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Merck & Co Inc.'s Capvaxive received FDA approval for expanded use in children and adolescents aged 2–17 with chronic conditions who completed a primary pneumococcal vaccine series, making it the sole pneumococcal conjugate vaccine studied and approved for this group in the U.S. The decision was influenced by Phase 3 STRIDE-13 data comparing Capvaxive to PPSV23 in pediatric and adolescent patients at high risk of pneumococcal disease. This trial served as the foundation for the label extension. Capvaxive is currently approved for adults 18 and above to prevent invasive pneumococcal disease from various Streptococcus pneumoniae serotypes, as well as for at-risk patients aged 2–17. Prior to this, the FDA had granted accelerated approval for Capvaxive's extended use.