Status:
COMPLETED
Regulatory Post-Marketing Surveillance Study for Hepatitis A Vaccine (AVAXIM 160U)
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Hepatitis A
Eligibility:
All Genders
16+ years
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 safe...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
614 Patients enrolled
Trial Details
Trial ID
NCT01838070
Start Date
April 1 2013
End Date
May 1 2016
Last Update
July 26 2016
Active Locations (1)
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1
Seoul, South Korea, 120 752