NCT04953325

Immunogenicity and Safety of an Inactivated COVID-19 Vaccine

Immunogenicity and Safety of an Inactivated COVID-19 Vaccine for Prevention of COVID-19 in Healthy Population Aged 18 Years and Older

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Sinovac Research and Development Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, placebo-controlled and open design, phase 4 clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the CoronaVac in healthy population aged 18 years and older.

Detailed description

This study is a randomized, placebo-controlled and opened, phase 4 clinical trial to evaluate the safety and immunogenicity of an inactivated COVID-19 vaccine(CoronaVac）in healthy population aged 18 years and older . The experimental vaccine is manufactured by Sinovac Research and Development Co.,Ltd. A total of 270 healthy subjects will be enrolled, including 135 adults aged 18-59 years and 135 elderly elderly aged 60 years and older. Subjects in each age group will be divided into two groups in a ratio of 1:1. Subjects in the experimental group will receive two doses of CoronaVac on day 0 and day 28. Subjects in the control group will receive one dose of 23-valent Pneumococcal Polysaccharide Vaccine on day 0 and one dose of Inactivated Hepatitis A Vaccine on day 28.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated COVID-19 Vaccine	600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
BIOLOGICAL	23-valent pneumococcal polysaccharide vaccine	25μg each of the following serotypes/each dose (0.5ml): 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F
BIOLOGICAL	Inactivated Hepatitis A Vaccine	500SU inactivated Hepatitis A virus in 1 mL of aluminium hydroxide solution per injection.

Timeline

• Start date: 2021-07-09
• Primary completion: 2021-10-31
• Completion: 2022-01-31
• First posted: 2021-07-07
• Last updated: 2022-04-14

Locations

1 site across 1 country: China