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

No results posted yet for this study

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04916886 on ClinicalTrials.gov