A Multicenter Post Marketing Surveillance Study to Monitor the Safety of GSK Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) Administered According to the Prescribing Information to Healthy Subjects from 2 Months to 55 Years of Age in the Republic of South Korea. - MENACWY CONJ-025 (V59_62)

GlaxoSmithKline Biologicals0 个研究点目标入组 3,960 人开始时间: 2017年10月4日最近更新: 2017年10月9日

适应症

试验速览

暂无简介。

•1. Male and female subjects from 2 months to 55 years of the age at the time of vaccination (including all 55 years of age subjects, up to one day before their 56th year birthday), who are scheduled to receive vaccination with MenACWY-CRM conjugate vaccine, according to the local prescribing information and routine clinical practice;
•2. To whom the nature of the study has been described and the subject or subject’s parent/legal representative has provided written informed consent;
•3. Whom the investigator believes that the subject can and will comply with the requirements of the protocol (e.g., completion of the Diary Card);
•4. Who are in good health as determined by the outcome of medical history, physical assessment and clinical judgment of the investigator.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 3960
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1100
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Contraindication, special warnings and/or precautions, as evaluated by the investigators, reported in the MenACWY-CRM conjugate vaccine Korean prescribing information.
•2. Infants who were already enrolled in this trial at another study site for previous vaccination.

发起方