Procedures
dysphagia, fever, constipation, vomiting, redness, dyspnea, rash, muscle pain, anorexia, arthralgia, nausea, fatigue, diarrhea, cough, pruritus, swelling, acute allergic reaction, pain, dizziness, headache
DYSPHAGIA, ADVERSE EVENTS, ACUTE ALLERGIC REACTION, INDURATION, BLOOD, ANOREXIA
At the clinical site, eligible participants were randomly assigned to receive a booster vaccination with NVSI-06-09 or BBIBP-CorV. The vaccine was administered intramuscularly to the participants’ upper arm muscles. After observation for at least 30 min, participants can leave the clinical site. Solicited local adverse events at injection site (including pain, pruritus, induration, swelling, rash, and redness) and solicited systemic adverse events (including non-vaccination site muscle pain, headache, fever, fatigue, pruritus at non-vaccination site, arthralgia, constipation, vomiting, nausea, cough, dyspnea, dizziness, diarrhea, dysphagia, anorexia, abnormal skin mucosa, and acute allergic reaction) were recorded within 7 days post-vaccination. Unsolicited adverse events were collected within 30 days after the receipt of vaccination. Serious adverse events and the adverse events of special interest were monitored for 12 months after vaccination. All the reported adverse events were reviewed and verified by investigators, and the grades of adverse events were determined based on the relevant guidance of China National Medical Products Administration. Blood samples were taken from participants for immunogenicity assessment on day 0, day 14, day 28, and at 3 months, 6 months, 9 months, and 12 months, respectively.