Pfizer (PFE) Announces Top-Line Results Of Prevenar 13 Phase 3 Trial
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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 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.
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