NCT04852705

A Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Adults Aged 18 Years and Older (COVID-19)

A Multi-national, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Vaccine (Vero Cells), Inactivated for the Prevention of COVID-19 in Healthy Adults Aged 18 Years and Older

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 28,000 (estimated)
• Sponsor: Shenzhen Kangtai Biological Products Co., LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study will be a multi-national, endpoint-driven, randomized, double-blind, placebo-controlled, adaptive study in which participating adults will be randomized 1:1 to receive 2 doses of either candidate vaccine or placebo on Day 0 and 28. A total of 28,000 healthy adults aged 18 years and older will be enrolled and followed for efficacy, safety, and immunogenicity evaluations.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 Vaccine (Vero Cells), Inactivated	2 doses of SARS-CoV-2 Vaccine (Vero Cells), Inactivated should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.
BIOLOGICAL	Placebo	2 doses of Placebo should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.

Timeline

• Start date: 2021-05-01
• Primary completion: 2021-11-01
• Completion: 2022-11-01
• First posted: 2021-04-21
• Last updated: 2021-04-22