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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

134476 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-26

Study Completion Date

2025-05-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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QIV-HD vaccine

EFLUELDA, Suspension for injection, one dose

Group Type EXPERIMENTAL

Influenza vaccine

Intervention Type DRUG

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-SD vaccine

INFLUVAC TETRA, Suspension for injection, one dose

Group Type ACTIVE_COMPARATOR

Influenza vaccine

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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)
* 2\. Informed consent form has been signed and dated

Minimum Eligible Age

65 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes