EUCTR2011-005173-23-AT进行中（未招募）不适用
A Phase III, Multicenter, Observer-blind, Safety and Immunogenicity Study of Rabies Vaccine and Japanese Encephalitis Vaccine Administered Concomitantly and/or Separately According to 1 of 2 Different Pre-exposure Prophylaxis Schedules to Healthy Adult Subjects
ovartis Vaccines and Diagnostics GmbH0 个研究点目标入组 660 人开始时间: 2012年2月6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
- 660
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.Males and females between 18 and 65 years of age (inclusive)
- •2.Subjects who have given written consent after the nature of the study has been explained according to local regulatory requirements.
- •3.Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 660
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.History of previous rabies/rabies immune globulin and/or JE immunization.
- •2.Any individuals with a contraindication or precaution against vaccination with Rabipur® or IXIARO® as highlighted in the package inserts of these products
- •3.Subjects currently receiving or planning to receive anti-malarial medications (e.g. Mefloquine) 14 days prior to Day 1 vaccination through Day 43.
研究者
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Safety and Immunogenicity Study of Rabies Vaccine and Japanese Encephalitis Vaccine Administered Together and/or Separately According to Different Schedules to Healthy SubjectsSafety and Immunogenicity of Rabies Vaccine and Japanese Encephalitis Vaccine administered concomitantly and/or separately according to 1 of 2 different pre-exposure prophylaxis schedules to healthy adult subjectsMedDRA version: 14.1Level: PTClassification code 10037742Term: RabiesSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: LLTClassification code 10023123Term: Japanese encephalitisSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: HLTClassification code 10037743Term: Rabies viral infectionsSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-005173-23-DEovartis Vaccines and Diagnostics GmbH660
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