Regulatory Post-Marketing Surveillance Study for Hepatitis A Vaccine (AVAXIM 160U)
2 other identifiers
observational
614
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 18, 2013
CompletedFirst Posted
Study publicly available on registry
April 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJuly 26, 2016
July 1, 2016
2.6 years
April 18, 2013
July 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Study Group
Participants that has received AVAXIM 160U vaccine administered under the routine practice according to Summary of Product Characteristics
Eligibility Criteria
Subjects who have received AVAXIM 160U (Hepatitis A Vaccine) according to Summary of Product Characteristics (SmPC)
You may qualify if:
- 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).
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Seoul, 120 752, South Korea
Related Publications (1)
Kim H, Oh Y, Thollot Y, Bravo C. Post-Marketing Surveillance of Hepatitis A Virus Vaccine (Avaxim(R) 160U) in South Korea from 2011 to 2015. Infect Dis Ther. 2019 Mar;8(1):105-112. doi: 10.1007/s40121-019-0230-9. Epub 2019 Jan 23.
PMID: 30673992DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur SA
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2013
First Posted
April 23, 2013
Study Start
April 1, 2013
Primary Completion
November 1, 2015
Study Completion
May 1, 2016
Last Updated
July 26, 2016
Record last verified: 2016-07