Regulatory Post-Marketing Surveillance Study for Hepatitis A Vaccine (AVAXIM 160U)
Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis A
Phase: Phase 4
Status: Recruiting
Sponsored by: Sanofi Pasteur, a Sanofi Company Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Sanofi Pasteur SA
Overall contact:
Public Registry Sanofi Pasteur, Email: RegistryContactUs@sanofipasteur.com
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.
Clinical Details
Official title: Regulatory Post-Marketing Surveillance (PMS) Study for AVAXIM 160U (Hepatitis A Vaccine)
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Safety profile in terms of solicited and unsolicited adverse events following the administration of AVAXIM 160U vaccine
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.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Public Registry Sanofi Pasteur, Email: RegistryContactUs@sanofipasteur.com
Seoul 120 752, Korea, Republic of; Recruiting
Additional Information
Starting date: April 2013
Last updated: May 14, 2015
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