NCT04916886

A Clinical Trial of Immunobridging and Lot-to-lot Consistency of COVID-19 Vaccine (Ad5-nCoV) in Different Age Groups.

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,021 (actual)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 6 Years – 59 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml	Containing 0.5E10vp
BIOLOGICAL	Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml	Containing 0.3E10vp

Timeline

• Start date: 2021-06-03
• Primary completion: 2022-07-31
• Completion: 2022-07-31
• First posted: 2021-06-08
• Last updated: 2023-02-08

Locations

1 site across 1 country: China