Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506812
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Pooled Analysis of Methodologically Harmonized Pragmatic Randomized Trials of High-Dose vs Standard-Dose Influenza Vaccine Against Severe Clinical Outcomes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pooled Analysis of Methodologically Harmonized Pragmatic Randomized Trials of High-Dose vs Standard-Dose Influenza Vaccine Against Severe Clinical Outcomes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prespecified analysis will pool the datasets from two pragmatic randomized trials evaluating the relative vaccine effectiveness of high-dose vs standard-dose influenza vaccine against severe clinical outcomes the DANFLU-2 A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs Standard-Dose Quadrivalent Influenza Vaccine in Older Adults trial and the GALFLU Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs Standard-Dose Quadrivalent Influenza Vaccine in Adults Aged 65 to 79 Years in Galicia Spain trial The purpose of the pooled analysis is to ensure adequate statistical power for evaluating relative vaccine effectiveness against severe clinical outcomes and to increase generalizability of the results by combining data from two countries
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None