JPRN-jRCT2071200069已完成1 期
A Phase 1/2, Randomized, Observer-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of TAK-919 by Intramuscular Injection in Healthy Japanese Male and Female Adults Aged 20 Years and Older (COVID-19)
Kuriyama Kenji0 个研究点目标入组 200 人开始时间: 2020年12月18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
- 200
研究概览
简要总结
In conclusion, 100 microgram dose of TAK-919 administered as 2 doses 28 days apart demonstrated acceptable safety profile, induced significant anti-SARS-CoV-2 immune responses and provided the persistence of immune responses in Japanese population aged 20 years and older.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Healthy Japanese male and female participants.
- •2. Participants who understand and are willing to comply with trial procedures and are available for the duration of follow-up.
排除标准
- •1. Participants who received any other SARS-CoV-2 or other experimental novel coronavirus vaccine prior to the trial.
- •2. Participants who have close contact of anyone known to have COVID-19 within 30 days prior to vaccine administration.
- •3. Participants who were tested positive for SARS-CoV-2 prior to the trial or on the test before the vaccination.
- •4. Participants who are on current treatment with other investigational agents for prophylaxis of COVID 19.
- •5. Participants who traveled outside of Japan in the 30 days prior to the trial participation.
- •6. Participants with a clinically significant active infection (as assessed by the Investigator) or oral temperature >= 38 degree Celsius within 3 days of the vaccination.
- •7. Participants with a known hypersensitivity or allergy to any of the IMP components.
- •8. Participants with any illness or history of any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose additional risk to the participants due to participation in the trial.
- •9. Participants with known or suspected impairment/alteration of immune function, including history of any autoimmune disease or neuro-inflammatory disease.
- •10. Abnormalities of splenic or thymic function.
- •11. Participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- •12. Participants with any serious chronic or progressive disease (eg, neoplasm, insulin dependent diabetes, cardiac, renal, or hepatic disease).
- •13. Participants with BMI >= 30 kg/m^2 (BMI=weight in kg/height in meters^2).
- •14. Participants participating in any clinical trial with another investigational product within 30 days prior to the vaccination or intend to participate in another clinical trial at any time during the conduct of this trial.
- •15. Participants who received or plan to receive any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to trial dose administration.
- •16. Participants with acute or chronic clinically significant disease including pulmonary, cardiovascular, hepatic, or renal abnormality evaluated by physical examination.
- •17. Participants involved in the trial conduct or their first-degree relatives.
- •18. Participants who are with or have history of hepatitis B and hepatitis C infection.
- •19. Female participants who are pregnant or breastfeeding.
研究者
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