EUCTR2013-001420-19-GB进行中（未招募）不适用
A Phase IV, Single-Centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2013/2014 Formulation of a bioCSL split virion, inactivated influenza vaccine in Healthy Volunteers aged 18-60 years
bioCSL Pty Ltd0 个研究点开始时间: 2013年4月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •* Males or females aged between 18 and 60 years at the time of vaccination.
- •* Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child-bearing potential must return a negative urine pregnancy test result prior to vaccination with the vaccine.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •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 vaccination with influenza vaccine or allergy to eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the vaccine.
- •* Clinical signs of an active infection.
- •* A clinically significant medical condition.
- •* Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
- •* Females who are pregnant or lactating.
研究者
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