A Test-Negative Case-Control Study to Evaluate the Effectiveness of V116, CAPVAXIVETM Against Pneumococcal Pneumonia in Older Adults

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

  Other
• Non-interventional study design, other:
  Data Collection Study

Study drug and medical condition

• Name of medicine, other:
  CAPVAXIVE™
• Anatomical Therapeutic Chemical (ATC) code:
  (J07AL02) pneumococcus, purified polysaccharides antigen conjugated

  pneumococcus, purified polysaccharides antigen conjugated
• Medical condition to be studied:
  Pneumonia pneumococcal

Population studied

• Short description of the study population:
  Participants who are 65 years or older with confirmed CAP by clinical signs and symptoms and radiography will be the source population for case and control identification.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  22000

Study design details

• Study design:
  This is a non-interventional study using primary and secondary data collection obtained from participants at site-based clinical primary data collection centers with real world data from electronic health records (EHR), claims and vaccine registries with CAP.
• Main study objective:
  To assess the effectiveness of CAPVAXIVE in preventing hospitalized, confirmed CAP (invasive and non-invasive) caused by S pneumoniae serotypes contained in CAPVAXIVE and/or cross-reactive serotypes 6C and 15B among participants who received no other pneumococcal vaccines than CAPVAXIVE in the previous 5 years.
• Setting:
  Adult participants, 65 years or older hospitalized with CAP included in site-based clinical primary data collection centers with real world data from electronic health records (EHR), claims and vaccine registries.
• Comparators:
  For the primary objective, the controls will be defined as confirmed CAP for whom CAPVAXIVE serotypes and cross-reactive serotypes 6C and 15B are not identified by any method. ; ; For the secondary objective, the controls will be defined as confirmed non-bacteremic CAP for whom CAPVAXIVE serotypes and cross-reactive serotypes 6C and 15B are not identified by any method. ; ; Controls are participants with confirmed CAP for whom CAPVAXIVE and cross-reactive serotypes 6C and 15B are not identified by any method.
• Outcomes:
  The primary outcome measure is to assess the effectiveness of CAPVAXIVE in preventing hospitalized, confirmed CAP (invasive and non-invasive) caused by S pneumoniae serotypes contained in CAPVAXIVE and/or cross-reactive serotypes 6C and 15B among participants who received no other pneumococcal vaccines than CAPVAXIVE in the previous 5 years. ; ; The Secondary outcome measure is to assess the effectiveness of CAPVAXIVE in preventing hospitalized, confirmed non-bacteremic pneumococcal pneumonia (NBPP) (confirmed CAP with absence of S pneumoniae in blood culture or culture from other sterile sites) caused by S pneumoniae serotypes contained in CAPVAXIVE and/or cross-reactive serotypes 6C and 15B among participants who received no other pneumococcal vaccines than CAPVAXIVE in the previous 5 years.
• Data analysis plan:
  The primary outcome measure will be calculated using logistic regression, odds ratios (OR) with 95% confidence interval (CI) will be estimated adjusting for potential confounders. The vaccine effectiveness (VE) will be expressed as a percentage and estimated as 1 minus the adjusted OR multiplied by 100. The OR will be the odds of vaccination with CAPVAXIVE among the cases (ie, confirmed CAP cases with any of the CAPVAXIVE serotypes and/or cross-reactive serotypes 6C and 15B) relative to the odds of vaccination with CAPVAXIVE among the test-negative controls (ie, confirmed CAP cases for whom CAPVAXIVE serotypes and cross-reactive serotypes 6C and 15B are not identified). ; ; The secondary outcome measure analysis will be conducted in the same manner as for the primary objective, but on NBPP participants meeting the inclusion and exclusion criteria for this objective (similar to those for the first objective, in particular with respect to vaccination history). VE against confirmed VT-NBPP will also be expressed in percent and estimated as 1 minus the OR multiplied by 100. Crude and adjusted ORs will be presented. The OR will be the odds of vaccination with CAPVAXIVE among the cases (ie, confirmed NBPP cases with any of the CAPVAXIVE serotypes and/or cross-reactive serotypes 6C and 15B) relative to the odds of vaccination with CAPVAXIVE among the test-negative controls (ie, confirmed non-bacteremic CAP cases for whom CAPVAXIVE serotypes and cross reactive serotypes 6C and 15B are not identified).;