EUCTR2004-000518-37-NO进行中（未招募）不适用
A phase III, double-blind, randomized, controlled study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ HPV-16/18 VLP/AS04 vaccine administered intramuscularly according to a 0, 1, 6 month schedule in healthy female subjects aged 10 – 14 years.Sponsor’s protocol code number, version, and date: , Final version, 17th March 2004Name or abbreviated title of the trial where available: HPV-013 - HPV-013
GlaxoSmithKline AS0 个研究点目标入组 2,000 人开始时间: 2004年5月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
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
- Female
入选标准
- •Female subjects 10 – 14 years of age who have a negative urine pregnancy test at the time of the first vaccination. (If they are of childbearing potential at the time of study entry, they must be abstinent or must be using an effective method of birth control.)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Pregnant or breastfeeding.
- •Planning to become pregnant or likely to become pregnant.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •History of vaccination against hepatitis A or a known clinical history of hepatitis A infection.
研究者
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