NCT01997450

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 4,121 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza Vaccine Effectiveness

Timeline

• Start date: 2013-12-02
• Primary completion: 2016-04-15
• Completion: 2016-04-15
• First posted: 2013-11-28
• Last updated: 2025-03-10

Locations

12 sites across 2 countries: United States, United Kingdom