A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age
- Conditions
- Influenza Vaccine Effectiveness
- Registration Number
- NCT01997450
- Lead Sponsor
- MedImmune LLC
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4121
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identification of cases positive for wild-type influenza with an end-point PCR genotyping assay. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇬🇧Tooting, United Kingdom