Pfizer said Monday that a late-stage trial of Prevnar 13 (pneumococcal 13-valent conjugate vaccine) met all of its goals in children and adolescents aged 5 through 17 years. The company noted that the data, which were presented at the ISPPD meeting, will support regulatory filings seeking to expand the product's label in the US, Europe and other countries.
The study enrolled 598 healthy children including those aged 5 to 10 years who had previously been vaccinated for the prevention of invasive pneumococcal disease with Prevnar (pneumococcal 7-valent conjugate vaccine) and vaccine-naïve children and adolescents aged 10 through 17 years. Results showed that the trial met its primary objective of pneumococcal immune response induced by Prevnar 13 measured one month after vaccination in each of the age groups.
Pfizer indicated that the trial also established the vaccine's safety profile in these groups of children and adolescents as measured by the incidence rates of local reactions, systemic events and adverse events. Emilio Emini, chief scientific officer of the company's vaccine research unit, commented that "while pneumococcal disease most often strikes younger children, older children and adolescents who have certain medical conditions are also at heightened risk for contracting the disease."
In December, the FDA expanded approval of Prevnar 13 for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae in people aged 50 or older.
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