Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-31 @ 10:42 AM
Study NCT ID:
NCT05104333
Status:
UNKNOWN
Last Update Posted:
2021-11-03
First Post:
2021-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Immunogenicity, Safety and Antibody Persistence of COVID-19 Booster Vaccine (Produced in Beijing) in Patients With Hypertension and/or Diabetes
Sponsor:
China National Biotec Group Company Limited
Organization:
Study Overview
Official Title:
A Post-marketing Clinical Study of a Third Dose of the Inactivated SARS-CoV-2 Vaccine (Vero Cells) (Produced in Beijing): Immunogenicity, Safety and Antibody Persistence Assessments in Patients With Hypertension and/or Diabetes
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
NOT_YET_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:
To evaluate the post-marketing immunogenicity, safety and antibody persistence of the third dose (booster) of Covid-19 vaccine in patients aged 60 years or older with hypertension and/or diabetes.
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, are given a third doses of the inactivated SARS-CoV-2 vaccine (Vero cells).
These subjects are all from the "COVAX (HT/DM)-Beijing" clinical trial (NCT05065879). 50% of them receive the booster vaccine 3 months after the second dose (0-1-4 schedule); 50% of them receive the booster vaccine 5 months after the second dose (0-1-6 schedule).
Venous blood samples are collected before the booster dose and on day 28 after the booster dose to evaluate the immunogenicity of the vaccine.
Venous blood samples are also collected on day 84/168/252/336 after the booster dose to evaluate the antibody persistence of the vaccine.
Adverse events are actively recorded on a diary card once daily from day 0 to day 7 and once from day 8 to day 21 after the booster dose. Serious adverse events (SAE) are collected within 6 months after the booster dose.
These subjects are all from the "COVAX (HT/DM)-Beijing" clinical trial (NCT05065879). 50% of them receive the booster vaccine 3 months after the second dose (0-1-4 schedule); 50% of them receive the booster vaccine 5 months after the second dose (0-1-6 schedule).
Venous blood samples are collected before the booster dose and on day 28 after the booster dose to evaluate the immunogenicity of the vaccine.
Venous blood samples are also collected on day 84/168/252/336 after the booster dose to evaluate the antibody persistence of the vaccine.
Adverse events are actively recorded on a diary card once daily from day 0 to day 7 and once from day 8 to day 21 after the booster dose. Serious adverse events (SAE) are collected within 6 months after the booster dose.
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?: