Do Some Healthy Adults Consistently Have Systemic Reactions to Trivalent Inactivated Split Virus Influenza Vaccines?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Systemic adverse event
研究概览
简要总结
This study will recruit 35 healthcare workers who had systemic reactions to influenza vaccine the last 2 times they were vaccinated, to ask whether influenza vaccine is indeed associated with systemic reactions in these workers.
详细描述
Randomized controlled trials of split virus vaccines in healthy adults have not been able to detect an increase in systemic adverse events compared to control vaccination. These trials do identify a non-trivial risk of systemic symptoms occurring in the week after both placebo and vaccine. There is a small population of healthcare workers who report consistent systemic symptoms after split virus vaccination which may occur because a small group of healthy adults have true physical reactions to components of the vaccine or excipients. If this is true, then alternatives - such as the use of subunit vaccines or live attenuated nasal spray vaccines - might be expected to be better tolerated by these people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Employed or volunteer in a healthcare facility or an ambulatory care setting providing healthcare
- •By self report, have had 2 or more doses of trivalent inactivated influenza vaccine (TIIV) in the last 15 years, and after at least the last 2 vaccine doses have had the same systemic adverse event in the 7 days after vaccination, including: fever, chills, myalgia, arthralgia, fatigue, headache, or insomnia;
- •Consent to the study, including two injections one month apart, with one being placebo and one a dose of TIIV;
排除标准
- •Has a contraindication to TIIV (previous allergic reaction to a dose of vaccine, or Guillain Barre syndrome with onset within 6 weeks of vaccination);
- •Has previously received a dose of TIIV for the current influenza season.
- •Receipt of another vaccine, or initiation of new medication within 7 days of the study injection (participant may enter the study as long as the gap between other vaccine/initiation of new medication is >7 days);
- •Moderate or severe acute illness or active infection or fever (temperature ≥37.8oC) on the day a dose of study medication due (participant may receive injection 48 hours after symptoms have resolved and body temperature has returned to normal without the use of antipyretics.
结局指标
主要结局
Systemic adverse event
时间窗: 7 days after each injection
Any systemic adverse event, self-reported
次要结局
未报告次要终点