A Double-blind, Randomized, Bridging Clinical Trial to Evaluate the Consistency, Immunogenicity and Safety of Live Attenuated Varicella Vaccines for Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,197
- 主要终点
- The overall seroconversion rates (SCRs) of each group.
研究概览
简要总结
The purpose of this study is to evaluate consistency, immunogenicity and safety of live attenuated varicella vaccines manufactured at commercialized scale in aged 1-3 years children.
详细描述
The study is a single-center, double-blind, randomized, bridging clinical trial. The purpose of this study is to evaluate the consistency between each two lots of live attenuated varicella vaccines, to evaluate the non-inferiority of the immunogenicity of live attenuated varicella vaccines manufactured at commercialized scale compared to trial-scale, and to evaluate the safety of live attenuated varicella vaccines. 1197 healthy Chinese children aged 1 to 3 years old were randomly assigned into four groups in the ratio 2:2:2:1. Children in the first three groups were administered with one dose of live attenuated varicella vaccines manufactured at commercialized scale, and children in the last group were administered with one dose of live attenuated varicella vaccines manufactured at trial-scale .
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer between 1-3 years old;
- •legal identity;
- •Guardian(s) of the volunteer should be capable of understanding the written - consent form, and such form should be signed before the children being included into this study.
排除标准
- •Prior vaccination with varicella vaccine or with history of varicella infection;
- •Axillaty temperature > 37.0 °C before vaccination;
- •History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
- •Epilepsy (except febrile seizures), history of seizures or convulsions, a family history of mental illness, autoimmune disease, or immunodeficiency;
- •Severe malnutrition, congenital malformation, developmental disorders, or serious chronic diseases;
- •Acute disease or acute stage of chronic disease within 7 days prior to study entry;
- •Receipt of any blood product, immunosuppressant, hormone, other investigational medicine(s) within 30 days prior to study entry;
- •Receipt of any live attenuated vaccine within 1 month prior to study entry, or receipt of any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
- •Any significant abnormity of heart, lung, liver, spleen, lymph nodes, or pharynx;
- •Based on the judgment of investigator(s), there was any condition indicating that the subject should be excluded.
研究组 & 干预措施
Experimental Group1
The investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale.
Intervention: Live attenuated varicella vaccine manufactured at commercialized scale
干预措施: Vaccine manufactured at commercialized scale (Biological)
Experimental Group2
The investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale.
Intervention: Live attenuated varicella vaccine manufactured at commercialized scale
干预措施: Vaccine manufactured at commercialized scale (Biological)
Experimental Group3
The investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale.
Intervention: Live attenuated varicella vaccine manufactured at commercialized scale
干预措施: Vaccine manufactured at commercialized scale (Biological)
Control Group
The control vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at trial-scale.
Intervention: Live attenuated varicella vaccine manufactured at trial-scale
干预措施: Vaccine manufactured at trial-scale (Biological)
结局指标
主要结局
The overall seroconversion rates (SCRs) of each group.
时间窗: 30 days
Subjects whose pre-immune antibody titer\< 1:4 and post-immune antibody titer≥ 1:4, or those whose pre-immune antibody titer≥1:4 and the increase of post-immune antibody titer≥4 folds are considered seroconverted.
The post-immune geometric mean titer (GMT) of susceptible subjects in each group.
时间窗: 30 days
Subjects whose pre-immune antibody titer \< 1:4 are considered susceptible. The GMT were measured using the method of Fluorescent Antibody to Membrane Antigen (FAMA).
次要结局
- The seroconversion rates (SCRs) of susceptible subjects in each group(30 days)
- The overall post-immune GMT of each group(30 days)
- The incidences of serious adverse events (SAEs) of each group(30 days)
- The overall GMI of each group(30 days)
- The incidences of adverse events (AEs) of each group(30 days)
- The geometric mean increase (GMI) of susceptible subjects in each group(30 days)