EUCTR2013-000881-12-BE进行中（未招募）1 期
Immunogenicity, Reactogenicity and Safety of the TrivalentInfluenza Subunit Vaccine Influvac® for the NorthernHemisphere Season 2013/2014. An Open-Label, Baseline-Controlled Study in Two Age Groups: Adult Subjects = 18 and= 60 Years and Elderly Subjects = 61 Years of Age.
Abbott Biologicals B.V0 个研究点目标入组 130 人开始时间: 2013年3月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
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
- •1. Willing and able to give informed consent and able to adhere to all protocol required study procedures.
- •2. Men and women aged = 18 and = 60 years or = 61 years of age at the day of study vaccination.
- •3. Being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the Investigator.
- •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 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •1. Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
- •2. A serious adverse reaction after a previous (influenza) vaccination.
- •3. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
- •4. Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period.
- •5. Having any condition which suppresses the immune system and autoimmune disorders.
研究者
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