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Merck

The US FDA Expands Merck’s Capvaxive Use to Children and Adolescents Aged 2-17 at Increased Risk for Pneumococcal Disease

Shots: 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

Merck Reports P-III (STRIDE-13) Trial of Capvaxive for Active Immunization Against Pneumococcal Disease

Shots: 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…

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Merck

Merck Secures the EC’s Approval for Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) for Invasive Pneumococcal Disease (IPD)

Shots: The EC has approved Capvaxive for active immunization against invasive disease & pneumonia caused by S. pneumoniae in adults (≥18yrs.) in 30 EEA states Approval was backed by P-III (STRIDE-3) data, assessing Capvaxive vs PCV20 in pneumococcal vaccine-naïve adults (≥18yrs.), plus data from various P-III trials (STRIDE-4, STRIDE-5,  STRIDE-6, STRIDE-7, & STRIDE-10) assessing it in both vaccine-naïve & vaccinated adults STRIDE…

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