A prospective, multi-center post marketing surveillance (PMS) study to monitor the safety of GlaxoSmithKline Biologicals’ SA’s (GSK) Meningococcal Group B (Bexsero) vaccine in Korean participants, when administered according to the prescribing information (PI) as per routine practice - EPI-NEISSERIA-095 KR PMS

GlaxoSmithKline Biologicals SA0 个研究点开始时间: 2023年10月3日最近更新: 2023年10月9日

适应症

试验速览

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•Participants, aged two months or older at the time of first vaccination, who receive Bexsero administered as per routine practice according to the approved PI in Korea. Participants with incomplete vaccination schedule will still be eligible for inclusion.
•Participants who have provided the written informed consent. For participants who are below the legal age of consent, written informed consent must be obtained from the parent(s)/ legally acceptable representative (LAR) (s) of the participant and informed assent must be obtained from the participant according to ethics committee (EC) requirement as well as local law. For participants (infants, toddlers, and children) who are too young to provide informed assent, the informed assent can be waived, and only legal consent will be obtained from their parent(s)/LAR(s)
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 600
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Child in care (CiC): CiC are children who have been placed under the control or protection of an agency, organization, institution or entity by the courts, the government, or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of CiC can include children cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of CiC does not include a child who is adopted or has appointed legal guardian.
•Participants who, based on the judgement of the prescribing physician, have contraindication for receiving Bexsero, as indicated in the locally approved Product Information, or are not appropriate for vaccination with Bexsero for any other reason

发起方