N/A
Completed N=1,821
PCV13 Effectiveness Study Against Hospitalised VT Pneumococcal CAP in Adults 60 Years and Older
Community Acquired Pneumonia (CAP)
Source: ClinicalTrials.gov NCT04613375 ↗
Enrolled (actual)
1,821
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP: Overall — 105; 1407 Participants — p=0.3685
Summary
Low interventional, prospective, multicentre, hospital-based study involving adults 60 years of age and older hospitalised with CAP at participating sites.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP: Overall |
105; 1407 | 0.3685 |
| SECONDARY Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP By Time Since Vaccination: Overall |
66; 910; 89; 1116; 66; 833 | 0.0817 |
| SECONDARY Percentage of CAP Participants Categorized Per Pneumococcal Serotypes Identified |
6.9; 13.2 | — |
| SECONDARY Percentage of CAP Participants in Whom Pneumococcus Identified From Saliva by Culture or Polymerase Chain Reaction (PCR) |
11.6 | — |
| SECONDARY Percentage of CAP Participants With Underlying At-risk Medical Conditions |
55.2 | — |
| SECONDARY Percentage of CAP Participants With Underlying at High-Risk Medical Conditions |
35.6 | — |
| SECONDARY Percentage of Streptococcus Pneumoniae (SP) Isolates With Antibiotic Resistance |
9.1; 9.1; 3.0; 12.1; 12.1; 3.0 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥60 years.
- Evidence of pneumonia within first 48 hours of hospital admission
- 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
- 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).
- Previously enrolled subjects readmitted ≤14 days after discharge for their study qualifying admission.
- At the time of enrollment, pneumonia has been excluded as the diagnosis or another diagnosis confirmed.
Data sourced from ClinicalTrials.gov (NCT04613375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.