EUCTR2015-005195-22-Outside-EU/EEA进行中（未招募）不适用
Immunogenicity and Safety of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine Given in Japanese Subjects
Sanofi Pasteur KK0 个研究点目标入组 200 人开始时间: 2015年11月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Aged 2 years and above on the day of inclusion
- •2. For subjects = 20 years of age: Informed consent form has been signed and dated by the subjects. For subjects 2 to 19 years of age: Informed consent form has been signed and dated by the parent or other legally representative. Also subjects 7 to 11 years of age will provide oral assent and subjects 12 to 19 years of age will provide written assent form
- •3. Able to attend all scheduled visits/phone call and to comply with all trial procedures
- •4. For a woman of childbearing potential, use of an effective method of contraception from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 188
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any acute and/or serious disease/illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- •2. History of typhoid fever or Salmonella typhi infection, confirmed either clinically, serologically, or microbiologically
- •3. Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to a vaccine containing the same substances of the study vaccine
- •4. Known or suspected congenital or current/previous acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- •5. Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion
- •6. Planned participation in another clinical trial during the present trial period
- •7. Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- •8. Receipt of any vaccine within the four weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least two weeks before the study vaccine
- •9. Planned receipt of any vaccine during the trial period
- •Clinical or known serological evidence of systemic illness including hepatitis B, hepatitis C and/or Human immunodeficiency virus (HIV) infection
- •10. Ineligible according to the investigator's clinical judgment
- •11. Known pregnancy, or a positive (serum and/or urine) pregnancy test
- •12. Currently breastfeeding a child
- •13. Known thrombocytopenia, contraindicating intramuscular (IM) vaccination
- •14. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
- •15. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •16. Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- •17. Identified as employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family member (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator
- •18. Previous vaccination against Salmonella typhi disease with either the trial vaccine or another vaccine.
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