临床试验/NCT00496327

NCT00496327已完成3 期

Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With VARIVAX (V210)in Healthy Indian Children

Merck Sharp & Dohme LLC0 个研究点目标入组 100 人开始时间: 2005年6月22日最近更新: 2019年1月18日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 100
主要终点: Percent of subjects with VZV specific antibody titre>= 5gp ELISA units/ml 6 weeks post-vaccination

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

To observe the safety and tolerability of the administration of VARIVAX in varicella history negative Indian children 12 months to 12 years of age.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Prevention
盲法: None

入排标准

年龄范围: 12 Years 至 12 Years（Child）
性别: All
接受健康志愿者: 是

入选标准

•Healthy Children, Between 12 Months And 12 Years Of Age
•Parent Or Legal Guardian Should Be Willing And Able To Sign The Informed Consent Form Prior To Entry Into The Study

排除标准

•Any Immune Impairment Or Deficiency, Neoplastic Disease, Or Depressed Immunity, Including That Resulting From Corticosteroid Or Other Immunosuppressive Therapy
•Any Immunoglobulin Or Blood Products 5 Months Prior To Or Expected Within 3 Months After Enrollment In This Study
•Any Medical Condition Which, In The Opinion Of The Investigator May Interfere With The Evaluation Of Teh Study Objectives
•Any Other Inactivated Vaccine Administered Within 14 Days Before Or Expected Within 42 Days After Administration Of The Study Vaccination
•Any Other Live Vaccine Administered Within 30 Days Before Or Expected Within 42 Days After Administration Of The Study Vaccination
•Female Subjects Who Are Pregnant Or Nursing
•History Of Anaphylactic Or Other Immediate Allergic Reactions
•Hypersensitivity To Any Of The Components Of The Vaccine Administered Under This Protocol Such As Gelatin Or Neomycin
•Past History Of Varicella
•Previous Vaccination With Any Varicella Vaccine In Either Monovalent Or Combination Form
•Recent Household, Daycare, Or School Exposure(In The Last 4 Weeks) To Varicella

研究组 & 干预措施

1

Experimental

Open label

干预措施: Varicella Virus Vaccine Live (Oka-Merck) (Biological)

结局指标

主要结局

Percent of subjects with VZV specific antibody titre>= 5gp ELISA units/ml 6 weeks post-vaccination

时间窗: 6 weeks post-vaccination

次要结局

未报告次要终点

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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