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Reply #15: Here is what you need to know about Gardasil [View All]

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antigop Donating Member (1000+ posts) Send PM | Profile | Ignore Tue Jul-03-07 06:02 PM
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15. Here is what you need to know about Gardasil
From the FDA approval letter:

http://www.fda.gov/cber/approvltr/hpvmer060806L.htm

>>
You have committed to conduct a short-term safety surveillance study in a U.S. Managed Care Organization (MCO). The study will include approximately 44,000 vaccinated subjects who will be followed for 60 days for assessment of general short-term safety (i.e., emergency room visits, hospitalizations, and deaths). The subjects will also be followed for 6 months subsequent to vaccination for new autoimmune disorders, rheumatologic conditions, or thyroiditis. Also, a sufficient number of children 11-12 years of age will be studied to permit an analysis of safety outcomes. The final study protocol will be submitted by December 31, 2006. Patient accrual will be completed by December 31, 2008. The study will be completed by June 30, 2009. The final study report will be submitted by September 30, 2009.
>>

THE STUDY WILL BE COMPLETED BY JUNE 30, 2009.


'nuff said.
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