Pfizer has reported positive top-line results from a Phase III trial of Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine) conducted in adults aged 18 to 49.
The primary objective of study 6115A1-004 was to demonstrate that the immune response to Prevenar 13 in 18 to 49 year olds is noninferior to the immune response to Prevenar 13 in 60 to 64 year olds as measured by serotype-specific opsonophagocytic assay (OPA) titres one month after vaccination.
The study data showed that the primary objective was met for all 13 serotypes in Prevenar 13.
The vaccine has also proven effective against invasive pneumococcal disease in children less than two years of age, when used as part of a routine paediatric immunisation programme.
Pfizer vaccine clinical research and development senior vice president Dr 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 data supports a European Union regulatory filing to expand the indication of Prevenar 13 to include adults aged between 18 and 49, and planned submissions in other countries in the future.
The multi-centre trial was designed to compare the immunogenicity, tolerability and safety of Prevenar 13, and the presently licensed nonconjugated pneumococcal polysaccharide vaccine (PPSV), in 740 adults aged 60 to 64 who were naïve to PPSV.
The randomised, double-blind study also assessed Prevenar 13 administered open-label to 370 adults aged 50 to 59, and compared to adults aged 60 to 64.
In addition, 900 healthy adults aged 18 to 49 were assessed to compare immune responses with participants aged 60 to 64.
The study measured serotype-specific anti-pneumococcal functional antibodies for all 18 to 49 year old participants before vaccination, at one month after vaccination and at one year after vaccination with Prevenar 13.
Image: Pfizer Prevenar 13 Phase III trial data will support regulatory filings. Photo: Courtesy of Jim.henderson.