This is a Phase 4, post-market US study, evaluating the efficacy and safety of a singledose of the NVX-CoV2705 Omicron JN.1 COVID-19 vaccine. Approximately 6,500 healthy adultsaged 50 to under 65 will be randomized to receive either the vaccine or a placebo, withfollow-up for 180 days.
This is a Phase 4, multicenter, randomized, double-blind, placebo-controlled,
post-marketing study to evaluate the efficacy and safety of a single dose of an Omicron
JN.1 subvariant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant
(r) spike (S) protein nanoparticle vaccine (SARS-CoV-2 rS) adjuvanted with Matrix-M
(NVX-CoV2705) in adults 50 to < 65 years of age who are not considered to be at high risk
of severe coronavirus disease 2019 (COVID-19). This study will be conducted in the United
States (US).
Approximately 6,500 participants will be randomized in a 1:1 ratio via block
randomization to receive a single intramuscular (IM) injection of NVX-CoV2705 or placebo
(normal saline) on Day 0 and remain on study for efficacy and safety data collection
through Day 180/end of study (EoS).
Biological: NVX-CoV2705
NVX-CoV2705 vaccine in a 0.5 mL injection volume at an antigenic dose of 5 µg with 50 µg
Matrix-M adjuvant
Other Name: Omicron JN.1 subvariant SARS-CoV-2 rS vaccine adjuvanted with Matrix-M
Biological: Placebo
Placebo (normal saline) in a 0.5 mL injection volume.
Inclusion Criteria:
- To be included in this study, each individual must satisfy all of the following
criteria:
1. Adults 50 to < 65 years of age at time of study vaccination (Day 0) who are not
considered to be at high risk of severe COVID-19.
2. Participants unvaccinated to SARS-CoV-2 or participants previously vaccinated
with a COVID-19 vaccine ≥ 90 days prior to study vaccination.
3. Participant or legally acceptable representative is willing and able to give
informed consent prior to study enrollment and to comply with study procedures.
4. Female participants of childbearing potential (defined as any participant who
has experienced menarche and who is NOT surgically sterile [ie, hysterectomy,
bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined
as amenorrhea ≥ 12 consecutive months]) must agree to be heterosexually
inactive from at least 28 days prior to enrollment and through 90 days after
vaccination OR agree to consistently use a medically acceptable method of
contraception listed below from ≥ 28 days prior to enrollment and through 90
days after vaccination.
1. Condoms (male or female) with spermicide (if acceptable in country)
2. Diaphragm with spermicide
3. Cervical cap with spermicide
4. Intrauterine device
5. Oral or patch contraceptives
6. Norplant®, Depo-Provera®, or other in country regulatory approved
contraceptive method that is designed to protect against pregnancy
7. Abstinence, as a form of contraception, is acceptable if in line with the
participant's lifestyle NOTE: Periodic abstinence (eg, calendar,
ovulation, sympto-thermal, post-ovulation methods) and withdrawal are not
acceptable methods of contraception.
5. Agrees not to participate in any research involving receipt of investigational
products (drug/biologic/device), including other SARS-CoV-2 prevention or
treatment trials, for the duration of the study.
Exclusion Criteria:
- If an individual meets any of the following criteria, he or she is ineligible for
this study:
1. Is considered to be at high risk of severe COVID-19 due to underlying medical
conditions or risk factors that demonstrated a conclusive increase in risk for
at least one severe COVID-19 outcome, as described by the Centers for Disease
Control and Prevention (CDC) .
2. Unstable acute illness at the time of vaccination.
3. Participation at the time of study enrollment or planned participation during
the present study period in another clinical study investigating a vaccine,
drug, medical device, or medical procedure.
4. Current participation in any other COVID-19 prevention clinical trial.
5. Known history of COVID-19 infection within 90 days of study vaccination.
6. Any known history of allergies to products contained in the investigational
product in the participant's lifetime.
7. Any known history of anaphylaxis to any prior vaccine in the participant's
lifetime.
8. Known history of myocarditis or pericarditis in the participant's lifetime.
9. Chronic administration (defined as > 14 continuous days) of immunosuppressant,
systemic glucocorticoids, or other immune-modifying drugs within 90 days prior
to study vaccination (Day 0).
NOTE: An immunosuppressant dose of glucocorticoid is defined as a systemic dose
≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, or
intranasal glucocorticoids is permitted. Topical tacrolimus and ocular
cyclosporin are permitted.
10. Received immunoglobulin or blood-derived products within 90 days prior to study
vaccination (Day 0).
11. Participants who are pregnant, or who plan to become pregnant within 90 days
following study vaccination.
12. Any other condition that, in the opinion of the investigator, would pose a
health risk to the participant if enrolled or could interfere with evaluation
of the study vaccine or interpretation of study results (including neurologic
or psychiatric conditions likely to impair the quality of safety reporting).
13. Study team member or immediate family member of any study team member
(inclusive of Sponsor, clinical research organization [CRO], and study site
personnel involved in the conduct or planning of the study).
North Alabama Research Center
Athens, Alabama, United States
TrialMed - Birmingham
Birmingham, Alabama, United States
Hawthorne Health - Gadsden
Gadsden, Alabama, United States
TrialdMed - Huntsville
Huntsville, Alabama, United States
AMR Mobile
Mobile, Alabama, United States
Headlands Research Scottsdale
Scottsdale, Arizona, United States
Orange Grove Family Practice
Tucson, Arizona, United States
310 Clinical Research
Inglewood, California, United States
Velocity Clinical Research - San Diego
La Mesa, California, United States
Profound Research LLC at Seaside Medical Group
Oceanside, California, United States
California Research Foundation
San Diego, California, United States
Bayview Research Group, LLC
Valley Village, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Alliance Clinical - West Hills
West Hills, California, United States
Lynn Institute of Denver
Aurora, Colorado, United States
Paradigm Clinical Research Centers, LLC
Wheat Ridge, Colorado, United States
Clinical Research Consulting, LLC
Milford, Connecticut, United States
SIMED Health, LLC / SIMED Research
Gainesville, Florida, United States
Indago Research and Health Center, Inc.
