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The problem
Intervention: Single dose of V116 (21-valent pneumococcal conjugate vaccine) compared to PPSV23 in children aged 2 to <18 years with chronic conditions who had completed primary pneumococcal vaccination
Who it was tested with: 882 children and adolescents aged 2 to <18 years with diabetes mellitus, chronic heart disease, chronic lung disease, chronic kidney disease, and/or chronic liver disease who had previously completed a primary pneumococcal vaccination regimen.
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"This phase 3 study evaluated the safety and immunogenicity of V116, a 21-valent pneumococcal conjugate vaccine, compared to PPSV23 in children aged 2 to <18 y with certain medical conditions that increase risk of PD who had previously completed a primary pneumococcal vaccination regimen." The randomized design with two groups measured at a defined timepoint and comparison of immune response endpoints provides experimental-level evidence for vaccine immunogenicity in this population.
The study measures immune response markers but does not assess clinical protection against actual disease. Long-term durability of immunity and protection in real-world conditions are not evaluated.
Across countries and designs
12 studies · 20 countries
