Safety assessment
nausea, myalgia, swelling, fever, diarrhea, fatigue, erythema, rash, pain, cough, pruritus, headache, acute hypersensitive reaction
ADVERSE EVENTS, ADVERSE REACTIONS, ERYTHEMA, INDURATION
The safety objectives were to evaluate the safety and reactogenicity of one booster dose of Omicron vaccine as compared with CoronaVac. Participants were observed in the trial center for at least 30 min after vaccination. For the first 7 days, participants were required to record any local adverse events at the injection site and systemic adverse events on diary cards. Solicited local adverse events included injection site pain, induration, swelling, erythema, rash, and pruritus. Solicited systemic adverse events included fever, acute hypersensitive reaction, diarrhea, nausea, myalgia, headache, cough, and fatigue. Investigators then conducted a face-to-face interview to confirm safety profiles on Day 7. From Day 8 to 28, adverse events were collected by spontaneous records or reports from participants combined with regular visits on Day 14 (only for immunogenicity subgroup participants) and Day 28. Serious adverse events (SAE) and adverse events of special interest (AESI) were recorded throughout the trial until 12 months after vaccination. The reported adverse events were graded according to the NMPA guidelines (Safety assessments in this article included solicited local and systemic adverse reactions and unsolicited adverse reactions, as well as SAE and AESI within 28 days after vaccination. The follow-up for SAE and AESI is continuing.