NCT01838070

Regulatory Post-Marketing Surveillance Study for Hepatitis A Vaccine (AVAXIM 160U)

Regulatory Post-Marketing Surveillance (PMS) Study for AVAXIM 160U (Hepatitis A Vaccine)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 614 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatitis A

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-11-01
• Completion: 2016-05-01
• First posted: 2013-04-23
• Last updated: 2016-07-26

Locations

1 site across 1 country: South Korea