EUCTR2014-005183-15-Outside-EU/EEA进行中（未招募）不适用
A Phase II, Multicentre, Randomised, Observer-blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children Aged >= 6 Months to < 9 Years.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- CSL Limited
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female aged >= 6 months to < 9 years at the time of the first study vaccination.
- •For children < 3 years of age at the time of first vaccination, born at or after 36 weeks of gestation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 400
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thiomersal, neomycin, polymyxin, or any components of the Study Vaccine.
- •Participants with confirmed or suspected 2009 H1N1 infection or those who had received an experimental vaccine during the preceding 6 months.
研究者
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