- 85,000 Expected to Enroll in Phase 4 Study Initiated Pre-Registration -
COLLEGEVILLE, Pa., Sept. 23 /PRNewswire/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced the initiation of the Community Acquired Pneumonia Immunization Trial in Adults a major study in adults of an investigational 13-valent conjugate vaccine designed to help prevent pneumococcal pneumonia -- the leading cause of bacterial pneumonia in adults.
In Europe and the United States, pneumococcal pneumonia is the most common community-acquired bacterial pneumonia, for which the adult mortality rate averages between 10 to 20 percent. That rate may exceed 50 percent in high-risk groups worldwide.
The results from this trial are not intended or required for inclusion in Wyeth's currently planned regulatory filings for the use of the 13-valent pneumococcal conjugate candidate vaccine in adults. Rather, this study is being initiated proactively as part of a Phase 4 commitment, and in agreement with the U.S. Food and Drug Administration (FDA).
The Community Acquired Pneumonia Immunization Trial in Adults is a double-blind, placebo-controlled study expected to enroll approximately 85,000 participants 65 years of age and older. The study is being conducted by the Julius Center for Health Sciences and Primary Care at the University Medical Center Utrecht in the Netherlands. Participants in the trial will receive either Wyeth's investigational 13-valent pneumococcal conjugate vaccine or placebo.
"We are very excited to conduct this major trial addressing the
important disease of adult pneumonia," says Marc Bonten, M.D., principal
investigator of the trial and Professor of Molecular Epidemiology of
Infectious Diseases, D
|SOURCE Wyeth Pharmaceuticals|
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