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

Last updated: June 9, 2025
Sponsor: Pfizer
Overall Status: Completed

Phase

N/A

Condition

Pneumonia

Treatment

Urine sample collection

Saliva collection

Clinical Study ID

NCT04613375
B1851202
CIBELES
  • Ages > 60
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 thatthe patient (or a legally acceptable representative) has been informed of allpertinent aspects of the study.

Exclusion

Exclusion Criteria:

  1. Any patient who develops signs and symptoms of pneumonia after being hospitalizedfor ≥48 hours (either at current hospital, another transferring hospital, or acombination of these).

  2. Previously enrolled subjects readmitted ≤14 days after discharge for their studyqualifying admission.

  3. At the time of enrollment, pneumonia has been excluded as the diagnosis or anotherdiagnosis confirmed.

Study Design

Total Participants: 1821
Treatment Group(s): 2
Primary Treatment: Urine sample collection
Phase:
Study Start date:
March 12, 2021
Estimated Completion Date:
March 24, 2024

Study 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.

Connect with a study center

  • Hospital Universitario Fundacion Alcorcon

    Alcorcon, Madrid 28922
    Spain

    Site Not Available

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, Madrid 28942
    Spain

    Site Not Available

  • Hospital Universitarios De Getafe

    Getafe, Madrid 28905
    Spain

    Site Not Available

  • Hospital Universitario Severo Ochoa

    Leganés, Madrid 28911
    Spain

    Site Not Available

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, 28922
    Spain

    Site Not Available

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid, 28922
    Spain

    Site Not Available

  • Hospital Universitario de Mostoles

    Mostoles, 28935
    Spain

    Site Not Available

  • Hospital Universitario de Móstoles / Servicio de Oncología Médica

    Mostoles, 28935
    Spain

    Site Not Available

  • Hospital Universitario Rey Juan carlos

    Móstoles, 28933
    Spain

    Site Not Available

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