Phase
Condition
Covid-19
Treatment
Bivalent BA.4/5
NVX-CoV2601 (5μg)
NVX-CoV2601 (35μg)
Clinical Study ID
Ages 50-99 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults ≥ 50 years of age at screening.
Willing and able to give informed consent prior to study enrollment and to complywith study procedures.
Female participants of childbearing potential (defined as any participant who hasexperienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateraltubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea ≥ 12 consecutive months]) must agree to be heterosexually inactive from at least 28days prior to enrollment and through the end of the study OR agree to consistentlyuse a medically acceptable method of contraception listed below from ≥ 28 days priorto enrollment and through the end of the study.
Is medically stable, as determined by the investigator (based on review of healthstatus, vital signs [to include body temperature], medical history, and targetedphysical examination [to include body weight]). Vital signs must be within medicallyacceptable ranges prior to the initial study vaccination.
Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials forthe duration of the study.
Have previously received ≥ 3 doses of a COVID-19 prototype or bivalent licensedmRNAvaccine with the last dose having been given ≥ 90 days previously prior to firststudy booster.
Exclusion
Exclusion Criteria:
Received COVID-19 vaccines other than a COVID-19 prototype or bivalent licensed mRNAvaccine in the past, inclusive of clinical trial COVID-19 vaccines.
Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to study vaccination.
Received influenza vaccination within 14 days prior to first study vaccination, orany other vaccine within 30 days prior to first study vaccination.
Any known allergies to products contained in the investigational product. 5. Anyhistory of anaphylaxis to any prior vaccine.
Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital)requiring ongoing immunomodulatory therapy.
Chronic administration (defined as > 14 continuous days) of immunosuppressant,systemic glucocorticoids, or other immune-modifying drugs within 90 days prior tostudy vaccination. NOTE: An immunosuppressant dose of glucocorticoid is defined as asystemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical orintranasal glucocorticoids is permitted. Topical tacrolimus and ocular cyclosporinare permitted. Use of inhaled glucocorticoids is prohibited.
Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to study vaccination, except for rabies immunoglobulin which may begiven if medically indicated.
Active cancer (malignancy) on therapy within 3 years prior to study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigomaligna and uterine cervical carcinoma in situ without evidence of disease, at thediscretion of the investigator).
Participants who are breastfeeding, pregnant, or who plan to become pregnant priorto the end of study.
Suspected or known history of alcohol abuse or drug addiction within 2 years priorto the study vaccine dose that, in the opinion of the investigator, might interferewith protocol compliance.
Any other condition that, in the opinion of the investigator, would pose a healthrisk to the participant if enrolled or could interfere with evaluation of the studyvaccine or interpretation of study results (including neurologic or psychiatricconditions likely to impair the quality of safety reporting).
Study team member or immediate family member of any study team member (inclusive ofSponsor, contract research organization (CRO), and study site personnel involved inthe conduct or planning of the study).
Participants with a history of myocarditis or pericarditis.
Study Design
Study Description
Connect with a study center
ARS-Birmingham CRU
Birmingham, Alabama 35216
United StatesSite Not Available
Tucson Neuroscience Research
Tucson, Arizona 85710
United StatesSite Not Available
Velocity Clinical Research, Banning
Banning, California 99202
United StatesSite Not Available
Velocity Clinical Research, Chula Vista
Chula Vista, California 91911
United StatesSite Not Available
Velocity Clinical Research, San Diego
La Mesa, California 91942
United StatesSite Not Available
Artemis Institute for Clinical Research
Riverside, California 92503
United StatesSite Not Available
Artemis - San Diego
San Diego, California 92103
United StatesSite Not Available
WR-MCCR
San Diego, California 92120
United StatesSite Not Available
Deland CRU
DeLand, Florida 32720
United StatesSite Not Available
Health Awareness
Jupiter, Florida 33458
United StatesSite Not Available
Wr-Msra, Llc
Lake City, Florida 32055
United StatesSite Not Available
Professional Urgent Care Services
Largo, Florida 33777
United StatesSite Not Available
Health Awareness
Miami, Florida 33458
United StatesSite Not Available
Research Institute of South Florida
Miami, Florida 33173
United StatesSite Not Available
Suncoast Research Associates, LLC
Miami, Florida 33173
United StatesSite Not Available
Headlands Research Orlando LLC
Orlando, Florida 32819
United StatesSite Not Available
Precision Clinical Research, LLC
Sunrise, Florida 33351
United StatesSite Not Available
TrueBlue Clinical Research
Tampa, Florida 33609
United StatesSite Not Available
Neurostudies CRU
Decatur, Georgia 30030
United StatesSite Not Available
Velocity Clinical Research
Savannah, Georgia 31406
United StatesSite Not Available
CRA Headlands LLC
Stockbridge, Georgia 30281
United StatesSite Not Available
Velocity Clinical Research
Meridian, Idaho 83642
United StatesSite Not Available
Velocity Clinical Research
Sioux City, Iowa 51106
United StatesSite Not Available
Velocity Clinical Research
Baton Rouge, Louisiana 70809
United StatesSite Not Available
Velocity Clinical Research - Covington
Covington, Louisiana 70433
United StatesSite Not Available
Velocity Clinical Research, Metairie
Metairie, Louisiana 70006
United StatesSite Not Available
Activmed Practices and Research, LLC
Methuen, Massachusetts 01844
United StatesSite Not Available
Velocity Clinical Research, Gulfport
Gulfport, Mississippi 39503
United StatesSite Not Available
Velocity Clinical Research
Grand Island, Nebraska 68803
United StatesSite Not Available
Velocity Clinical Research
Norfolk, Nebraska 68701
United StatesSite Not Available
Velocity Clinical Research
Omaha, Nebraska 68134
United StatesSite Not Available
Activmed Practices and Research, LLC
Portsmouth, New Hampshire 03801
United StatesSite Not Available
Velocity Clinical Research
Binghamton, New York 13905
United StatesSite Not Available
Hypercore (Lucas Research)
New Bern, North Carolina 28562
United StatesSite Not Available
M3 Wake Research Inc
Raleigh, North Carolina 27612
United StatesSite Not Available
Trial Management Associates, LLC
Wilmington, North Carolina 28403
United StatesSite Not Available
Javara Inc./Wake Forest Health Network, LLC
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Velocity Clinical Research
Cincinnati, Ohio 45246
United StatesSite Not Available
Tekton Research
Edmond, Oklahoma 73013
United StatesSite Not Available
Lynn Health Science Institute
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Velocity Clinical Research, Grants Pass
Grants Pass, Oregon 97527
United StatesSite Not Available
Velocity Clinical Research, Providence
East Greenwich, Rhode Island 02818
United StatesSite Not Available
Velocity Clinical Research, Gaffney
Gaffney, South Carolina 29340
United StatesSite Not Available
Coastal Carolina Research Center an ALCANZA Clinical Research company
North Charleston, South Carolina 29405
United StatesSite Not Available
Central Texas Clinical Research, LLC
Austin, Texas 78705
United StatesSite Not Available
Research Your Health
Plano, Texas 75093
United StatesSite Not Available
Benchmark Research
San Angelo, Texas 76904
United StatesSite Not Available
Velocity Clinical Research, Salt Lake City
West Jordan, Utah 84088
United StatesSite Not Available
Health Research of Hampton Roads, Inc
Newport News, Virginia 23606
United StatesSite Not Available
Clinical Research Partners
Richmond, Virginia 23226
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.