Pfizer announced Thursday that a Phase III trial of Prevenar 13 (pneumococcal 13-valent conjugate vaccine) in people aged 18 to 49 met its main goal, supporting the company's European filing seeking expanded approval of the product. The drugmaker indicated that the results will also be used in similar applications in other countries in the future.
Study 6115A1-004 was designed to demonstrate that the immune response to Prevenar 13 in people aged 18 to 49 is non-inferior to the immune response for the vaccine in those aged 60 to 64 years old, a population for which the product is already approved. The trial included 900 healthy adults aged 18 to 49 years old and 740 adults aged 60 to 64 who were naïve to pneumococcal polysaccharide vaccine. Pfizer said that the study's primary objective was met for all 13 serotypes in Prevenar 13, adding that detailed analysis of the immunogenicity data will be submitted for future publication.
"Prevenar 13 is the first and only pneumococcal conjugate vaccine for adults, and we continue to study the vaccine in new populations with the aim of broadening its availability," remarked William Gruber, senior vice president of vaccine clinical R&D at Pfizer. In both Europe and the US, where the vaccine is known as Prevnar 13, the product is approved for use in adults aged 50 years and older and in infants and children from six weeks to five years of age.
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