EUCTR2017-001819-36-BE进行中（未招募）1 期
A Phase 3 Double-Blind Randomized Controlled Trial to Compare the Immunogenicity and Safety of a Three-dose Regimen of Sci-B-Vac™ to a Three-dose Regimen of Engerix-B® in Adults (PROTECT). - PROTECT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,564
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
- •Subjects must meet all the following criteria to be eligible:
- •1. Any gender.
- •2. Age = 18 years.
- •3. In stable health as determined by a physical examination and laboratory tests values. Common chronic conditions such as, but not limited to, type 2 diabetes, high blood pressure, COPD, asthma will be accepted if the condition is well controlled, as determined by the investigator, and not meeting the exclusion criteria. For subjects > 65 years old, Frailty Index =3 17(see Appendix 1 of the protocol).
- •4. If female:
- •either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy),
- •is of childbearing potential and must agree to use an adequate birth control method during the screening period and until the end of her participation in the study (effective birth control includes: 1) hormonal (implant, oral, vaginal, transdermal) contraceptives; 2) diaphragm with spermicide, condom (with or without spermicide); 3) intra-uterine devices; and 4) vasectomy of male partner; 5) abstinence from penile-vaginal intercourse (if the preferred and usual lifestyle of the subject)).
- •5. Able and willing to give consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 938
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 626
排除标准
- •Subjects meeting any of the following criteria will be excluded:
- •1.Previous vaccination with any HBV vaccine (licensed or experimental).
- •2.Treatment by immunosuppressant within 30 days of enrollment including but not limited to corticosteroids at a dose that is higher than an oral or injected physiological dose, or a prednisolone-equivalent dose >20 mg /day (Inhaled and topical steroids are allowed.
- •3.Known history of immunological function impairment, including but not limited to:
- •a) autoimmune diseases (e.g., multiple sclerosis, type 1 diabetes, myasthenia gravis, Crohn disease and other inflammatory bowel diseases, celiac disease, systemic lupus erythematosus, scleroderma, including diffuse systemic form and CREST syndrome, systemic sclerosis, dermatomyositis polymyositis, rheumatoid arthritis, juvenile idiopathic arthritis, autoimmune thyroiditis -including Hashimoto thyroiditis, Grave's or Basedow’s disease, immune thrombocytopenic purpura, autoimmune hemolytic anemia, autoimmune hepatitis, psoriasis, vitiligo, vasculitis, Guillain-Barré syndrome, Addison’s disease, Bell’s palsy and alopecia areata);
- •b)secondary immunodeficiency disorders (e.g. resulting from HIV/AIDS (Acquired Immunodeficiency Syndrome caused by Human Immunodeficiency Virus infection), solid organ transplant, splenectomy);
- •c) primary immunodeficiency disorders (e.g. common variable immune deficiency (CVID), Defective phagocytic cell function and neutropenia syndromes, complement deficiency).
- •4.Pregnancy or breastfeeding.
- •5.Immunization with attenuated vaccines (e.g. MMR) within 4 weeks prior to enrollment.
- •6.Immunization with inactivated vaccines (e.g. influenza) within 2 week prior to enrollment.
- •7.Has received blood products or immunoglobulin within 90 days of enrollment or likely to require blood products during the study period.
- •8.Subject in another clinical trial with an investigational drug or a biologic within 30 days of enrollment.
- •9.Has received granulocyte-macrophage colony stimulating factor (G/GM-CSF) or erythropoietin (EPO) within 30 days of enrollment or likely to require GM-CSF/erythropoietin during the study period.
- •10.Any history of cancer requiring chemotherapy or radiation within 5 years of randomization or current disease. Subject with a history of low risk basal cell carcinoma will be accepted (low risk being defined by the following: 1) location on the trunk of the body, arms, legs, cheeks, forehead, temples, scalp, neck or chin and 2) less than 2 cm, and 3) nodular or superficial, and 4) primary cancer that has not come back after treatment and 5) edge of the cancerous area is clear and smooth and 6) not located in or around nerves).
- •11.Any skin abnormality or tattoo that would limit post-vaccination injection site assessment.
- •12.History of allergic reactions or anaphylactic reaction to any vaccine component (Engerix-B® or Sci-B-Vac™).
- •13.Unwilling, or unable in the opinion of the investigator, to comply with study requirements, including the use of an adequate birth control method.
- •14.Immediate family members of study center staff (parents, sibling, children).
- •15.Current or past hepatitis B infection or prior vaccination as evidenced by HBV markers (anti-HBc, anti-HBs, HBsAg) at screening.
- •16.Known hepatitis C infection or positive Hepatitis C serology at screening, unless treated and cured (defined as documented sustained virologic response (SVR) or negative viral load = 12 weeks after cessation of
研究者
相似试验
进行中（未招募）
1 期
A trial to compare the immune response and safety of 3 doses of Sci-B-Vac™ compared to 3 doses of Engerix-B® in AdultsHepatitis B vaccination in healthy adultsMedDRA version: 20.0 Level: LLT Classification code 10054181 Term: Hepatitis B immunization System Organ Class: 100000004865EUCTR2017-001819-36-FIVBI Vaccines Inc.1,564
已完成
3 期
Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory MyopathyPolymyositis, Dermatomyositis, Autoimmune Necrotizing Myopathy, Overlap Myositis, Juvenile Myositis Above the Age of 18JPRN-jRCT2080223614Bristol-Myers Squibb K.K.150
进行中（未招募）
1 期
A Phase 3 trial to evaluate the effectiveness and safety of Abatacept SC alongside standard treatment in comparison to standard treatment alone in improving disease activity in adults with active idiopathic inflammatory myopathy, a group of chronic autoimmune inflammatory diseases that affect skeletal muscle.Idiopathic Inflammatory Myopathy (IIMeg, Dermatomyositis [DM], Polymyositis [PM], autoimmune necrotizing myopathy)MedDRA version: 20.0Level: LLTClassification code 10042753Term: Symptomatic inflammatory myopathySystem Organ Class: 100000004859EUCTR2016-002269-77-SEBristol-Myers Squibb International Corporation148
进行中（未招募）
1 期
A Phase 3 trial to evaluate the effectiveness and safety of Abatacept SC alongside standard treatment in comparison to standard treatment alone in improving disease activity in adults with active idiopathic inflammatory myopathy, a group of chronic autoimmune inflammatory diseases that affect skeletal muscle.Idiopathic Inflammatory Myopathy (IIMeg, Dermatomyositis [DM], Polymyositis [PM], autoimmune necrotizing myopathy)MedDRA version: 20.0Level: LLTClassification code 10042753Term: Symptomatic inflammatory myopathySystem Organ Class: 100000004859EUCTR2016-002269-77-DEBristol-Myers Squibb International Corporation150
进行中（未招募）
1 期
A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC with Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults with Active Idiopathic Inflammatory Myopathy (IIM)EUCTR2016-002269-77-FRBristol-Myers Squibb International Corporation150