EUCTR2013-000373-76-BE进行中（未招募）1 期
A phase III, randomized, double blind multicenter study, to evaluate consistency, immunogenicity, safety and reactogenicity of 3 lots of GSK Biologicals’ herpes zoster HZ/su candidate vaccine when administered intramuscularly on a 0 and 2 month schedule to adults =50 years of age. - ZOSTER-007
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 651
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 who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •- A male or female aged 50 years or older at the time of the first vaccination.
- •- Written informed consent obtained from the subject.
- •- Female subjects of non-childbearing potential may be enrolled in the study.
- •* Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause
- •- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •* has practiced adequate contraception for 30 days prior to vaccination, and
- •* has a negative pregnancy test on the day of vaccination, and
- •* has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
- •Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •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 434
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 217
排除标准
- •- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. A prednisone dose of <20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
- •- Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine (E.g. inactivated and subunit vaccines) within 8 days prior to or within 14 days after either dose of study vaccine.
- •- Administration of long-acting immune-modifying drugs within six months prior to the first vaccine dose or expected administration at any time during the study period.
- •- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- •- Previous vaccination against HZ or varicella.
- •- Planned administration during the study of an HZ or varicella vaccine other than the study vaccine.
- •- History of HZ.
- •- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
- •- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- •- Acute disease and/or fever at the time of enrolment.
- •* Fever is defined as temperature = 37.5°C (99.5°F) by oral route. The preferred route for recording temperature in this study will be oral.
- •* Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- •- Administration of immunoglobulins and/or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
- •- Pregnant or lactating females.
- •- Females planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 4
- •- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- •- Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study
- •- Any condition which, in the judgment of the investigator would make intramuscular injection unsafe.
研究者
相似试验
已完成
3 期
A Phase-III Clinical Trials of Xylentra Versus Silver Sulfadiazine for efficacy and safety in burnwound patientsCTRI/2012/04/002592Issar Pharmaceuticals Private Limited200
进行中（未招募）
不适用
A phase III, randomized, double blind, multicenter, parallel group, placebo and active controlled, dose optimization safety and efficacy study of Lisdexamfetamine Dimesylate (LDX) in children and adolescent aged 6-17 with attention-deficit/hyperactivity disorder (ADHD)Attention Deficit/Hyperactivity Disorder ADHDMedDRA version: 14.1Level: LLTClassification code 10064104Term: ADHDSystem Organ Class: 100000004873EUCTR2008-000679-90-ITShire Pharmaceutical Development Limited300
进行中（未招募）
1 期
Weekly 30000 IU vitamin D treatment in PCOS patientsVitamin D deficient female subjects diagnosed with PCOSMedDRA version: 19.0Level: PTClassification code 10047626Term: Vitamin D deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2016-000503-87-HUPharma Patent Kft
进行中（未招募）
1 期
Study of efficacy and safety of canakinumab as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected non-small cell lung cancerstages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-004011-39-ROovartis Pharma AG1,500
进行中（未招募）
1 期
Study of efficacy and safety of canakinumab as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected non-small cell lung cancerstages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC)MedDRA version: 20.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-004011-39-CZovartis Pharma AG1,500