NCT05137418

Safety and Immunogenicity of COVID-19 Vaccine, Inactivated in Healthy Population Aged From 3 to 11 Years

An Open-labelled, Bridging Phase Ⅲ Clinical Trial to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine in Healthy Population Aged From 3 to 11 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: Sinovac Research and Development Co., Ltd. · Industry
• Sex: All
• Age: 3 Years – 11 Years
• Healthy volunteers: Accepted

Summary

This is an open-labelled, bridging phase Ⅲ clinical trial of COVID-19 Vaccine manufactured by Sinovac Research \& Development Co., Ltd. The main purpose of this study is to evaluate the superiority of the COVID-19 Vaccine in healthy population aged from 3 to 11 years against that in adults aged 18-26 years.

Detailed description

This study is a single-center, open-labelled, bridging phase Ⅲ clinical trial of COVID-19 Vaccine.The main purpose of this study is to evaluate the superiority of the COVID-19 Vaccine in healthy population aged from 3 to 11 years against that in adults aged 18-26 years.This study (PRO-nCOV-3002-1) will be used as a sub-trial of the Phase Ⅲ global multi-center clinical trial in children and adolescents(PRO-nCOV-3002) to provide safety and immunogenicity data.A total of 1000 healthy children aged 3-11 years will be enrolled ,including 500 children aged 3-5 years and 500 children aged 6-11 years.All subjects will receive 2 doses of experimental vaccine (600SU) with an interval of 28 days,and adverse reactions/events will be collected from all subjects after each dose and SAE and AESI monitoring will be completed from the beginning of vaccination to 6 and 12 months after full vaccination to evaluate the safety of the vaccine.About 3.0-3.5ml of venous blood will be collected from all subjects before immunization, 28 days after the whole immunization, 6 months after the whole immunization and 12 months after the whole immunization. Neutralizing antibody and S antibody will be detected to evaluate the immunogenicity and immune persistence of the vaccine.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 Vaccine,Inactivated	The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd..600SU Inactivated SARS-COV-2 virus in 0·5 mL of aluminium hydroxide solution per injection

Timeline

• Start date: 2021-11-27
• Primary completion: 2023-01-27
• Completion: 2023-01-27
• First posted: 2021-11-30
• Last updated: 2023-10-16

Locations

1 site across 1 country: China