NCT04894227

Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults

A Double-blind, Randomized Clinical Trial to Evaluate the Lot-to-lot Consistency, Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac） in Health Adults Aged 26-45 Years

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,080 (actual)
• Sponsor: Sinovac Research and Development Co., Ltd. · Industry
• Sex: All
• Age: 26 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is a double-blind, randomized phase Ⅳ clinical trial of the inactivated SARS-CoV-2 vaccine (CoronaVac）manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the lot-to-lot consistency, immunogenicity and safety of CoronaVac in healthy adults aged 26-45 years.

Detailed description

This study is a double-blind, randomized phase Ⅳ clinical trial in healthy adults aged 26-45 years to evaluate the lot-to-lot consistency, immunogenicity and safety of the commercial-scale CoronaVac in healthy adults aged 26-45 years .The experimental vaccine was manufactured by Sinovac Research \& Development Co.,Ltd. A total of 1080 healthy subjects aged 26 to 45 years old will be enrolled.The subjects will be randomly divided into three groups in a ratio of 1:1:1 to received two doses of vaccine on day 0 and day 28.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated SARS-CoV-2 Vaccine (Vero cell）	600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

Timeline

• Start date: 2021-05-11
• Primary completion: 2021-05-11
• Completion: 2021-11-30
• First posted: 2021-05-20
• Last updated: 2022-04-13

Locations

1 site across 1 country: China