Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine Coadministered With Varicella Vaccine and Measles, Mumps and Rubella Combined Vaccine in Shanghai, China: A Non-inferiority, Open-label, Randomised, Controlled, Phase 4 Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- non-inferiority of the seroconversion rate and IgG antibody level against measles, rubella, and mumps
研究概览
简要总结
Eligible participants were randomly assigned (1:1:1), using block randomization stratified, to either 3 groups. Group 1 will be immunized inactivated SARS-CoV-2 vaccine and varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28.
Group 2 will be immunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine and MMR in day 28.
Group 3 will be immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28.
Vaccines were administered 28 days apart, with blood samples taken on day 0 and day 28 before vaccination, and on day 56. Local and systemic symptoms and serious adverse events following immunzation were collected.
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
- 4 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 4 years old
- •With legal guardian signing the informed consent
- •Able to participate in all planned visits and comply with all research procedures (such as completing diary cards of adverse events and participating visits)
- •With clear vaccination records including no SARS-CoV-2 vaccine history, with 1 varicella vaccine and 2 measles-containing vaccines history
- •the last attenuated vaccine was administered ≥28 days ago, and other vaccines administered ≥14 days ago
- •With an axillary temperature ≤37.5℃ at the time of vaccination
排除标准
- •First dose exclusion criteria:
- •With SARS-CoV-2 infection in the last 3 months (any of the following conditions shall be met: positive nucleic acid test; positive antigen test; suspected SARS-CoV-2 infection symptoms of subject or close contacts)
- •allergic to any substance of the vaccine or with a severe allergic reactions history of vaccines (such as acute allergic reactions, angioneurotic edema, breathing difficulties, etc.)
- •Suffering uncontrolled epilepsy or progressive nerve system diseases, or with a history of Gribali syndrome
- •With acute illness, severe or acute attack of chronic illness or fever
- •With immunodeficiency or weakened immune system or being treated with immunosuppressant drugs (oral steroids)
- •Received non specific immunoglobulin within 3 months
- •Any situation that researchers thought that might influence the consequence of the clinical trial Second dose exclusion criteria：
- •Occurrence of any serious adverse event that may be related to the previous dose of study vaccine
- •Occurrence of systemic adverse reactions or allergic reactions with a severity level ≥ 3 recognized by researchers after vaccination
- •Any new situations that fit the first dose exclusion criteria
- •Any situation that researchers thought that might influence the consequence of the clinical trial
研究组 & 干预措施
Group 1
immunized inactivated SARS-CoV-2 vaccine and varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28.
干预措施: Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine (Biological)
Group 2
immunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine and MMR in day 28.
干预措施: Inactivated SARS-CoV-2 vaccine coadministered with MMR (Biological)
Group 3
immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28.
干预措施: Inactivated SARS-CoV-2 vaccine administered alone (Biological)
结局指标
主要结局
non-inferiority of the seroconversion rate and IgG antibody level against measles, rubella, and mumps
时间窗: on day 28 after vaccination
IgG antibodies of measles, rubella, and mumps is an index of immunogenicity
non-inferiority of the seroconversion rate and neutralising antibody level against SARS-CoV-2
时间窗: on day 28 after vaccination
Neutralizing antibody of SARS-CoV-2 is an index of immunogenicity
non-inferiority of the seroconversion rate and IgG antibody level against varicella
时间窗: on day 28 after vaccination
IgG antibodies of varicella is an index of immunogenicity
次要结局
- incidence of reported vaccine-related adverse events within 28 days of each immunization.(from 0 to 28 days after vaccination)
研究者
HUANG Zhuoying
Doctor
Shanghai Municipal Center for Disease Control and Prevention