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

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506977-36-00

Acronym

GALFLU

Enrollment

114011

Registered

2023-09-13

Start date

2023-10-26

Completion date

Unknown

Last updated

2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of influenza infection in adults aged 65-79 years

Brief summary

The primary endpoint of the study is the occurrence of a hospitalization due to influenza or pneumonia [composite endpoint].

Detailed description

The secondary endpoints of the study are as follows: 1. Hospitalization for any cardio-respiratory disease [composite endpoint] 2. All-cause hospitalization 3. All-cause mortality 4. Hospitalization for influenza 5. Hospitalization for pneumonia

Interventions

DRUGInfluvac Tetra suspensión inyectable en jeringa precargada (vacuna antigripal inactivada de antígenos de superficie)

DRUGEfluelda

DRUGsuspensión inyectable en jeringa precargada Vacuna antigripal tetravalente (virus fraccionados

DRUGinactivados)

DRUG60 microgramos HA/cepa

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is the occurrence of a hospitalization due to influenza or pneumonia [composite endpoint].	—

Secondary

Measure	Time frame
The secondary endpoints of the study are as follows: 1. Hospitalization for any cardio-respiratory disease [composite endpoint] 2. All-cause hospitalization 3. All-cause mortality 4. Hospitalization for influenza 5. Hospitalization for pneumonia	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026