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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

614 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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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

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Hepatitis A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group

Participants that has received AVAXIM 160U vaccine administered under the routine practice according to Summary of Product Characteristics

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes