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

Completed

• Conditions: Hepatitis A

• Registration Number: NCT01838070
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-23
• Primary Completion: 2015-11
• Study Completion: 2016-05
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 614

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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