NCT04917523

Immuno-bridging Study of Inactivated SARS-CoV-2 Vaccine in Healthy Population Aged 3-17 vs Aged 18 Years Old and Above

Immunogenicity Non-inferiority Immuno-bridging Study of Inactivated SARS-CoV-2 Vaccine in Healthy Population Aged 3-17 Years Old vs Healthy Population Aged 18 Years Old and Above

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,800 (actual)
• Sponsor: China National Biotec Group Company Limited · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

Summary

This is a open label clinical trial to evaluate the efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines (Vero cell) in healthy people aged 3-17 years old in comparison with healthy population aged 18 years old and above

Detailed description

This is a open label clinical trial to evaluate the efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines (Vero cell) developed by Beijing Institute of Biological Products Co., Ltd in healthy people aged 3-17 years old in comparison with healthy population aged 18 years old and above. Total of 1800 healthy volunteers aged 3 years old and above will be enrolled, of whom the subjects will be divided into two groups, 3-17 years old group and 18 years old and above group with each consisting of 900 volunteers. The 3-17 years old group was further divided into three subgroups: 3-6 years old, 7-12 years old and 13-17 years old, with 300 volunteers in each subgroup. 2 doses of vaccines will be injected into the deltoid muscle of either upper arm according to the immunization schedule of D0, D21 (+7 Days). Based on interim analysis'results of the booster dose administered to adults aged 18 years old and above, a booster dose might be introduced.

Conditions

• COVID-19 Pneumonia
• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 Vaccine (Vero Cell), Inactivated	0.5 mL per dose, containing 6.5U inactivated SARS-CoV-2 antigen

Timeline

• Start date: 2021-07-02
• Primary completion: 2022-03-31
• Completion: 2022-04-29
• First posted: 2021-06-08
• Last updated: 2023-06-18

Locations

1 site across 1 country: United Arab Emirates