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NCT07721649

Overview

NCT ID: NCT07721649
Lead Sponsor: Stephan BaldusOTHER
Official Title: 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
Brief 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).

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 23, 2026Actual
Start Date: Sep 2026Estimated
Primary Completion Date: Mar 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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

Exclusion Criteria:

Already received seasonal influenza vaccination in the current season, based on self-reported vaccination status and/or vaccination certificate

Laboratory-confirmed active influenza infection during the index hospitalization

Contraindication for vaccination (e.g., known allergy)

Inability to provide written informed consent

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 482Estimated
Primary Purpose: Health Services Research
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Sebastian Heyne, Dr. med.Contact
sebastian.heyne@uk-koeln.de+49 221 478-82019

Similar Studies

Participant Group/Arms

Intrahospital vaccination offerExperimental

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.

Biological: Intrahospital seasonal influenza vaccination offer

Behavioral: Standardized active influenza vaccination counseling

Active counseling alone (standard of care)Active Comparator

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.

Behavioral: Standardized active influenza vaccination counseling