Exclusion criteria
unstable chronic disease, anaphylaxis, SARS-CoV-2 infection, immune-mediated disease, allergy, myocarditis, urticaria, pericarditis, psychiatric, human immunodeficiency virus, ill, febrile, ≤28, coronavirus disease 2019
ANAPHYLAXIS, CORONAVIRUS DISEASE 2019, SARS-COV-2 INFECTION, HUMAN IMMUNODEFICIENCY VIRUS, DISEASE, ALLERGY, MYOCARDITIS, URTICARIA, PERICARDITIS, ADVERSE REACTION, BLEEDING DISORDER, INFLUENZA
Participants meeting any of the following criteria at the Screening Visit, unless noted otherwise, will be excluded from the study:Had substantial exposure to someone with SARS-CoV-2 infection or coronavirus disease 2019 (COVID-19) in the past 14 days, as defined by the CDC as a close contact of someone who has COVID-19).Has known history of SARS-CoV-2 infection within 3 months before enrollment.Is acutely ill or febrile (temperature ≥38.0 °C (100.4 °F)) less than 72 hours before or at the Screening Visit or day 1. Participants meeting this criterion may be rescheduled and will retain their initially assigned participant number.Currently has symptomatic acute or unstable chronic disease requiring medical or surgical care, to include substantial change in therapy or hospitalization for worsening disease, at the discretion of the investigator.Has a medical, psychiatric or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator’s judgment.Has a current or previous diagnosis of immunocompromising condition to include human immunodeficiency virus, immune-mediated disease requiring immunosuppressive treatment or other immunosuppressive condition.Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months before Screening (for corticosteroids ≥10 mg dayHas known or suspected allergy or history of anaphylaxis, urticaria or other important adverse reaction to the vaccine or its excipients.Has a documented history of myocarditis or pericarditis within 2 months before Screening Visit (day 0).Coagulopathy or bleeding disorder considered a contraindication to intramuscular (IM) injection or phlebotomy.Has received or plans to receive any licensed vaccine ≤28 days before the injection (day 1) or a licensed vaccine within 28 days before or after the study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine.Has received systemic immunoglobulins or blood products within 3 months before the Screening Visit (day 0) or plans for receipt during the study.Has donated ≥450 ml of blood products within 28 days before the Screening Visit or plans to donate blood products during the study.Plans to participate in an interventional clinical trial of an investigational vaccine or drug while participating in this study.Is an immediate family member or household member of study personnel, study site staff or sponsor personnel.Is currently experiencing an SAE in COVE trial at the time of screening for this study.