NCT05065879

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

A Post-marketing Clinical Study of the Inactivated SARS-CoV-2 Vaccine (Vero Cells) (Produced in Beijing): Immunogenicity and Safety Assessments in Patients With Hypertension and/or Diabetes

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,440 (actual)
• Sponsor: China National Biotec Group Company Limited · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

After giving informed consent, patients with hypertension, patients with diabetes, patients with both diseases, and healthy controls, all aged 60 years or older, were given two doses of the inactivated SARS-CoV-2 vaccine (Vero cells). Venous blood samples were collected before the first dose and on day 28 after the second dose to evaluate the immunogenicity of the vaccine. Adverse events were actively recorded on a diary card once daily from day 0 to day 7 and once from day 8 to day 21 after the first dose and the second dose. Within 3 months after immunization with the second dose and collection of diary cards, the subjects were followed up by phone once a month as well as self-report to collect serious adverse events.

Conditions

• COVID-19 Pneumonia

Interventions

Type	Name	Description
BIOLOGICAL	COVAX	2 doses of Covid-19 vaccine

Timeline

• Start date: 2021-10-05
• Primary completion: 2022-01-05
• Completion: 2022-01-05
• First posted: 2021-10-04
• Last updated: 2022-01-10

Locations

5 sites across 1 country: China