NCT05075057

Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥60 Years With Chronic Bronchitis and COPD

Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥60 Years With Chronic Bronchitis and Chronic Obstructive Pulmonary Disease

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: China National Biotec Group Company Limited · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of immunogenicity and safety of the subjects aged 60 years and above with chronic bronchitis and chronic obstructive pulmonary disease recruited to receive the schedule of three doses of inactivated COVID-19 vaccine on day 0, day 21 and day 111, respectively .

Detailed description

The subjects aged 60 years and above with chronic bronchitis and chronic obstructive pulmonary disease were recruited to receive three doses of inactivated COVID-19 vaccine on day 0, day 21 and day 111, respectively. Blood samples were collected before the first dose, 28 days after the second dose, before the third dose, 28 days after the third dose and 6 months after the third dose, respectively. Any local or systemic adverse events that occurred within 21/28 days after vaccination will be recorded.

Conditions

• COVID-19
• Chronic Bronchitis
• Copd

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated COVID-19 vaccine	three doses of inactivated COVID-19 vaccine

Timeline

• Start date: 2021-10-08
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2021-10-12
• Last updated: 2021-10-22

Locations

1 site across 1 country: China