Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-28 @ 9:02 AM
Study NCT ID:
NCT05075057
Status:
UNKNOWN
Last Update Posted:
2021-10-22
First Post:
2021-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥60 Years With Chronic Bronchitis and COPD
Sponsor:
China National Biotec Group Company Limited
Organization:
Study Overview
Official Title:
Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥60 Years With Chronic Bronchitis and Chronic Obstructive Pulmonary Disease
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: