CTRI/2019/04/018635已完成1 期
An open label Phase I study to evaluate the safety and immunogenicity of HBI Measles and Rubella vaccine (Live) when administered to two age groups of healthy male subjects.
Human Biologicals Institute0 个研究点目标入组 55 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
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
入选标准
- •1. Healthy male subjects of 12 to 49 years of age.
- •2. Judged to be in good health on the basis of reported medical history, physical examination and clinical judgement of the investigator.
- •3. Plans to remain in the study area for the entire length of the trial.
- •4. Subject and the LAR are literate and have understood and provided written Informed Consent.
排除标准
- •1. Participation in any other clinical trial in the four weeks preceding the trial vaccination.
- •2. Planned participation in any other clinical trial during the present trial period.
- •3. Subject who has a known history of allergy to any component of the vaccine.
- •4. Known or suspected primary or acquired disease of the immune system.
- •5. Allergy immunotherapy or receiving immunosuppressive therapy.
- •6. History of any significant underlying disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, hematologic or hepatic dysfunction and autoimmune disease.
- •7. Known or suspected acute respiratory illness at the time of study vaccination with active symptoms and signs including one or more of the following: rhinorrhea, new cough, pharyngitis and respiratory problems (e.g. asthma, wheezing, shortness of breath).
- •8. Any fever with temperature >= 38.0°C (100.4oF) in last 3 days prior to the study vaccination.
- •9. Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures or evidence of any other evolving neurological signs and symptoms.
- •10. Any known history or suspicion of thrombocytopenia or a bleeding disorder.
- •11. History or suspicion of HIV, HCV or Hepatitis B.
- •12. History of alcoholic abuse.
- •13. Any history of receipt of blood products or immunoglobulins in last 3 months.
- •14. Subjects who have received any live attenuated vaccine in past 30 days and any subunit or inactivated vaccine except for tetanus toxoid vaccine in past 14 days.
- •15. Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
研究者
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