A Time-Motion Study to Compare Self-vaccination With Intanza® Intradermal Influenza Vaccine to Nurse-administered Vaxigrip® Intramuscular Influenza Vaccine in Small Group Settings of Health Care Workers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 868
- 试验地点
- 3
- 主要终点
- Time to Administer Influenza Vaccine (in Seconds)
研究概览
简要总结
The investigators hypothesize that people working in an acute care hospital setting will be able to successfully self-administer the intradermal vaccine (Intanza) in less time than nurse-administration of the regular intramuscular influenza vaccine (Vaxigrip). The investigators also hypothesize that people administering the intradermal vaccine for the second time will take less time to successfully administer than people administering it for the first time.
详细描述
Vaccination of healthcare workers has been shown to reduce mortality and morbidity in the patients they care for, as well as reducing illness and absenteeism in the healthcare workers themselves, and healthcare worker vaccination programs have been shown to be cost-effective for hospitals because of the reduced absenteeism. Although influenza vaccination programs based on nurse-administered intramuscular vaccination are effective, easy access to vaccination for hospital staff remains a challenge, in part because of large numbers of staff working evening, night and weekend shifts. In addition, in the Canadian setting, increasing the efficiency of all hospital programs is a priority. If regular recipients of seasonal vaccine became accustomed to the practice, self-administration may significantly improve the efficiency of pandemic mass vaccination campaigns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically stable men or women 18 to 69 years of age (inclusive)
- •Work in any capacity (including physicians and midwives with admitting privileges), volunteer, or student at participating hospital
- •Able to read, understand, and respond to questionnaires
- •Able to read, understand, and sign an informed consent form
- •Available for follow-up for 8 days post-vaccination
- •Participants in Part B (repeat administration) of the study must also have participated in the previous randomized control trial of self- versus nurse-administered intradermal influenza vaccine and must have attempted to self-administer the vaccine
排除标准
- •Already received 2012-13 influenza vaccine
- •History of a severe reaction following influenza vaccination
- •Known allergy to components of study vaccines (Intanza® or Vaxigrip®)
- •History of Guillain-Barré Syndrome (GBS) within 8 weeks following influenza vaccination
- •Acute febrile illness (>37.9ºC orally) within the past 48 hours (participation may be deferred until recovery for these subjects)
结局指标
主要结局
Time to Administer Influenza Vaccine (in Seconds)
时间窗: Vaccination (Day 0)
Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination
次要结局
- Pain at Injection Site(Follow up (Day 8)
- Acceptability of Vaccine(Follow up (Day 8))
- Success Rate(Vaccination (Day 0))
- Local & Systemic Reactogenicity(Follow up (Day 8))
研究者
Brenda Coleman
Clinical Scientist
Mount Sinai Hospital, Canada