EUCTR2006-004129-27-DE进行中（未招募）不适用
An open, randomised, comparative, multicentre study of the immunogenicity and safety of concomitant versus separate administration of a combined measles, mumps, rubella and varicella live vaccine (ProQuad®) and a booster dose of Infanrix® hexa in healthy children 12 to 23 months of age.
Sanofi Pasteur MSD0 个研究点目标入组 960 人开始时间: 2006年10月5日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 960
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.Healthy subject of either gender,
- •2.Age from 12 to 23 months [from the 12th month birthday to 1 day prior to the 24th month birthday],
- •3.Negative clinical history of measles, mumps, rubella, varicella and zoster,
- •4.For Italy: Primary vaccination with the combined diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine Infanrix® hexa as a 2-dose schedule, with receipt of the second dose = 6 months prior to inclusion,
- •For Germany: Primary vaccination with the combined diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine Infanrix® hexa as a 3-dose schedule, with receipt of the third dose = 6 months prior to inclusion,
- •5.Consent form signed by parent(s) according to local regulations or by the legal representative properly informed about the study,
- •6.Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.
- •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.Prior receipt of measles, mumps, rubella and/or varicella vaccine either alone or in any combination,
- •2.Any recent (a.continuous household contact, or
- •b.playmate contact (generally >1 hour of play indoors), or
- •c.hospital contact (in same 2- to 4-bed room or adjacent beds in a large ward or face-to-face contact with an infectious staff member or subject), or
- •d.in the case of varicella, contact with a newborn whose mother had onset of varicella 5 days or less before delivery or within 48 hours after delivery,
- •3.Receipt of any other diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenzae type b containing vaccine (either alone or in any combination) than Infanrix® hexa,
- •4.Any recent (or= 38.0°C),
- •5.Any severe chronic disease,
- •6.Active untreated tuberculosis,
- •7.Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
- •8.Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic or lymphatic systems,
- •9.Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
- •10.Prior known sensitivity/allergy to any component of the vaccines including neomycin, sorbitol or gelatin,
- •11.Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity including those resulting from corticosteroid [any long-term (>or= 14 days) administration of systemic corticosteroid therapy given daily or on alternate days at high doses (>or= 2 mg/kg/day prednisone equivalent or >or= 20 mg/day if weight more than 10kg) within the previous 30 days] or other immunosuppressive therapy,
- •12.Any recent (13.Any previous (14.Any recent (15.Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives,
- •16.Any recent (
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