EUCTR2017-000112-42-Outside-EU/EEA进行中（未招募）1 期
A Phase II Double-Blind Comparative Study of V501 in Females Aged 9 to 17 Years - A Phase II Double-Blind Comparative Study of V501 in Females Aged 9 to 17 Years
Banyu Pharmaceutical Co., Ltd. a subsidiary of Merck & Co., Inc, Kenilworth, New Jersey0 个研究点目标入组 107 人开始时间: 2017年1月11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
- 107
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
- •The subjects who satisfy all the criteria below at Visit 1 will be enrolled in the study.
- •1) Preadolescent and adolescent girls between the ages 9 years and 17 years.
- •2) Must not yet have had coitarche and does not plan on becoming sexually active through the course of the study.
- •3) Temperature (oral) measured at the test before the initial injection of the investigational product is <37.5?C.
- •4) Subject from whom written informed consent form is obtained from the guardian (legal representative) before the start of study (assent should be obtained from the subject whenever possible)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 107
- •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
- •The subject who violates any of the criteria below at Visit 1 will be excluded from the study.
- •1) Concurrent participation in any other trial within 1 month of the start of this study
- •2) Positive to the pregnancy test (by a urinary pregnancy test with HCG sensitivity adjusted to 25 IU) at the initial visit of this study. Also a person who wish to become pregnant during the period from the start of investigational vaccination to 7 months after vaccination or a breastfeeding subject.
- •3) History of known prior vaccination with a HPV vaccine
- •4) Receipt of inactivated vaccines within 14 days before the start of this study or receipt of live virus vaccines within 28 days before the start of this study.
- •5) History of serious allergic reaction (e.g., swelling of the mouth and throat, difficulty of breathing, hypotension, or shock) by drug administration.
- •6) Allergic to the ingredients of vaccine containing aluminum or to yeast
- •7) Treatment with immunoglobulin or any blood-derived products during the 6 months before the start of this study or scheduled treatment with any such product during the study period
- •8) Individuals with history of splenectomy, known immune disorder (e.g., systemic erythematosus, rheumatic disease), receiving immunosuppressives (e.g., substances or treatment known to diminish immune response such as radiation therapy, administration of antimetabolite, antilymphocytic sera, oral or parenteral systemic corticosteroid). Individuals who have received periodic treatments with immunosuppressives, defined as at least 3 courses of systemic corticosteroids each lasting at least 1 week in duration for the year prior to enrollment, will be excluded. Those who have received topical (e.g., inhaled or intranasal) corticosteroid therapy may be enrolled.
- •9) Thrombocytopenia or coagulopathy that contradicts intramuscular injection
- •10) Diagnosed immunodeficiency or HIV infection
- •11) Presence or history of alcohol or drug abuse. Alcohol abuse is defined as the failure to abstain from taking alcohol despite repetition of alcohol-related social, interpersonal, and legal troubles.
- •12) Any other condition that disqualifies the individual for the study in the opinion of the investigator/subinvestigator
研究者
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