Trials / Completed
CompletedNCT04613375
PCV13 Effectiveness Study Against Hospitalised VT Pneumococcal CAP in Adults 60 Years and Older
Low Intervention Study of the Effectiveness Of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) Against Vaccine Type Pneumococcal Hospitalised Community Acquired Pneumonia (CAP) in Adults 60 Years and Older Using A Test Negative Design Study in A Well-Defined Area of the South of Madrid Region
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,821 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
Low interventional, prospective, multicentre, hospital-based study involving adults 60 years of age and older hospitalised with CAP at participating sites.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Urine sample collection | Serotype specific UAD (urinary antigen detection) test |
| DIAGNOSTIC_TEST | Saliva collection | Streptococcus pneumonia identification in saliva samples by culture or PCR / RSV identification in saliva samples by PCR |
Timeline
- Start date
- 2021-03-12
- Primary completion
- 2023-10-25
- Completion
- 2024-03-24
- First posted
- 2020-11-03
- Last updated
- 2025-06-11
- Results posted
- 2025-01-27
Locations
5 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT04613375. Inclusion in this directory is not an endorsement.