The data assessing immunogenicity, tolerability and safety of Prevenar 13 support EU regulatory filing and planned worldwide regulatory filings for the age group.
Pfizer vaccine clinical research and development senior vice president William Gruber said, "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."
The primary objective of the Phase 3, multi-center trial 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 titers a month after vaccination.
According to the study data, primary objective was met for all 13 serotypes in Prevenar 13, which provides the coverage of any pneumococcal conjugate vaccine.
Prevenar 13 is effective against invasive pneumococcal disease in children less than two years of age when used as part of a routine pediatric immunization program.