This is a randomized, double-blind, parallel-controlled, equivalence trial, for evaluation of safety and immunogenicity, and batch-to-batch consistency of a recombinant adenovirus type-5-vectored Covid-19 vaccine Convidecia in one shot schedule in Chinese healthy adults aged 18 years and above. In total 1050 healthy adults will be recruited in this study. Subjects in both cohort will be randomized stratified into two cohort by age(18\~59 years and≥60 years) in a 1:1:1 ratio to receive one of three consecutive batches of Convidecia. The primary objective is to test the equivalence of the immune responses to three consecutive manufacturing lots of Convidecia in healthy adults. The secondary objectives were to evaluate the immunogenicity and safety of Convidecia for each lot and the pooled data of three lots)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,050
The vaccine is a replication defective Ad5 vectored vaccine expressing the full-length spike glycoprotein of SARS-CoV-2 produced by CanSino, lot NCOV202101001. It contains 5×10\^10 viral particles per 0.5 mL in a vial.
The vaccine is a replication defective Ad5 vectored vaccine expressing the full-length spike glycoprotein of SARS-CoV-2 produced by CanSino, lot NCOV202101002. It contains 5×10\^10 viral particles per 0.5 mL in a vial.
The vaccine is a replication defective Ad5 vectored vaccine expressing the full-length spike glycoprotein of SARS-CoV-2 produced by CanSino, lot NCOV202102003. It contains 5×10\^10 viral particles per 0.5 mL in a vial.
Guanyun Center for Disease Control and Prevention
Lianyungang, Jiangsu, China
GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.
GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.
Time frame: On day 28 after vaccination
GMFIs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.
GMFIs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.
Time frame: On day 28 after vaccination
Propotion of participants with at least four-fold increase of post-vaccination antibody level against SARS-CoV-2 RBD-specific binding IgG compared to that at baseline on day 28 after vaccination.
Propotion of participants with at least four-fold increase of post-vaccination antibody level against SARS-CoV-2 RBD-specific binding IgG compared to that at baseline on day 28 after vaccination.
Time frame: On day 28 after vaccination
GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination stratified by neutralizing antibody levels against Ad5 at baseline.
GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination stratified by neutralizing antibody
Time frame: On day 28 after vaccination
Incidence of solicited adverse events within 7 days after vaccination.
Incidence of solicited adverse events within 7 days after vaccination.
Time frame: Within 7 days after vaccination
Incidence of adverse reactions within 28 days after vaccination.
Incidence of adverse reactions within 28 days after vaccination.
Time frame: Within 28 days after vaccination
Incidence of unsolicited adverse events within 28 days after vaccination.
Incidence of unsolicited adverse events within 28 days after vaccination.
Time frame: Within 28 days after vaccination
Incidence of serious adverse events (SAE) within the 6 months after vaccination.
Incidence of serious adverse events (SAE) within the 6 months after vaccination.
Time frame: Within the 6 months after vaccination
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