Last updated: 03/31/2025 09:31:03
An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety of Arexvy administered in Korean subjects in real-world practice
GSK study ID
221734
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: An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety of Arexvy administered in Korean subjects in real-world practice
Trial description: The study aims to observe the safety profile on Arexvy used according to its approved label and to monitor important identified and potential risks according to RMP in a real-world practice.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Present rate of solicited adverse events (AEs)
Timeframe: Within 4 days post Arexvy vaccination
Present rate of AEs/adverse drug reactions (ADRs), unexpected AEs/ADRs, and serious adverse event (SAEs)/serious adverse drug reactions (SADRs)
Timeframe: Within 30 days post Arexvy vaccination
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
3600
Primary completion date:
2030-13-09
Observational study model:
Other
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Respiratory Syncytial Virus Infections
Product
Not applicable
Collaborators
Not applicable
Study date(s)
June 2025 to September 2030
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
60+ years
Accepts healthy volunteers
Yes
- Prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 60 years and older.
- Individuals with Hypersensitivity to the component of Arexvy
Inclusion and exclusion criteria
Inclusion criteria:
- Prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 60 years and older.
Exclusion criteria:
- Individuals with Hypersensitivity to the component of Arexvy
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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