A Clinical Trial of Immunobridging and Lot-to-lot Consistency of COVID-19 Vaccine (Ad5-nCoV) in Different Age Groups.
NCT04916886 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2021
Last updated 2023-02-08
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
Interventions
- 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
Sponsors & Collaborators
-
Jiangsu Province Centers for Disease Control and Prevention
collaborator NETWORK -
CanSino Biologics Inc.
lead INDUSTRY
Principal Investigators
-
Fengcai Zhu, MSD · Jiangsu Provincal Center for Disease Control and Prevention
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 59 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-06-03
- Primary Completion
- 2022-07-31
- Completion
- 2022-07-31
Countries
- China
Study Locations
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