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

Sanofi Pasteur Korea Ltd0 个研究点目标入组 700 人开始时间: 2016年5月6日最近更新: 2016年5月9日

适应症

试验速览

暂无简介。

•- 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

•- 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)

发起方

Sanofi Pasteur Korea Ltd