Safety assessment
myalgia, swelling, fever, diarrhea, fatigue, erythema, rash, pain, appetite, vomiting, nausea, cough, pruritus, headache, mucocutaneous disorder, acute hypersensitive reaction
ADVERSE EVENTS, ADVERSE REACTIONS, ERYTHEMA, INDURATION
Participants stayed in the trial center for at least 30 minutes after each vaccination for immediate adverse events (AE) observation. Within28 days after each vaccination, participants and their legal guardians were required to record any local AEs (at the injection site) and systemic AEs on the electronic diary cards through an application program using their phones. At 7 and 28 days after each vaccination, investigators verified the AE recordings via telephone or face-to-face interview with participants and their legal guardians. In this trial, solicited period referred to the first 7 days after vaccination, and 8 to 28 days was then defined as the unsolicited period. Solicited local adverse events included pain, induration, swelling, erythema, rash, and pruritus, which occurred at the injection site in the solicited period. Solicited systemic adverse events included fever, acute hypersensitive reaction, mucocutaneous disorder, diarrhea, decreased appetite, vomiting, nausea, myalgia, headache, cough, and fatigue, which occurred in the solicited period. Serious adverse events (SAE) and adverse events of special interest (AESI) were recorded throughout the trial period up to 28 days after full course of vaccination. The reported AEs were graded according to the NMPA guideline (The safety endpoints in this trial included the incidence of solicited local and systemic adverse reactions and unsolicited adverse reactions, as well as SAE and AESI until 28 days after full course of vaccination (Day 0-56). Safety assessment was conducted in the safety set (SS) of participants who received at least one dose of vaccination.