Pfizer Inc. has  presented the results from a phase III 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 (US) 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 23rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Berlin, Germany.

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 favourable 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 Paediatrics at the University of Louisville.

Currently, Prevenar 13, or Prevnar 13 as it is called in the US, 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 at ECCMID 2013.

Pneumococcal Disease (PD) is a group of illnesses caused by the bacterium Streptococcus pneumoniae (S. pneumoniae), also known as pneumococcus. It can affect people of all ages, although older adults, young children and individuals with certain chronic medical conditions are at heightened risk. PD is associated with significant morbidity and mortality. Invasive manifestations of the disease include bacteremia (bacteria in the blood) and meningitis (infection of the tissues surrounding the brain and spinal cord).

Prevenar 13 is approved in the EU for the prevention of invasive disease, pneumonia and acute otitis media caused by S. pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in children and adolescents aged six weeks to 17 years. It is also approved in the EU for the prevention of invasive disease caused by 13 S. pneumoniae serotypes (single dose) in adults 50 years and older.

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