The study is a single-center, randomized and double-blinded trial to evaluate the immunobridging between different manufacture scales, lot-to-lot consistency of the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)(Ad5-nCOV) in population 6-59 years of age. The immunobridging between different manufacture scales will be evaluated first, the immunobridging between different age groups will be evaluated second, the lot-to-lot consistency will be evaluated at last.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
2,021
Containing 0.5E10vp
Containing 0.3E10vp
Funing Center for Disease Control and Prevention
Yancheng, Jiangsu, China
GMT of anti SARS-CoV-2 specific neutralizing antibody
GMT of anti SARS-CoV-2 specific neutralizing antibody in all groups (wild type variants test).
Time frame: 28 days after vaccination
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Seroconversion rate of anti SARS-CoV-2 specific neutralizing antibody (wild type variants test).
Time frame: 28 days after vaccination
GMI of SARS-CoV-2 neutralizing antibody
GMI of anti SARS-CoV-2 specific neutralizing antibody (wild type variants test).
Time frame: 28 days after vaccination
GMT of SARS-CoV-2 S protein RBD antibody
GMT of SARS-CoV-2 S protein RBD antibody measured by ELISA in all groups
Time frame: 28 days after vaccination
Seroconversion rate of SARS-CoV-2 S protein RBD antibody
Seroconversion rate of SARS-CoV-2 S protein RBD antibody measured by ELISA in all groups.
Time frame: 28 days after vaccination
GMI of SARS-CoV-2 S protein RBD antibody
GMI of SARS-CoV-2 S protein RBD antibody measured by ELISA in all groups.
Time frame: 28 days after vaccination
GMT of Ad5 vector neutralizing antibody
GMT of anti Ad5 vector neutralizing antibody responses post vaccination in all groups
Time frame: 28 days after vaccination
GMI of Ad5 vector neutralizing antibody
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GMI of Ad5 vector neutralizing antibody responses post vaccination in all groups
Time frame: 28 days after vaccination
Stratified analysis on Ad5 vector neutralizing antibody
Stratified analysis based on the GMT of Ad5 vector neutralizing antibody responses post vaccination.
Time frame: 28 days after vaccination
Incidence of Adverse Reactions/Events (AE/AR)
The occurance of Adverse Reactions/Events within 30 minutes post vaccination
Time frame: Within 30 minutes after vaccination
Incidence of Adverse Reactions/Events (AE/AR)
The occurance of Adverse Reactions/Events (AE/AR) within 7 days post vaccination.
Time frame: Within 0-7 days after vaccination
Incidence of Adverse Reactions/Events (AE/AR)
The occurance of Adverse Reactions/Events (AE/AR) within 28 days post vaccination.
Time frame: Within 0-28 days after vaccination
Incidence of Serious Adverse Events (SAE)
Occurance of Serious Adverse Events (SAE) post vaccination.
Time frame: Within 12 months after vaccination
Incidence of Adverse Events of Special Interest (AESI)
Occurance of Adverse Events of Special Interest (AESI) post vaccination.
Time frame: Within 12 months after vaccination