NCT00408395已完成2 期
A Phase II, Observer-Blind, Randomized, Parallel Groups, Multicenter, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of One and Two 0.25 mL Intramuscular Doses of a Commercially Available Influenza Vaccine Versus Two 0.25 mL Intramuscular Doses of a Commercially Available Influenza Vaccine in Healthy Children
Novartis Vaccines1 个研究点 分布在 1 个国家目标入组 281 人开始时间: 2006年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 281
- 试验地点
- 1
- 主要终点
- To evaluate the immunogenicity of the 2 vaccines in terms of post-immunization geometric mean titers (GMTs), as measured by the hemagglutination inhibition (HI) test
研究概览
简要总结
This is a study of the safety and immunogenicity of three commercially available influenza vaccines in children.
详细描述
A Phase II, Observer-Blind, Randomized, Parallel Groups, Multicenter, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of One and Two 0.25 mL Intramuscular Doses of a commercially available influenza vaccine versus Two 0.25 mL Intramuscular Doses of a commercially available influenza vaccine in Healthy Children
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 (Participant)
入排标准
- 年龄范围
- 6 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6 months to < 36 months of age
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, or 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
研究组 & 干预措施
2: Adjuvanted Trivalent Seasonal Influenza Vaccine
Experimental
干预措施: Influenza vaccine (Biological)
1: Trivalent Seasonal Influenza Vaccine
Experimental
干预措施: Influenza vaccine (Biological)
结局指标
主要结局
To evaluate the immunogenicity of the 2 vaccines in terms of post-immunization geometric mean titers (GMTs), as measured by the hemagglutination inhibition (HI) test
次要结局
- To evaluate the safety and tolerability of the 2 vaccines administered 4 weeks apart
- To evaluate the immunogenicity of the 2 vaccines in terms of seroprotection, and seroconversion or significant increase, as measured by HI test
研究者
研究点 (1)
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