Immunogenicity and Safety of a Third Dose of COVID-19 Vaccine(Vero Cell), Inactivated in the Elderly
NCT ID: NCT05398926
Last Updated: 2022-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
400 participants
INTERVENTIONAL
2021-12-06
2022-07-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Booster Immunization With COVID-19 Vaccine,Inactivated Co -Administration With Influenza Vaccine and Pneumococcal Polysaccharide Vaccine
NCT05499351
Study on Combined Vaccination With SARS-CoV-2 Inactivated Vaccine and Quadrivalent Influenza Vaccine
NCT04801888
A Clinical Trial of Split-virion Influenza A/H1N1 Vaccines
NCT01004653
Comparative Trial Evaluating Safety and Immunogenicity of an Adjuvanted and a Conventional Influenza Vaccine in Elderly Subjects (> 60 Years)
NCT00310648
Combined Immunization of COVID-19 Inactivated Vaccine With QIV and PPV23
NCT05298800
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental group 1 (3-month interval)
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）.
COVID-19 Vaccine (Vero cell), Inactivated
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.
Experimental group 2 (4-month interval)
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）.
COVID-19 Vaccine (Vero cell), Inactivated
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.
Experimental group 3 (5-month interval)
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）.
COVID-19 Vaccine (Vero cell), Inactivated
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.
Experimental group 4 (6-month interval)
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）.
COVID-19 Vaccine (Vero cell), Inactivated
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
COVID-19 Vaccine (Vero cell), Inactivated
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sinovac Life Sciences Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jun Yang, Master
Role: PRINCIPAL_INVESTIGATOR
Yunnan Provincial Center for Disease Control and Prevention
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Yongde Center for Diseases Control and Prevention
Lincang, Yunnan, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRO-nCoV-4011
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.