A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4,121
- 试验地点
- 1
- 主要终点
- Identification of cases positive for wild-type influenza with an end-point PCR genotyping assay.
研究概览
简要总结
This is a post-marketing case-controlled study of the effectiveness of a quadrivalent live attenuated influenza vaccine (Q/LAIV/FluMist® Quadrivalent) versus Inactivated Influenza Vaccine (IIV) and No Vaccine in subjects 2-17 years of age.
详细描述
This post-marketing study will enroll approximately 5,200 subjects 2-17 years of age who are seeking care in an outpatient setting for febrile acute respiratory illness. This study will begin in the fall of 2013 and will be completed after 4 influenza seasons (i.e.after the 2016-2017 influenza season). No investigational product will be administered in this study. A nasal swab will be obtained and tested for the presence of influenza virus and other viral pathogens. This study will be conducted at 4 sites in the United States of America. The duration of study participation for each subject is one day.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community-dwelling children and adolescents 2 to 17 years of age.
- •Written Informed Consent or Assent.
- •Acute respiratory illness documented at study visit or at home with fever (oral temperature ≥ 100.0° Fahrenheit at study visit, or history of fever reported by parents, or use of antipyretic prior to study visit)
- •Symptom onset less than 5 days prior to study visit.
- •Subject and/or subject's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator.
排除标准
- •Treatment with an antiviral drug for influenza (oseltamivir or Tamiflu®, zanamivir or Relenza®) during the 14 days before enrollment
- •Any condition that, in the opinion of the investigator, would interfere with interpretation of subject safety or study results
- •Concurrent enrollment in another clinical study
- •Patient already enrolled during this influenza season
- •Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
结局指标
主要结局
Identification of cases positive for wild-type influenza with an end-point PCR genotyping assay.
时间窗: Up to 6 months for each individual flu season
Vaccine Effectiveness is defined as 100 x (1-odds ratio), where the odds ratio is the odds of exposures (Q/LAIV versus Inactivated Influenza Vaccine or no vaccine) among laboratory confirmed cases of flu versus controls. Effectiveness will be monitored by flu season, class of age and by influenza strain.
次要结局
未报告次要终点