Efficacy and Safety of NVX-CoV2705

NCT07086222 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2019nCoV-420
• Study Type: interventional
• Target: 6,500
• Locations: 1 country
• Sites: 99

Brief Summary

This is a Phase 4, post-market US study, evaluating the efficacy and safety of a single dose of the NVX-CoV2705 Omicron JN.1 COVID-19 vaccine. Approximately 6,500 healthy adults aged 50 to under 65 will be randomized to receive either the vaccine or a placebo, with follow-up for 180 days.

Conditions

COVID-19; Sars-CoV-2 Infection

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• First episode of PCR-positive symptomatic COVID 19

  First episode of PCR-positive symptomatic COVID 19 from Day 0 (post vaccination) through Day 180/EoS

  Day 0 to Day 180

Secondary Outcomes (2)

• First episode of PCR-positive symptomatic COVID 19

  Day 42 to Day 180

• Participants with Medically attended adverse events (MAAEs), Serious adverse event (SAEs) and Adverse event of special interest (AESIs)

  Day 180

Study Arms (2)

NVX-CoV2705

EXPERIMENTAL

a single intramuscular (IM) injection of NVX-CoV2705 on Day 0

Biological: NVX-CoV2705

Placebo

PLACEBO COMPARATOR

a single intramuscular (IM) injection of placebo (normal saline) on Day 0

Biological: Placebo

Interventions

NVX-CoV2705 BIOLOGICAL

NVX-CoV2705 vaccine in a 0.5 mL injection volume at an antigenic dose of 5 µg with 50 µg Matrix-M adjuvant

Also known as: Omicron JN.1 subvariant SARS-CoV-2 rS vaccine adjuvanted with Matrix-M

NVX-CoV2705

Placebo BIOLOGICAL

Placebo (normal saline) in a 0.5 mL injection volume.

Placebo

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be included in this study, each individual must satisfy all of the following criteria:
• 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.
• Participants unvaccinated to SARS-CoV-2 or participants previously vaccinated with a COVID-19 vaccine ≥ 90 days prior to study vaccination.
• Participant or legally acceptable representative is willing and able to give informed consent prior to study enrollment and to comply with study procedures.
• 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.
• Condoms (male or female) with spermicide (if acceptable in country)
• Diaphragm with spermicide
• Cervical cap with spermicide
• Intrauterine device
• Oral or patch contraceptives
• Norplant®, Depo-Provera®, or other in country regulatory approved contraceptive method that is designed to protect against pregnancy
• 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.
• 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.

You may not qualify if:

• If an individual meets any of the following criteria, he or she is ineligible for this study:
• 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) .
• Unstable acute illness at the time of vaccination.
• 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.
• Current participation in any other COVID-19 prevention clinical trial.
• Known history of COVID-19 infection within 90 days of study vaccination.
• Any known history of allergies to products contained in the investigational product in the participant's lifetime.
• Any known history of anaphylaxis to any prior vaccine in the participant's lifetime.
• Known history of myocarditis or pericarditis in the participant's lifetime.
• 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.
• Received immunoglobulin or blood-derived products within 90 days prior to study vaccination (Day 0).
• Participants who are pregnant, or who plan to become pregnant within 90 days following study vaccination.
• 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).
• 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).

Sponsors & Collaborators

• Novavax: lead
• Sanofi: collaborator

Study Sites (99)

North Alabama Research Center

Athens, Alabama, 35611, United States

Location

TrialMed - Birmingham

Birmingham, Alabama, 35211, United States

Location

Hawthorne Health - Gadsden

Gadsden, Alabama, 35901, United States

Location

TrialdMed - Huntsville

Huntsville, Alabama, 35802, United States

Location

AMR Mobile

Mobile, Alabama, 36608, United States

Location

Headlands Research Scottsdale

Scottsdale, Arizona, 85260, United States

Location

Orange Grove Family Practice

Tucson, Arizona, 85741, United States

Location

310 Clinical Research

Inglewood, California, 90301, United States

Location

Velocity Clinical Research - San Diego

La Mesa, California, 91942, United States

Location

Profound Research LLC at Seaside Medical Group

Oceanside, California, 92058, United States

Location

California Research Foundation

San Diego, California, 92123, United States

Location

Bayview Research Group, LLC

Valley Village, California, 91607, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Alliance Clinical - West Hills

West Hills, California, 91303, United States

Location

Lynn Institute of Denver

Aurora, Colorado, 80012, United States

Location

Paradigm Clinical Research Centers, LLC

Wheat Ridge, Colorado, 80033, United States

Location

Clinical Research Consulting, LLC

Milford, Connecticut, 06460, United States

Location

SIMED Health, LLC / SIMED Research

Gainesville, Florida, 32607, United States

Location

Indago Research and Health Center, Inc.

Hialeah, Florida, 33012, United States

Location

Health Awareness, LLC

Jupiter, Florida, 33458, United States

Location

TrialMed - Melbourne

Melbourne, Florida, 32934, United States

Location

Acevedo Clinical Research Associates

Miami, Florida, 33142, United States

Location

Research Institute Of South Florida, Inc.

