COVID-19 Clinical Trial
Official title:
A Single Center, Randomized ,Controlled and Open Clinical Trial to Evaluate the Immunogenicity and Safety of the Booster Immunization With the Third Dose of COVID-19 Vaccine,Inactivated Co -Administration With Influenza Vaccine and Pneumococcal Polysaccharide Vaccine
Verified date | September 2021 |
Source | Sinovac Biotech Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a single center , randomized ,controlled and open-label phase â…£clinical trial of the booster immunization with the third dose of inactivated COVID-19 vaccine(CoronaVac)manufactured by Sinovac Research & Development Co.,Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the third dose of COVID-19 vaccine,inactivated (Vero Cell) co-administration with influenza vaccine and pneumococcal polysaccharide vaccine in healthy population aged 18 years and older.
Status | Completed |
Enrollment | 3000 |
Est. completion date | May 5, 2022 |
Est. primary completion date | December 5, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Healthy adults aged 18 years and above; - Have been received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research & Development Co., Ltd at an interval of 6 months or more; - Participants should be capable of understanding the informed consent form, and such form should be signed prior to enrolment ; - Proven legal identity; Exclusion Criteria: - History of SARS-CoV-2 infection; - Have been received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research & Development Co., Ltd at an interval of less than 6 months; - Have received received any circulating seasonal influenza vaccine; - Have received any pneumococcal vaccine within 5 years; - History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema; - History of uncontrolled epilepsy and other serious neurological diseases such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases; - History of fever at the time of vaccination, or acute onset of chronic disease, or severe uncontrolled chronic disease, or acute disease; - Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 3 months; - Receipt of other investigational drugs in the past 30 days; - Receipt of attenuated live vaccines in the past 14 days; - Receipt of inactivated or subunit vaccines in the past 7 days; - According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Centers for Diseases Control and Prevention | Beijing |
Lead Sponsor | Collaborator |
---|---|
Sinovac Biotech Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immunogenicity index of seroconversion rate of the neutralizing antibody | Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 28 days after the booster immunization with the third single dose of COVID-19 vaccine | 28 days after the booster immunization with the third dose of COVID-19 vaccine | |
Secondary | Immunogenicity index of seropositivity rate of the neutralizing antibody | Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 28 days after combined immunization | 28 days after combined immunization | |
Secondary | Immunogenicity index of GMT of the neutralizing antibody | GMT of the neutralizing antibody to live SARS-CoV-2 28 days after combined immunization | 28 days after combined immunization | |
Secondary | Immunogenicity index of GMI of the neutralizing antibody | GMI of the neutralizing antibody to live SARS-CoV-2 28 days after combined immunization. | 28 days after combined immunization | |
Secondary | Immunogenicity index of seroconversion rate of 23 pneumonia antibodies | Seroconversion rate of 23 pneumonia antibodies 28 days after single and combined vaccination of 23 valent pneumonia vaccine. | 28 days after single and combined vaccination of 23 valent pneumonia vaccine | |
Secondary | Immunogenicity index of GMC increase of 23 pneumonia antibodies | GMC increase of 23 pneumonia antibodies 28 days after single and combined vaccination of 23 valent pneumonia vaccine | 28 days after single and combined vaccination of 23 valent pneumonia vaccine | |
Secondary | Immunogenicity index of seroconversion rate of 4 influenza antibodies | Seroconversion rate of 4 influenza antibodies 28 days after single and combined vaccination | 28 days after single and combined vaccination | |
Secondary | Immunogenicity index of GMT of 4 influenza antibodies | GMT of 4 influenza antibodies 28 days after single and combined vaccination | 28 days after single and combined vaccination | |
Secondary | Immunogenicity index of GMI of 4 influenza antibodies | GMI of 4 influenza antibodies 28 days after single and combined vaccination | 28 days after single and combined vaccination | |
Secondary | Immunogenicity index of protection rate of 4 influenza antibodies | Protection rate of 4 influenza antibodies 28 days after single and combined vaccination | 28 days after single and combined vaccination |
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