Prevenar 13: Phase III data

Pfizer reported data from an open-label Phase III trial 598 healthy children showing that Prevnar 13 met all study endpoints by demonstrating immunogenicity at 1 month post-vaccination and establishing a safety profile in children aged 5-17 years old regardless of prior vaccination with Prevnar ( PCV7), the pharma's vaccine containing 7 serotypes. Two age groups of children were enrolled in the trial - healthy children aged 5-10 years of age previously vaccinated with >=1 dose of PCV7 and healthy pneumococcal vaccine-naïve children aged 10-18 years of age. Specifically, IgG geometric mean concentrations in both age groups increased from pre- to post-vaccination by >=4-fold for most of the 7 serotypes common to both Prevnar 13 and PCV7 and by >=2-fold for most of the additional 6 serotypes in Prevnar 13. Additionally, microcolony opsonophagocytic antibody (OPA) geometric mean titers in both age groups increased by >=4-fold for the 7 serotypes common to both vaccines and by >=9.7-fold for the additional 6 serotypes. Data were presented at the International Symposium on Pneumococci and Pneumococcal Diseases in Iguazu Falls. ...