Pfizer reports that Prevenar 13 Phase 3 study meets all primary, secondary objectives

Pfizer Inc. (NYSE:PFE) presented today the results from a Phase 3 study investigating immunogenicity, tolerability and safety of Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) in adults 18 to 49 years of age. The study met all primary and secondary objectives and provides the clinical foundation for the Company's regulatory submission in the European Union (EU) and planned regulatory submissions in the United States (U.S.) and other countries around the world to seek expansion of the use of Prevenar 13 to include adults 18 to 49 years of age. These results were presented at the 23^rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Berlin, Germany.

“This important analysis shows the immunogenicity and safety profile following vaccination with Prevenar 13 in adults aged 18 to 49 years. This vaccine has the potential to help prevent pneumococcal disease caused by the Streptococcus pneumoniae serotypes contained in the vaccine”

Data from this study showed that Prevenar 13 was at least as immunogenic in adults 18 to 49 years of age as it is in adults 60 to 64 years of age, as measured one month after vaccination; for adults 18 to 49 years of age, functional antibody responses to all 13 serotypes included in the vaccine were non-inferior to responses in adults 60 to 64 years of age. In the study, Prevenar 13 showed a favorable safety profile and was generally well tolerated. Pain at the injection site was the most frequently observed local reaction. Muscle pain, headache and fatigue were the most common systemic events.

"This important analysis shows the immunogenicity and safety profile following vaccination with Prevenar 13 in adults aged 18 to 49 years. This vaccine has the potential to help prevent pneumococcal disease caused by the Streptococcus pneumoniae serotypes contained in the vaccine," said lead investigator Dr. Kristina Bryant, associate professor of Pediatrics at the University of Louisville.

Currently, Prevenar 13, or Prevnar 13 as it is called in the U.S., Canada and Taiwan, is approved in more than 120 countries worldwide for use in infants and young children and in more than 80 countries for use in adults 50 years of age and older.

"Pfizer is committed to developing vaccines with the goal of preventing serious disease through every stage of life," said Dr. William Gruber, senior vice president, Pfizer Vaccine Clinical Research and Development. "We continue to further investigate the use of Prevenar 13 with the aim of broadening prevention efforts to additional populations."

This study, titled "Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults 18-49 years, naïve to 23-valent pneumococcal polysaccharide vaccine," was presented as an ePoster during the session "Streptococcus pneumoniae: Serotypes and Vaccination," at ECCMID 2013 on April 28 at 1:30 p.m. CEST.