NCT06141655

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134,476

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

October 26, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

August 8, 2025

Status Verified

November 1, 2023

Enrollment Period

1.6 years

First QC Date

October 26, 2023

Last Update Submit

August 4, 2025

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

  • Occurrence of a hospitalization due to influenza or pneumonia

    ≥14 days after vaccination and up to May 31 the following year

Secondary Outcomes (5)

  • Hospitalization for any cardio-respiratory disease [composite endpoint]

    ≥14 days after vaccination and up to May 31 the following year

  • All-cause hospitalization

    ≥14 days after vaccination and up to May 31 the following year

  • All-cause mortality

    ≥14 days after vaccination and up to May 31 the following year

  • Hospitalization for influenza

    ≥14 days after vaccination and up to May 31 the following year

  • Hospitalization for pneumonia

    ≥14 days after vaccination and up to May 31 the following year

Study Arms (2)

QIV-HD vaccine

EXPERIMENTAL

EFLUELDA, Suspension for injection, one dose

Drug: Influenza vaccine

QIV-SD vaccine

ACTIVE COMPARATOR

INFLUVAC TETRA, Suspension for injection, one dose

Drug: Influenza vaccine

Interventions

Influenza vaccineDRUG

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

QIV-HD vaccineQIV-SD vaccine

Eligibility Criteria

Age65 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • \. 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)
  • \. Informed consent form has been signed and dated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Public Health Directorate of Galician Health Service

Santiago de Compostela, A Coruña, Spain

Location

Related Publications (1)

  • Pardo-Seco J, Rodriguez-Tenreiro-Sanchez C, Gine-Vazquez I, Mallah N, Miras-Carballal S, Pineiro-Sotelo M, Cribeiro-Gonzalez M, Conde-Pajaro M, Gonzalez-Perez JM, Rivero-Calle I, Bello X, Razzini JL, Dacosta-Urbieta A, Salas A, Harris RC, Loiacono MM, van Aalst R, Farre JM, Dufournet M, Johansen ND, Modin D, Biering-Sorensen T, Duran-Parrondo C, Martinon-Torres F; GALFLU Trial Team. High-Dose Influenza Vaccine to Reduce Hospitalizations. N Engl J Med. 2025 Dec 11;393(23):2303-2312. doi: 10.1056/NEJMoa2509834. Epub 2025 Aug 30.

    PMID: 40888694DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 26, 2023

First Posted

November 21, 2023

Study Start

October 26, 2023

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

August 8, 2025

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)