Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-01-23 @ 5:05 AM
Study NCT ID:
NCT01997450
Status:
TERMINATED
Last Update Posted:
2025-03-10
First Post:
2013-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age
Sponsor:
MedImmune LLC
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
FDA did not require the fourth season of recruitment as planned originally. Study closed.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICICLE
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: