NCT00311428已完成4 期
A Phase IV, Observer-Blind, Randomized, Parallel Groups, Single-Center, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of Two 0.25 mL Intramuscular Doses of Three Commercially Available Influenza Vaccines in Healthy Subjects Aged 6 to <36 Months.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Seroprotection, GMR's and Seroconversion rate at day 0 and day 50 following vaccination.
研究概览
简要总结
This phase IV protocol is designed to evaluate the safety, clinical tolerability and immunogenicity of the 2005-2006 formulation of three widely used conventional influenza vaccines in children aged 6 to 35 months
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
- Single
入排标准
- 年龄范围
- 6 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children of 6 months to <36 months of age, whose parents or legal guardians have given written informed consent prior to study entry
排除标准
- •Any severe acute respiratory disease and infections requiring systemic antibiotic or antiviral therapy ongoing or resolved within 30 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable)
- •Other serious diseases such as: cancer, autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic or renal disease, surgery planned during the study period.
- •Known or suspected impairment/alteration of immune function
- •History of hypersensitivity to any component of the study vaccine, egg products or other vaccine component, or impairment/alteration of immune function
结局指标
主要结局
Seroprotection, GMR's and Seroconversion rate at day 0 and day 50 following vaccination.
次要结局
- Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Thought the Study.
研究者
研究点 (1)
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