Phase
Condition
Corona Virus
Covid-19
Treatment
Normal saline placebo
BNT162b2 (Omi XBB.1.5)
RIV
Clinical Study ID
Ages > 50 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female participants aged 50 years or older at Visit 1 (Day 1).
Participants who are willing and able to comply with all scheduled visits, theinvestigational plan, laboratory tests, lifestyle considerations, and other studyprocedures.
Healthy participants who are determined by medical history, physical examination (ifrequired), and clinical judgment of the investigator to be eligible for inclusion inthe study.
Capable of giving signed informed consent as described in the protocol, whichincludes compliance with the requirements and restrictions listed in the informedconsent document (ICD) and in the protocol.
Exclusion
Exclusion Criteria:
Any medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality that may increase therisk of study participation or, in the investigator's judgment, make the participantinappropriate for the study.
Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), orhepatitis B virus (HBV).
History of severe adverse reaction associated with any vaccine and/or severeallergic reaction (eg, anaphylaxis) to any component of the study interventions.
Participants with a history of autoimmune disease or an active autoimmune diseaserequiring therapeutic intervention, including but not limited to systemic orcutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, multiplesclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura,glomerulonephritis, autoimmune thyroiditis, temporal arteritis, psoriasis, and/orinsulin-dependent diabetes mellitus.
Immunocompromised individuals with known or suspected immunodeficiency, determinedby history and/or laboratory/physical examination.
Current heart disease, uncontrolled hypertension, or a prior history of myocarditisor pericarditis.
Bleeding diathesis or condition associated with prolonged bleeding that would, inthe opinion of the investigator, contraindicate intramuscular injection.
Women who are pregnant, plan to become pregnant during the study, or arebreastfeeding.
Prior history of ischemic stroke or transient ischemic attack.
Prior history of Guillain-Barré syndrome (GBS).
Participants with a calculated BMI of ≥35.
Receipt of chronic medications with known systemic immunosuppressant effects (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60days before enrollment through conclusion of the study.
Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies used forthe treatment or prevention of COVID 19 or those that are consideredimmunosuppressive, from 90 days before study intervention administration, or plannedreceipt throughout the study.
Vaccination with any investigational or licensed influenza vaccine within 6 months (180 days) before study intervention administration, or ongoing receipt of chronicantiviral therapy with activity against influenza.
Vaccination with any investigational or licensed COVID-19 vaccine within 6 months (180 days) before study intervention administration.
Participation in other studies involving administration of an investigationalproduct within 28 days prior to, and/or during, participation in this study.
Investigator site staff directly involved in the conduct of the study and theirfamily members, site staff otherwise supervised by the investigator, and sponsor andsponsor delegate employees directly involved in the conduct of the study and theirfamily members.
Deprived of freedom by an administrative or court order, or in an emergency setting,or hospitalized involuntarily.
Current alcohol abuse or drug addiction that in the opinion of the investigatormight interfere with the study conduct or completion.
Study Design
Study Description
Connect with a study center
Orange County Research Center
Lake Forest, California 92630
United StatesSite Not Available
Orange County Research Center
Tustin, California 92780
United StatesSite Not Available
Diablo Clinical Research, Inc.
Walnut Creek, California 94598
United StatesSite Not Available
Clinical Research Consulting
Milford, Connecticut 06460
United StatesSite Not Available
GW Medical Faculty Associates
Washington, District of Columbia 20037
United StatesSite Not Available
GW Vaccine Research Unit
Washington, District of Columbia 20037
United StatesSite Not Available
JEM Research Institute
Atlantis, Florida 33462
United StatesSite Not Available
Indago Research & Health Center, Inc
Hialeah, Florida 33012
United StatesSite Not Available
Optimal Research
Melbourne, Florida 32934
United StatesSite Not Available
Headlands Research Orlando
Orlando, Florida 32819
United StatesSite Not Available
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida 32789
United StatesSite Not Available
Clinical Research Atlanta
Stockbridge, Georgia 30281
United StatesSite Not Available
East-West Medical Research Institute
Honolulu, Hawaii 96814
United StatesSite Not Available
Optimal Research
Peoria, Illinois 61614
United StatesSite Not Available
Bio-Kinetic Clinical Applications LLC DBA QPS-MO(Patient Screening Center)
Springfield, Missouri 65807
United StatesSite Not Available
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri 65802
United StatesSite Not Available
Bio-Kinetic Clinical Applications, LLD dba QPS-MO
Springfield, Missouri 65802
United StatesSite Not Available
Las Vegas Clinical Trials
Las Vegas, Nevada 89030
United StatesSite Not Available
Las Vegas Clinical Trials
North Las Vegas, Nevada 89030
United StatesSite Not Available
ActivMed Practices & Research, LLC.
Portsmouth, New Hampshire 03801
United StatesSite Not Available
Rochester Clinical Research, LLC
Rochester, New York 14609
United StatesSite Not Available
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio 43213
United StatesSite Not Available
Clinical Research Associates Inc
Nashville, Tennessee 37203
United StatesSite Not Available
DM Clinical Research - Bellaire
Houston, Texas 77081
United StatesSite Not Available
DM Clinical Research- Cyfair
Houston, Texas 77065
United StatesSite Not Available
SMS Clinical Research
Mesquite, Texas 75149
United StatesSite Not Available
Clinical Trials of Texas, LLC
San Antonio, Texas 78229
United StatesSite Not Available
IMA Clinical Research San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
DM Clinical Research
Tomball, Texas 77375
United StatesSite Not Available
DM Clinical Research - MDC
Tomball, Texas 77375
United StatesSite Not Available
Charlottesville Medical Research
Charlottesville, Virginia 22911
United StatesSite Not Available
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