EUCTR2006-003476-35-GB进行中（未招募）1 期
A Phase II, Single Centre, Open-label, Randomized Study to Investigate Meningococcal Serogroup A, C, W-135 and Y Saccharide Specific B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants
ovartis Vaccines and Diagnostics S.r.l0 个研究点目标入组 216 人开始时间: 2007年3月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 216
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
入选标准
- •1.healthy infants aged 2 months (56 – 83 days old, inclusive)
- •2.available for the visits scheduled in the study;
- •3.mother available for blood draw at Visit 1;
- •4.in good health as determined by:
- •-medical history
- •-clinical judgment of the investigator
- •-pre-vaccination check performed by a physician;
- •5.whose parents can give written informed consent for the infant to be enrolled in the study. The infant’s parents must be willing for the infant to receive the full primary immunization course
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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. Whose parents have not given or are unwilling or unable to give written informed consent to their child’s participation in the study
- •2. With known hypersensitivity to any vaccines contained within the routine immunization schedule
- •3. With unacceptable concurrent illnesses or conditions – e.g.:
- •a. a severe acute or chronic illness; with any present or suspected serious disease such as metabolic, cardiac or autoimmune disease or insulin dependent diabetes or with any other serious disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
- •b. a genetic anomaly, e.g. Down’s syndrome;
- •c. any immunodeficiency, including use of systemic corticosteroids;
- •d. born at less than 36 weeks gestation;
- •e. weighing less than 2.5 kg at birth;
- •f. previous clinical or bacteriological diagnosis of meningitis, or with a history of household contact or intimate exposure to an individual with culture proven Neisseria meningitidis disease;
- •g.known bleeding diathesis, or any condition associated with a prolonged bleeding time;
- •4. Who have received any prohibited prior or concomitant medications - e.g.:
- •a. any immunizations within the 30 days prior to enrollment, with the exception of BCG or hepatitis B;
- •b. immunoglobulin;
- •c. any blood products;
- •5. Participating in any other clinical trial either currently or in the previous month;
- •6. Unable to adhere to the protocol, including plans to move from the area;
- •With any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
研究者
相似试验
进行中（未招募）
不适用
A randomized, open label, single center, phase IIa controlled trial to assess tolerability, safety and effect of treatment with deferasirox plus standard antiviral therapy versus standard antiviral therapy in chronic hepatitis C patients na?ve to treatment with interferon and/or ribavirin - NDChronic hepatitis CMedDRA version: 9.1Level: LLTClassification code 10008912EUCTR2009-012344-17-ITAZIENDA OSPEDALIERA POLICLINICO DI MODENA
尚未招募
不适用
A randomized, open-label, single-center phase II study comparing conversion rate to surgery with hepatic aterial infusion chemotherapy to systemic chemotherapy in patients with non resectable liver-only colorectal metastasesKCT0006102Yonsei University Health System, Severance Hospital108
已完成
2 期
An open-label, phase 2, single centre, randomised, crossover pharmacokinetic study assessing two application areas of 0.5ml (5mg) of a testosterone 1% cream, ANDROFEME(Registered trademark) in healthy postmenopausal womeAndrogen deficiency in postmenopausal womenReproductive Health and Childbirth - Other reproductive health and childbirth disordersACTRN12614000962639awley Pharmaceuticals20
已完成
2 期
Bioequivalence study comparing AndroForte 5 (Registered Trademark (R)) and Testogel (R) 1%Testosterone replacement therapyHypogonadismMetabolic and Endocrine - Normal metabolism and endocrine development and functionACTRN12610000834055awley Pharmaceuticals16
进行中（未招募）
1 期
Study investigating new drug, IMC-1121B, in patients with recurring or persistant cancer of the ovary, fallopian tube or lining of the abdominal cavity. Both patient and doctor will know the treatment administered.EUCTR2007-006717-17-GBImClone LLC60