This trial is a clinical study to evaluate the safety of sequential boosters of novel coronavirus mRNA vaccine in adults aged 18 years and older who have completed three doses of novel inactivated coronavirus vaccination. According to the results of the previous phase I clinical trial, the incidence of adverse reactions in the 0.3 ml dose group was lower than that in the 0.5 ml dose group, and the degree of adverse reactions was weaker. The dose of 0.3ml was chosen for the current study, and a 1-dose immunization program was completed for safety observation.
According to the results of the preliminary phase I clinical trial, the incidence of adverse reactions in subjects in the 0.3 ml dose group was lower than in the 0.5 ml dose group and the degree of adverse reactions was weaker. The dose of 0.3ml was chosen for the current study. The trial was designed to enroll 800 adult subjects aged 18 years and older who had completed three doses of inactivated New Coronavirus vaccine with an interval of more than 6 months between doses, and the proportion of elderly people aged 60 years and older was approximately 20%. Subjects will receive 0.3 ml of mRNA vaccine, complete a 1-dose immunization program, and undergo safety observations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
800
Subjects received 0.3ml of mRNA vaccine intramuscularly
West China Second University Hospital
Chengdu, China
Evaluation of the incidence of adverse reactions (AR) in all subjects within 28 days of exemption
Incidence of adverse reaction (AR)
Time frame: 28 days post vaccination
Evaluation of the incidence of Serious Adverse Event (SAE) and Adverse Event of Special Interest (AESI) in all subjects at 6 months after exemption
Incidence of Serious Adverse Event (SAE) and Adverse Event of Special Interest (AESI)
Time frame: 6 months post vaccination
Evaluation of the incidence of adverse reactions in all subjects at 30 minutes post-dispensing
Incidence of adverse reaction (AR)
Time frame: 30 minutes post vaccination
Evaluation of the incidence of adverse events in all subjects within 28 days of exemption
Incidence of adverse events (AE)
Time frame: 28 days post vaccination
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