Preference for Fluzone Vaccine Administered Intradermally Versus Intramuscularly in Healthy Adult Subjects 18-49 Years of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
研究概览
简要总结
To describe any degree of preference for the route of administration of Fluzone influenza vaccine, ID versus IM, in healthy adult subjects 18-49 years of age.
To collect safety data, injection site reactions, and systemic reactions, through Day 7 post-vaccination; SAEs through day 28 post-vaccination
详细描述
The purpose of this clinical trial is to determine, in a relatively small sample of persons 18-49 years of age, if there is a preference trend for a particular route of administration, ID vs IM, when receiving a seasonal influenza vaccine. Uptake of influenza vaccine is disappointingly low in this age group, and there is the perception that aversion to IM injection plays a role in vaccination avoidance. The BD Micro-Injection System to be used in this study may offer a more acceptable alternative to the standard IM injection for influenza immunization and thereby promote wider acceptance of influenza vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subject (can have underlying medical condition, as long as they are stable), greater than or equal to 18 to < 50 years of age on the day of inclusion.
- •Informed consent form signed.
- •Able to attend both scheduled visits and to comply with all trial procedures.
- •For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination.
排除标准
- •Subject currently breast-feeding.
- •Participation in another investigational clinical trial in the 4 weeks preceding and during the trial period.
- •Hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing any of the same substances.
- •Thrombocytopenia or bleeding disorder contraindicating IM vaccination.
- •Any other condition which in the opinion of the Investigator would pose a health risk to the subject or interfere with the evaluation of the vaccine.
- •Personal history of Guillain-Barre syndrome.
- •Current use of alcohol or recreational drugs that in the opinion of the Investigator might interfere with the subject's ability to comply with trial procedures.
- •Febrile illness (oral temperature greater than or equal to 99.5 degrees F) on day of inclusion (temporary deferral).
- •Influenza vaccination received this season (2007-2008).
结局指标
主要结局
Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
时间窗: Day 0 and up to 7 days post-vaccination
Pain or other discomfort was assessed on a scale of 0 to 10 (None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; Unbearable = 9, 10) according to route of administration: intradermal (ID) as Group 1 and intramuscular (IM) as Group 2. Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population.
Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
时间窗: Days 0, 3, and 7 after vaccination
Numerical scores were assigned to pain by participants on the preference questionnaire as: None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; or Unbearable = 9, 10. Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population.
次要结局
未报告次要终点