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Prevnar 20 was studied in pneumococcal vaccine-naïve patients1 | |
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Study description | Phase 3 randomized, active-controlled, double-blind, noninferiority clinical trial |
Countries | United States and Sweden |
Age (years) | ≥18 |
Evaluated |
Safety and noninferior immunogenicity of Prevnar 20 (n=1157-1430) in pneumococcal vaccine-naïve adults as compared to:
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Risk factors | Healthy and immunocompetent adults with stable underlying conditions, including chronic cardiovascular disease, chronic pulmonary disease, renal disorders, diabetes, chronic liver disease, and medical risk conditions and behaviors (eg, smoking) that are known to increase the risk of serious pneumococcal pneumonia and IPD. |
Response measures | Immune responses elicited by Prevnar 20 and the control pneumococcal vaccines were measured by OPA assay. Serotype-specific OPA GMTs were measured before vaccination and 1 month after vaccination. Noninferiority of immune responses was evaluated for adults age 60 or older. Immunobridging in adults age 18-59: The effectiveness of Prevnar 20 in adults age 50-59 and in adults age 18-49 was inferred following comparison of the immune response to each of the 20 vaccine serotypes in each of these age groups to the corresponding serotype-specific immune responses in adults age 60-64 following Prevnar 20. |
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