JPRN-jRCT2071210081已完成2 期
Multicenter, open-label, uncontrolled study to evaluate the safety and immunogenicity of KD-414, a vaccine against COVID-19, in healthy Japanese subjects aged 18 years or older.
Shinmura Yasuhiko0 个研究点目标入组 2,000 人开始时间: 2021年10月22日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,000
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Japanese subjects aged 18 years or older at the time of informed consent (regardless of sex)
- •(2) Subjects with written consent (in the case of a minor subject, whose legally acceptable representatives have provided written informed consent.)
排除标准
- •(1) Subjects infect with the novel coronavirus (SARS-CoV-2), or previously infected with SARS-CoV-2 (based on the interview with subject),
- •(2) Close contacts with patients with infected with SARS-CoV-2 (except those denied infection by testing) (based on the interview with subject),
- •(3) Subjects who have been received any vaccines against the novel coronavirus (including unapproved drugs),
- •(4) Subjects who have experienced documented anaphylaxis caused by an ingredient of the investigational product (thimerosal),
- •(5) Female subjects who are pregnant, may be pregnant, are desiring to become pregnant before completion of the test 28 days after the last dose of the study drug as specified, or are breast-feeding
- •(6) Patients with progressive ossifying fibrodysplasia,
- •(7) Subjects with a history of Guillain-Barre syndrome or other demyelinating disease,
- •(8) Subjects with a history of capillary leak syndrome
- •(9) Subjects with clinically significant bleeding or a history of serious bleeding or internal bleeding after intramuscular or intravenous injection,
- •(10) Subjects with previous thrombocytopenia or venous or arterial thrombosis associated with thrombocytopenia,
- •(11) Subjects who are immunosuppressed or immunocompromised, including subjects with asplenic syndrome, or suspected of having such conditions
- •(12) Subjects who participated in another clinical trial and have received another investigational product (excluding placebo) within 4 months (120 days) prior to the date of the first dose of the investigational product in this study, those who plan to participate in another clinical trial during their participation in this study, or those who are scheduled to receive the novel corona vaccine,
- •(13) Subjects who have received transfusion or a gamma globulin preparation within 3 months (90 days), or a bolus therapy (>=200 mg/kg) with a gamma globulin preparation within 6 months (180 days), prior to the date of the first dose of the investigational product,
- •(14) Subject who have received any treatments that may affect the immune function* within 6 months (180 days) prior to the date of the first dose of the investigational product,
- •* radiotherapy, immunosuppressants (except for external use), immunosuppressive therapy, antirheumatics, adrenocorticotropic hormones, or corticosteroids (treatment at prednisolone equivalent doses >=2 mg/kg/day for >=14 days, except for external use.).
- •(15) Subjects having an underlying disease, such as cardiovascular diseases, renal diseases, hepatic diseases, hematological diseases, developmental disorders, respiratory diseases, diabetes mellitus, etc., whose symptoms are unstable and for whom the principal investigator or the subinvestigator judged that there are difficulties in participating in the study,
- •(16) Subject being otherwise ineligible for this study in the principal investigator's or subinvestigator's opinion.
研究者
相似试验
招募中
Unknown
A Study to investigate the safety and tolerability of sirolimus in patients with primary immunodeficiencyJPRN-jRCTs031230296Imai Kohsuke20
已完成
4 期
A multicenter, randomised, open-label study to evaluate the clinical efficacy and pharmacokinetics of oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitisulcerative colitisJPRN-UMIN000003952Department of lower gastroenterology, Hyogo College of Medicine40
招募中
1 期
A multicenter, uncontrolled, open-label study to investigate the safety and the efficacy of human (allogeneic) amnion-derived mesenchymal stem cells KA-301 for Duchenne muscular dystrophyDuchenne muscular dystrophyJPRN-jRCT2033230295akaishi Tomoyuki18
进行中（未招募）
不适用
Multi-center, open-label, uncontrolled study to investigate the efficacy and safety of the transdermal contraceptive patch containing 0.55 mg ethinyl estradiol and 2.1 mg gestodene (material no. 80876395) in a 21-day regimen for 13 cycles in 1650 healthy female subjects - EU/LA/AUS Pearl Index study ? transdermal contraceptive patchEUCTR2008-004214-27-ITBayer HealthCare AG1,650
进行中（未招募）
1 期
Multi-center, open-label, uncontrolled study to investigate the efficacy and safety of the transdermal contraceptive patch containing 0.55 mg ethinyl estradiol and 2.1 mg gestodene (material no. 80876395) in a 21-day regimen for 13 cycles in 1650 healthy female subjects - EU/LA/AUS Pearl Index study – transdermal contraceptive patchThe primary objective of this study is to investigate the contraceptive efficacy of the transdermal contraceptive patch (material no. 80876395).MedDRA version: 9.1Level: PTClassification code 10060346Term: Transdermal contraceptionEUCTR2008-004214-27-FRBayer Healthcare AG