临床试验/NCT00127010

NCT00127010已完成3 期

Blinded, Randomized Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Measles-mumps-rubella-varicella Candidate Vaccine Given to Healthy Children During the Second Year of Life

GlaxoSmithKline49 个研究点分布在 3 个国家开始时间: 2005年11月最近更新: 2016年9月26日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: GlaxoSmithKline
试验地点: 49
主要终点: Antibody levels after vaccination

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy children in their second year of life.

详细描述

This study included an active control group who received the licensed Priorix (measles, mumps, rubella [MMR] vaccine).

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: None

入排标准

年龄范围: 11 Months 至 13 Months（Child）
性别: All
接受健康志愿者: 是

入选标准

•A male or female subject between 11-13 months of age (i.e. from 11 month birthday until the day before the 14 month birthday) at the time of the first vaccination.

排除标准

•History of previous measles, mumps, rubella and/or varicella vaccination or disease, or known exposure to any of these diseases within 30 days prior to the start of the trial
•Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination

结局指标

主要结局

Antibody levels after vaccination

次要结局

Safety of the study vaccines

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

研究点 (49)

Loading locations...

相似试验

已完成

3 期

Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox DiseasesMeaslesMumpsRubellaVaricella

NCT00127023GlaxoSmithKline944

已完成

4 期

Immunogenicity and Safety of Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox DiseasesMeaslesMumpsRubellaVaricella

NCT00126997GlaxoSmithKline1,439

已完成

3 期

Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)Influenza

NCT01204671GlaxoSmithKline4,659

已完成

3 期

Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy AdultsTetanusDiphtheriaPertussis

NCT01267058GlaxoSmithKline550

已完成

3 期

Evaluation of Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Years and OlderInfluenza

NCT00760617GlaxoSmithKline526