Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-04-16 @ 6:11 PM
Study NCT ID:
NCT02267733
Status:
COMPLETED
Last Update Posted:
2016-08-25
First Post:
2014-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing In Gammopathy Patients
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients (SHIVERING Trial)
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHIVERING
Brief Summary:
A Pilot Study utilizing high dose trivalent influenza vaccine dose in a booster dosing schedule for patients with monoclonal gammopathies stratified by disease status
Detailed Description:
In this study, we will administer Fluzone® High-Dose vaccine with a planned booster to patients with monoclonal gammopathies (stratified by requirement for therapy) irrespective of age. All patients will receive an initial vaccine followed by a booster vaccine 30 days (+/- 7 days) later and will then be followed for outcomes until the end of flu season.
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?: