drugset / Trial / NCT05107375

Clinical Study of Recombinant Novel Coronavirus(COVID-19) Vaccine (CHO Cell) Combined With Influenza Vaccine

NCT05107375 ↗

Phase 3 Completed 299 enrolled Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
RandomizedParallel-groupOpen-labelPrevention

Summary

Popular topic:Clinical study of recombinant Novel Coronavirus vaccine (CHO cell) combined with influenza vaccine. Research purpose:Main purpose:To evaluate the immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) combined with influenza vaccine in people aged 18 years and over. Secondary purpose:To evaluate the safety of recombinant Novel Coronavirus vaccine (CHO cells) combined with influenza vaccine in people aged 18 years and over. Overall design:An open experimental design was adopted in this study, and 300 subjects were planned to be enrolled. To evaluate the immunogenicity and safety of recombinant Novel Coronavirus vaccine (CHO cells) in combination with influenza vaccine. Study population:The study involved people 18 years of age and older. Test groups:A total of 300 cases were enrolled. 240 patients in 18-59 years old group, 60 patients in ≥60 years old group. There were 150 cases in group A, 120 cases in 18-59 years old group, and 30 cases in ≥60 years old group. There were 150 cases in group B, 120 cases in 18-59 years old group and 30 cases in ≥60 years old group.

Timeline

Start
2021-09-03
Primary completion
2022-03-04
Completion
2022-03-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Recombinant new coronavirus vaccine (CHO cell) Vaccine 0.5 ml Intramuscular
Subject Tetravalent influenza virus lysis vaccine Vaccine 0.5 ml Intramuscular

Indications