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Intrahospital Vaccination and Active Counseling Versus Active Counseling Alone to Increase Seasonal Influenza immUnization in Patients at High Cardiovascular Risk in Germany: The Randomized Controlled VACC-UP Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Biological
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of this study is to evaluate the effect of offering intrahospital influenza vaccination as an adjunct to active counseling during the index hospitalization to adult patients hospitalized for acute coronary syndrome (ACS) or congestive heart failure (CHF), compared with active counseling alone, on influenza vaccination rates in patients at high cardiovascular risk. Patients are randomized 1:1 to either an offer of bedside intrahospital influenza vaccination according to the recommendations of the German Standing Vaccination Committee (STIKO) in addition to standardized active counseling (intervention group), or standardized active counseling plus the standard-of-care recommendation for ambulatory vaccination in the discharge papers (control group). The primary endpoint is the influenza vaccination rate at the end of the index season (March 31).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years or older

• Hospitalized due to acute coronary syndrome (ACS) or congestive heart failure (CHF) and fulfilling the criteria for influenza vaccination according to the recommendations of the German Standing Vaccination Committee (STIKO)

• Written informed consent

Locations
Other Locations
Germany
Clinic III for Internal Medicine, University Hospital of Cologne
RECRUITING
Cologne
Department of Cardiology, University Heart and Vascular Centre Hamburg
RECRUITING
Hamburg
Contact Information
Primary
Sebastian Heyne, Dr. med.
sebastian.heyne@uk-koeln.de
+49 221 478-82019
Backup
Stephan Baldus, Prof. Dr. med.
stephan.baldus@uk-koeln.de
+49 221 478-32511
Time Frame
Start Date: 2026-09-30
Estimated Completion Date: 2029-06
Participants
Target number of participants: 482
Treatments
Experimental: Intrahospital vaccination offer
Patients receive standardized active influenza vaccination counseling and are additionally offered bedside intrahospital vaccination against seasonal influenza according to the latest STIKO recommendations at any time prior to discharge during the index hospitalization.
Active_comparator: Active counseling alone (standard of care)
Patients receive standardized active influenza vaccination counseling and the current standard of care in Germany, i.e., the recommendation to obtain ambulatory influenza vaccination as stated in the discharge papers. No intrahospital influenza vaccination is administered during the index hospitalization.
Sponsors
Collaborators: Sanofi
Leads: Stephan Baldus

This content was sourced from clinicaltrials.gov