Pfizer Inc. (PFE) Monday said the phase 3 study of its Pneumococcal conjugate vaccine - Prevnar 13 met all endpoints, showing immunogenicity and safety in children and adolescents aged 5 through 17 years. Pfizer said the late-stage study was part of its plan to expand the labeling for Prevnar 13.
The positive data will help Pfizer for planned regulatory submissions and to expand the Prevnar 13 label in the U.S., the EU, and other countries.
The late-stage study comprised 598 healthy children, including children aged 5 to 10 years who earlier were vaccinated with Prevnar - the original version of the vaccine, and vaccine-naive children and adolescents aged 10 through 17 years.
The primary objective of the 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 most common adverse events after vaccination were cough, headache, vomiting, fever, sore throat, influenza and sinusitis.
Pfizer said the Phase 3 data is being presented today during the 8th "International Symposium on Pneumococci and Pneumococcal Diseases," convened in Brazil.
Pneumococcal disease or PD is a group of illnesses caused by the bacterium Streptococcus pneumoniae, and can affect people of all ages, although young children, older adults, and individuals with certain chronic medical conditions are at more risk.
PD is associated with significant morbidity and mortality. Non-invasive PD includes non-bacteremic pneumonia, otitis media and sinusitis and invasive manifestations of the disease include bacteremia and meningitis.
Prevnar 13 is a vaccine approved for use in children 6 weeks through 5 years for prevention of invasive disease and ear infections. It is also approved for adults 50 years and older for the prevention of pneumococcal pneumonia and invasive disease due to certain vaccine strains.
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. In Pfizer's fourth quarter, Prevnar/Prevnar 13 global recorded sales of $834 million.
PFE is trading at $21.47, down $0.01 or 0.05%, on a volume of 16.2 million shares on the NYSE.
by RTT Staff Writer
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