Safety and Immunogenicity of NVX-CoV2705 (NCT07079670) | Clinical Trial Compass
CompletedPhase 3
Safety and Immunogenicity of NVX-CoV2705
United States676 participantsStarted 2025-10-09
Plain-language summary
This study is a Phase 3 trial designed to check the safety and immune response to a new Omicron JN.1 COVID-19 vaccine. Study researchers will give a single dose of this vaccine, called NVX-CoV2705, to approximately 120 participants. This includes adults aged 65 and older, and individuals aged 12 to 64 who have existing health conditions that put them at high risk for severe COVID-19. All participants must have received a previous COVID-19 vaccine at least 90 days before joining this study. Study researchers will be closely monitoring participants for their immune response for 28 days and collecting safety data for 180 days after vaccination.
Who can participate
Age range
12 Years – 90 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
. Participants ≥ 65 years of age and participants 12 through 64 years who have at least one underlying condition that puts them at high risk of severe outcomes from COVID-19 at time of study vaccination. In each instance, the investigator's judgment may be exercised and other eligibility criteria must be respected.
. Previously vaccinated with a COVID-19 vaccine with the last dose administered ≥ 90 days prior to study vaccination (written or verbal confirmation by participant).
. Participant and parent(s)/caregiver(s) or legally acceptable representative willing and able to give informed consent and assent 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 the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from ≥ 28 days prior to enrollment and through the end of the study.
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
Pseudovirus neutralization (ID50) of Omicron JN.1 subvariant vaccine expressed as GMFR
. Condoms (male or female) with spermicide (if acceptable in country)
. Diaphragm with spermicide
. Cervical cap with spermicide
. Intrauterine device
Exclusion criteria
. Current participation in research involving receipt of investigational products (drug/biologic/device).
. Received any other vaccine (except for a licensed seasonal influenza vaccine or rabies vaccine \[if medically indicated\]) within 28 days prior to study vaccination. For the influenza vaccine, a participant is eligible as long as the vaccine was administered ≥ 14 days prior to 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.
. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to study vaccination that, in the opinion of the investigator, might interfere with protocol compliance.
. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) that requires the use of immune modulators.
. 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).