临床试验/NCT00483574

NCT00483574已完成3 期

Safety Study of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) When Administered With Other Pediatric Vaccines to Healthy Toddlers

Sanofi Pasteur, a Sanofi Company80 个研究点分布在 1 个国家目标入组 1,378 人开始时间: 2007年5月最近更新: 2016年5月16日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Sanofi Pasteur, a Sanofi Company
入组人数: 1,378
试验地点: 80
主要终点: Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following 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 clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US.

Safety Objective:

To describe the safety profile of two doses of Menactra® Vaccine.

研究设计

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

入排标准

年龄范围: 9 Months 至 12 Months（Child）
性别: All
接受健康志愿者: 是

入选标准

未提供

排除标准

未提供

结局指标

主要结局

Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination.

时间窗: Day 0 to 7 Post-vaccination

Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability

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

研究点 (80)

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