PCV13 Effectiveness Study Against Hospitalised VT Pneumococcal CAP in Adults 60 Years and Older
NCT04613375
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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.
4. Residence in districts of Fuenlabrada or Alcorcón in any setting (including residents living in community, nursing home, or other settings).
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.
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Descriptive Information | |||||
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Brief Title ICMJE | PCV13 Effectiveness Study Against Hospitalised VT Pneumococcal CAP in Adults 60 Years and Older | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | Multicenter, prospective, epidemiological, hospital-based surveillance study involving adults 60 years of age and older hospitalized with CAP in the participating hospital 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. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention | ||||
Condition ICMJE | Community Acquired Pneumonia (CAP) | ||||
Intervention ICMJE |
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Study Arms ICMJE | All participants
1 arm study Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE | 3600 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | November 27, 2024 | ||||
Estimated Primary Completion Date | November 27, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 60 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Spain | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04613375 | ||||
Other Study ID Numbers ICMJE | B1851202 CIBELES ( Other Identifier: Alias Study Number ) | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | November 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |