NCT04456595

Clinical Trial of Efficacy and Safety of Sinovac's Adsorbed COVID-19 (Inactivated) Vaccine in Healthcare Professionals

Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate Efficacy and Safety in Healthcare Professionals of the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12,688 (actual)
• Sponsor: Butantan Institute · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a phase III clinical trial to assess efficacy and safety of the Adsorbed COVID-19 (inactivated) vaccine manufactured by Sinovac in health care professionals

Detailed description

This is a phase III clinical trial to assess efficacy and safety of the Adsorbed COVID-19 (inactivated) vaccine manufactured by Sinovac in health care professionals. The study will be double-blind placebo-controlled trial with participants randomly allocated 1:1 to placebo and vaccine arms. The immunization schedule is two doses intramuscular injections (deltoid) with a 14-days interval. For efficacy, the study aims to detect COVID-19 cases, defined as symptomatic SARS-CoV-2 infections, after the second week post-immunization schedule. For safety and immunogenicity, participants are categorized in two age groups, Adults (18-59 years) and Elderly (60 years and above). Safety database aims to detect adverse reactions with frequency of 1:1000 or higher in adults and 1:500 in elderly. All participants will be followed up to 12 months. Interim preliminary efficacy analysis can be triggered by reaching the target number of 61 cases. Primary efficacy analysis requires 151 cases.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Adsorbed COVID-19 (inactivated) Vaccine	Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac
BIOLOGICAL	Placebo	Placebo of Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac

Timeline

• Start date: 2020-07-21
• Primary completion: 2020-12-17
• Completion: 2022-02-17
• First posted: 2020-07-02
• Last updated: 2024-02-15

Locations

16 sites across 1 country: Brazil