EUCTR2007-004978-16-GB进行中（未招募）不适用
A Phase 2, Open-label, Controlled, Multi-center Study to Evaluate Meningococcal ACWY Antibody Response in Children Aged 40 and 60 Months who Have Previously Received Novartis MenACWY Conjugate Vaccine as Infants
ovartis Vaccines and Diagnostics S.r.l.0 个研究点目标入组 476 人开始时间: 2007年11月23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
- 476
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
- •Participants eligible to be enrolled in the follow-on study are those who:
- •1. have completed the V59P5 study;
- •2. are healthy children age 40 months inclusive (+84 days) (Visit 7) or 60 months (+84 days) (Visit 8);
- •3. are children in good health as determined by:
- •- medical history;
- •- physical assessment;
- •- clinical judgment of the investigator;
- •4. children whose parent(s) give written informed consent for their child to be enrolled in the study.
- •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
- •Participants who are not eligible for the follow up study are those:
- •1. whose parents have not given or are unwilling or unable to give written informed consent for their child’s participation in the study;
- •2. who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
- •a. receipt of immunosuppressive therapy within the past 30 days (any systemic corticosteroid administered for more than 5 days, or in a daily dose >1mg/kg/day prednisone or equivalent during any of the previous 30 days, or cancer chemotherapy);
- •b. receipt of immunostimulants;
- •c. receipt of parenteral immunoglobulin preparation, blood products, and /or plasma derivatives within the past 90 days and for the full length of the study;
- •3. who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis serogroup A, C, W, or Y infection within 60 days prior to enrollment;
- •4. who have experienced, within the 7 days prior to enrollment, significant acute or chronic infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as body temperature = 38°C) within 3 days prior to enrollment;
- •5. who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;
- •6. who have a history of anaphylaxis, serious vaccine reactions, or allergy to any study vaccine component (including latex allergy);
- •7. who have any serious acute, chronic or progressive disease such as
- •a. history of cancer (excluding minor non-melanoma skin cancer)
- •b. diabetes mellitus
- •c. arteriosclerotic disease
- •d. autoimmune disease
- •e. HIV infection or AIDS
- •f. blood dyscrasias
- •g. congestive heart failure
- •h. renal failure
- •i. severe malnutrition
- •8. who have a condition that is a contraindication to vaccination;
- •9. who are participating in any other clinical trial either currently or in the previous 90 days prior to enrolment;
- •10. who are unable to adhere to the protocol;
- •11. who have a 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）
1 期
A Phase 2, Open-label, Controlled, Multi-Center Extension Study to Evaluate 4-Year Antibody Persistence and Booster Response Fol-lowing MenABCWY Vaccination in Healthy Adolescents and Young Adults who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158).EUCTR2016-004420-29-Outside-EU/EEAGlaxoSmithKline Biologicals171
进行中（未招募）
1 期
Immunogenicity and Safety of Meningococcal MenABCWY Vaccine, and of rMenB+OMV NZ and MenACWY Administered Concomitantly in the Same Arm or in 2 Different Arms, or Alone.EUCTR2017-005128-12-CZGlaxoSmithKline Biologicals SA500
进行中（未招募）
1 期
A Phase II, Open-label, Randomized, Multicenter Study to Assess the Safety and Cardiovascular Effects of MyoCell™ Implantation by a Catheter Delivery System in Congestive Heart Failure Patients Post Myocardial Infarction(s) - SEISMICEUCTR2004-001922-26-GBBioheart, Inc46
进行中（未招募）
1 期
A Phase II, Open-label, Randomized, Multicenter Study to Assess the Safety and Cardiovascular Effects of MyoCell™ Implantation by a Catheter Delivery System in Congestive Heart Failure Patients Post Myocardial Infarction(s) - SEISMICPatients with congestive heart failure who have had a previous myocardial infarction.EUCTR2004-001922-26-BEBioheart46
招募中
1 期
Efficacy and safety of UV1 vaccination +/- standard of care as first line treatment of patients with non-small cell lung canceradvanced or metastatic non-small cell lung cancerMedDRA version: 20.0Level: LLTClassification code: 10025044Term: Lung cancer Class: 10029104MedDRA version: 21.1Level: LLTClassification code: 10029514Term: Non-small cell lung cancer NOS Class: 10029104CTIS2022-502437-25-00Vestre Viken HF141