PCV13 Effectiveness Study Against Hospitalised VT Pneumococcal CAP in Adults 60 Years and Older

Pfizer

Status: Completed

Conditions: Community Acquired Pneumonia (CAP)

Treatments: Diagnostic Test: Urine sample collection; Diagnostic Test: Saliva collection

Study type: Observational

Funder types: Industry

Identifiers

NCT04613375

CIBELES

B1851202

Details and patient eligibility

About

Low interventional, prospective, multicentre, hospital-based study involving adults 60 years of age and older hospitalised with CAP at participating sites.

Full description

PCV13 efficacy for the prevention of vaccine-type community-acquired pneumonia (VT-CAP) and invasive pneumococcal disease (IPD) was established in the Community-acquired Pneumonia Immunization Trial in Adults (CAPITA) aged 65 and older. However, there are still few available real-life effectiveness estimates in adults. The aim of this study is to evaluate the PCV13 vaccine effectiveness (VE) against hospitalised VT-pneumococcal CAP among adults aged ≥60 years in the Region of Madrid (Spain). Determination of the effectiveness of PCV13 to prevent hospitalised vaccine-type (VT)-pneumococcal CAP among adults aged ≥60 years in Madrid will be evaluated using a test-negative design study, overall and among immunocompetent persons only.

Enrollment: 1,821 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥60 years.
2. Evidence of pneumonia within first 48 hours of hospital admission
3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion criteria

1. Any patient who develops signs and symptoms of pneumonia after being hospitalized for ≥48 hours (either at current hospital, another transferring hospital, or a combination of these).
2. Previously enrolled subjects readmitted ≤14 days after discharge for their study qualifying admission.
3. At the time of enrollment, pneumonia has been excluded as the diagnosis or another diagnosis confirmed.

Trial design

1,821 participants in 1 patient group

All participants

Treatment:

Diagnostic Test: Saliva collection

Diagnostic Test: Urine sample collection