Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells) in Children and Adolescents

This is a phase Ⅰ/Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the safety, tolerability and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy aged 6-17 years with immunization procedures 0, 21, 42 days and doses (10μg/20μg/40μg).

This is a phase Ⅰ/Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the safety, tolerability and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy aged 6-17 years with immunization procedures 0, 21, 42 days and doses (10μg/20μg/40μg). The phase Ⅰ clinical trials designed 4 research group, including immunization procedures 0, 21 42 days , three doses (10μg/0.25ml, 20μg/0.5ml, 40μg/1.0ml) and two ages group (6-11 and 12-17years): Each group including 30 participants. Vaccination or placebo group will be randomly assigned to receive in a 2:1 ratio, 120 in total. The phase Ⅱ clinical trials designed 4 research group, including immunization procedures 0, 21 42 days , three doses (10μg/0.25ml, 20μg/0.5ml, 40μg/1.0ml) and two ages group (6-11 and 12-17years): Each group including 120 participants. Vaccination or placebo group will be randomly assigned to receive in a 2:1 ratio, 480 in total.