CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12,551 enrolled
Drug / intervention
Standard-Dose Quadrivalent Influenza Vaccine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05048589
NCT05048589Phase 2Completed

Feasibility of Randomizing Danish Citizens Aged 65-79 Years to High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in a Pragmatic Registry-Based Setting

Tor Biering-Sørensen·interventional·Posted Sep 17, 2021·Updated Aug 23, 2022

In Brief

A Phase 2 clinical trial evaluating Standard-Dose Quadrivalent Influenza Vaccine and High-Dose Quadrivalent Influenza Vaccine for Influenza. Completed, enrolled 12,551 participants across 2 sites.

Detailed Summary

The purpose of the study is to assess the feasibility of identifying, recruiting and randomizing a large sample of Danish citizens aged 65-79 years to high-dose quadrivalent influenza vaccine or standard-dose quadrivalent influenza vaccine in the 2021/2022 influenza season in a registry-based setting using Danish nationwide registries for all data collection including baseline information and outcome assessment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesDenmark

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedSep 17, 2021
Enrollment StartOct 1, 2021
Primary CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 4.8 years ago

Interventions

Standard-Dose Quadrivalent Influenza Vaccinedrug

For the control arm, the standard-dose quadrivalent influenza vaccines Influvactetra® and Vaxigriptetra will be used.

High-Dose Quadrivalent Influenza Vaccinedrug

For the control arm, the high-dose quadrivalent influenza vaccine Efluelda®/Fluzone® High-Dose Quadrivalent will be used.