EUCTR2013-001602-28-IT进行中（未招募）不适用
An open-label, controlled, multi-centre study of the immunogenicity and safety of a challenge dose of HBVAXPRO® to explore the anamnestic immune response in healthy children vaccinated 10 years ago with a primary series (3 doses) of either HEXAVAC® or INFANRIX®-HEXA - HXV02C
Sanofi Pasteur MSD S.N.C.0 个研究点开始时间: 2013年5月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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 have to meet all the following criteria to be eligible for inclusion:
- •1.Healthy child of either gender
- •2.Child vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA as infants (documented vaccination history)
- •3.Child vaccinated with the third dose of HEXAVAC® or INFANRIX®-HEXA at least 10 years prior to challenge dose
- •4.Subject and parent(s) or legal representative fully understand study procedures, alternative treatments available, the risks involved with the study, and voluntarily agree to participate by giving written informed consent and assent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 750
- •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
- •Subjects meeting at least one of the following criteria will be ineligible for inclusion. Please note for criteria marked with an asterisk, a subject can return to be entered into the study once these criteria no longer apply:
- •1.*History of febrile illness (body temperature =38.0°C) in the 3 days prior to challenge dose
- •2.Receipt of more than 3 doses of any Hepatitis B containing vaccine either alone or in any combination
- •3.History of clinical diagnosis of infection due to Hepatitis B
- •4.History or current close contact with known carriers of Hepatitis B virus
- •5.Prior known sensitivity or allergy to any component of HBVAXPRO®
- •6.Known blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopoietic and lymphatic systems
- •7.Severe thrombocytopenia or other coagulation disorder that would contraindicate intramuscular injection
- •8.Immune impairment or humoral/cellular deficiency or depressed immunity
- •9.Subject is pregnant (as determined by a urine pregnancy test provided by the sponsor)
- •10.*High dose systemic corticosteroids (i.e. = 1 mg/day/kg prednisone equivalent administered orally or parenterally) given =14 days in the 30 days prior to challenge dose. Inhaled, nasal or topical corticosteroids are not considered as systemic treatment
- •11.Immunoglobulins, blood or blood-derived products in the 3 months prior to challenge dose
- •12.*Inactivated vaccine in the 14 days prior to challenge dose
- •13.*Live vaccine in the 28 days prior to challenge dose
- •14.Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
- •15.Subject that, in the investigator’s opinion, is likely to be lost to follow-up or to be poorly compliant with the study requirements
- •16.Planned participation in another clinical study during the present study period
研究者
相似试验
进行中（未招募）
1 期
orazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in JapaStatus EpilepticusEUCTR2017-000125-13-Outside-EU/EEAPfizer Inc25
已完成
4 期
To study how safe and efficacious Gemcitabine with Cisplatin in lung cancer patientsCTRI/2011/05/001722Cipla Ltd40
进行中（未招募）
不适用
An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial SeizuresEpilepsyPartial SeizuresMedDRA version: 17.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersEUCTR2014-004335-39-Outside-EU/EEACB Japan Co. Ltd.70
已完成
4 期
To study how safe and effective is Irinotecanin treatment of colorectal cancer patients.CTRI/2011/05/001723Cipla Ltd40
进行中（未招募）
2 期
Multicenter, single-group, open-label study of T-cell-replete haploidentical stem cell transplantation for relapsed and refractory childhood acute leukemia with low dose anti-thymocyte immunoglobuliAcute leukemiaJPRN-jRCTs041190061Kobayashi Shogo38