Last updated: 07/15/2024 09:20:33
A post marketing surveillance (PMS) study to monitor the safety of GSK’s Meningococcal Group B (Bexsero) vaccine in Korean participants, when administered according to the prescribing information (PI) as per routine practice
GSK study ID
217270
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Trial overview
Official title: 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
Trial description: The objective of this study is to collect safety data on Bexsero vaccine from participants receiving first dose and each dose of vaccine administered as per routine practice according to the approved prescribing information (PI) during the participation to this study.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Numbers and percentage of participants reporting adverse events (AE)s
Timeframe: Day 1 to Day 30 following each vaccination
Numbers and percentage of participants reporting Unexpected adverse events (UAE)s and Unexpected adverse drug reaction (UADR)s
Timeframe: Day 1 to Day 30 following each vaccination
Numbers and percentage of participants reporting Serious adverse events (SAE)s and Serious adverse drug reaction (SADR)s
Timeframe: Day 1 to Day 30 following each vaccination
Numbers and percentage of participants reporting Specific adverse events (SpAE)s
Timeframe: Day 1 to Day 30 following each vaccination
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
600
Primary completion date:
2028-31-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Meningitis, Meningococcal
Product
GSK3536829A
Collaborators
Not applicable
Study date(s)
September 2024 to March 2028
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
2+ years
Accepts healthy volunteers
Yes
- 1. Participants, aged two months or older at the time of first vaccination, who will receive first Bexsero administration as per routine practice according to the approved prescribing information in Korea.
- 2. 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).
- 1. Child in care*
- *Child in Care (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.
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Participants, aged two months or older at the time of first vaccination, who will receive first Bexsero administration as per routine practice according to the approved prescribing information in Korea. 2. 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).
Exclusion criteria:
- 1. Child in care* *Child in Care (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. 2. 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.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Will be recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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