A Pilot Study to Compare the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine and the Concomitant Administration of the Currently Licensed VARIVAX™ and M-M-R II™ in Healthy Children

Merck Sharp & Dohme LLC0 个研究点目标入组 480 人开始时间: 1998年3月最近更新: 2015年10月6日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 480
主要终点: Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline

研究概览研究设计入排标准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

This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant administration of Varivax and M-M-R II vaccines in healthy children.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 12 Months 至 23 Months（Child）
性别: All
接受健康志愿者: 是

入选标准

•In good health
•Negative clinical history of varicella, shingles, measles, mumps, and rubella

排除标准

•Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination
•Any immune impairment or deficiency
•Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
•Vaccination with an inactive vaccine with in the past 14 days
•Vaccination with a live vaccine within the past 30 days
•Immune globulin or any blood product administered in the past 3 months

结局指标

主要结局

Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline

时间窗: 6 weeks Postvaccination

Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of \<0.6 gpELISA units/mL) to Varicella at Baseline

次要结局

Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline(6 weeks Postvaccination)
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL(6 weeks Postvaccination)
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL(6 weeks Postvaccination)
Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL(6 weeks Postvaccination)

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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