A Randomized Controlled Trial To Compare The Immunogenicity Of Self-Administered And Nurse-Administered Intradermal Influenza Vaccine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 4
- 主要终点
- Immunogenicity
研究概览
简要总结
The purpose of this study is to compare the immunogenicity and reactogenicity of self-administered intradermal influenza vaccine (Intanza)to nurse-administered.
详细描述
Participants will be randomized at visit one to either receive self-administered or nurse-administered intradermal influenza vaccine (Intanza). A blood sample will be taken prior to vaccination and 21 days post-vaccination. Participants will record information in a memory aid for 7 days including daily temperatures, solicited, unsolicited and general reactions. They will be called on study Day 8 to collect this information. Participants will return 21-24 days later for follow-up serology and review of adverse events.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically stable persons between age of 18-60
- •Available during the trial period and for follow-up
- •Able to read, understand, and sign informed consent
- •Able to be contacted by telephone for follow-up of adverse events
排除标准
- •Use of experimental vaccines within the month prior to study entry, or expected use of experimental or licensed vaccines or blood/blood products during the duration of the study.
- •Receipt of immunoglobulin or other blood product within 3 months prior to enrollment
- •Receipt of other licensed vaccines within the preceding 4 weeks
- •History of a severe reaction following influenza vaccination
- •Use of cytotoxic therapy or biologic modifiers in the previous 2 years.
- •Plans to receive cytotoxic therapy during the study period.
- •Concurrent acute moderate to severe illness. (Vaccination will be deferred until recovery. Subjects with mild illnesses with fever ≤37.8ºC orally may be enrolled).
- •History of medical disorder associated with immunosuppression (eg. including HIV-infected individuals, transplant recipients)
- •History of chronic lung, cardiac, renal or liver disease, which has required hospitalization in the last year.
- •Receipt of any high-dose daily systemic corticosteroids (inhaled steroids are acceptable) within two weeks of study entry. High dose is defined as a dose of 20 mg of prednisone daily or its equivalent. Topical steroids are allowed.
- •Failure to give written, informed consent
- •History of febrile illness (>37.8ºC orally) within the past 72 hours (immunization may be deferred).
- •Known allergy to eggs or other components of vaccine (i.e., thimerosal)
- •History of Guillain-Barré Syndrome (GBS)
研究组 & 干预措施
Intanza - self-administered
Self-administered intradermal influenza vaccine
干预措施: Intanza (Biological)
Intanza - nurse-administered
Nurse-administered intradermal influenza vaccine
干预措施: Intanza (Biological)
结局指标
主要结局
Immunogenicity
时间窗: 21 days post-vaccination
That the immunogenicity of self-administered intradermal 2010/11 seasonal influenza vaccine (Intanza) is non-inferior to that of nurse administered intradermal 2010/11 seasonal influenza vaccine. Specifically, that ratio of increase in geometric mean titres between day 0 and day 21 post-vaccination are greater than 2/3 (i.e. GMT (IDS)/GMT (IDN) \> 0.65).
次要结局
- Reactogenicity(7 days post-vaccination)
- Observational(at vaccination)