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Regulatory Post-Marketing Surveillance (PMS) Study for AVAXIM 160U (Hepatitis A Vaccine)
This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) "Basic standard for reexamination of new drug". Primary objective: * To assess the safety of AVAXIM 160U (Hepatitis A vaccine) administered under the routine practice, according to Korea Food and Drug Administration "Basic standard for reexamination of new drug" based on the pharmaceutical law in Korea.
The study will be conducted under the real clinical practices in accordance with Korea Food and Drug Administration "Basic standard for reexamination of new drug". No vaccine will be provided and/or administered as part of this protocol, however only participants that has received AVAXIM 160U vaccine administered under the routine practice according to Summary of Product Characteristics will be part of the surveillance.
Age
16 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Seoul, South Korea
Start Date
April 1, 2013
Primary Completion Date
November 1, 2015
Completion Date
May 1, 2016
Last Updated
July 26, 2016
614
ACTUAL participants
Lead Sponsor
Sanofi Pasteur, a Sanofi Company
NCT07032610
NCT03855176
Data Source & Attribution
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