Phase III Clinical Trial of Lyophilized Live Attenuated Varicella Vaccine for Children Aged 1-12 Years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- seroconversion rate
研究概览
简要总结
Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Children Aged 1-12 Years: A Phase III, Randomized, Double-Blind, Active-Controlled Study
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages ranging from 1 to 12 years for the general healthy population ;
- •Obtain informed consent from the volunteer and/or their legal guardian, and sign the informed consent form;
- •The volunteer and/or their legal guardian is able to comply with the requirements of the clinical trial protocol;
- •Axillary body temperature ≤37.0℃.
排除标准
- •Those who have previously been vaccinated against varicella, have a history of varicella or herpes zoster infection;
- •Allergy to known components of the study vaccine, or a history of severe allergic reactions to any vaccination;
- •A history of epilepsy, seizures, or convulsions, or a family history of psychiatric disorders;
- •Individuals with immunodeficiency, undergoing immunosuppressive therapy (e.g., oral corticosteroids), or HIV-related immunocompromised individuals, or those with family members closely exposed to congenital immune diseases;
- •Those with congenital malformations, developmental disorders, or severe chronic diseases (such as Down syndrome, diabetes, sickle cell anemia, neurological disorders, Guillain-Barré syndrome);
- •Known or suspected concurrent diseases, including respiratory diseases, acute infections, or active chronic diseases, cardiovascular diseases, skin diseases, severe hypertension, or during treatment for malignant tumors;
- •Diagnosed with coagulation dysfunction (e.g., deficiency of coagulation factors, coagulation disorders, platelet abnormalities) or significant bruising or coagulation disorders;
- •Receipt of blood products within the past 3 months;
- •Receipt of attenuated live vaccines within the past 14 days or subunit or inactivated vaccines within the past 7 days;
- •Acute illnesses or acute exacerbations of chronic diseases in the past 7 days;
- •A history of high fever (axillary body temperature ≥38.0℃) within the past 3 days;
- •Any other factors deemed by the investigator as unsuitable for participation in the clinical trial.
研究组 & 干预措施
Live Attenuated Varicella vaccine candidates
The test group received the freeze-dried live attenuated VarV developed by Beijing Minhai Biotechnology Co., LTD., which are derived from the Oka strain, cultured and harvested from inoculated MRC-5 human diploid cells inoculated human diploid cells (MRC-5), and then lyophilized with appropriate stabilizers.
干预措施: Oka strain varicella attenuated live vaccine (Biological)
Marketed Live Attenuated Varicella vaccine
the active control group received VarV produced by Changchun BCHT Biotechnology Co.,which are derived from the Oka strain, cultured and harvested from inoculated MRC-5 human diploid cellsinoculated human diploid cells (MRC-5), and then lyophilized with appropriate stabilizers.
干预措施: Oka strain varicella attenuated live vaccine (Biological)
结局指标
主要结局
seroconversion rate
时间窗: 42 days after completing the full course of vaccination.
The primary immunogenicity endpoint was the seroconversion rate of VZV antibodies
次要结局
- geometric mean titer (GMT)(42 days after completing the full course of vaccination.)
- geometric mean fold increase (GMFI)(42 days after completing the full course of vaccination.)
研究者
Shiyuan Wang
MD, Department of epidemiology and biostatistics, School of public health,
Southeast University, China