Funing Center for Disease Control and Prevention
Yancheng, Jiangsu, China
NCT Number: NCT04916886
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.
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Notify Me6 year–59 year
All sexes
Interventional
Not applicable
Yancheng, Jiangsu, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Containing 0.5E10vp
Containing 0.3E10vp
Time frame: 28 days after vaccination
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 anti SARS-CoV-2 specific neutralizing antibody (wild type variants test).
Time frame: 28 days after vaccination
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 measured by ELISA in all groups
Time frame: 28 days after vaccination
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 measured by ELISA in all groups.
Time frame: 28 days after vaccination
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 responses post vaccination in all groups
Time frame: 28 days after vaccination
Stratified analysis based on the GMT of Ad5 vector neutralizing antibody responses post vaccination.
Time frame: Within 30 minutes after vaccination
The occurance of Adverse Reactions/Events within 30 minutes post vaccination
Time frame: Within 0-7 days after vaccination
The occurance of Adverse Reactions/Events (AE/AR) within 7 days post vaccination.
Time frame: Within 0-28 days after vaccination
The occurance of Adverse Reactions/Events (AE/AR) within 28 days post vaccination.
Time frame: Within 12 months after vaccination
Occurance of Serious Adverse Events (SAE) post vaccination.
Time frame: Within 12 months after vaccination
Occurance of Adverse Events of Special Interest (AESI) post vaccination.
CanSino Biologics Inc.
Industry
To Evaluate the Immunogenicity Bridging Between Different Manufacture Scales and Between Different Lots of Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV) in Population 6-59 Years of Age.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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