Intrahospital Influenza Vaccination in Patients at High Cardiovascular Risk (VACC-UP)

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).

Conditions

• Acute Coronary Syndrome
• Heart Failure
• Influenza, Human
• Cardiovascular Diseases
• Vaccination Refusal

Interventions

BIOLOGICAL

Intrahospital seasonal influenza vaccination offer

Offer of bedside vaccination against seasonal influenza during the index hospitalization, administered in a standardized manner by trained treating physicians according to the latest STIKO recommendations and the respective product information. The appropriate vaccine is selected according to current recommendations (e.g., high-dose quadrivalent vaccine for patients aged 60 years and older, standard-dose quadrivalent vaccine otherwise). Vaccination is offered from September 1 to February 28 of the respective influenza season.

BEHAVIORAL

Standardized active influenza vaccination counseling

Standardized active counseling on influenza vaccination using a cardiovascular gain-framed information sheet, including the recommendation to be vaccinated and the opportunity to discuss vaccination with the treating physician. Counseling is provided to all patients in both arms after completion of the baseline 7C questionnaire and prior to randomization.

BEHAVIORAL

Standard of care discharge recommendation for ambulatory vaccination

Current standard of care in Germany: the recommendation to obtain ambulatory influenza vaccination from the primary care physician, stated in the discharge papers.

Sponsors & Collaborators

• Sanofi

  collaborator INDUSTRY

• Stephan Baldus

  lead OTHER

Principal Investigators

• Stephan Baldus, Prof. Dr. med. · Clinic III for Internal Medicine, University Hospital of Cologne

• Sebastian Heyne, Dr. med. · Clinic III for Internal Medicine, University Hospital of Cologne

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2028-03-31

Completion

2029-06-30

Countries

• Germany

Study Locations