Safety and Immunogenicity of Three Seasonal Trivalent Influenza Vaccines in China Military
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- Hemagglutination inhibition (HI) titers of each strain which were recommended by WHO for the 2014 seasonal influenza vaccines
研究概览
简要总结
The purpose of this study is to assess the safety and immunogenicity of three seasonal trivalent influenza vaccines (TIVs)manufactured by Glaxosmith Kline (GSK), Beijing Sinovac Biotech (Sinovac) and Shenzhen Sanofi Pasteur (Pasteur) in Chinese healthy servicemen. Using imported GSK's TIV as control, to compare it with other two domestic TIVs in Chinese healthy servicemen.
详细描述
This study is a 1:1:1 randomized, double-blinded, controlled phase Ⅳ clinical trial in a military command in Beijing. Healthy individuals aged between 18～34 years who had not received any influenza vaccine during recent three years will be enrolled and administrated one dose TIV. Safety data will be collected for whole study (Day 0 to Day 30).Blood samples will be collected for immunogenicity assessments before injection and 21 days after vaccination.
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
- 18 Years 至 34 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy servicemen aged between 18-34 years ,who had not received any influenza vaccine during recent three years;
- •Proven legal identity;
- •Written informed consent;
- •Complying with the requirement of the study protocol;
排除标准
- •Pregnant, breast feeding women;
- •History of allergy to any vaccine or vaccine ingredient;
- •Receipt of any immunosuppressant within 6 month prior to study entry;
- •Congenital malformation, developmental disorders, serious chronic diseases, autoimmune disease, immunodeficiency, serious cardiovascular disease, diabetes, Guillain-Barré syndrome, hypertension that cannot be stabilized by medication, liver or kidney disease, or malignant tumor;
- •Acute disease or acute stage of chronic disease within 7 days prior to study entry;
- •Axillaty temperature > 37.0 °C;
- •Any other factor that in the opinion of the investigator suggesting the volunteer is unsuitable for this study;
结局指标
主要结局
Hemagglutination inhibition (HI) titers of each strain which were recommended by WHO for the 2014 seasonal influenza vaccines
时间窗: 21 days after vaccination
Hemagglutination inhibition (HI) titers were measured using the antigen and standard serum provided by the National Institute for Biological Standards and Control (NIBSC).
次要结局
- The post-vaccination seroprotection rates of each of the influenza vaccines(21 days after vaccination)
- The post-vaccination mean geometric increases (GMIs) of each of the influenza vaccines(21 days after vaccination)
- The incidences of adverse events (AEs)(21 days after vaccination)
- The post-vaccination seroconversion rates of each of the influenza vaccines(21 days after vaccination)