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

NCT01997450

TerminatedN/A

Sponsor: MedImmune LLC

Conditions: Influenza Vaccine Effectiveness

Countries: United States, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 2 Years to 17 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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.
Locations (12)
  • Gainesville, Florida, United States
  • Bloomington, Minnesota, United States
  • Winston-Salem, North Carolina, United States
  • Akron, Ohio, United States
  • Portland, Oregon, United States
  • Nashville, Tennessee, United States
  • Temple, Texas, United States
  • Marshfield, Wisconsin, United States
  • Bristol, United Kingdom
  • Oxford, United Kingdom
  • Southampton, United Kingdom
  • Tooting, United Kingdom