Miami, Florida, 33173, United States

Location

MOORE Clinical Research

Tampa, Florida, 33609, United States

Location

TrialMed - The Villages

The Villages, Florida, 32162, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

CenExel Atlanta GA

Atlanta, Georgia, 30331, United States

Location

Centricity Research

Columbus, Georgia, 31904, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Velocity Clinical Research, Boise

Meridian, Idaho, 83642, United States

Location

Accellacare of Duly

Lombard, Illinois, 60148, United States

Location

Accellacare Duly Health and Care

Oak Lawn, Illinois, 60453, United States

Location

TrialMed

Evansville, Indiana, 47714, United States

Location

Velocity Clinical Research, Valparaiso

Valparaiso, Indiana, 46383, United States

Location

Velocity Clinical Research, Sioux City

Sioux City, Iowa, 51106, United States

Location

Integrated Clinical Trial Services

West Des Moines, Iowa, 50265, United States

Location

DelRicht Research @ Concierge and Direct Primary Care

Overland Park, Kansas, 66209, United States

Location

Alliance for Multispecialty Research, LLC

Wichita, Kansas, 67207, United States

Location

Alliance for Multispecialty Research, L.L.C.

Lexington, Kentucky, 40509, United States

Location

DelRicht Research @ Touro Medical Center

New Orleans, Louisiana, 70115, United States

Location

DelRicht Research @ Matthew Mintz Clinic

Rockville, Maryland, 20852, United States

Location

Profound Research LLC at Millennium Affiliated Physicians

Farmington Hills, Michigan, 48334, United States

Location

Great Lakes Research Institute, LLC

Southfield, Michigan, 48075, United States

Location

Clinical Research Institute, Inc

Minneapolis, Minnesota, 55402, United States

Location

DelRicht Research at Gulfport Memorial

Gulfport, Mississippi, 39503, United States

Location

AMR Kansas City

Kansas City, Missouri, 64114, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Boeson Research

Missoula, Montana, 59804, United States

Location

Velocity Clinical Research, Lincoln

Lincoln, Nebraska, 68510, United States

Location

Velocity Clinical Research

Norfolk, Nebraska, 68701, United States

Location

Velocity Clinical Research, Omaha

Omaha, Nebraska, 68134, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

TrialMed - Las Vegas

Las Vegas, Nevada, 89113, United States

Location

AMR Clinical - Las Vegas

Las Vegas, Nevada, 89119, United States

Location

Hawthorne Health - Lindenwold

Lindenwold, New Jersey, 08021, United States

Location

IMA Clinical Research - Albuquerque

Albuquerque, New Mexico, 87109, United States

Location

Velocity Clinical Research - Binghampton

Binghamton, New York, 13905, United States

Location

Rochester Clinical Research

Buffalo, New York, 14217, United States

Location

Rochester Clinical Research, LLC

Rochester, New York, 14609, United States

Location

Hawthorne Health - Staten

Staten Island, New York, 10309, United States

Location

Hawthorne Health - Concord

Concord, North Carolina, 28025, United States

Location

Monroe Pharmaceutical Research

Monroe, North Carolina, 28112, United States

Location

Accellacare of Rocky Mount

Rocky Mount, North Carolina, 27804, United States

Location

Accellacare Research of Salisbury

Salisbury, North Carolina, 28144, United States

Location

Accellacare Research of Winston Salem

Winston-Salem, North Carolina, 27103, United States

Location

DSI Research - Northridge

Dayton, Ohio, 45414, United States

Location

Lynn Institute of Norman

Norman, Oklahoma, 73072, United States

Location

Lynn Health Institute - OKC

Oklahoma City, Oklahoma, 73112, United States

Location

DelRicht Research @ Grassroots Healthcare

Tulsa, Oklahoma, 74133, United States

Location

Velocity Clinical Research, Medford

Medford, Oregon, 97504, United States

Location

Capital Area Research, LLC

Camp Hill, Pennsylvania, 17011, United States

Location

Hawthorne Health - Horsham

Horsham, Pennsylvania, 19044, United States

Location

Suburban Research Associates - West Chester Office

West Chester, Pennsylvania, 19380, United States

Location

K2 Medical Research - East Providence

East Providence, Rhode Island, 02914, United States

Location

DelRicht Research @ Newton Family Medicine

Charleston, South Carolina, 29407, United States

Location

Piedmont Research Partners

Fort Mill, South Carolina, 29707, United States

Location

Trial Management Associates (TMA ) Headlands LLC

Myrtle Beach, South Carolina, 29572, United States

Location

Accellacare of Bristol

Bristol, Tennessee, 37620, United States

Location

WR Clinsearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

Summit-Halls Family Practice

Knoxville, Tennessee, 37938, United States

Location

Hawthorne Health - Lebanon

Lebanon, Tennessee, 37087, United States

Location

International Clinical Research - Tennessee

Murfreesboro, Tennessee, 37130, United States

Location

Avacare

Austin, Texas, 78705, United States

Location

TrialMed - Austin

Austin, Texas, 78744, United States

Location

Howland Allergy & Asthma PLLC dba Orion Clinical Research

Austin, Texas, 78759, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230, United States

Location

Avacare

Fort Worth, Texas, 76135, United States

Location

SMS Clinical Research LLC

Mesquite, Texas, 75149, United States

Location

ACRC Trials

Plano, Texas, 75093, United States

Location

Research Your Health

Plano, Texas, 75093, United States

Location

Flourish San Antonio - Clinical

San Antonio, Texas, 78229, United States

Location

TrialMed - San Antonio

San Antonio, Texas, 78229, United States

Location

Sugar Lakes Family Practice, P.A.

Sugar Land, Texas, 77479, United States

Location

Boeson Research - Utah

Provo, Utah, 84604, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

Charlottesville Medical Research Center, LLC

Charlottesville, Virginia, 22911, United States

Location

Health Research of Hampton Roads, Inc

Newport News, Virginia, 23606, United States

Location

Velocity Clinical Research, Seattle

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Matrix-M

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Clinical Development

  Novavax, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 25, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): November 18, 2026
• Study Completion (Estimated): November 18, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

US (99)