Top-line data from Pfizer’s Prevenar 13 Phase 3 trial on pneumococcal disease

Pfizer Inc. (NYSE:PFE) today announced top-line data assessing immunogenicity, tolerability and safety of Prevenar 13^® (Pneumococcal polysaccharide conjugate vaccine [13-valent, absorbed]) in adults 18 to 49 years of age. These data support a recent regulatory submission to expand the indication of Prevenar 13 in the European Union to include adults between 18 and 49 years old, and will be used to support similar planned submissions in other countries around the world in the future.

The primary objective of this study was to demonstrate that the immune response to Prevenar 13 in the 18 to 49 year old age group is noninferior to the immune response to Prevenar 13 in the 60 to 64 year old age group as measured by serotype specific opsonophagocytic assay (OPA) titers one month after vaccination. The primary objective was met for all 13 serotypes in Prevenar 13.

"The clinical program for Prevenar 13 demonstrates our commitment to developing vaccines that can prevent serious disease through every stage of life," said William Gruber, M.D., senior vice president, Vaccine Clinical Research and Development, Pfizer Inc. "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."

Pneumococcal disease is associated with significant mortality and morbidity for individuals of all ages. Prevenar 13 provides the broadest coverage of any pneumococcal conjugate vaccine and has proven effectiveness against invasive pneumococcal disease in children less than 2 years of age when used as part of a routine pediatric immunization program.

Prevenar 13 is currently approved in more than 110 countries worldwide for use in infants and young children and in more than 70 countries for use in adults 50 years of age and older. Prevenar 13 also is available through the World Health Organization (WHO) pre-qualification program for active immunization of infants and young children, as well as adults 50 years and older.