EUCTR2022-003868-25-Outside-EU/EEA进行中（未招募）1 期
Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Dengue 1,2,3,4 (Attenuated) Vaccine produced by Instituto Butantan
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- 性别
- All
入选标准
- •1. Children who have completed 24 months of age, adolescents and adults who have not completed 60 years of age;
- •2. Agree with periodic contacts, either/or by phone, electronic means, and home visits.
- •3. Show voluntary intention to participate in the study, documented by the participant's or participant's legal representative's signature of the informed consent form.
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. For women: Pregnancy (confirmed by positive beta-hCG test) or breastfeeding;
- •2. Evidence of active neurological, cardiac, pulmonary, hepatic or renal disease as per clinical history and/or physical examination;
- •3. Compromised immune system diseases including: decompensated diabetes mellitus, cancer (except basal cell carcinoma), congenital or acquired immune deficiencies and not controlled autoimmune, as per clinical history and/or physical examination;
- •4. Behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements;
- •5. Abusive usage of alcohol or drugs in the past 12 months that has caused medical, professional or family problems, indicated by clinical history;
- •6. History of severe allergic reactions or anaphylaxis to the vaccine or to components of the vaccine in study;
- •7. History of asplenia;
- •8. Use of any investigational product within 28 days before or after receiving this study vaccination;
- •9. Has participated in another clinical trial six months prior to inclusion in the study or planning to participate in another clinical trial within 2 years following inclusion;
- •10. Use of immunosuppressant drugs such as: antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use (except topical or nasal). For this protocol will be considered for exclusion use of corticosteroids 3 months prior to the inclusion in the study and 6 months prior to the inclusion for the other therapies mentioned, and planned use of any immunosuppressant therapy within 2 years following inclusion in the study. It will be considered immunosuppressive dose of corticosteroids the equivalent to a dose =20 mg of prednisone per day for adults and the equivalent of prednisone at 2 mg/kg/day for children for over 7 days;
- •11. Have received blood products in the past three months, including transfusions or immunoglobulin, or scheduled administration of blood products or immunoglobulin for the following 2 years after vaccination;
- •12. Fever or suspected fever within 72 hours prior to vaccination or axillary temperature greater than 37,8°C on the day of vaccination (inclusion might be postponed until participant has completed 72 hours of no fever);
- •13. Have received live virus vaccine within 28 days or killed virus vaccine in the last 14 days prior to vaccination, or have a scheduled immunization during the first 28 days after receiving the investigational product;
- •14. Any other condition that might put in risk the safety/rights of a potential participant or hurdle his/her compliance with this protocol in investigator's opinion or his representative physician.
研究者
相似试验
撤回
2 期
Double-Blind, Randomized, Placebo-Controlled Phase IIa Clinical Trial to Investigate the Safety and Immunogenicity of RUTI® Therapeutic Vaccination in Patients with Multi-Drug Resistant Tuberculosis after successful intensive-phase treatment.Infection with Mycobacterium tuberculosis resistant to at least the two first line antibioticsMultidrug-resistant Tuberculosis1002844010024970NL-OMON43117Archivel Farma S.L.5
进行中（未招募）
1 期
V160 2-Dose and 3-Dose Regimens vs. Placebo in Healthy CMV Seronegative FemalesCytomegalovirus infection (CMVi)MedDRA version: 20.0Level: LLTClassification code 10009703Term: CMV infectionSystem Organ Class: 100000004862EUCTR2017-004233-86-FIMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.2,100
进行中（未招募）
1 期
Evaluation of the safety and ability to induce an immune response of RUTI vaccine for patients that have completed the first 12 or 16 weeks of standard therapy for drug-resistant tuberculosisThe medical condition to be investigated is culture-confirmed Multidrug-resistant tuberculosis, i.e. tuberculosis resistant to the two first-line drugs Rifampicin and IsoniazidEUCTR2016-000850-36-NLArchivel Farma S.L.27
进行中（未招募）
1 期
V160 2-Dose and 3-Dose Regimens vs. Placebo in Healthy CMV Seronegative FemalesEUCTR2017-004233-86-ESMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.2,100
进行中（未招募）
不适用
Randomized, Double-Blind, Placebo-Controlled Phase II Study Comparing the Safety of Ipilimumab Administered With or Without Prophylactic Oral Budesonide (Entocort EC) in Patients with Unresectable Stage III or IV Malignant MelanomaRevised Protocol 03 Incorporating Amendment 02, 03 and 05 (version 1.0, dated 12-Mar-07)+ Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0 dated 01-Aug-05)MELANOMAEUCTR2005-002678-31-GBBristol-Myers Squibb International Corporation100