Last updated: 02/27/2025 10:30:12
A study to evaluate the risk of Guillain-Barré syndrome, acute disseminated encephalomyelitis, and atrial fibrillation in adults 50 years and older vaccinated with GSK’s Arexvy vaccine in the United States
GSK study ID
220149
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 post-marketing active surveillance study to evaluate the risk of Guillain-Barré syndrome, acute disseminated encephalomyelitis, and atrial fibrillation in adults 50 years and older vaccinated with GSK’s Arexvy vaccine in the United States
Trial description: The purpose of the study is to evaluate whether GSK’s Arexvy is associated with an increased risk of new-onset Guillain-Barré syndrome (GBS), new-onset acute disseminated encephalomyelitis (ADEM), and new-onset atrial fibrillation (AF) within specified time periods after vaccination among people ≥50 years of age in the United States.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Risk of new-onset GBS in adults ≥50 years of age in the US based on claims
Timeframe: Within 42 days after Arexvy vaccination
Risk of new-onset ADEM in adults ≥50 years of age in the US based on claims
Timeframe: Within 42 days after Arexvy vaccination
Secondary outcomes:
Risk of new-onset AF in adults ≥50 years of age in the US based on claims
Timeframe: Within 8 days after Arexvy vaccination
Interventions:
Not applicable
Enrollment:
4400000
Primary completion date:
2031-30-06
Observational study model:
Case-Only
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Virus Diseases
Product
GSK3844766A
Collaborators
Harvard Pilgrim Health Care Institute, University of Pennsylvania, CVS Health, Carelon Research, HealthPartners, Humana, Point32Health
Study date(s)
March 2025 to June 2031
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
Yes
- 1. Evidence of receipt of a single dose Arexvy.
- 2. 365 days of continuous medical and pharmacy enrolment, allowing up to 45-days’ gap, prior to Arexvy receipt.
- N/A
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Evidence of receipt of a single dose Arexvy. 2. 365 days of continuous medical and pharmacy enrolment, allowing up to 45-days’ gap, prior to Arexvy receipt. 3. For evaluation of GBS and ADEM cases: Continuous enrollment through the end of the respective control interval and extra days except in case of death after Arexvy vaccination. 4. For evaluation of AF cases: Continuous enrolment through the Day 106 post-vaccination, except in case of death after Arexvy vaccination. 5. For each outcome: First-in-365-days case of the outcome in the risk or control interval (i.e., definition of an incident case). 6. No evidence of a second dose of Arexvy vaccine during the follow-up period. 7. No evidence of administration of another medical product indicated for RSV disease prevention (i.e., vaccine from different manufacturer or a monoclonal antibody to prevent RSV lower respiratory tract disease) prior to the index Arexvy vaccination or during the follow-up period.
Exclusion criteria:
- N/A
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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