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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

Primary Purpose

Meningitis, Meningococcal

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
rLP2086 vaccine
control
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningitis, Meningococcal focused on measuring phase 3 safety study, 5700 healthy subjects, 3 vaccine doses at month 0, 2, and 6, control HAV/saline/HAV

Eligibility Criteria

10 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Accelovance,Inc.
  • Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
  • Clinical Research Advantage, Inc/ East Valley Family Physicians, PLC
  • Cassidy Medical Group/Clinical Research Advantage
  • Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
  • Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC Administrative/Mailing Address
  • Harrisburg Family Medical Center
  • Accelovance. Inc
  • Benchmark Research
  • Cassidy Medical Group/Clinical Research Advantage
  • Avail Clinical Research, LLC
  • Jacksonville Center for Clinical Research
  • Optimal Research, LLC
  • Accelovance
  • Miami Research Associates
  • Accelovance,Inc.
  • Clinical Research Advantage,Inc/Ridge Family Practice
  • Kentucky Pediatric/Adult Research
  • Clinical Research Advantage, Inc./ Pediatric Partners, LLC Additional Site-No IP
  • Prairie Fields Family Medicine/Clinical Research Advantage
  • Rochester Clinical Research, Inc.
  • Rapid Medical Research. Inc.
  • Ohio Pediatric Research Association
  • Coastal Carolina Research Center
  • PMG Research of Bristol
  • Benchmark Research
  • Tekton Research
  • Research Across America
  • Benchmark Research
  • West Houston Clinical Research Service
  • Research Across America
  • Clinical Trials of Texas, Inc.
  • J. Lewis Research, Inc. - Foothill Family Clinic
  • J. Lewis Research, Inc. / Foothill Family Clinic South
  • Jean Brown Research
  • J. Lewis Research, Inc. - Jordan River Family Medicine
  • Advanced Clinical Research
  • PI-Coor Clinical Research, LLC
  • Pediatric Research of Charlottesville
  • Australian Clinical Research Network
  • The Children's Hospital at Westmead
  • AusTrials Pty Ltd
  • Vaccinology and Immunology Research Trials Unit (VIRTU), Discipline of Paediatrics
  • Telethon Institute for Child Health Research
  • Centro De Investigacion Clinica Del Sur
  • Hospital Clinico de la Pontificia Universidad Catolica de Chile/
  • Centro de Estudios de Vacunas, CESFAM Gabriela Mistral
  • Cesfam Dr. Jose Symon Ojeda
  • Hospital Luis Calvo Mackenna
  • Ordinace praktickeho lekare pro deti a dorost
  • Samostatna ordinace praktickeho lekare pro deti a dorost
  • Samostatna ordinace praktickeho lekare pro deti a dorost
  • Ordinace praktickeho lekare pro deti a dorost
  • Ordinace praktickeho lekare pro deti a dorost
  • Prakticky Lekar Pro Deti a Mladez
  • Aarhus Universitetshospital, Skejby
  • Eraarst Kersti Veidrik Ou
  • Innomedica OU
  • Merekivi Perearstid OU
  • Merelahe Family Doctors Centre
  • Pori Vaccine Research Clinic
  • Tampere Vaccine Research Clinic
  • Turku Vaccine Research Clinic
  • Clinical Trial Center North
  • Clinical Trial Center North GmbH & Co.KG
  • Bernhard Nocht Centre for Clinical Trials (BNCCT)
  • Juliusspital Wuerzburg
  • JSC "InMedica"
  • Saules Family Medicine Centre
  • Kaunas Clinical Hospital, Public Institution, Clinic of Infectious Diseases
  • LITHUANIAN HEALTH SCIENCE UNIVERSITY HOSPITAL, CLINIC of FAMILY MEDICINE
  • Centro poliklinika, Public Institution
  • Prywatny Gabinet Lekarski Dr.n.med.Jerzy Brzostek
  • Krakowski Szpital Specjalistyczny im Jana Pawla II
  • Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny
  • NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak
  • Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu
  • NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska
  • NZOZ Nasz Lekarz
  • Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
  • Instituto Hispalense de Pediatria
  • Clinicas Universitarias. Universidad Catolica de Valencia San Vicente Martir
  • Vaccinenheten Barn- och ungdomsmedicinska kliniken
  • Norrlands Universitetssjukhus, Institution för Pediatrik

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

rLP2086 vaccine

control

Arm Description

rLP2086 vaccine

The control treatment will be HAVRIX vaccine at month 0 and 6 and a normal saline injection at month 2.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
May 11, 2011
Last Updated
February 25, 2015
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01352793
Brief Title
A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
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 Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Meningococcal
Keywords
phase 3 safety study, 5700 healthy subjects, 3 vaccine doses at month 0, 2, and 6, control HAV/saline/HAV

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5715 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rLP2086 vaccine
Arm Type
Experimental
Arm Description
rLP2086 vaccine
Arm Title
control
Arm Type
Other
Arm Description
The control treatment will be HAVRIX vaccine at month 0 and 6 and a normal saline injection at month 2.
Intervention Type
Biological
Intervention Name(s)
rLP2086 vaccine
Intervention Description
120 mcg, 3 doses, at month 0, 2, and 6.
Intervention Type
Biological
Intervention Name(s)
control
Intervention Description
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 Measure Information:
Title
Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study
Description
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.
Time Frame
Vaccination 1 up to 6 months after Vaccination 3
Title
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1
Description
A medically attended AE was defined as a non-serious AE that required medical attention.
Time Frame
Within 30 days after Vaccination 1
Title
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2
Description
A medically attended AE was defined as a non-serious AE that required medical attention.
Time Frame
Within 30 days after Vaccination 2
Title
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3
Description
A medically attended AE was defined as a non-serious AE that required medical attention.
Time Frame
Within 30 days after Vaccination 3
Secondary Outcome Measure Information:
Title
Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods
Description
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.
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)
Title
Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods
Description
A medically attended AE was defined as a non-serious AE that required medical attention.
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)
Title
Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods
Description
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.
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)
Title
Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods
Description
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.
Time Frame
Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)
Title
Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination
Description
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.
Time Frame
Within 30 minutes after Vaccination 1, 2, 3
Title
Number of Days Participant Missed School or Work Due to Adverse Events (AEs)
Time Frame
Vaccination 1 up to 1 month after Vaccination 3

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
35164991
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1971014&StudyName=A%20Global%20Phase%203%20Safety%20Study%20of%20120%20mcg%20rLP2086%20Vaccine%20in%20Adolescents%20and%20Young%20Adults%20Aged%2010%20to%2025%20Years
Description
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Learn more about this trial

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

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