The study will collect real-world post-vaccination adverse events.
Conditions
Interventions
Trade Name: Bexsero Prefilled Syringe
Pharmaceutical Form:
Sponsors
GlaxoSmithKline Biologicals SA
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this PMS is to collect safety data on Bexsero vaccine from participants receiving at least one dose of vaccine administered as per routine practice according to the approved prescribing information (PI).;Secondary Objective: Not applicable.;Primary end point(s): 1. Number of occurrences of adverse events (AEs) 2. Percentage of participants with AEs 3. Number of occurrences of unexpected adverse events (UAEs) and unexpected adverse drug reaction (UADRs) 4. Percentage of participants with UAEs and UADRs 5. Number of occurrences of serious adverse events (SAEs) and serious adverse drug reaction (SADRs) 6. Percentage of participants with SAEs and SADRs 7. Number of occurrences of specific adverse events (SpAEs) 8. Percentage of participants with SpAEs;Timepoint(s) of evaluation of this end point: 1, 2, 3, 4, 5, 6, 7, 8. During the 30 days (including the day of intervention) following each dose, during the 6-year study period (May 2022-May 2028) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Korea, Republic of
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals SA
Outcome results
None listed