JPRN-jRCTs031220030进行中（未招募）未知
Comparison with subcutaneous injections using a needle-free injection system
Takazawa Kenji0 个研究点目标入组 40 人开始时间: 2022年4月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- >= 20age old 至 < 40age old（—）
- 性别
- All
入选标准
- •1)Men and women between the age of 20 and 40 at the time of obtaining informed consent
- •2)Those who can obtain document informed consent from the person in question
- •3)Those who have a wind shin antibody titer (HI method) of less than 1:32 at the time of screening test
- •4)Those who are able to observe compliance items during participation in this clinical research, receive medical examinations and examinations stipulated in this research plan, and declare symptoms, etc.
- •5)Those who have been judged to be eligible as subject of this clinical research by research responsibility (sharing) doctor in consideration of the results of the screening test.
排除标准
- •1)Those who have or have a history of hypersensitivity or specific constitution to drugs that have presented anaphylaxis by food or medicine in the past
- •2)Pregnant women, breastfeeding and those who have the possibility or intention of pregnancy, and those who cannot agree to contraception from obtaining consent until 6 to 8 weeks (Visit 3) after inoculation regardless of gender.
- •3)Those who have a clear fever
- •4)Those who are clearly involved in severe acute diseases
- •5)Those who have been found to have anaphylaxis dependent on the ingredients of the research drug used.
- •6)Those who have a disease with clearly abnormal immune function or who are receiving treatment for immune- suppression
- •7)Those who are prone to bleeding or who are using blood clotting inhibitors.
- •8)Those who are extremely slim (BMI 16.0 or less)
- •9)Those who have been vaccinated with a vaccine containing a rubella vaccine, a measles vaccine, or both active ingredients at least 12 years of age.
- •10) Those who have a history of suffering from measles
- •11)Those who developed measles or rubella between screening test and inoculation of research drugs, or those who have come into contact with people who develop measles or rubella.
- •12)Those who have been given blood transfusion or gamma globulin preparation within 3 months prior to inoculation of research drugs, or those who have received mass therapy (200 mg / kg or more) of gamma globulin preparation within 6 months before inoculation of the research drugs.
- •13)Those who received other live vaccine (injection) within 27 days before vaccination of the research use drug.
- •14) Persons with underlying diseases such as cardiovascular disease, kidney disease, liver disease, blood disease, and stunted growth, which are judged by research responsibility (sharing) doctor to affect the evaluation of this clinical study.
- •15)Those who participated in other clinical studies or clinical trials within 3 months before inoculation of the drug used for research and received the drug.
- •16)In addition, those who have determined that the registration of this clinical research is inappropriate by research responsibility (sharing) doctor.
研究者
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