pausarir hacia adelante

Wyeth Pharmaceuticals Starts Phase IV Trial with Adults with Investigational Pneumococcal Vaccine (Update)

Wyeth Pharmaceuticals, a division of Wyeth, has initiated the community acquired pneumonia immunization trial in adults, with their investigational 13-valent conjugate vaccine Prevnar designed to help prevent pneumococcal pneumonia, as part of a Phase IV commitment with the Food and Drug Administration.
09-25-2008 |  12:06 hs.
Author: Cate Kirby |

A division of Wyeth, Wyeth Pharmaceuticals, announced it has started a Phase IV study with adults with their experimental 13-valent conjugate vaccine Prevnar designed for community acquired pneumonia.

The results from this trial are not required for inclusion in Wyeth´s currently planned regulatory filings of this new version of the vaccine in adults - a follow-up to Wyeth´s already blockbuster Prevnar - rather as part of a Phase IV commitment in agreement with the Food and Drug Administration (FDA).

According to previously published data, the vaccine has added six new serotypes to the former seven: 1, 3, 5, 6A, 7F and 19A, adding to Prevenar´s 4, 6B, 9V, 14, 18C, 19F and 23F.

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.

Participants in the trial, being conducted in the Netherlands, will receive either Wyeth´s candidate 13-valent pneumococcal vaccine based on Prevnar, or placebo.

Wyeth´s Prevnar had sales of just under $ 1.4 million dollars in the first half of this year.

Publish comment:
* Requiered fields
* Your name:
* E-mail:
* Your opinion:
 
Estimated reading time: 0:54
Word count: 1204
  • BLOGS
  • NM Extra
  • VIDEOS