Pfizer has announced that the Community-Acquired Pneumonia Immunization Trial in Adults ( CAPiTA ), the landmark study of approximately 85,000 subjects evaluating the efficacy of Prevenar 13 ( pneumococcal polysaccharide conjugate vaccine [ 13-valent, adsorbed ] ) in adults 65 years of age and older, achieved its primary clinical objective and both secondary clinical objectives.
CAPiTA is the largest double-blind, randomized, placebo-controlled vaccine efficacy trial ever conducted in adults.
The primary objective of the study was to demonstrate efficacy of Prevenar 13 against a first episode of vaccine-type community-acquired pneumonia ( CAP ).
The CAPiTA study also met both secondary objectives, which were efficacy against (i) a first episode of non-bacteremic/non-invasive vaccine-type CAP and (ii) a first episode of vaccine-type invasive pneumococcal disease ( IPD ).
Vaccine-type CAP ( VT-CAP ) was defined as CAP caused by any Streptococcus pneumoniae serotype included in the vaccine.
Non-bacteremic/non-invasive VT-CAP was defined as CAP in which vaccine-type Streptococcus pneumoniae caused the pneumonia, but was not detected concurrently in the bloodstream or any other normally sterile site.
Vaccine-type invasive pneumococcal disease was defined as a case in which vaccine-type Streptococcus pneumoniae was present in the bloodstream or any other normally sterile site, with or without pneumonia.
Pneumococcal disease refers to a group of illnesses caused by Streptococcus pneumoniae bacteria. Invasive pneumococcal disease occurs when bacteria enter the bloodstream, or another site that is normally sterile. Non-invasive pneumococcal pneumonia occurs when the bacteria cause infection in the lungs but are not detected in the blood concurrently.
In adults, pneumonia is the most common presentation of pneumococcal disease. For every one case of invasive pneumococcal pneumonia in adults, it is estimated that at least three cases of non-invasive pneumococcal pneumonia occur. While non-invasive forms of pneumococcal disease are typically more common, the invasive types of disease are generally more severe.
Prevenar 13 was first introduced for use in infants and young children in December 2009 in Europe and is now approved for such use in more than 120 countries worldwide, including the United States and Japan.
It is the most widely used pneumococcal conjugate vaccine ( PCV ) in the world, and more than 640 million doses of Prevenar 7-valent / Prevenar 13 have been distributed worldwide.
In addition, Prevenar 13 is approved for use in adults 50 years of age and older in more than 90 countries, and is also approved in the United States and European Union ( EU ) for use in older children and adolescents aged 6 to 17 years.
Recently, Prevenar 13 was also approved in the EU for use in adults 18 to 49 years of age. ( Xagena )
Source: Pfizer, 2014