Study identifier:MA-VA-MEDI3250-1116
ClinicalTrials.gov identifier:NCT01997450
EudraCT identifier:N/A
CTIS identifier:N/A
A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age
Influenza Vaccine Effectiveness
Phase 4
Yes
-
All
4121
Observational
2 Years - 17 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: Open Label
Primary Purpose: -
Verified 01 Feb 2025 by MedImmune, LLC
MedImmune, LLC
AstraZeneca
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.
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.
Location
Location
Marshfield, WI, United States, 54449
Location
Temple, TX, United States, 76508
Location
Winston-Salem, NC, United States, 27157
Location
Nashville, TN, United States, 37212
Location
Gainesville, FL, United States, 32608
Location
Portland, OR, United States, 97227
Location
Southampton, United Kingdom, SO16 6YD
Location
Bristol, United Kingdom, BS2 8AE
Arms | Assigned Interventions |
---|---|
Q/LAIV FluMist Quadrivalent | - |
Inactivated Influenza Vaccine Inactivated Influenza Vaccine | - |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.