Safety assessments
AIDS, nausea, myalgia, fever, swelling, fatigue, erythema, vomiting, pain, headache, tenderness, arthralgia
ADVERSE EVENT, ADVERSE EVENTS, AIDS, ERYTHEMA, INDURATION
Solicited local and systemic adverse events (AEs) were actively collected for 7 days after vaccination using participant diary cards. The solicited local AEs included injection site pain, tenderness, erythema, swelling, and induration. The solicited systemic AEs included fever, headache, fatigue, malaise, arthralgia, myalgia, nausea, and vomiting. Unsolicited AEs were collected for 28 days after vaccination. Unsolicited AEs were any AEs reported by the participant, observed by the study staff during study visits or those identified during review of medical records or source documents. Serious adverse events (SAEs), and adverse events of special interest (AESIs) including potentially immune-mediated medical condition (PIMMCs) and AESIs relevant to COVID-19 were collected throughout the study.The severity of all AEs was graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017. A subjective grading scale was used to grade the severity of all AEs that were not listed in the DAIDS Table.Safety was monitored during the study by on-site clinical staff. Periodic reviews of safety data was performed by the protocol safety review team (PSRT). In addition, an independent data safety monitoring board (DSMB) reviewed the safety data and provided oversight on the study.