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New Phase 3 Data Continue to Indicate that Wyeth's Investigational 13-valent Vaccine Has the Potential to Broaden Coverage Against Pneumococcal Disease
Date:6/11/2009

global Phase 3 clinical trials in adults, with regulatory submissions expected in 2010.

Pneumococcal Disease

Pneumococcal disease is complex and describes a group of illnesses, all caused by the bacterium Streptococcus pneumoniae. Pneumococcal disease affects both children and adults, and includes invasive infections such as bacteremia/sepsis and meningitis, as well as pneumonia and otitis media (middle ear infection).

Most recently serotype 19A, which is included in the candidate vaccine, has been increasing in prevalence in many regions of the world and is frequently resistant to antibiotics.

Indication for Prevenar

Prevenar is indicated for active immunization against disease by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteremia, and acute otitis media) in infants and children from 2 months up to 5 years of age.

Important Safety Information for Prevenar

In clinical studies (n=18,168), the most frequently reported adverse events included injection site reactions, fever (greater than or equal to 38 degrees C/100.4 degrees F), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, and rash.

Risks are associated with all vaccines, including Prevenar. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. Prevenar does not provide 100% protection against vaccine serotypes or protect against non vaccine serotypes. The decision to administer Prevenar should be based on its efficacy in preventing invasive pneumococcal disease (IPD).

About Wyeth Pharmaceuticals

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervou
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SOURCE Wyeth Pharmaceuticals
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