NCT04540419

Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Against COVID-19

Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group Study Evaluating Efficacy, Reactogenicity and Safety of Recombinant Vaccine Ad5-nCoV Against Novel Coronavirus Infection in Adult Volunteers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: NPO Petrovax · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This study is a phase III clinical trial to evaluate efficacy, reactogenicity and safety of the vaccine Ad5-nCoV compared with placebo in volunteers at the age from 18 to 85 years，with the randomized, double-blind design

Detailed description

A total of 500 healthy adult volunteers at the age from 18 to 85 years will be randomized into two treatment (vaccination) groups in ratio 3:1 by double-blind design. Volunteers in group 1 (n=375) will be administered a single dose of the vaccine Ad5-nCoV (5E10vp). Volunteers in group 2 (n=125): will be administered a single dose of placebo. Vaccine Ad5-nCoV or placebo will be administered intramuscularly into the deltoid muscle of the arm at a single dose of 0.5 mL (1 prefilled syringe).

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)	Intramuscular administration
BIOLOGICAL	Placebo	Intramuscular administration

Timeline

• Start date: 2020-09-11
• Primary completion: 2021-06-19
• Completion: 2021-07-30
• First posted: 2020-09-07
• Last updated: 2024-04-23

Locations

7 sites across 1 country: Russia