Regulatory Post-Marketing Surveillance Study for Hepatitis A Vaccine (AVAXIM 160U)
This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) "Basic standard for reexamination of new drug".
- 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Regulatory Post-Marketing Surveillance (PMS) Study for AVAXIM 160U (Hepatitis A Vaccine)|
- Safety profile in terms of solicited and unsolicited adverse events following the administration of AVAXIM 160U vaccine [ Time Frame: Day 0 up to 30 Days post-vaccination ] [ Designated as safety issue: No ]Solicited injection site: Pain, Erythema, and Swelling: Solicited Systemic Reactions: Fever (temperature), headache, and myalgia. Unsolicited averse events including non serious and serious adverse events.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||May 2016|
|Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Participants that has received AVAXIM 160U vaccine administered under the routine practice according to Summary of Product Characteristics
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01838070
|Korea, Republic of|
|Seoul, Korea, Republic of, 120 752|
|Study Director:||Medical Director||Sanofi Pasteur SA|