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NCT Number: NCT07721649

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

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).

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Key information

Conditions

Acute Coronary Syndrome Behavior Cardiovascular Diseases Health Behavior Heart Diseases Heart Failure Infections Influenza, Human Myocardial Ischemia Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Treatment Adherence and Compliance Treatment Refusal Vaccination Hesitancy Vaccination Refusal Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic III for Internal Medicine, University Hospital of Cologne, Cologne, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Seasonal influenza vaccine (high-dose or standard-dose according to STIKO recommendations)

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.

Primary outcomes

  1. 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

    Proportion of patients vaccinated against seasonal influenza at the end of the index season (defined as March 31). For intervention group patients vaccinated during the index hospitalization, vaccination status is documented from inpatient medical records. For control group patients and intervention group patients who declined intrahospital vaccination, self-reported vaccination status is assessed by telephone interview beginning April 1 and cross-validated with data from the treating general practitioner.

Secondary outcomes

  1. Influenza vaccination rate at the end of the post-index influenza season

    Time frame: From randomization to the end of the post-index influenza season (March 31 of the following year), up to approximately 19 months

    Proportion of patients vaccinated against seasonal influenza at the end of the post-index season. For all patients, self-reported vaccination status is assessed by telephone interview beginning April 1 of the post-index season and cross-validated with data from the treating general practitioner.

  2. Association of the individual components of the 7C psychological antecedents of vaccination questionnaire with vaccination status

    Time frame: Baseline (prior to counseling and randomization) and end of the index influenza season (March 31), up to approximately 7 months

    Association of the individual components of the 7C psychological antecedents of vaccination questionnaire (7-point scale, long version), assessed at baseline prior to active counseling, with vaccination status at the end of the index season. Assessed using univariate and multivariable regression models reporting odds ratios with 95% confidence intervals.

  3. Patient satisfaction with the offer of intrahospital influenza vaccination

    Time frame: During the index hospitalization, up to approximately 14 days

    Descriptive assessment of patient satisfaction with the intrahospital vaccination offer, based on a study-specific patient satisfaction questionnaire completed by patients in the intervention group.

Study contacts

Contact information is provided by the study sponsor or research team.

Sebastian Heyne, Dr. med.

CONTACT

[email protected]

+49 221 478-82019

Stephan Baldus, Prof. Dr. med.

CONTACT

[email protected]

+49 221 478-32511

Sponsors and collaborators

Lead sponsor

Stephan Baldus

Other

Collaborators

  • Sanofi

Registry information

Official study 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

Acronym: VACC-UP

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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