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

Stopped early

Conditions studied: Influenza Vaccine Effectiveness

In brief

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.

Key facts

Study ID

NCT01997450

Run by

MedImmune LLC

People needed

4121

Starts

2013-12-02

Expected to finish

2016-04-15

Last updated by the study team

2025-03-10

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Gainesville, Florida, United States
• Research Site — Bloomington, Minnesota, United States
• Research Site — Winston-Salem, North Carolina, United States
• 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
• Research Site — Southampton, United Kingdom
• Research Site — Tooting, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.