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The US FDA has expanded the indication for Capvaxive to incl. pts aged 2–17yrs. with certain chronic medical conditions who have completed a primary pediatric pneumococcal vaccination series & remain at increased risk of pneumococcal disease
Approval was supported by P-III (STRIDE-13) trial data, which compared Capvaxive with PPSV23 in the above-mentioned pts
Capvaxive…
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Merck has reported P-III (STRIDE-13) trial evaluating Capvaxive (21-valent pneumococcal conjugate vaccine) vs PPSV23 in pts (n=882; 2 to <18yrs.) with prior pediatric pneumococcal vaccination & chronic conditions increasing pneumococcal disease risk
Trial showed that Capvaxive induced immune responses to all 21 serotypes per opsonophagocytic activity (OPA) geometric mean titers (2EP), plus was noninferior…

