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

Cases were participants with CAP with a valid urinary antigen detection (UAD) result in whom PCV13 serotypes were identified by any method. Controls were participants with CAP with a valid UAD result and without having PCV13 serotype. VE was calculated as 1 minus the odd ratio comparing the odds of having received PCV13 for cases and controls, multiplied by 100%. VE is reported as part of statistical data in this outcome measure.

Time frame: Approximately 30 months

Population: CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result.

Cases were participants with CAP with a valid UAD result in whom PCV13 serotypes were identified by any method. Controls were participants with CAP with a valid UAD result and without having PCV13 serotype. VE was calculated as 1 minus the odd ratio comparing the odds of having received PCV13 for cases and controls, multiplied by 100%. Data is presented in this outcome by time since vaccination. VE is reported as part of statistical data in this outcome measure.

Time frame: Approximately 30 months

Population: CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result. Here, Number Analyzed signifies participants who were evaluable for each category.

Percentage of CAP participants in whom streptococcus pneumoniae was identified for PCV13 and 20-valent pneumococcal conjugate vaccine (PCV20) serotypes is reported.

Time frame: Approximately 30 months

Population: CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result.

Respiratory pneumococcal carriage was determined by testing saliva specimens using both conventional culture and the sensitive molecular method of PCR for the detection of two target genes (lytA and piaB).

Time frame: Approximately 30 months

Population: CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result. Here, Number of Participants Analyzed signifies participants who had a valid saliva specimen test result.

High-risk medical conditions included: asplenia, cancer/malignancy (hematologic), cancer/malignancy (solid tumor), chronic kidney disease, human immunodeficiency virus (HIV) - acquired immunodeficiency syndrome (AIDS), HIV - No AIDS, immunodeficiency, immunosuppressant drug therapy, multiple myeloma, organ transplantation.

Time frame: Approximately 30 months

Population: CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result.

At-risk medical conditions included: alcoholism, asthma, celiac disease, chronic liver disease with hepatic failure, chronic liver disease without hepatic failure, chronic neurologic diseases, chronic obstructive pulmonary disease, coagulation factor replacement therapy, cochlear implant, congestive heart failure, coronary artery disease, cerebrospinal fluid leak, diabetes treated with medication, down syndrome, living in a nursing home, living in a long-term care facility, occupational risk with exposure to metal fumes, other chronic heart disease, other chronic lung disease, other pneumococcal disease risk factors, previous invasive pneumococcal disease, tobacco smoking (tobacco/e-cigarettes).

Time frame: Approximately 30 months

Population: CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result.

Percentage of SP isolates with antibiotic resistance to penicillin, amoxicillin, cefotaxime, erythromycin, tetracycline, levofloxacin were reported in this outcome measure.

Time frame: Approximately 30 months

Population: CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result. Here, Number of Participants Analyzed = participants in CAP UAD population from whom valid SP isolates were obtained; Number of SP isolates analyzed = number of SP isolates with antimicrobial susceptibility tests performed. Only isolates with antimicrobial susceptibility tests performed were included in analysis.

Cases were participants with CAP with a valid UAD result in whom PCV13 serotypes were identified by any method. Controls were participants with CAP with a valid UAD result and without having PCV13 serotype. VE was calculated as 1 minus the odd ratio comparing the odds of having received PCV13 for cases and controls, multiplied by 100%. Data is presented in this outcome by time since vaccination. VE is reported as part of statistical data in this outcome measure.

Time frame: Approximately 13.5 months

Population: CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result. Here, Number of Participants Analyzed signifies participants in CAP UAD population for post-pandemic period and Number Analyzed signifies participants who were evaluable for each category.

Cases were participants with CAP with a valid UAD result in whom PCV13 serotypes were identified by any method. Controls were participants with CAP with a valid UAD result and without having PCV13 serotype. VE was calculated as 1 minus the odd ratio comparing the odds of having received PCV13 for cases and controls, multiplied by 100%. VE is reported as part of statistical data in this outcome measure.

Time frame: Approximately 13.5 months

Population: CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result. Here, Number of Participants Analyzed signifies participants in CAP UAD population for post-pandemic period.