About this trial
AMBU-VAX is a prospective, single-center observational study designed to develop and implement an organizational model for delivering recommended vaccinations within a hospital setting.
The study targets adult and elderly patients with chronic diseases or immunocompromising conditions who are eligible for vaccination according to national immunization guidelines. Vaccination is actively proposed during outpatient visits, hospital admissions, or at discharge and, when accepted, administered within the hospital or coordinated with local public health vaccination services.
The study aims to evaluate the feasibility, uptake, and completion of hospital-based vaccination pathways and to support integration between hospital and territorial prevention services for vulnerable populations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged ≥18 years
Presence of at least one chronic or immunocompromising condition eligible for vaccination according to national guidelines
Written informed consent provided
Disqualifiers
Age <18 years
Conditions not included among the predefined eligibility criteria
Trial population
The study population includes adult patients (≥18 years) with chronic diseases or immunocompromising conditions who are eligible for recommended vaccinations according to the Italian National Immunization Plan 2023-2025. Patients are identified during outpatient visits, hospital admissions, or at discharge from the Fondazione Policlinico Universitario "A. Gemelli" IRCCS. The population includes both male and female patients and reflects a broad spectrum of chronic and immunocompromising conditions, including cancer, solid organ transplantation, hematopoietic stem cell transplantation, autoimmune diseases, chronic kidney disease, HIV infection, asplenia, and frailty.
Trial design
Cohort
Prospective
Treatments tested in this trial
Hospital-Based Vaccination Pathway
Biological/VaccineIntegration of vaccination counseling, prescription, and administration into hospital care pathways for vulnerable adult patients, including coordination with local public health vaccination services. No experimental vaccine is used; all vaccines are administered according to national guidelines.
Treatment groups
Trial outcomes
Primary outcomes
Vaccination Offer Rate
Proportion of patients evaluated by the vaccination service who are offered at least one recommended vaccination.
Vaccination Uptake Rate
Proportion of patients who receive at least one vaccination among those evaluated.
Number of Administered Vaccine Doses
Number of doses administered by vaccine type
Completion of Hospital-Based Vaccination Pathway
Proportion of patients completing all scheduled vaccine doses within the hospital setting.
Secondary outcomes
Reasons for Vaccine Refusal
Distribution of reported reasons for refusal among patients offered vaccination.
Referral to Territorial Vaccination Services
Proportion of patients referred to local public health vaccination services.
Specialist Evaluation for Contraindications
Proportion of patients with contraindications who complete specialist evaluation and receive clearance for vaccination.
Locations
Sponsors and contacts
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead sponsor
Pfizer
Collaborator
This trial is not recruiting at the moment. You can still explore other options: