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

February 25, 2015 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5715

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Subiaco, Australia, 6008
        • Telethon Institute for Child Health Research
    • New South Wales
      • Maroubra, New South Wales, Australia, 2035
        • Australian Clinical Research Network
      • Westmead, New South Wales, Australia, 2145
        • The Children's Hospital at Westmead
    • Queensland
      • Sherwood, Queensland, Australia, 4075
        • AusTrials Pty Ltd
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
        • Vaccinology and Immunology Research Trials Unit (VIRTU), Discipline of Paediatrics
  • Chile
      • Santiago, Chile, 7500539
        • Hospital Luis Calvo Mackenna
    • Araucania
      • Temuco, Araucania, Chile, 4781156
        • Centro de Investigación Clínica del Sur
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 8330034
        • Hospital Clinico de la Pontificia Universidad Catolica de Chile/
      • Santiago, Region Metropolitana, Chile, 886000
        • Centro de Estudios de Vacunas, CESFAM Gabriela Mistral
    • Santiago
      • Conchali, Santiago, Chile, 8550442
        • Cesfam Dr. Jose Symon Ojeda
  • Czech Republic
      • Jindrichuv Hradec, Czech Republic, 377 01
        • Ordinace praktického lékaře pro děti a dorost
      • Jindrichuv Hradec, Czech Republic, 377 01
        • Samostatna ordinace praktickeho lekare pro deti a dorost
      • Jindrichuv Hradec, Czech Republic, 37701
        • Samostatna ordinace praktickeho lekare pro deti a dorost
      • Plzen, Czech Republic, 30138
        • Ordinace praktického lékaře pro děti a dorost
      • Praha 2, Czech Republic, 120 00
        • Ordinace praktického lékaře pro děti a dorost
      • Tynec nad Sazavou, Czech Republic, 257 41
        • Prakticky Lekar Pro Deti A Mladez
  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus Universitetshospital, Skejby
  • Estonia
      • Rakvere, Estonia, 44316
        • Eraarst Kersti Veidrik Ou
      • Tallinn, Estonia, 10117
        • Innomedica OÜ
      • Tallinn, Estonia, 10617
        • Merekivi Perearstid OU
      • Tallinn, Estonia, 10617
        • Merelahe Family Doctors Centre
  • Finland
      • Pori, Finland, 28100
        • Pori Vaccine Research Clinic
      • Tampere, Finland, 33100
        • Tampere Vaccine Research Clinic
      • Turku, Finland, 20520
        • Turku Vaccine Research Clinic
  • Germany
      • Hamburg, Germany, 20246
        • Clinical Trial Center North
      • Hamburg, Germany, 20251
        • Clinical Trial Center North GmbH & Co.KG
      • Hamburg, Germany, 20359
        • Bernhard Nocht Centre for Clinical Trials (BNCCT)
      • Wuerzburg, Germany, 97070
        • Juliusspital Wuerzburg
  • Lithuania
      • Kaunas, Lithuania, 48259
        • JSC "InMedica"
      • Kaunas, Lithuania, LT-49449
        • Saules Family Medicine Centre
      • Kaunas, Lithuania, LT47116
        • Kaunas Clinical Hospital, Public Institution, Clinic of Infectious Diseases
      • Kaunas, Lithuania, LT50009
        • LITHUANIAN HEALTH SCIENCE UNIVERSITY HOSPITAL, CLINIC of FAMILY MEDICINE
      • Vilnius, Lithuania, LT01117
        • Centro poliklinika, Public Institution
  • Poland
      • Debica, Poland, 39-200
        • Prywatny Gabinet Lekarski Dr.n.med.Jerzy Brzostek
      • Krakow, Poland, 31-202
        • Krakowski Szpital Specjalistyczny im Jana Pawla II
      • Krakow, Poland, 31-302
        • Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska
      • Lubartow, Poland, 21-100
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny
      • Oborniki Slaskie, Poland, 55-120
        • NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak
      • Poznan, Poland, 61-709
        • Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu
      • Siemianowice Slaskie, Poland, 41-103
        • NZLA Michalkowice Jarosz i partnerzy Spolka Lekarska
      • Torun, Poland, 87-100
        • NZOZ Nasz Lekarz
      • Trzebnica, Poland, 55-100
        • Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny
      • Wroclaw, Poland, 50-345
        • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
  • Spain
      • Sevilla, Spain, 41014
        • Instituto Hispalense de Pediatria
      • Valencia, Spain, 46001
        • Clinicas Universitarias. Universidad Catolica de Valencia San Vicente Martir
  • Sweden
      • Umeå, Sweden, 90185
        • Norrlands Universitetssjukhus, Institution för Pediatrik
    • SE
      • Malmo, SE, Sweden, 205 02
        • Vaccinenheten Barn- och ungdomsmedicinska kliniken
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35802
        • Accelovance,Inc.
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
      • Chandler, Arizona, United States, 85224
        • Clinical Research Advantage, Inc/ East Valley Family Physicians, PLC
      • Tempe, Arizona, United States, 85282
        • Cassidy Medical Group/Clinical Research Advantage
      • Tempe, Arizona, United States, 85282
        • Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
      • Tempe, Arizona, United States, 85282
        • Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC Administrative/Mailing Address
    • Arkansas
      • Harrisburg, Arkansas, United States, 72432
        • Harrisburg Family Medical Center
    • California
      • San Diego, California, United States, 92108
        • Accelovance. Inc
      • San Francisco, California, United States, 94102
