A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine 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.

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.