HD vs SD Quadrivalent Influenza Vaccine in Adults Aged 65 to 79 Years in Galicia

Sponsor

Federico Martinón Torres (Other)

Overall Status

Recruiting

CT.gov ID

NCT06141655

Collaborator

(none)

114,011

Enrollment

Location

Arms

21.2

Anticipated Duration (Months)

5380.2

Patients Per Site Per Month

Study Details

Study Description

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 2023/2024 and 2024/2025 seasons.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Drug: Influenza vaccine	Phase 4

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 114.011 participants over 2 influenza seasons (2023/2024 and 2024/2025) with approximately 57,000 participants per season (pending any further potential sample size adjustments following interim analysis).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

114011 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Oct 26, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: QIV-HD vaccine EFLUELDA, Suspension for injection, one dose	Drug: Influenza vaccine Participants will be individually randomized 1:1 to receive either QIV-HD or QIV-SD, one dose, the day of the inclusion in the trial
Active Comparator: QIV-SD vaccine INFLUVAC TETRA, Suspension for injection, one dose	Drug: Influenza vaccine Participants will be individually randomized 1:1 to receive either QIV-HD or QIV-SD, one dose, the day of the inclusion in the trial

Arm

Intervention/Treatment

Experimental: QIV-HD vaccine

EFLUELDA, Suspension for injection, one dose

Drug: Influenza vaccine

Participants will be individually randomized 1:1 to receive either QIV-HD or QIV-SD, one dose, the day of the inclusion in the trial

Active Comparator: QIV-SD vaccine

INFLUVAC TETRA, Suspension for injection, one dose

Drug: Influenza vaccine

Participants will be individually randomized 1:1 to receive either QIV-HD or QIV-SD, one dose, the day of the inclusion in the trial

Outcome Measures

Primary Outcome Measures

Occurrence of a hospitalization due to influenza or pneumonia [≥14 days after vaccination and up to May 31 the following year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

1. Age 65-79 years residing in the community (only individuals who are not eligible to receive QIV-HD as part of the standard of care)
1. Informed consent form has been signed and dated

Exclusion Criteria:

There are no specific exclusion criteria for this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Public Health Directorate of Galician Health Service	Santiago de Compostela	A Coruña	Spain

Sponsors and Collaborators

Federico Martinón Torres

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Federico Martinón Torres, Principal investigator, Hospital Clinico Universitario de Santiago

ClinicalTrials.gov Identifier:

NCT06141655

Other Study ID Numbers:

GALFLU

First Posted:

Nov 21, 2023

Last Update Posted:

Nov 21, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Influenza, Human

Study Results

No Results Posted as of Nov 21, 2023