        • Benchmark Research
      • Vista, California, United States, 92083
        • Cassidy Medical Group/Clinical Research Advantage
    • Florida
      • DeLand, Florida, United States, 32720
        • Avail Clinical Research, LLC
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Melbourne, Florida, United States, 32934
        • Optimal Research, LLC
      • Melbourne, Florida, United States, 32935
        • Accelovance
      • South Miami, Florida, United States, 33143
        • Miami Research Associates
    • Indiana
      • Mishawaka, Indiana, United States, 46545
        • Accelovance,Inc.
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
        • Clinical Research Advantage,Inc/Ridge Family Practice
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Kentucky Pediatric/Adult Research
    • Nebraska
      • Fremont, Nebraska, United States, 68025
        • Clinical Research Advantage, Inc./ Pediatric Partners, LLC Additional Site-No IP
      • Fremont, Nebraska, United States, 68025
        • Prairie Fields Family Medicine/Clinical Research Advantage
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, Inc.
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research. Inc.
      • Dayton, Ohio, United States, 45414
        • Ohio Pediatric Research Association
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • PMG Research of Bristol
    • Texas
      • Austin, Texas, United States, 78705
        • Benchmark Research
      • Austin, Texas, United States, 78745
        • Tekton Research
      • Dallas, Texas, United States, 75234
        • Research Across America
      • Fort Worth, Texas, United States, 76135
        • Benchmark Research
      • Houston, Texas, United States, 77055
        • West Houston Clinical Research Service
      • Katy, Texas, United States, 77450
        • Research Across America
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc.
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Jean Brown Research
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research, Inc. / Foothill Family Clinic South
      • Salt Lake City, Utah, United States, 84109
        • J. Lewis Research, Inc. - Foothill Family Clinic
      • South Jordan, Utah, United States, 84095
        • J. Lewis Research, Inc. - Jordan River Family Medicine
      • West Jordan, Utah, United States, 84088
        • Advanced Clinical Research
    • Virginia
      • Burke, Virginia, United States, 22015
        • PI-Coor Clinical Research, LLC
      • Charlottesville, Virginia, United States, 22902
        • Pediatric Research of Charlottesville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects aged 10 to 25 years.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rLP2086 vaccine
Biological: rLP2086 vaccine
120 mcg, 3 doses, at month 0, 2, and 6.
Other: control
The control treatment will be HAVRIX vaccine at month 0 and 6 and a normal saline injection at month 2.
Biological: control
HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Vaccination 1 up to 6 months after Vaccination 3
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1
Time Frame: Within 30 days after Vaccination 1
A medically attended AE was defined as a non-serious AE that required medical attention.
Within 30 days after Vaccination 1
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2
Time Frame: Within 30 days after Vaccination 2
A medically attended AE was defined as a non-serious AE that required medical attention.
Within 30 days after Vaccination 2
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3
Time Frame: Within 30 days after Vaccination 3
A medically attended AE was defined as a non-serious AE that required medical attention.
Within 30 days after Vaccination 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods
Time Frame: 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)
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.
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)
Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods
Time Frame: 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)
A medically attended AE was defined as a non-serious AE that required medical attention.
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)
Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods
Time Frame: 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)
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.
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)
Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods
Time Frame: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)
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.
Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)
Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination
Time Frame: Within 30 minutes after Vaccination 1, 2, 3
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.
Within 30 minutes after Vaccination 1, 2, 3
Number of Days Participant Missed School or Work Due to Adverse Events (AEs)
Time Frame: Vaccination 1 up to 1 month after Vaccination 3
Vaccination 1 up to 1 month after Vaccination 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

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)

March 11, 2015

Last Update Submitted That Met QC Criteria

February 25, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1971014
  • 2009-015198-11 (EudraCT Number)
  • 6108A1-3003 (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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