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news.Wyeth Pharmaceuticals, a division of Wyeth, has initiated 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.
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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 IV commitment, and in agreement with the 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. The investigational 13-valent vaccine being evaluated in this trial in adults uses Wyeth-pioneered conjugation technology, and is based on the science of Prevenar.
Emilio Emini, executive vice president of vaccine R&D at Wyeth Pharmaceuticals, said: “Pneumococcal pneumonia in adults represents a significant burden, both clinically and economically. This will be an important trial to evaluate our conjugate vaccine’s potential to address this medical need.”