NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) noted that the data from a Phase 3 study of Prevnar 13 met all study endpoints, demonstrating immunogenicity and establishing a safety profile in children and adolescents aged 5 through 17 years. These data would support planned regulatory submissions seeking to expand the Prevnar 13 label in the United States, the European Union, and other countries around the world, the company added.
Vaccine immunogenicity and safety were evaluated in the Phase 3, open-label trial of 598 healthy children, including children aged 5 to 10 years who had previously been vaccinated for the prevention of invasive pneumococcal disease with Prevnar, the original version of the vaccine, and vaccine-naïve children and adolescents aged 10 through 17 years.
The study's primary objective was to assess the pneumococcal immune responses induced by Prevnar 13 when measured one month after vaccination in each of the age groups, while the safety objective was to evaluate the safety profile of Prevnar 13 as measured by the incidence rates of local reactions, systemic events, and adverse events. The most common adverse events after vaccination were cough, headache, vomiting, fever, sore throat, influenza and sinusitis.
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