Regulatory Post-Marketing Surveillance Study for Hepatitis A Vaccine (AVAXIM 160U)
|ClinicalTrials.gov Identifier: NCT01838070|
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : July 26, 2016
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||614 participants|
|Official Title:||Regulatory Post-Marketing Surveillance (PMS) Study for AVAXIM 160U (Hepatitis A Vaccine)|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||May 2016|
Participants that has received AVAXIM 160U vaccine administered under the routine practice according to Summary of Product Characteristics
- 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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838070
|Korea, Republic of|
|Seoul, Korea, Republic of, 120 752|
|Study Director:||Medical Director||Sanofi Pasteur SA|