Hialeah, Florida, United States
Health Awareness, LLC
Jupiter, Florida, United States
TrialMed - Melbourne
Melbourne, Florida, United States
Acevedo Clinical Research Associates
Miami, Florida, United States
Research Institute Of South Florida, Inc.
Miami, Florida, United States
MOORE Clinical Research
Tampa, Florida, United States
TrialMed - The Villages
The Villages, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
CenExel Atlanta GA
Atlanta, Georgia, United States
Centricity Research
Columbus, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Velocity Clinical Research, Boise
Meridian, Idaho, United States
Accellacare of Duly
Lombard, Illinois, United States
Accellacare Duly Health and Care
Oak Lawn, Illinois, United States
TrialMed
Evansville, Indiana, United States
Velocity Clinical Research, Valparaiso
Valparaiso, Indiana, United States
Velocity Clinical Research, Sioux City
Sioux City, Iowa, United States
Integrated Clinical Trial Services
West Des Moines, Iowa, United States
DelRicht Research @ Concierge and Direct Primary Care
Overland Park, Kansas, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States
Alliance for Multispecialty Research, L.L.C.
Lexington, Kentucky, United States
DelRicht Research @ Touro Medical Center
New Orleans, Louisiana, United States
DelRicht Research @ Matthew Mintz Clinic
Rockville, Maryland, United States
Profound Research LLC at Millennium Affiliated Physicians
Farmington Hills, Michigan, United States
Great Lakes Research Institute, LLC
Southfield, Michigan, United States
Clinical Research Institute, Inc
Minneapolis, Minnesota, United States
DelRicht Research at Gulfport Memorial
Gulfport, Mississippi, United States
AMR Kansas City
Kansas City, Missouri, United States
Sundance Clinical Research
St Louis, Missouri, United States
Boeson Research
Missoula, Montana, United States
Velocity Clinical Research, Lincoln
Lincoln, Nebraska, United States
Velocity Clinical Research
Norfolk, Nebraska, United States
Velocity Clinical Research, Omaha
Omaha, Nebraska, United States
Excel Clinical Research
Las Vegas, Nevada, United States
TrialMed - Las Vegas
Las Vegas, Nevada, United States
AMR Clinical - Las Vegas
Las Vegas, Nevada, United States
Hawthorne Health - Lindenwold
Lindenwold, New Jersey, United States
IMA Clinical Research - Albuquerque
Albuquerque, New Mexico, United States
Velocity Clinical Research - Binghampton
Binghamton, New York, United States
Rochester Clinical Research
Buffalo, New York, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
Hawthorne Health - Staten
Staten Island, New York, United States
Hawthorne Health - Concord
Concord, North Carolina, United States
Monroe Pharmaceutical Research
Monroe, North Carolina, United States
Accellacare of Rocky Mount
Rocky Mount, North Carolina, United States
Accellacare Research of Salisbury
Salisbury, North Carolina, United States
Accellacare Research of Winston Salem
Winston-Salem, North Carolina, United States
DSI Research - Northridge
Dayton, Ohio, United States
Lynn Institute of Norman
Norman, Oklahoma, United States
Lynn Health Institute - OKC
Oklahoma City, Oklahoma, United States
DelRicht Research @ Grassroots Healthcare
Tulsa, Oklahoma, United States
Velocity Clinical Research, Medford
Medford, Oregon, United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, United States
Hawthorne Health - Horsham
Horsham, Pennsylvania, United States
Suburban Research Associates - West Chester Office
West Chester, Pennsylvania, United States
K2 Medical Research - East Providence
East Providence, Rhode Island, United States
DelRicht Research @ Newton Family Medicine
Charleston, South Carolina, United States
Piedmont Research Partners
Fort Mill, South Carolina, United States
Trial Management Associates (TMA ) Headlands LLC
Myrtle Beach, South Carolina, United States
Accellacare of Bristol
Bristol, Tennessee, United States
WR Clinsearch, LLC
Chattanooga, Tennessee, United States
Summit-Halls Family Practice
Knoxville, Tennessee, United States
Hawthorne Health - Lebanon
Lebanon, Tennessee, United States
International Clinical Research - Tennessee
Murfreesboro, Tennessee, United States
Avacare
Austin, Texas, United States
TrialMed - Austin
Austin, Texas, United States
Howland Allergy & Asthma PLLC dba Orion Clinical Research
Austin, Texas, United States
Zenos Clinical Research
Dallas, Texas, United States
Avacare
Fort Worth, Texas, United States
SMS Clinical Research LLC
Mesquite, Texas, United States
ACRC Trials
Plano, Texas, United States
Research Your Health
Plano, Texas, United States
Flourish San Antonio - Clinical
San Antonio, Texas, United States
TrialMed - San Antonio
San Antonio, Texas, United States
Sugar Lakes Family Practice, P.A.
Sugar Land, Texas, United States
Boeson Research - Utah
Provo, Utah, United States
University of Utah
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, United States
Health Research of Hampton Roads, Inc
Newport News, Virginia, United States
Velocity Clinical Research, Seattle
Seattle, Washington, United States
Clinical Development, Study Director
Novavax, Inc.