Efficacy and Safety of NVX-CoV2705 (NCT07086222) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Efficacy and Safety of NVX-CoV2705
United States6,500 participantsStarted 2025-11-20
Plain-language 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.
Who can participate
Age range
50 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
First episode of PCR-positive symptomatic COVID 19
. 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.