A Phase IV, Single Centre, Open-label Study to Investigate the Kinetics of the B Cell Response to the First and the Third Immunization With Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Infants at 2, 3 and 4 Months of Age

Novartis2 个研究点分布在 1 个国家目标入组 75 人开始时间: 2005年5月1日最近更新: 2014年9月19日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Novartis
入组人数: 75
试验地点: 2
主要终点: To establish at which day meningococcal C specific B cells are detectable in the blood of healthy infants following first and third immunisation with MenC Conjugate Vaccine as determined by Men C specific B-cell ELISPot assay.

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

Kinetics of B cell response in infants Menjugate vaccination

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: 8 Weeks 至 11 Weeks（Child）
性别: All
接受健康志愿者: 是

入选标准

•healthy infants

排除标准

•previously ascertained or suspected disease caused by N. meningitidis
•previous household contact with an individual with a positive culture of N. meningitidis serogroup C

结局指标

主要结局

To establish at which day meningococcal C specific B cells are detectable in the blood of healthy infants following first and third immunisation with MenC Conjugate Vaccine as determined by Men C specific B-cell ELISPot assay.

次要结局

To note the difference between plasma cell response following the first and third MenC vaccination.
To determine the immune response to Neisseria meningitidis serogroup C 26-34 days after the third immunisation
To establish how long the B cells persist in the blood

研究者

发起方

Novartis

申办方类型

Industry

研究点 (2)

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