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

Phase 1

Conditions: Hepatitis A
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2016-001964-13-Outside-EU/EEA

Lead Sponsor: Sanofi Pasteur Korea Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 700

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).
Are the trial subjects under 18? yes
Number of subjects for this age range: 700
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main 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.;Secondary Objective: Not applicable;Primary end point(s): Safety profile in terms of solicited and unsolicited adverse events following the administration of AVAXIM 160U vaccine;Timepoint(s) of evaluation of this end point: Day 0 up to Day 30 post-vaccination

Secondary Outcome Measures