Merck's Capvaxive Shows Strong Phase 3 Results in Kids

Merck (known as MSD outside of the US and Canada) presented positive Phase 3 trial results for Capvaxive for kids at the 6th ESCMID Conference on Vaccines in Lisbon, Portugal.

The STRIDE-13 study assessed the vaccine in children and adolescents (2 years to under 18 years) with chronic medical conditions known to increase the chance of developing pneumococcal disease.

The results demonstrated that Capvaxive elicited immune responses against all 21 pneumococcal serotypes, with data showing noninferior immune response to PPSV23 for the 12 strains common to both studies, and superior immune response for the 9 serotypes unique to Capvaxive. Safety data were reported to be consistent across groups with adverse events comparable to that of PPSV23, although injection site reactions were increased for Capvaxive.

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Capvaxive, currently approved in the United States, European Union, Japan, and other markets for adults 18 years and older, protects for serotypes accounting for around 84% of invasive pneumococcal disease (IPD) in adults aged 50+, where PCV20 provides only 52%, according to data from the Centers for Disease Control and Prevention. The finding from the STRIDE-13 study is critical and reinforces Capvaxive's ability to expand protection to high-risk children and adolescents, covering about 78% of cases for this population, with 11 unique strains accounting for 34% of cases.

Merck stated that this data will serve as the last readout regarding the STRIDE data to be sent to regulators worldwide. It remains an important issue as a considerable number of hospitalization have still forced by pneumococcal disease and in the vulnerable population, Capvaxive’s broader coverage makes it an important vaccine in global pneumococcal disease prevention strategies.