Hepatitis A Clinical Trial
Official title:
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.
;
Observational Model: Cohort, Time Perspective: Prospective
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