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.
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.
Study Type
OBSERVATIONAL
Enrollment
4,121
Research Site
Gainesville, Florida, United States
Research Site
Bloomington, Minnesota, United States
Research Site
Winston-Salem, North Carolina, United States
Identification of cases positive for wild-type influenza with an end-point PCR genotyping assay.
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.
Time frame: Up to 6 months for each individual flu season
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Research Site
Akron, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Nashville, Tennessee, United States
Research Site
Temple, Texas, United States
Research Site
Marshfield, Wisconsin, United States
Research Site
Bristol, United Kingdom
Research Site
Oxford, United Kingdom
...and 2 more locations