Merck has announced positive phase 3 results for Capvaxive, its 21-valent pneumococcal conjugate vaccine, in children and adolescents with chronic medical conditions that increase their risk of pneumococcal disease.
Findings from the STRIDE-13 trial were presented at the 6th ESCMID Conference on Vaccines in Lisbon. The study compared Capvaxive with PPSV23 in patients aged 2 to under 18 years who had completed a primary paediatric pneumococcal vaccination regimen.
Capvaxive elicited immune responses to all 21 serotypes included in the vaccine. It was noninferior to PPSV23 for the 12 shared serotypes and superior for the nine unique serotypes, based on serotype-specific opsonophagocytic activity geometric mean titers measured 30 days post-vaccination.
Safety data showed comparable rates of adverse events between the two groups. Systemic and serious vaccine-related events were similar, supporting the tolerability of Capvaxive in this vulnerable population.
Dr Rotem Lapidot, chief of Paediatric Infectious Diseases at Rambam Health Care Campus and trial investigator, said: “Children and adolescents living with chronic medical conditions are at increased risk of pneumococcal disease and offering them additional protection is essential.
“Results from STRIDE-13 demonstrate the potential of Capvaxive to deliver protection for these vulnerable populations, who may benefit from additional pneumococcal disease coverage by including serotypes not contained in other approved pneumococcal infant regimens.”
Merck plans to share the STRIDE-13 data with global regulatory authorities.
