NCT00432523已完成3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 752
- 试验地点
- 2
研究概览
简要总结
Primary objective:
To compare if, when given concomitantly with VARIVAX® by the same route at 12-18 months of age using separate injection sites, a single dose of M-M-RTMII administered by IM route is as immunogenic as a single dose of M-M-RTMII administered by SC route in terms of response rates to measles, mumps and rubella at 42 days following the vaccination.
AND/OR
To compare if, when given concomitantly with M-M-RTMII by the same route at 12-18 months of age using separate injection sites, a single dose of VARIVAX® administered by IM route is as immunogenic as a single dose of VARIVAX® administered by SC route in terms of response rate to varicella at 42 days following the vaccination
Secondary objectives:
- To summarise the antibody titres to measles, mumps, rubella and varicella at 42 days following the vaccination in children immunised with M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC,
- To evaluate the safety profiles of M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subject of either gender,
- •Age 12 to 18 months ,
- •Consent form signed by both parent(s) or by the legal representative properly informed about the study,
- •Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.
排除标准
- •Prior receipt of measles, mumps, rubella or varicella vaccine either alone or in combination vaccine,
- •Known or suspected clinical history of infection with measles, mumps, rubella, varicella or zoster,
- •Any recent (≤30 days) exposure to measles, mumps or rubella,
- •Any recent (≤30 days) exposure to varicella or zoster involving:
- •Any recent (≤3 days) history of febrile illness
- •Any severe chronic disease,
- •Active untreated tuberculosis,
- •Known personal history of seizures,
- •Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems,
- •Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
- •Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed
- •Any recent tuberculin test (≤7 days) or scheduled tuberculin test through visit 2,
- •Any previous (≤150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through visit 2,
- •Any recent receipt of an inactivated or a live vaccine (≤30 days) or scheduled vaccination through visit 2
研究者
研究点 (2)
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