Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06141655
Status:
RECRUITING
Last Update Posted:
2023-11-21
First Post:
2023-10-26
Brief Title:
HD vs SD Quadrivalent Influenza Vaccine in Adults Aged 65 to 79 Years in Galicia
Sponsor:
Federico Martinón Torres
Organization:
Hospital Clinico Universitario de Santiago
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2023-11
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:
None
Brief Summary:
This pragmatic randomized trial is designed to evaluate the relative vaccine effectiveness of QIV-HD vs QIV-SD in reducing the risk of hospitalization for influenza or pneumonia in adults 65-79 years of age in Galicia during 20232024 and 20242025 seasons
Detailed Description:
The study is a pragmatic registry-based open-label active-controlled individually randomized trial using the infrastructure of the Regional Vaccination Program of Galicia for patient recruitment inclusion randomization and vaccine administration and the Galician health registries for data collection including baseline information follow-up data and safety monitoring Participants will have the opportunity of receiving all the information for the trial prior to the vaccination appointment Informed consent will be obtained during the vaccination appointment by the study team prior to their vaccine administration The participation in the study is voluntary and only individuals who accept signing the informed consent will be recruited Participants may withdraw from the study at any point
The study aims to randomize at least 114011 participants over 2 influenza seasons 20232024 and 20242025 with approximately 57000 participants per season pending any further potential sample size adjustments following interim analysis
The study aims to randomize at least 114011 participants over 2 influenza seasons 20232024 and 20242025 with approximately 57000 participants per season pending any further potential sample size adjustments following interim analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None