EUCTR2021-001541-13-SE进行中（未招募）1 期
A Phase 2 immunological bridging study assessing the non-inferiority of a new formulation of ETVAX®. A prospective double-blind, randomized study in healthy volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 280
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
- •Male or female aged 18-50 years, inclusive at the time of signing the informed consent.
- •Healthy constitution as established by medical history and physical examination.
- •Willing and able to give written informed consent for participation in the study
- •Able to comply with study activities, as judged by the Investigator.
- •Female Participants: Women of child-bearing potential (for definition see Section 9.3.6):
- •- Have to agree to use an acceptable birth control method during participation in the investigation (see Section 9.3.6).
- •- A negative pregnancy test (beta human chorionic gonadotropin dipstick test in urine) at Visit 2/Day 1 will be required.
- •Male Participants:
- •- Have to agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.
- •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 280
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •An acute or chronic medical condition that, in the opinion of the investigator/physician, would render ingestion of the investigational products unsafe or would interfere with the evaluation of responses. This includes, but is not limited to gastrointestinal diseases, and autoimmune diseases.
- •Current malignancy or history of malignancy during the last five years, based on anamnesis.
- •Gastroenteritis within two weeks prior to vaccination.
- •Regular use of laxatives, antacids or other agents that lower stomach acidity.
- •Any planned major surgery during the duration of the study.
- •After 10 minutes supine rest, any vital signs outside the following ranges:
- •-Systolic BP > 160 mm Hg
- •-Diastolic BP > 100 mm Hg
- •-Heart rate < 40 or >85 beats per minute
- •Antibiotic therapy within two weeks prior to the vaccination.
- •Known Hepatitis A, B, C, and/or HIV infection.
- •Concomitant intake of immunomodulating drugs during the study period or less than three months prior to the first immunization. Local anti-histamine treatment is however allowed.
- •Any other significant medical conditions (e.g. poorly controlled psychiatric condition) judged by the Investigator to preclude entry.
- •Intends to receive any other vaccine during the study period, or within two weeks prior to trial vaccination.
- •Has previously received Dukoral or any type of enterotoxigenic Escherichia coli (ETEC) or cholera vaccines.
- •Brought up in ETEC-endemic areas (e.g., urban and rural areas of Central and South America, Caribbean, most countries in Asia, Africa, etc.).
- •Has travelled to ETEC-endemic areas within the last 3 years OR spent > two months in ETEC endemic areas during the last 10 years.
- •Intends to travel to ETEC endemic countries during the study period.
- •Known or suspected history of drug, chemical or alcohol abuse, as deemed by the investigator/physician.
- •History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to ETVAX®.
- •Participation in any other clinical study that included drug treatment with the last administration within the past 3 months prior to administration of treatment in this study. Patients consented and screened but not dosed in previous clinical studies are not excluded
- •Concomitant participation in any other clinical study.
- •Females who are pregnant as determined by urine test at inclusion and prior to each vaccination.
- •Females who are nursing.
- •Unable to participate in all study visits.
- •Any condition or circumstance which would make the subject unsuitable for participation in the study in the opinion of the investigator/physician.
研究者
相似试验
进行中（未招募）
不适用
A Phase II trial evaluating the immunological and clinical efficay and safety of HER-2 Protein Autovac(TM) monotherapy in patients with metastatic breast cancer - NAFemale patients with histologically proven metastatic or locally advanced breast cancer who have HER-2 overexpression in the primary tumour and/or a metastatic lesion.EUCTR2004-000838-36-HUPharmexa A/S60
进行中（未招募）
不适用
A Phase II trial evaluating the immunological and clinical efficacy and safety of HER-2 Protein AutoVac(TM) and Stimulon® Adjuvant QS-21 monotherapy in patients with metastatic breast cancerEUCTR2005-000558-60-HUPharmexa A/S60
未知
2 期
DNK-651-3JPRN-jRCT2080223664DENKA SEIKEN CO.,LTD.500
进行中（未招募）
不适用
A Phase II Study to Evaluate the Immunogenicity, Safety and Tolerability of a H1N1 Influenza Vaccine in Immunocompromised Adults Who Have Undergone Solid Organ Transplantation or Bone Marrow Transplantation and in Age-Matched Healthy Volunteers - Focetria TxVaccination for H1N1sw of immunocompromised adults who have undergone solid organ or bone marrow transplantation and of healthy adultsMedDRA version: 12.1Level: LLTClassification code 10022000Term: InfluenzaEUCTR2009-017052-27-DEMedizinische Hochschule Hannover
进行中（未招募）
不适用
A Phase II Study to Evaluate the Immunogenicity, Safety and Tolerability of a Seasonal Influenza Vaccine including H1N1 in Immunocompromised Adults Who Have Undergone Solid Organ Transplantation or Bone Marrow Transplantation and in Age-Matched Healthy Volunteers - Fluad TxEUCTR2010-022871-78-DEMedizinische Hochschule Hannover