Evaluation of Safety and Immunogenicity Among Different Age-groups Receiving Different Split Influenza Vaccines
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- To evaluate the immunogenicity of evaluated vaccine
研究概览
简要总结
The purpose of this study is to observe the adverse reaction ratio and hemagglutination inhibition (HI) antibody positive rate, Geometric mean titer (GMT) of three brands split influenza virus vaccine in different population.
详细描述
Observational Objectives:
To describe the safety of evaluated vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to ≤ 36 months,6th to 12th birthday and ≥ 60th birthday.
To describe the immunogenicity of evaluated vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to ≤ 36 months, 6th to 12th birthday and ≥ 60rd birthday.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •participants were enrolled (toddlers: 6 months to 3 years; school-aged children: 6 to 12 years and older adults: ≥60 years）
- •Eligible participants were generally healthy or had stable chronic medical conditions (for older adults only)
排除标准
- •History of allergic reaction to any component of the study vaccines or previous influenza vaccine
- •History of systemic hypersensitivity to hens' eggs
- •History of Guillain Barré syndrome following administration of any influenza vaccine
- •Any immunodeficient or immunocompromised conditions
- •Receipt of cytotoxic or immunosuppressive drugs within the past 6 months
- •Receipt of blood-derived product within the past 3 months
- •Receipt of any vaccine within one month prior to study entry with exception of paediatric routine vaccination
- •Receipt of non-study 2010-2011 seasonal TIV
- •Participation in any other study with a non-approved drug during the study
- •Acute febrile disease and other self-limiting illness were the temporary exclusion criteria
结局指标
主要结局
To evaluate the immunogenicity of evaluated vaccine
时间窗: 6 months
The immunologic equivalence of 7days after vaccination of influenza virus vaccine was measured in terms of GMTs.
To evaluate the safety
时间窗: 4 months
The incidence of adverse events was analyzed statistically
次要结局
未报告次要终点