EUCTR2011-001943-60-DK进行中（未招募）1 期
Cellular immunity in adult Hepatitis B-vaccinated serologic non-responders - CMI HBV vacc
ars Jørgen Østergaard0 个研究点目标入组 400 人开始时间: 2011年6月6日最近更新:
适应症
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
- 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
- •1) Written informed consent and authority statement provided according
- •to local regulatory and ethical practice using a participant information
- •sheet and informed consent form approved by the responsible Ethics Committee.
- •2) Male or female participants = 18 years.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Allergy to formaldehyde (contained in Twinrix)
- •2) Former HBV immunization
- •3) Former HBV infection
- •4) Known chronic HBV infection
- •5) Participants unwilling to use reliable contraception for the duration of the trial (if female). Reliable methods of birth control include:
- •pharmacologic contraceptives including oral, parenteral and transdermal
- •delivery, surgical sterilization, vaginal ring, intrauterine device,
- •abstinence and post-menopause (if female).
- •6) Pregnancy or wish of pregnancy within six months after time of study inclusion.
研究者
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