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

NCT05398926 | Completed Phase 4

• 1 other identifier: PRO-nCoV-4011
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

• Immunogenicity index-GMT of neutralizing antibodies

  GMT of neutralizing antibodies at 14 days after vaccination

  At 14 days after vaccination

• Immunogenicity index- GMT of neutralizing antibodies

  GMT of neutralizing antibodies at 28 days after vaccination

  At 28 days after vaccination

• Safety index-Incidence of adverse reactions

  Incidence of adverse reactions 0\~28 days after vaccination

  0~28 days after vaccination

Secondary Outcomes (5)

• Immunogenicity index-seropositive rate of neutralizing antibodies

  Day 0 before vaccination and 14 days, 28 days and 180 days after vaccination

• Immunogenicity index-GMT of neutralizing antibodies

  Day 0 before vaccination and 180 days after vaccination

• Immunogenicity index-4-fold increase rate of neutralizing antibodies

  At 14 days and 28 days after vaccination.

• Safety index-Incidence of adverse reactions

  0~7 days after vaccination

• Safety index-Incidence of serious adverse events

  6 months after vaccination

Study Arms (4)

Experimental group 1 (3-month interval)

EXPERIMENTAL

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）.

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

Experimental group 2 (4-month interval)

EXPERIMENTAL

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）.

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

Experimental group 3 (5-month interval)

EXPERIMENTAL

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）.

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

Experimental group 4 (6-month interval)

EXPERIMENTAL

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）.

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

Interventions

COVID-19 Vaccine (Vero cell), Inactivated BIOLOGICAL

The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd.600SU inactivated SARS-CoV-2 CZ strain virus in 0.5 mL of aluminium hydroxide solution per injection.

Also known as: CoronaVac®

Experimental group 1 (3-month interval); Experimental group 2 (4-month interval); Experimental group 3 (5-month interval); Experimental group 4 (6-month interval)

Eligibility Criteria

• Age: 60 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinovac Life Sciences Co., Ltd.: lead

Study Sites (1)

Yongde Center for Diseases Control and Prevention

Lincang, Yunnan, 677600, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines; sinovac COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Jun Yang, Master

  Yunnan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 1, 2022
• Study Start: December 6, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-05

Locations

CN (1)