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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Hepatitis A

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects aged 16 years and older Informed consent signed by the subject and by parent or legal representative for subject aged 16 to 19 years Informed consent sign by subject for subject aged of 20 year of age and older Receipt of AVAXIM 160U according to Summary of Product Characteristics (SmPC). Exclusion Criteria: Contraindications to vaccination according to AVAXIM 160U Summary of Product Characteristics (SmPC) Subject is known to be pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence for at least 4 weeks prior to the vaccination until at least 4 weeks after)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>Participants that has received AVAXIM 160U vaccine administered under the routine practice according to Summary of Product Characteristics | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile in terms of solicited and unsolicited adverse events following the administration of AVAXIM 160U vaccine | 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. | Day 0 up to 30 Days post-vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis A, Hepatitis A vaccine, AVAXIM 160U