Evaluation of Immunogenicity and Safety of COVID-19 Vaccine (Produced in Beijing) in Patients With Hypertension and/or Diabetes

Phase 4 Completed 1440 enrolled China National Biotec Group Company Limited Beijing Institute of Biological Products Co Ltd. · collab Center for Disease Control and Prevention, Fujian · collab Guizhou Center for Disease Control and Prevention · collab Hunan Provincial Center for Disease Control and Prevention · collab

Non-randomizedParallel-groupSingle-blindPrevention

Summary

To evaluate the post-marketing immunogenicity and safety of the inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine (Vero cells) in patients aged 60 years or older with hypertension and/or diabetes, thus to further collect the immunogenicity and safety data of this product in special populations.

Timeline

Start: 2021-10-05
Primary completion: 2022-01-05
Completion: 2022-01-05

Publications

Huang R, Liu X, Xie F, Li J, Tang Z, Wu Y, Zhou P, Zhang D. Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (BBIBP-CorV) in Hypertensive and/or Diabetic People Aged over 60 Years: A Prospective Open-Label Study. Diabetes Ther. 2023 Jan;14(1):139-151. doi: 10.1007/s13300-022-01343-8. Epub 2022 Nov 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	COVAX	Unknown	—	—

Evaluation of Immunogenicity and Safety of COVID-19 Vaccine (Produced in Beijing) in Patients With Hypertension and/or Diabetes

Summary

Timeline

Publications

Drugs

Indications