NCT00537524已完成2 期
A Phase II, Randomized, Controlled, Observer-blind, Single-center Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of an H5N1 Influenza Vaccine in Subjects Aged 6 Months to 17 Years
Novartis Vaccines1 个研究点 分布在 1 个国家目标入组 471 人开始时间: 2007年9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
- 471
- 试验地点
- 1
- 主要终点
- safety and tolerability of, and magnitude of antibody responses to two 0.5mL intramuscular injections of an H5N1 influenza vaccineapart
研究概览
简要总结
Evaluate the immune response and reactogenicity of H5N1 vaccination in subjects aged 6 months to 17 years compared to seasonal flu 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
排除标准
- •Receipt of Seasonal Influenza Vaccine for season 2007/2008
- •Receipt of another vaccine within 3 weeks before and after each vaccination
- •Previous vaccination with a pandemic candidate vaccine and/or vaccine containing the adjuvant MF59 or a similar adjuvant
- •Children who are in the local recommendation for influenza vaccination due to underlying diseases
研究组 & 干预措施
Arm 1
Experimental
0.5mL of H5N1 vaccine 7.5ug
干预措施: H5N1 Influenza Vaccine (Biological)
Arm 2
Active Comparator
0.25 or 0.5mL of H5N1 vaccine
干预措施: H5N1 Influenza Vaccine (Biological)
结局指标
主要结局
safety and tolerability of, and magnitude of antibody responses to two 0.5mL intramuscular injections of an H5N1 influenza vaccineapart
时间窗: administered 3 weeks apart
次要结局
- safety and tolerability of, and magnitude of antibodies to one booster dose with a H5N1(12 months after primary immunization)
- safety profile of a H5N1 compared to a seasonal flu vaccinepersistence of specific antibodies(12 months after primary immunization)
研究者
研究点 (1)
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