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New novavax JN.1 vaccine trial aims to protect adults 50-64 from COVID

NCT ID NCT07086222

Vaccine Sponsor: Novavax Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a single dose of an updated Novavax COVID-19 vaccine designed to target the JN.1 variant. About 6,500 healthy adults aged 50 to under 65 who are not at high risk for severe COVID will receive either the vaccine or a placebo. Researchers will track how well the vaccine prevents symptomatic COVID-19 over 180 days and monitor for side effects.

Why investors are watching

Novavax is testing its updated JN.1 COVID-19 vaccine in 6,500 adults aged 50 to under 65 without high-risk conditions. This Phase 4 post-marketing study matters because a positive result could support broader use of the vaccine in a large, generally healthy age group, which is important for a small company whose revenue depends on COVID vaccine sales.

If it works: A positive result could strengthen Novavax's position in the adult COVID vaccine market and support future recommendations for this age group. That could help the company maintain a steady revenue stream from its only commercial product.

If it fails: The trial could fail to show the vaccine prevents COVID better than placebo, or safety issues could emerge. Trials fail often, and a negative result would likely hurt Novavax's credibility and sales prospects for this vaccine.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

6,500 people

The number who actually took part.

Started

Nov 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID -19 SARS-CoV-2 infection

Contacts and locations

Locations

  • 310 Clinical Research

    Inglewood, California, 90301, United States

  • ACRC Trials

    Plano, Texas, 75093, United States

  • AMR Clinical - Las Vegas

    Las Vegas, Nevada, 89119, United States

  • AMR Kansas City

    Kansas City, Missouri, 64114, United States

  • AMR Mobile

    Mobile, Alabama, 36608, United States

  • Accellacare Duly Health and Care

    Oak Lawn, Illinois, 60453, United States

  • Accellacare Research of Salisbury

    Salisbury, North Carolina, 28144, United States

  • Accellacare Research of Winston Salem

    Winston-Salem, North Carolina, 27103, United States

  • Accellacare of Bristol

    Bristol, Tennessee, 37620, United States

  • Accellacare of Duly

    Lombard, Illinois, 60148, United States

  • Accellacare of Rocky Mount

    Rocky Mount, North Carolina, 27804, United States

  • Acevedo Clinical Research Associates

    Miami, Florida, 33142, United States

  • Alliance Clinical - West Hills

    West Hills, California, 91303, United States

  • Alliance for Multispecialty Research, L.L.C.

    Lexington, Kentucky, 40509, United States

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas, 67207, United States

  • Avacare

    Austin, Texas, 78705, United States

  • Avacare

    Fort Worth, Texas, 76135, United States

  • Bayview Research Group, LLC

    Valley Village, California, 91607, United States

  • Boeson Research

    Missoula, Montana, 59804, United States

  • Boeson Research - Utah

    Provo, Utah, 84604, United States

  • California Research Foundation

    San Diego, California, 92123, United States

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania, 17011, United States

  • CenExel Atlanta GA

    Atlanta, Georgia, 30331, United States

  • Centricity Research

    Columbus, Georgia, 31904, United States

  • Charlottesville Medical Research Center, LLC

    Charlottesville, Virginia, 22911, United States

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281, United States

  • Clinical Research Consulting, LLC

    Milford, Connecticut, 06460, United States

  • Clinical Research Institute, Inc

    Minneapolis, Minnesota, 55402, United States

  • DSI Research - Northridge

    Dayton, Ohio, 45414, United States

  • DelRicht Research @ Concierge and Direct Primary Care

    Overland Park, Kansas, 66209, United States

  • DelRicht Research @ Grassroots Healthcare

    Tulsa, Oklahoma, 74133, United States

  • DelRicht Research @ Matthew Mintz Clinic

    Rockville, Maryland, 20852, United States

  • DelRicht Research @ Newton Family Medicine

    Charleston, South Carolina, 29407, United States

  • DelRicht Research @ Touro Medical Center

    New Orleans, Louisiana, 70115, United States

  • DelRicht Research at Gulfport Memorial

    Gulfport, Mississippi, 39503, United States

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598, United States

  • Excel Clinical Research

    Las Vegas, Nevada, 89109, United States

  • Flourish San Antonio - Clinical

    San Antonio, Texas, 78229, United States

  • Great Lakes Research Institute, LLC

    Southfield, Michigan, 48075, United States

  • Hawthorne Health - Concord

    Concord, North Carolina, 28025, United States

  • Hawthorne Health - Gadsden

    Gadsden, Alabama, 35901, United States

  • Hawthorne Health - Horsham

    Horsham, Pennsylvania, 19044, United States

  • Hawthorne Health - Lebanon

    Lebanon, Tennessee, 37087, United States

  • Hawthorne Health - Lindenwold

    Lindenwold, New Jersey, 08021, United States

  • Hawthorne Health - Staten

    Staten Island, New York, 10309, United States

  • Headlands Research Scottsdale

    Scottsdale, Arizona, 85260, United States

  • Health Awareness, LLC

    Jupiter, Florida, 33458, United States

  • Health Research of Hampton Roads, Inc

    Newport News, Virginia, 23606, United States

  • Howland Allergy & Asthma PLLC dba Orion Clinical Research

    Austin, Texas, 78759, United States

  • IMA Clinical Research - Albuquerque

    Albuquerque, New Mexico, 87109, United States

  • Indago Research and Health Center, Inc.

