RPCEC00000244尚未招募4 期
Evaluation in adults of the immunogenicity and reactogenicity of lot 5C0701/0 of the HEBERBIOVAC HB vaccine candidate for reference material.
Center for Genetic Engineering and Biotechnology (CIGB), in Havana.0 个研究点目标入组 190 人开始时间: 2017年4月30日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 190
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Prevention
入排标准
- 年龄范围
- 35 years 至 55 years（—）
- 性别
- All
入选标准
- •1. Voluntariness of the subject through the signing of informed consent.
- •2. Age between 35 and 55 years.
- •3. Subjects of both sexes.
- •4. Do not present evidence of decompensated organic or psychiatric disease according to questioning and physical examination.
- •5. Women of childbearing age who use a contraceptive method and continue their use throughout the study.
- •6. Post-menopausal woman (with at least 2 years of amenorrhea) or documented history of hysterectomy and / or double annexectomy.
排除标准
- •1. History of Hepatitis B virus infection.
- •2. Positivity for Hepatitis B surface antigen (HBsAg +) or presence of antibodies against surface antigen (Anti-HBs).
- •3. Pregnancy, puerperium or breastfeeding.
- •4. Acute infection of any type requiring specific treatment.
- •5. Decompensated chronic diseases (High blood pressure, Diabetes mellitus, Chronic renal failure, Heart failure, Ischemic heart disease).
- •6. Severe allergic history (Urticaria, Atopic dermatitis, Severe bronchitis, Grade III or IV bronchial asthma).
- •7. Immunosuppressive treatment in the 6 months prior to inclusion in the study.
- •8. Allergy to Thiomersal or any component of the vaccine.
研究者
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