Pfizer reports positive data from Phase III study of Prevenar 13

29th April 2013 (Last Updated April 29th, 2013 18:30)

Pfizer has reported positive results from a Phase III study evaluating immunogenicity, tolerability and safety of Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine) in adults between 18 to 49 years old.

pfizer japan

Pfizer has reported positive results from a Phase III study evaluating immunogenicity, tolerability and safety of Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine) in adults between 18 to 49 years old.

Prevenar 13 is a preventative vaccine for pneumococcal disease.

The study met all primary and secondary objectives. The data demonstrated 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, when measure one month following vaccination.

The University of Louisville paediatrics associate professor and lead investigator Dr Kristina Bryant said; "This vaccine has the potential to help prevent pneumococcal disease caused by the Streptococcus pneumoniae serotypes contained in the vaccine."

Functional antibody responses to all 13 serotypes included in the vaccine for adults 18 to 49 years of age were non-inferior to responses in adults aged 60 to 64 years.

Prevenar 13 was generally well-tolerated and demonstrated a favourable safety profile.

The most common systemic events noted were muscle pain, headache and fatigue.

Pfizer vaccine clinical research and development senior vice president Dr William Gruber said; "We continue to further investigate the use of Prevenar 13 with the aim of broadening prevention efforts to additional populations."

Based on the Phase III safety and immunogenicity data, the company expects to seek expanded use of Prevenar 13 to include adults 18 to 49 years of age in the European Union, US and other countries across the globe.


Image: The immunogenicity and safety profile following vaccination with Pfizer's Prevenar 13 in adults aged 18 to 49 years was demonstrated in this Phase III study. Photo: Neruru.