EUCTR2009-011676-30-ES进行中（未招募）不适用
Estudio de extensión, fase 2b, abierto, multicéntrico, para evaluar la seguridad, tolerabilidad e inmunogenicidad de una dosis de refuerzo de la vacuna recombinante de Novartis contra el meningococo del grupo B administrada a los 12,18 ó 24 meses de edad a niños que con anterioridad hayan recibido una primera serie de tres dosis de la vacuna recombinante de Novartis contra el meningococo del grupo B en el estudio V72P12
ovartis Vaccines and Diagnostics S.r.l.0 个研究点目标入组 1,900 人开始时间: 2009年7月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,900
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
- •1. Group 5: healthy 18-month-old toddlers (0/ +29 days window); Group 6: healthy 24-month-old toddlers (0/ +29 days window); 2. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained; 3. available for all the visits scheduled in the study; 4. in good health as determined by medical history, physical examination, clinical judgment of the investigator Inclusion Criteria for follow-on participants (Groups 1, 2, 3 and 4): Inclusion criteria are the same as for Groups 5 and 6, with the addition that are subjects: 1. who participated and completed V72P12 study 2. who are aged: o 12 months or older - Groups 1a, 2a, 3a, 4 o 18 months (0/ +29 days window) - Groups 1b, 2b, 3b) o 24 months (0/ +29 days window) - Groups 1c, 2c, 3c)
- •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.subjects whose parents/legal guardians are unwilling or unable to give written informed consent to participate in the study; 2.history of any meningococcal B vaccine administration (only groups 5 and 6); 3.previous ascertained or suspected disease caused by N. meningitidis; 4.household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis; 5.history of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; 6.significant acute or chronic infection within the previous 7 days or axillary temperature ³ 38°C within the day before Visit 1; 7.antibiotics within 7 days prior to Visit 1; 8.any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition); 9.known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within 30 days prior to Visit 1; 10.receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to Visit 1; 11.receipt of, or intent to immunize with any other vaccine(s), within 30 days prior to Visit 1; 12.participation in another clinical trial within 90 days prior to enrolment or planned for during study; 13.family members and household members of research staff; 14.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
Estudio fase II, multicéntrico, abierto, para comparar la eficacia y seguridad de RAD001 en primera línea seguido de sunitinib en segunda línea frente a sunitinib en primera línea seguido de RAD001 en segunda línea en el tratamiento de pacientes con carcinoma de células renales metastásicoCarcinoma de células renalesMedDRA version: 9.1Level: LLTClassification code 10050513Term: Metastatic renal cell carcinomaEUCTR2009-011056-21-ESovartis Farmacéutica, S.A427
进行中（未招募）
不适用
Estudio en fase II, abierto, multicéntrico, prospectivo y aleatorizado, con DTIC o la combinación de Gemcitabina y DTIC en sarcomas de partes blandas avanzados del adultoEUCTR2005-001709-24-ESGrupo Español de Investigación en Sarcomas (GEIS)
进行中（未招募）
1 期
Estudio de fase 2, multicéntrico, en abierto, para evaluar la seguridad y la eficacia del IMC-1121B en combinación con 5-FU/AF y oxaliplatino (FOLFOX-6 modificado) como tratamiento de primera línea en pacientes con cáncer colorrectal metastásico.An Open Label, Multicenter, Phase 2 Study Evaluating the Safety and Efficacy of IMC-1121B in Combination with 5-FU/FA and Oxaliplatin (Modified FOLFOX-6) as First-line Therapy in Patients with Metastatic Colorectal Cancer.Cáncer colorrectal metastásicoMetastatic Colorectal CancerMedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerEUCTR2008-004936-19-ESImClone Systems Incorporated45
进行中（未招募）
不适用
Estudio de fase II, abierto y multicéntrico para evaluar la eficacia y seguridad de la combinación de panitumumab con irinotecán en pacientes con cáncer colorrectal metastásico con KRAS no mutado y refractario a la quimioterapia basada en irinotecán.Open, multicenter phase II study to evaluate the efficacy and safety of the combination of Panitumumab with Irinotecan in patients with Wild-Type KRAS metastatic colorectal cancer refractory to irinotecan based chemotherapy - SPECTRACáncer colorrectal metastástasico KRAS no mutado y refractarios a la quimioterápia basada en irinotecánEUCTR2009-010833-27-ESGrupo de Tratamiento de los Tumores Digestivos - TTD
进行中（未招募）
1 期
Estudio en fase II, abierto, multicéntrico y aleatorizado de RO5083945 en combinación con FOLFIRI frente a FOLFIRI más cetuximab o FOLFIRI en monoterapia como tratamiento de segunda línea en pacientes con cáncer colorrectal metastásico con KRAS natural o mutado. A randomized, multicenter, open-label phase II study of RO5083945 in combination with FOLFIRI versus FOLFIRI plus cetuximab or FOLFIRI alone as second line treatment in patients with KRAS wild-type or mutant metastatic colorectal cancer .Cáncer colorrectal metastásico con o sin mutación de gen KRAS y con progresión de la enfermedad tras un tratamiento de primera línea mediante un régimen con oxaliplatino. Metastatic colorectal cancer, KRAS wild-type (WT) or mutant, with disease progression after first line treatment with an oxaliplatin-containing regimen.MedDRA version: 12.1Level: LLTClassification code 10052358Term: Colorectal cancer metastaticEUCTR2010-022983-11-ESF. Hoffmann-La Roche Ltd.169