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

Sanofi

Status: Completed

Conditions: Hepatitis A

Study type: Observational

Funder types: Industry

Identifiers

NCT01838070

U1111-1127-7211 (Other Identifier)

HAF85

Details and patient eligibility

About

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.

Full 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.

Enrollment: 614 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

614 participants in 1 patient group

Study Group

Description:

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