    Hialeah, Florida, 33012, United States

  • Integrated Clinical Trial Services

    West Des Moines, Iowa, 50265, United States

  • International Clinical Research - Tennessee

    Murfreesboro, Tennessee, 37130, United States

  • J. Lewis Research, Inc. / Foothill Family Clinic

    Salt Lake City, Utah, 84109, United States

  • K2 Medical Research - East Providence

    East Providence, Rhode Island, 02914, United States

  • Lynn Health Institute - OKC

    Oklahoma City, Oklahoma, 73112, United States

  • Lynn Institute of Denver

    Aurora, Colorado, 80012, United States

  • Lynn Institute of Norman

    Norman, Oklahoma, 73072, United States

  • MOORE Clinical Research

    Tampa, Florida, 33609, United States

  • Monroe Pharmaceutical Research

    Monroe, North Carolina, 28112, United States

  • North Alabama Research Center

    Athens, Alabama, 35611, United States

  • Orange Grove Family Practice

    Tucson, Arizona, 85741, United States

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409, United States

  • Paradigm Clinical Research Centers, LLC

    Wheat Ridge, Colorado, 80033, United States

  • Piedmont Research Partners

    Fort Mill, South Carolina, 29707, United States

  • Profound Research LLC at Millennium Affiliated Physicians

    Farmington Hills, Michigan, 48334, United States

  • Profound Research LLC at Seaside Medical Group

    Oceanside, California, 92058, United States

  • Research Institute Of South Florida, Inc.

    Miami, Florida, 33173, United States

  • Research Your Health

    Plano, Texas, 75093, United States

  • Rochester Clinical Research

    Buffalo, New York, 14217, United States

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609, United States

  • SIMED Health, LLC / SIMED Research

    Gainesville, Florida, 32607, United States

  • SMS Clinical Research LLC

    Mesquite, Texas, 75149, United States

  • Suburban Research Associates - West Chester Office

    West Chester, Pennsylvania, 19380, United States

  • Sugar Lakes Family Practice, P.A.

    Sugar Land, Texas, 77479, United States

  • Summit-Halls Family Practice

    Knoxville, Tennessee, 37938, United States

  • Sundance Clinical Research

    St Louis, Missouri, 63141, United States

  • Trial Management Associates (TMA ) Headlands LLC

    Myrtle Beach, South Carolina, 29572, United States

  • TrialMed

    Evansville, Indiana, 47714, United States

  • TrialMed - Austin

    Austin, Texas, 78744, United States

  • TrialMed - Birmingham

    Birmingham, Alabama, 35211, United States

  • TrialMed - Las Vegas

    Las Vegas, Nevada, 89113, United States

  • TrialMed - Melbourne

    Melbourne, Florida, 32934, United States

  • TrialMed - San Antonio

    San Antonio, Texas, 78229, United States

  • TrialMed - The Villages

    The Villages, Florida, 32162, United States

  • TrialdMed - Huntsville

    Huntsville, Alabama, 35802, United States

  • University of Utah

    Salt Lake City, Utah, 84108, United States

  • Velocity Clinical Research

    Norfolk, Nebraska, 68701, United States

  • Velocity Clinical Research - Binghampton

    Binghamton, New York, 13905, United States

  • Velocity Clinical Research - San Diego

    La Mesa, California, 91942, United States

  • Velocity Clinical Research, Boise

    Meridian, Idaho, 83642, United States

  • Velocity Clinical Research, Lincoln

    Lincoln, Nebraska, 68510, United States

  • Velocity Clinical Research, Medford

    Medford, Oregon, 97504, United States

  • Velocity Clinical Research, Omaha

    Omaha, Nebraska, 68134, United States

  • Velocity Clinical Research, Seattle

    Seattle, Washington, 98105, United States

  • Velocity Clinical Research, Sioux City

    Sioux City, Iowa, 51106, United States

  • Velocity Clinical Research, Valparaiso

    Valparaiso, Indiana, 46383, United States

  • WR Clinsearch, LLC

    Chattanooga, Tennessee, 37421, United States

  • Zenos Clinical Research

    Dallas, Texas, 75230, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.