2776. Post-marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Review of Spontaneous Reports Since Introduction
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چکیده
منابع مشابه
Evaluation of Aryoseven Safety (Recombinant Activated Factor VII) in Patients with Bleeding Disorders (An Observational Post-Marketing Surveillance Study)
Background: Recombinant activated factor VII induces hemostasis in patients with coagulopathy disorders. AryoSeven™ as a safe Iranian Recombinant activated factor VII has been available on our market. This study was performed to establish the safety of AryoSeven on patients with coagulopathy disorder. Methods: This single-center, descriptive,...
متن کاملPost-marketing safety surveillance conducted in Korea (2008–2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix™)
PURPOSE According to regulations from the Ministry of Food and Drug Safety in Korea, additional safety information on the use of Rotarix™ vaccine (RIX4414; GSK, Belgium) in ≥3000 evaluable Korean infants was required following vaccine registration. In order to comply with these regulations, we conducted a 6-year open, non-comparative, multicenter post-marketing surveillance (NCT00750893). MET...
متن کاملDid narcolepsy occur following administration of AS03-adjuvanted A(H1N1) pandemic vaccine in Ontario, Canada? A review of post-marketing safety surveillance data.
A vaccine safety signal and association between new onset of narcolepsy and AS03-adjuvanted pandemic influenza A(H1N1) vaccine (Pandemrix, GlaxoSmithKline) in children and young adults has been reported in several European countries. In Ontario, Canada, AS03-adjuvanted pandemic A(H1N1) vaccine (Arepanrix, GlaxoSmithKline) was the primary vaccine administered in 2009/10, with 4.8 million doses d...
متن کاملTolerability of a recombinant DNA hepatitis B vaccine--results of post-marketing surveillance.
Hepatitis B virus (HBV) is the most important cause of hepatitis both in children and adults. Hepatitis B virus is distributed alt over the world with a much marked infection level (5 20%) in Asia specially South East Asia, Person to person HBV transmission occurs through contact of slightly damaged skin or mucosa, infected body fluids like blood, semen and saliva. Direct transmission of the di...
متن کاملSocial Media Listening for Routine Post-Marketing Safety Surveillance.
INTRODUCTION Post-marketing safety surveillance primarily relies on data from spontaneous adverse event reports, medical literature, and observational databases. Limitations of these data sources include potential under-reporting, lack of geographic diversity, and time lag between event occurrence and discovery. There is growing interest in exploring the use of social media ('social listening')...
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ژورنال
عنوان ژورنال: Open Forum Infectious Diseases
سال: 2019
ISSN: 2328-8957
DOI: 10.1093/ofid/ofz360.2453