NCT05895110

To Evaluate the Immunogenicity and Safety of Sequential Booster Immunization of Recombinant Novel Coronavirus Vaccine (CHO Cells) for SARS-CoV-2

To Evaluate the Immunogenicity and Safety of Sequentially Enhanced Recombinant Novel Coronavirus Vaccine (CHO Cells) in Patients Aged 3-17 Years After Completion of Two Doses of Novel Coronavirus Inactivated Vaccine

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Accepted

Summary

An open experimental design was used in this study, and 240 subjects were planned to be enrolled. To evaluate the immunogenicity and safety of recombinant Novel Coronavirus vaccine (CHO cells) after sequential intensification in populations vaccinated with two doses of marketed Novel Coronavirus inactivated vaccine.

Detailed description

One dose of recombinant novel coronavirus vaccine (CHO cell) for test was injected into the upper arm deltoid muscle muscle of the subject

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Novel Coronavirus vaccine (CHO Cells)	The experimental vaccine dose used in this study is 25μg/0.5mL. All subjects recruited should have received two doses of novel Coronavirus inactivated vaccine on the market for 6-9 months, and all eligible subjects will receive one dose of recombinant Novel Coronavirus vaccine (CHO cells).

Timeline

• Start date: 2022-04-29
• Primary completion: 2022-11-19
• Completion: 2022-11-19
• First posted: 2023-06-08
• Last updated: 2023-06-08

Locations

1 site across 1 country: China