Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Elderly People With Chronic Bronchitis and COPD

Phase 4

• Conditions: COVID-19; Chronic Bronchitis; COPD
• Interventions: Biological: Inactivated COVID-19 vaccine

• Registration Number: NCT05075083
• Lead Sponsor: China National Biotec Group Company Limited

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 two doses inactivated COVID-19 vaccine with the interval of 21 days .

Detailed Description

The subjects aged 60 years and above with chronic bronchitis and chronic obstructive pulmonary disease were recruited to receive the schedule of two doses inactivated COVID-19 vaccine with the interval of 21 days .

Blood samples will be collected 2 times: before the 1st dose of vaccinatioin and 28 days after the 2nd dose of vaccination.

Any local or systemic adverse events that occurred within 21 days after vaccination will be recorded.

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-06
• Study Start: 2021-10-08
• Study First Posted: 2021-10-12
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-22
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Group	Inactivated COVID-19 vaccine	A total 400 subjects receive two doses inactivated COVID-19 vaccine with the interval of 21 days

Primary Outcome Measures

Name	Time	Method
Seroconversion rate	28 days after the 2th dose (Day 49)	The rate of seroconversion against coronavirus
Baseline neutralizing antibody level	Before vaccination (Day 0)	Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination
Neutralizing antibody level	28 days after the 2th dose (Day 49)	Neutralizing antibody GMT against coronavirus after the 2th dose

Secondary Outcome Measures

Name	Time	Method
Serious adverse event rate	0-6 months	Report and analyse serious adverse events
Adverse events rate	0-21days following vaccinations	Analyse the incidence of adverse events following vaccination, both solicited and unsolicited

Trial Locations

Locations (1)

Zhejiang provincial center for disease control and prevention; 🇨🇳 Hangzhou, Zhejiang, China