• Had a known history of SARS-CoV-2 infection within 2 weeks prior to administration of IP or known close contact with anyone with laboratory confirmed SARS-CoV-2 infection or Covid-19 within 2 weeks prior to administration of IP
• Was acutely ill or febrile 24 hours prior to or at the screening visit. Fever was defined as a body temperature ≥38.0°C/≥100.4°F. Participants who met this criterion could have visits rescheduled within the relevant study visit windows. Afebrile participants with minor illnesses were enrolled at the discretion of the investigator
• Had previously been administered an investigational or approved CoV (eg, SARS-CoV-2, SARS-CoV, Middle East respiratory syndrome-CoV) vaccine
• Had undergone treatment with investigational or approved agents for prophylaxis against Covid-19 (eg, receipt of SARS-CoV-2 monoclonal antibodies) within 6 months of enrollment
• Had a known hypersensitivity to a component of the vaccine or its excipients. Hypersensitivity included, but was not limited to, anaphylaxis or immediate allergic reaction of any severity to a previous dose of messenger RNA Covid-19 vaccine or any of its components (including polyethylene glycol [PEG] or immediate allergic reaction of any severity to polysorbate)
• Had a medical or psychiatric condition that, according to the investigator’s judgment, may pose additional risk because of participation, interfere with safety assessments, or interfere with interpretation of results
• Had a history of a diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety, specifically the following: • Congenital or acquired immunodeficiency, excluding HIV infection, as described in Inclusion Criteria 2 • Chronic hepatitis or suspected active hepatitis • A bleeding disorder that was considered a contraindication to IM injection or phlebotomy • Dermatologic conditions that could affect local solicited AR assessments • Any prior diagnosis of malignancy (excluding nonmelanoma skin cancer)
• Had received the following: • Any routine vaccination with inactivated or live vaccine(s) within 14 days of the first vaccination or plans to receive such a vaccine through 14 days following the last study vaccination. • Influenza vaccine could be given, however, not within 14 days of or following Dose 1 or Dose 2. If a participant received an influenza vaccine, this was captured within the concomitant medication electronic case report form • Systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months of the day of enrollment (for corticosteroids, ≥1 mg/kg/day or ≥10 mg/day prednisone equivalent, if participant weighed >10 kg). Participants could have visits rescheduled for enrollment if they no longer met this criterion within the screening visit window. Inhaled, nasal, and topical steroids were allowed. • Intravenous or subcutaneous blood products (red cells, platelets, immunoglobulins) within 3 months of enrollment
• Had participated in an interventional clinical study within 28 days prior to the screening visit or planned to do so while participating in this study
• Was an immediate family member, or household contact, of an employee of the study site or Moderna or someone otherwise directly involved with the conduct of the study. As applicable, family members/household contacts of employees of the larger institution or affiliated private practice not part of the study site were enrolled.

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated: No, As the trial is ongoing, access to patient-level data and supporting clinical documents with qualified external researchers may be available upon request and subject to review once the trial is complete.
Data accessibility: Dr. Schnyder Ghamloush, email: sabine.schnyder.ghamloush@modernatx.com