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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01352793
Recruitment Status : Completed
First Posted : May 12, 2011
Results First Posted : March 11, 2015
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief 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.

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


Condition or disease Intervention/treatment Phase
Meningitis, Meningococcal Biological: rLP2086 vaccine Biological: control Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5715 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : November 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: rLP2086 vaccine
rLP2086 vaccine
Biological: rLP2086 vaccine
120 mcg, 3 doses, at month 0, 2, and 6.

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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  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.

  4. 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.

  5. 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.

  6. Number of Days Participant Missed School or Work Due to Adverse Events (AEs) [ Time Frame: Vaccination 1 up to 1 month after Vaccination 3 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01352793


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

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01352793     History of Changes
Other Study ID Numbers: B1971014
2009-015198-11 ( EudraCT Number )
6108A1-3003 ( Other Identifier: Alias Study Number )
First Posted: May 12, 2011    Key Record Dates
Results First Posted: March 11, 2015
Last Update Posted: March 11, 2015
Last Verified: February 2015
Keywords provided by Pfizer:
phase 3 safety study
5700 healthy subjects
3 vaccine doses at month 0
2
and 6
control HAV/saline/HAV
Additional relevant MeSH terms:
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Meningitis, Meningococcal
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs