Clinical Trials Directory

Trials / Completed

CompletedNCT04526990

Phase III Trial of A COVID-19 Vaccine of Adenovirus Vector in Adults 18 Years Old and Above

A Global Multicenter, Randomized, Double-blind, Placebo -Controlled, Adaptive Designed Phase Ⅲ Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of Ad5-nCoV in Adults 18 Years of Age and Older

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
44,247 (actual)
Sponsor
CanSino Biologics Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

This study is a global multicenter, randomized, double-blind, placebo -controlled, adaptive designed phase Ⅲ clinical trial, in order to evaluate the efficacy, safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in adults 18 years old and above.

Detailed description

This is a global phase III clinical trial to evaluate efficacy,safety, immuogenicity of Ad5-nCoV manufactured by Cansino and Beijing Institute of Biotechnology in health adults aged 18 years old and above. The study will be double-blind, placebo-controlled trial with participants randomly allocated 1:1 to placebo and experimental vaccine cohorts. The immunization schedule is one doses intramuscular injections (deltoid).

Conditions

Interventions

TypeNameDescription
BIOLOGICALRecombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)Intramuscular administration
BIOLOGICALPlaceboIntramuscular administration

Timeline

Start date
2020-09-15
Primary completion
2021-08-07
Completion
2022-10-21
First posted
2020-08-26
Last updated
2023-06-15

Locations

74 sites across 5 countries: Argentina, Chile, Mexico, Pakistan, Russia

Source: ClinicalTrials.gov record NCT04526990. Inclusion in this directory is not an endorsement.