A Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of Booster Immunization With Varicella Vaccine at Different Intervals Among Children Aged 7-12 Years
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 412
- 试验地点
- 1
- 主要终点
- Geometric mean titer (GMT) of varicella-zoster virus (VZV) antibodies
研究概览
简要总结
The goal of this clinical trial is to evaluate the immunogenicity and safety of booster immunization of varicella live attenuated vaccine (varicella vaccine hereafter) at different intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged 7-12 years;
- •Has previously received a single dose of varicella vaccine, with at least 3 months since the first dose;
- •The subject or legal guardian can understand and sign the informed consent form (double signature is required for those over 8 years old);
- •Participants and their legal guardians voluntarily participate in the study and are able to comply with all study procedures;
- •Provide legal identity proof;
排除标准
- •History of varicella;
- •History of severe allergic reactions to vaccines (such as acute anaphylaxis, angioedema, dyspnea, etc.);
- •Suffering from acute disease, severe chronic disease, acute exacerbation of chronic disease;
- •With any confirmed or suspected immunodeficiency disease, immunocompromised or receiving immunosuppressive therapy (including systemic steroid therapy);
- •With a history of congenital immune diseases or close contact with family members with a history of congenital immune diseases;
- •With encephalopathy, uncontrolled epilepsy, other progressive neurological disorders, history of Guillain-Barre syndrome;
- •Body temperature >37℃ at the time of vaccination;
- •Receipt of blood products within 3 months before receiving investigational vaccine;
- •Receipt of another study drug within 30 days before receipt of the investigational vaccine;
- •Receipt of live attenuated vaccine within 28 days before receipt of investigational vaccine;
- •Receipt of subunit or inactivated vaccine within 7 days before receipt of investigational vaccine;
- •Participated in other clinical trials before enrollment and were enrolled in another clinical trial during the follow-up period or planned to participate in another clinical trial within 3 months;
- •The participant had any other factors that were ineligible for vaccination by in the investigator's judgment.
研究组 & 干预措施
Group A
Participants received a single dose of varicella vaccine as booster immunization 3 months after their primary vaccination.
干预措施: Varicella vaccine (Biological)
Group B
Participants received a single dose of varicella vaccine as booster immunization 18-30 months after their primary vaccination.
干预措施: Varicella vaccine (Biological)
Group C
Participants received a single dose of varicella vaccine as booster immunization 36-48 months after their primary vaccination.
干预措施: Varicella vaccine (Biological)
Group D
Participants received a single dose of varicella vaccine as booster immunization 60-72 months after their primary vaccination.
干预措施: Varicella vaccine (Biological)
结局指标
主要结局
Geometric mean titer (GMT) of varicella-zoster virus (VZV) antibodies
时间窗: 30 days after booster dose immunization
GMT of VZV antibodies 30 days after booster dose immunization
次要结局
- Seroconversion rate of varicella-zoster virus (VZV) antibodies(30 days after booster dose immunization)
- Seropositive rate of varicella-zoster virus (VZV) antibodies(30 days after booster dose immunization)
- Geometric mean increase (GMI) of varicella-zoster virus (VZV) antibodies(30 days after booster dose immunization)