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 range50 Years – 65 Years
SexALL
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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
✕. 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) .
What they're measuring
1
First episode of PCR-positive symptomatic COVID 19
. 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.