PER-069-10已完成未知
A PHASE III CLINICAL TRIAL TO STUDY THE IMMUNOGENICITY, TOLERABILITY, AND MANUFACTURING CONSISTENCY OF V503 (A MULTIVALENT HUMAN PAPILLOMAVIRUS [HPV] L1 VIRUS-LIKE PARTICLE [VLP] VACCINE) IN PREADOLESCENTS AND ADOLESCENTS (9 TO 15 YEAR OLDS) WITH A COMPARISON TO YOUNG WOMEN (16 TO 26 YEAR OLDS)
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 156 人开始时间: 2010年12月6日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 156
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 9 至 26（—）
入选标准
- •A. Inclusion Criteria Children from 9 to 15 years:
- •Male or female participant between the ages 9 years 0 days and 15 years and 364 days on the day of enrollment.
- •The participant is considered to be in good health based on HCl, physical examination and lab results.
- •The participant (or parent / legal guardian) fully understands study procedures; available alternative treatments, the risks involved with the study, and voluntarily agrees to participate by providing written informed consent.
- •The participant agrees to provide the study staff with a primary telephone number as well as an alternative telephone number for tracking purposes.
- •Participant has not had sexual intercourse prior to the study and does not plan to become sexually active during the study period Day 1 to Month 7
- •B. Inclusion Criteria Young women aged 16 to 26:
- •Participants enrolled in this group will not participate in extension V503-002-10.
排除标准
- •Exclusion criteria Children and Girls aged 9 to 15:
- •The participant presents a known allergy to any component of the vaccine including aluminum, yeast or BENZONASE.
- •The participant has a history of severe allergic reaction.
- •The participant has thrombocytopenia or any coagulation disorder that may contraindicate MI.
- •The participant is currently enroll in research agent studies.
- •(Girls only) Participant is pregnant
- •The participant has donated blood within 1 week prior to the vaccination on day 1 or intends to do so during the period from day 1 to month 7 of the study.
- •The participant is currently immunocompromised.
- •The participant has undergone a splenectomy,
- •The participant is receiving or has received in the year prior to enrollment any immunosuppressive therapy listed
- •The participant has received or plans to receive any immunoglobulin or blood product products within 3 months prior to vaccination from day 1 through month 7 of the study.
- •Participant has received non-replicative (inactive) vaccines within 14 days prior to vaccination on day 1 or received replicative vaccines within 21 days prior to vaccination on day 1.
- •The participant has received a commercially available HPV vaccine.
- •Participant has experienced fever within 24 hours prior to vaccination on day 1.
- •Current history or evidence of any condition, therapy, or abnormality of the lab that could confuse the study results.
- •Participant cannot give consent / assent.
研究者
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