Immunogenicity and Safety of a Third Dose of COVID-19 Vaccine(Vero Cell), Inactivated in the Elderly

Sinovac

Status and phase: Completed; Phase 4

Conditions: COVID-19

Treatments: Biological: COVID-19 Vaccine (Vero cell), Inactivated

Study type: Interventional

Funder types: Industry

Identifiers

NCT05398926

PRO-nCoV-4011

Details and patient eligibility

About

This is an open phase Ⅲ clinical trial of COVID-19 vaccine (Vero cell), inactivated manufactured by Sinovac Research & Development Co., Ltd.The purpose of this study is to evaluate Immunogenicity and safety of a third dose at different times after two-dose of COVID-19 vaccine (Vero cell), Inactivated in the Elderly Aged 60 years and above.

Full description

This study is an open phase Ⅲ clinical trial. The main purpose of this study is to evaluate Immunogenicity and safety of a third dose at different times after two-dose of COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Research & Development Co., Ltd. in the elderly aged 60 years and above.A total of 400 subjects aged 60 years and above who had received two doses of COVID-19 vaccine(Vero Cell), inactivated manufactured by Sinovac Research & Development Co., Ltd. between 3 - 6 months ago (100 subjects for 3 months, 4 months, 5 months and 6 months,respectively) will be enrolled and receive a third dose of two-dose of COVID-19 vaccine (Vero cell), inactivated were enrolled.

Enrollment: 400 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects aged 60 years and above;
• Provide legal identification;
• Have completed two-dose of COVID-19 vaccine (Vero cell), inactivated manufactured by Sinovac Research& Development Co., Ltd. for 3~6 months（The interval between two doses was 21~35 days）；
• Be able to understand and voluntarily sign the informed consent form and be willing to complete the study according to the research plan.

Exclusion criteria

• History of SARS-CoV-2 infection(laboratory confirmed);
• Those who have received COVID-19 vaccine from other manufacturers other than Sinovac Research& Development Co., Ltd., or who have received booster immunization with COVID-19 vaccine after two doses of COVID-19 vaccine (Vero cell),inactivated manufactured by Sinovac Research& Development Co., Ltd.;
• History of serious adverse reactions to the vaccine or vaccine components, such as urticaria dyspnea and angioneuroedema;
• Autoimmune disease or immunodeficiency/immunosuppression;
• Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc;
• Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
• Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months or plan to receive these treatments during the study period;
• Receipt of blood products within in the past 3 months or plan to receive these treatments during the study period;
• Receipt of other investigational drugs in the past 30 days;
• Receipt of attenuated live vaccines in the past 14 days,or receipt of inactivated or subunit vaccines in the past 7 days;
• Onset of various acute or chronic diseases within 7 days prior to the study;
• Axillary temperature >37.0°C;
• According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 4 patient groups

Experimental group 1 (3-month interval)

Experimental group

Description:

100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (3-month interval）.

Treatment:

Biological: COVID-19 Vaccine (Vero cell), Inactivated

Experimental group 2 (4-month interval)

Experimental group

Description:

100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (4-month interval）.

Treatment:

Biological: COVID-19 Vaccine (Vero cell), Inactivated

Experimental group 3 (5-month interval)

Experimental group

Description:

100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (5-month interval）.

Treatment:

Biological: COVID-19 Vaccine (Vero cell), Inactivated

Experimental group 4 (6-month interval)

Experimental group

Description:

100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (6-month interval）.

Treatment:

Biological: COVID-19 Vaccine (Vero cell), Inactivated