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临床试验/NCT01716130
NCT01716130已完成不适用

Acceptability of Fluzone Intradermal Vaccine to Patients and Vaccine Administrators

Touro University, California1 个研究点 分布在 1 个国家目标入组 249 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
249
试验地点
1
主要终点
Overall patient satisfaction with intradermal vaccine

研究概览

简要总结

To assess the acceptance of the Fluzone Intradermal (ID)vaccine in adults and vaccine administrators in the United States. Patients completed 2 surveys, one immediately post-vaccination and one seven days later, that documented demographics and assessed their injection pain, injection anxiety, speed of injection, overall satisfaction, and preference for next year's vaccine. Vaccine administrators completed one survey assessing ease of vaccine preparation and administration, time required to administer, and safety/risk of needle stick injury for patient and administrator.

详细描述

Patients were divided into two groups: 1) those that reported receiving the intramuscular (IM) influenza vaccine in the past 3 years; and 2) those that reported not receiving the IM influenza vaccine in the past 3 years. The survey responses were compared between the two groups. In addition, the subjects that reported receiving the IM vaccine in the past 3 years were asked to compare their experience with the IM vaccine versus the ID vaccine.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 18 -64 years of age Desire to receive the Fluzone Intradermal vaccine to protect against influenza. -

排除标准

  • •Less than 18 years of age, or 65 years of age and older. Desire to receive the Fluzone Intramuscular vaccine to protect against influenza.
  • •problems of the immune system, current illness, severe allergy to eggs, severe (life threatening) allergies, history of having Guillain-Barre Syndrome (a severe paralytic illness) or having received a flu vaccine in the past three months.

结局指标

主要结局

Overall patient satisfaction with intradermal vaccine

时间窗: 7 days

Overall patient satisfaction was assessed immediately post-vaccination and seven days later by patient survey.

次要结局

  • Overall satisfaction with the Fluzone ID vaccine by vaccine administrators(seven days)

研究者

发起方
Touro University, California
申办方类型
Other
责任方
Principal Investigator
主要研究者

James E. Foy, D.O.

Professor of Pediatrics, Touro University College of Osteopathic Medicine

Touro University, California

研究点 (1)

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