A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age

Study Overview
=================
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.

Official Title
-----------------
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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Q/LAIV<br>FluMist Quadrivalent | |
| Inactivated Influenza Vaccine<br>Inactivated Influenza Vaccine | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 6 months for each individual flu season | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Q/LAIV/FluMist® Quadrivalent Vaccine, Inactivated Influenza Vaccine (IIV), Effectiveness, Influenza