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

Sponsor
Stephan Baldus
Study ID
NCT07721649
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intrahospital seasonal influenza vaccination offer — BIOLOGICAL
    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.
  • Standardized active influenza vaccination counseling — BEHAVIORAL
    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.
  • Standard of care discharge recommendation for ambulatory vaccination — BEHAVIORAL
    Current standard of care in Germany: the recommendation to obtain ambulatory influenza vaccination from the primary care physician, stated in the discharge papers.

Study Details

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).

Key Dates

First listed
Jul 23, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
482 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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.

Primary Outcome Measure

Influenza vaccination rate at the end of the index influenza season [ Time Frame: From randomization to the end of the index influenza season (March 31), up to approximately 7 months ]

Central Contacts

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