Phase
Condition
N/ATreatment
ExPEC9V
HD quadrivalent influenza vaccine
Placebo
Clinical Study ID
Ages > 65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must be medically stable at the time of vaccination such that, according to thejudgment of the investigator, hospitalization within the study period is notanticipated and the participant appears likely to be able to remain on study throughthe end of protocol specified follow-up. A stable medical condition is defined asdisease not requiring significant change in therapy during the 6 weeks beforeenrollment and when hospitalization for worsening of the disease is not anticipated.Participants will be included on the basis of physical examination, medical history,and vital signs performed between informed consent form (ICF) signature andvaccination
Participant must be: a) postmenopausal (postmenopausal state is defined as no mensesfor 12 months without an alternative medical cause); and b) not intending toconceive by any methods
Must sign an ICF indicating that the participant understands the purpose, proceduresand potential risks and benefits of the study, and is willing to participate in thestudy
Willing and able to adhere to the lifestyle restrictions specified in this protocol
Agrees to not donate blood from the time of vaccination until 3 months afterreceiving the last dose of study vaccine
Exclusion
Exclusion Criteria:
History of an underlying clinically significant acute or uncontrolled chronicmedical condition or significant cognitive impairment or physical examinationfindings for which, in the opinion of the investigator, participation would not bein the best interest of the participant (for example, compromise the well-being) orthat could prevent, limit, or confound the protocol-specified assessments
Known or suspected allergy or history of severe allergic reaction, anaphylaxis, orother serious adverse reactions to vaccines or vaccine excipients
History of severe allergic reactions (for example anaphylaxis) to any component ofthe high-dose (HD) quadrivalent seasonal influenza vaccine, including egg protein,or following a previous dose of any influenza vaccine
Has had major surgery (per the investigator's judgment) within 4 weeks beforeadministration of the first study vaccine or will not have recovered from surgeryper the investigator's judgment at time of vaccination
History of acute polyneuropathy (for example, Guillain-Barré syndrome) or chronicinflammatory demyelinating polyneuropathy
Study Design
Connect with a study center
Universiteit Antwerpen - Centrum voor de Evaluatie van Vaccinaties (CEV)
Edegem, 2650
BelgiumSite Not Available
Center for Vaccinology (CEVAC)
Gent, 9000
BelgiumSite Not Available
Az Sint-Maarten
Mechelen, 2800
BelgiumSite Not Available
Aggarwal and associates Ltd
Brampton, Ontario L6T 0G1
CanadaSite Not Available
Milestone Research
London, Ontario N5W 6A2
CanadaSite Not Available
Centricity Research- Manna Research (MR) - Quebec Location
Levis, Quebec G6W 0M5
CanadaSite Not Available
PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p.
Gdansk, 80405
PolandSite Not Available
Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, 80 382
PolandSite Not Available
Synexus Polska Sp. z o.o. Oddzial w Gdynia
Gdynia, 81 537
PolandSite Not Available
Synexus Polska Sp z o o Oddzial w Katowicach
Katowice, 40 040
PolandSite Not Available
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, 40-040
PolandSite Not Available
Pratia MCM Krakow
Krakow, 30 727
PolandSite Not Available
KO-MED Centra Kliniczne LUBLIN
Lublin, 20-362
PolandSite Not Available
Velocity Lublin
Lublin, 20 362
PolandSite Not Available
KO-MED Centra Kliniczne Staszow
Staszow, 28-200
PolandSite Not Available
Velocity Staszow
Staszow, 28 200
PolandSite Not Available
MICS Centrum Medyczne Torun
Torun, 87-100
PolandSite Not Available
MICS Centrum Medyczne Warszawa
Warszawa, 00 874
PolandSite Not Available
Synexus Polska Sp z o o Oddzial w Warszawie
Warszawa, 02 672
PolandSite Not Available
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warszawa, 02-672
PolandActive - Recruiting
Synexus Polska Sp z o o Oddzial we Wroclawiu
Wroclaw, 50 381
PolandSite Not Available
Synexus Polska Sp z o o Oddzial we Wroclawiu
Wrocław, 50 381
PolandSite Not Available
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wrocław, 50-381
PolandActive - Recruiting
Medical Affiliated Research Center Inc. (MARC)
Huntsville, Alabama 35801
United StatesSite Not Available
Alliance for Multispeciality Research
Mobile, Alabama 36608
United StatesSite Not Available
Artemis Institute for Clinical Research
San Diego, California 92103
United StatesSite Not Available
Diablo Clinical Research, Inc.
Walnut Creek, California 94598
United StatesSite Not Available
Optimal Research
Melbourne, Florida 32934
United StatesSite Not Available
Pharmax Research Clinic Inc
Miami, Florida 33126
United StatesSite Not Available
Suncoast Research Associates, LLC
Miami, Florida 33173
United StatesSite Not Available
Atlanta Center for Medical Research
Atlanta, Georgia 30331
United StatesSite Not Available
Velocity Clinical Research
Savannah, Georgia 31406
United StatesSite Not Available
Synexus Clinical Research US Inc
Chicago, Illinois 60602
United StatesSite Not Available
Synexus Clinical Research US, Inc
Chicago, Illinois 60602
United StatesSite Not Available
Optimal Research
Peoria, Illinois 61614
United StatesSite Not Available
Synexus Radiant Research, Inc
Evansville, Indiana 47714
United StatesSite Not Available
Heartland Research Associates, LLC
Newton, Kansas 67114
United StatesSite Not Available
Heartland Research Associates, an AMR Company
Wichita, Kansas 67207
United StatesSite Not Available
Alliance for Multispeciality Research
Lexington, Kentucky 40509
United StatesSite Not Available
Synexus Clinical Research US Inc
Creve Coeur, Missouri 63141
United StatesSite Not Available
Synexus Clinical Research US, Inc
Creve Coeur, Missouri 63141
United StatesSite Not Available
Accellacare
Wilmington, North Carolina 28401
United StatesSite Not Available
CTI Clinical Trial and Consulting Services
Cincinnati, Ohio 45212
United StatesSite Not Available
Velocity Clinical Research
Cleveland, Ohio 44122
United StatesSite Not Available
Velocity Clinical Research
East Greenwich, Rhode Island 02818
United StatesSite Not Available
Alliance for Multispeciality Research
Knoxville, Tennessee 37909
United StatesSite Not Available
Benchmark Clinical Research - Austin
Austin, Texas 78705
United StatesSite Not Available
Optimal Research
Austin, Texas 78744
United StatesSite Not Available
Tekton Research Inc.
Beaumont, Texas 77706
United StatesSite Not Available
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