NCT06592456已完成3 期
Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Adolescents and Adults Aged Between 13 to 55 Years : a Double-Blind, Randomized, Parallel-Controlled Phase III Clinical Trial in China
Southeast University, China1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2019年7月21日最近更新:
适应症
干预措施
相关药物
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 Adolescents and adults Aged 13-55 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
- 13 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals aged between 13 to 55 years who are permanent residents; Have obtained informed consent from the volunteer and/or their legal guardian, and signed the informed consent form; The volunteer and/or their legal guardian can comply with the requirements of the clinical trial protocol; Axillary temperature ≤37.0°C.
排除标准
- •Females aged 18 to 55 years with a positive urine pregnancy test, pregnant women, women who are breastfeeding, or women planning to become pregnant within the next 3 months; Have a history of varicella vaccination, a history of chickenpox, or a history of herpes zoster infection; Allergic 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 having HIV-related immunocompromised status, or having close family members with congenital immune diseases; Have 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 (such as coagulation factor deficiencies, coagulopathies, platelet abnormalities) or significant bruising or coagulation disorders; Have received blood products in the past 3 months; Have received live attenuated vaccines in the past 14 days or subunit or inactivated vaccines in the past 7 days; Have had various acute diseases or acute exacerbations of chronic diseases in the past 7 days; Have had a fever (axillary temperature ≥38.0°C) in 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
Experimental
freezedried 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: Chickenpox Vaccines (Biological)
Marketed Live Attenuated Varicella vaccine
Active Comparator
the active control group received VarV produced by Changchun BCHT Biotechnology Co.,which are derived from human diploid cellsinoculated human diploid cells (MRC-5), and then lyophilized with appropriate stabilizers
干预措施: Chickenpox Vaccines (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
Department of epidemiology and biostatistics
Southeast University, China
研究点 (1)
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