NCT01263327已完成1 期
An Open-Label, Single-dose, Non-Randomized, Safety and Tolerability Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 55 Years
Xiamen University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2010年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Measure injection-site complaints within 7 days after each vaccination; Measure systematic adverse reactions within 1 month after vaccination; Measure serious adverse experience; Measure blood, liver and kidney functions pre- and 3 days post vaccination.
研究概览
简要总结
This phase I clinical study was designed to evaluate the safety of novel recombinant HPV 16/18 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women 18-55 years of age at enrolment. Approximately 30 study subjects will receive the novel HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Written informed consent from the subject prior to enrolment;
- •Female between, and including, 18 and 55 years of age at the time of enrolment;
- •Subjects must be free of obvious health problems;
- •Not pregnant and having no plan for pregnancy;
排除标准
- •Pregnant or breastfeeding or having plan for pregnancy during the whole study (Month 0-7);
- •Previous vaccination against HPV;
- •Having severe allergic history or other immunodeficiency;
- •Chemotherapy and other immunosuppressive agents using;
结局指标
主要结局
Measure injection-site complaints within 7 days after each vaccination; Measure systematic adverse reactions within 1 month after vaccination; Measure serious adverse experience; Measure blood, liver and kidney functions pre- and 3 days post vaccination.
时间窗: 7 months
次要结局
未报告次要终点
研究者
Jun Zhang
Professor
Xiamen University
研究点 (1)
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