This study is a phase Ⅱ clinical trial to evaluate the safety and immunogenicity of SCTV01E-2 in people of different ages who had been vaccinated with COVID-19 vaccines. A total of at least 600 subjects aged 3 years and older who were previously vaccinated with domestically licensed SARS-CoV-2 vaccines with recommended doses and immunization schedules are planned to be enrolled. Group A included 400 patients aged 18 years and above, and group B included 200 patients aged 3-17 years.
For participants in Group A, they will be randomized to receive SCTV01E or SCTV01E-2 in a ratio of 1:1. For participants in Group B, they will all receive SCTV01E-2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
600
Geometric mean titers (GMT) of neutralizing antibodies against SARS-CoV-2 dominant epidemic variant on D14.
Time frame: day 14 after the study vaccination
Seroresponse Rate (SRR) of neutralizing antibodies against SARS-CoV-2 dominant epidemic variant on D14.
Time frame: day 14 after the study vaccination
GMT of neutralizing antibodies against other SARS-CoV-2 variants on D14.
Time frame: Day 14 after the study vaccination
SRR of neutralizing antibodies against other SARS-CoV-2 variants on D14.
Time frame: Day 14 after the study vaccination
GMT and SRR of neutralizing antibodies against SARS-CoV-2 variants on D180.
Time frame: day 14 after the study vaccination
Incidence and severity of solicited Adverse Events (AEs) of SCTV01E from D0 to D7.
Time frame: Day 0 to Day 7 after the study vaccination
Incidence and severity of all unsolicited AEs of SCTV01E from D0 to D28.
Time frame: Day 0 to Day 28 after the study vaccination
Incidence and severity of Serious Adverse Events (SAEs) and Adverse Event of Special Interests (AESIs) of SCTV01E within 365 days.
Time frame: Day 0 to Day 180 after the study vaccination
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