Post-licensure Safety Surveillance Study of Routine Use of Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Recipients 2 to 10 Years of Age.

Sanofi Pasteur, a Sanofi Company0 个研究点目标入组 1,421 人开始时间: 2005年7月最近更新: 2015年2月12日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Sanofi Pasteur, a Sanofi Company
入组人数: 1,421
主要终点: Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.

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

To further characterize the safety profile of Menactra vaccine and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.

研究设计

研究类型: Observational
观察模型: Cohort

入排标准

性别: All
接受健康志愿者: 是

入选标准

•Receipt of Menactra vaccine during the study period.

排除标准

未提供

结局指标

主要结局

Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.

时间窗: Day 31 up to Day 180 post-vaccination

Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison window. Clinical setting is given in parenthesis as (H) for hospital.

次要结局

未报告次要终点

研究者

发起方

Sanofi Pasteur, a Sanofi Company

申办方类型

Industry

责任方

Sponsor

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