Pfizer Inc. (NYSE:PFE) announced that data from a Phase 3 study of Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) met all study endpoints, showing immunogenicity and establishing a safety profile in children and adolescents aged 5 through 17 years. These data, which are being presented today during the 8th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in Iguacu Falls, Brazil, will support planned regulatory submissions seeking to expand the Prevnar 13 label in the United States, the European Union, and other countries around the world.
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® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the original version of the vaccine, and vaccine-naïve children and adolescents aged 10 through 17 years.
"As a global leader in pneumococcal disease prevention, we are excited about the potential to further define the clinical utility of Prevnar 13 with the aim of seeking to broaden prevention efforts to additional age groups," says Emilio Emini, PhD, chief scientific officer, Vaccine Research, Pfizer Inc. "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."
The primary objective of this study was to assess the pneumococcal immune responses induced by Prevnar 13 when measured one month after vaccination in each of the age groups. The safety objective of the study 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.
The data (late-breaker poster #881) will be presented at ISPPD during the daily poster viewing sessions.
About Prevnar 13
Prevnar 13, which is based on the scientific foundation and proven experience of Prevnar, offers the broadest coverage of any pneumococcal conjugate vaccine. Prevnar 13 was first introduced for use in infants and young children in December 2009 in Europe and is now approved for such use in more than 110 countries worldwide. The most widely used pneumococcal conjugate vaccine in the world, Prevnar 13 is part of the routine immunization program in more than 50 countries.
Pneumococcal Disease
Pneumococcal disease (PD) is a group of illnesses caused by the bacterium Streptococcus pneumoniae (S. pneumoniae), also known as pneumococcus. It can affect people of all ages, although young children, older adults, and individuals with certain chronic medical conditions are at heightened risk. PD is associated with significant morbidity and mortality. Non-invasive PD includes non-bacteremic pneumonia, otitis media and sinusitis (upper respiratory tract infection) and invasive manifestations of the disease include bacteremia (bacterial infections of the blood) and meningitis (inflammation of the membrane surrounding the spinal cord and brain).
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