EUCTR2023-000765-14-Outside-EU/EEA
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- The study will collect real-world post-vaccination adverse events.
- Sponsor
- GlaxoSmithKline Biologicals SA
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 4
Superia: Sirolimus Eluting Coronary Stent System (SSECSS) India Post Marketing RegistryCTRI/2012/01/002393Innvolution Med System200
Not yet recruiting
Phase 4
Post marketing surveillance of Aripiprazole tabletHealth Condition 1: F209- Schizophrenia, unspecifiedCTRI/2022/01/039860Torrent Pharmaceuticals Limited
Active, not recruiting
Phase 4
A post marketing study to monitor safety of Abiraterone Acetate (Zytiga) in Indian patients with Prostate CancerHealth Condition 1: null- Indian participants with metastatic, castration-resistant prostate cancer will be enrolled in this study.CTRI/2016/04/006854Johnson Johnson Private Limited
Completed
Phase 4
Post Marketing Study of Perampanel in Patients with EpilepsyHealth Condition 1: G401- Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizuresCTRI/2019/01/016844Eisai Pharmaceutical India Limited200
Completed
Not Applicable
Prospective multicenter post- marketing surveillance study for surgical pelvic floor reconstruction in the anterior compartment with the polypropylen mesh InGYNiousN81.1N81.2CystoceleIncomplete uterovaginal prolapseDRKS00011657A.M.I. GmbH (Agency for Medical Innovations)254