EUCTR2004-002586-21-DE进行中（未招募）不适用
An open, randomised, comparative, multicentre study of the immunogenicity and safety of M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX® when administered concomitantly by intramuscular (IM) route or subcutaneous (SC) route at two separate injection sites in healthy subjects 12 to 18 months of age - MMR rHA + VARIVAX IM or SC in 12-18 month-old healthy subjects
Aventis Pasteur MSD SNC0 个研究点目标入组 700 人开始时间: 2004年11月2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
- 入组人数
- 700
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 will be included in the study if they meet all of the following inclusion criteria:
- •1.Healthy subjects of either gender,
- •2.Age 12 to 18 months [from the 12th month birthday to 1 day prior to the 19th month birthday],
- •3.Consent form signed by both parent(s) or by the legal representative properly informed about the study,
- •4.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
- •Subjects will not be included in the study if they meet any of the following non-inclusion criteria:
- •1.Prior receipt of measles, mumps, rubella or varicella vaccine either alone or in combination vaccine,
- •2.Known or suspected clinical history of infection with measles, mumps, rubella, varicella or zoster,
- •3.Any recent ( < or = 30 days) exposure to measles, mumps or rubella,
- •4.Any recent (< or = 30 days) exposure to varicella or zoster involving:
- •continuous household contact, or
- •playmate contact (generally >1 hour of play indoors), or
- •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
- •contact with a newborn whose mother had onset of varicella 5 days or less before delivery or within 48 hours after delivery,
- •5.Any recent (< or = 3 days) history of febrile illness (rectal temperature > or = 38.0°C),
- •6.Any severe chronic disease,
- •7.Active untreated tuberculosis,
- •8.Known personal history of seizures,
- •9.Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems,
- •10.Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
- •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 = 2mg/kg/day prednisone equivalent or > or = 20mg/day if weight more than 10kg) within the previous 30 days] or other immunosuppressive therapy
- •12.Any recent tuberculin test (< or = 7 days) or scheduled tuberculin test through visit 2,
- •13.Any previous (< or = 150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through visit 2,
- •14.Any recent receipt of an inactivated or a live vaccine (< or = 30 days) or scheduled vaccination through visit 2,
- •15.Prior known sensitivity/allergy to any component of the vaccines including neomycin, sorbitol or gelatin,
- •16.True allergy to egg proteins (anaphylatic or anaphylactoid reaction after ingesting eggs),
- •17.Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives,
- •18.Subject that, in the investigator’s opinion, is likely to be lost to follow-up or to be poorly compliant with the study requirements,
- •19.Any recent participation (< or = 30 days) or scheduled participation in any other clinical trial through visit 2
研究者
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