska kliniken

    Malmö, SE, 205 02

  • Norrlands Universitetssjukhus, Institution för Pediatrik

    Umeå, 90185

Other trials in Sweden

Denmark1 site

  • Aarhus Universitetshospital, Skejby

    Aarhus N, 8200

Other trials in Denmark

About this study

Official title: A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Safety And Tolerability Of A Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rlp2086) Vaccine Given In Healthy Subjects Aged Greater Than Or Equal To 10 To Less Than 26 Years

A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.

All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.

Being tested
rLP2086 vaccine, control
Keywords
phase 3 safety study, 5700 healthy subjects, 3 vaccine doses at month 0, 2, and 6, control HAV/saline/HAV
Medical subject headings
Meningitis, Meningococcal

What participants receive

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

  • rLP2086 vaccineBiological

    120 mcg, 3 doses, at month 0, 2, and 6.

  • controlBiological

    HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.

Study groups in NCT01352793
Study groupRoleWhat they receive
rLP2086 vaccineExperimentalrLP2086 vaccine
Receives: Biological: rLP2086 vaccine
controlOtherThe control treatment will be HAVRIX vaccine at month 0 and 6 and a normal saline injection at month 2.
Receives: Biological: control

What is being measured

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

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

    An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.

    Measured: Vaccination 1 up to 6 months after Vaccination 3

  2. Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1

    A medically attended AE was defined as a non-serious AE that required medical attention.

    Measured: Within 30 days after Vaccination 1

  3. Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2

    A medically attended AE was defined as a non-serious AE that required medical attention.

    Measured: Within 30 days after Vaccination 2

  4. Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3

    A medically attended AE was defined as a non-serious AE that required medical attention.

    Measured: Within 30 days after Vaccination 3

Secondary outcomes (6)

  1. Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods

    An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.

    Measured: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3)

  2. Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods

    A medically attended AE was defined as a non-serious AE that required medical attention.

    Measured: Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3)

  3. Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods

    A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.

    Measured: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3)

  4. Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods

    An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.

    Measured: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)

  5. Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination

    An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.

    Measured: Within 30 minutes after Vaccination 1, 2, 3

  6. Number of Days Participant Missed School or Work Due to Adverse Events (AEs)

    Measured: Vaccination 1 up to 1 month after Vaccination 3

Timeline

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

  1. First posted12 May 2011 (estimated)
  2. Study startNov 2012
  3. Primary completionSep 2014
  4. Study completionSep 2014

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
5,715 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01352793
Sponsor's protocol ID
B1971014
Other IDs
2009-015198-11, 6108A1-3003, 2009
Status last verified
Feb 2015
First submitted
11 May 2011
Last updated
11 Mar 2015
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rLP2086 vaccine in people with Meningitis, Meningococcal, run by Pfizer at 86 sites in 12 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 1 inclusion and 5 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 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Poland, Czechia, Australia, Chile and 7 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 11 Mar 2015). 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 at Least One Serious Adverse Event (SAE) Throughout the Study (time frame: Vaccination 1 up to 6 months after Vaccination 3). The study lists 4 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 NCT01352793, which also lists 1 linked publication.

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 11 Mar 2015.

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