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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Immunogenicity index of seroconversion rate of the neutralizing antibody
研究概览
简要总结
This study is a single center , randomized ,controlled and open-label phase Ⅳclinical 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.
详细描述
This study is a single center , randomized ,controlled and open-label phase Ⅳclinical trial in healthy adult aged 18 years and older. 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.The COVID-19 vaccine was manufactured by Sinovac Research &Development Co., Ltd,and the quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine(PPV23) were manufactured by Sinovac Biotech Co.A total of 3000 subjects will be enrolled, with 300 aged 18~59years(adult group) and 300 aged 60 years and above(adult group) in the section of immunogenicity and safety of combined immunization ,with 1200 aged 18~59 years(adult group) and 1200 aged 60 years and above(elderly Group) in the section of safety observation study of combined immunization.Each age group will be randomly divided into 3 subgroups of 100 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine in the section of immunogenicity and safety of combined immunization and each age group will be randomly divided into 2 subgroups of 600 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine in the section of safety observation study of combined immunization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
Adult group in immunogenicity and safety study of combined immunization
300 participants will be randomly divided into 3 subgroups of 100 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine
干预措施: Adult group in immunogenicity and safety study of combined immunization (Biological)
Elderly group in immunogenicity and safety study of combined immunization
300 participants will be randomly divided into 3 subgroups of 100 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine
干预措施: Elderly group in immunogenicity and safety study of combined immunization (Biological)
Adult group in safety observation study of combined immunization
1200 participants will be randomly divided into 2 subgroups of 600 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine
干预措施: Adult group in safety observation study of combined immunization (Biological)
Elderly group in safety observation study of combined immunization
1200 participants will be randomly divided into 2 subgroups of 600 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine
干预措施: Elderly group in safety observation study of combined immunization (Biological)
结局指标
主要结局
Immunogenicity index of seroconversion rate of the neutralizing antibody
时间窗: 28 days after the booster immunization with the third dose of COVID-19 vaccine
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
次要结局
- Immunogenicity index of GMI of the neutralizing antibody(28 days after combined immunization)
- Immunogenicity index of seroconversion rate of 23 pneumonia antibodies(28 days after single and combined vaccination of 23 valent pneumonia vaccine)
- Immunogenicity index of GMC increase of 23 pneumonia antibodies(28 days after single and combined vaccination of 23 valent pneumonia vaccine)
- Immunogenicity index of seropositivity rate of the neutralizing antibody(28 days after combined immunization)
- Immunogenicity index of GMT of the neutralizing antibody(28 days after combined immunization)
- Immunogenicity index of GMI of 4 influenza antibodies(28 days after single and combined vaccination)
- Immunogenicity index of seroconversion rate of 4 influenza antibodies(28 days after single and combined vaccination)
- Immunogenicity index of GMT of 4 influenza antibodies(28 days after single and combined vaccination)
- Immunogenicity index of protection rate of 4 influenza antibodies(28 days after single and combined vaccination)