Last updated: 02/20/2024 09:20:15
Targeted safety study to assess the real-world safety of Shingrix vaccine in adults aged 65 and older in the United States (US)
GSK study ID
209696
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
Official title:
Trial description: Post-authorization safety study to assess the real-world safety of Shingrix vaccine in the US using the Centers for Medicare and Medicaid Services (CMS) Chronic Condition Warehouse (CCW) database with a focus on specific health outcomes of interest in adults aged 65 and older.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The risk of new onset Guillain-Barré Syndrome (GBS) within 42 days following RZV vaccination using a Self-controlled Risk Interval (SCRI) design
Timeframe: Within 42 days following RZV vaccination
The risk of new onset gout within 30 days following RZV vaccination using a SCRI design
Timeframe: Within 30 days following RZV vaccination
The risk of new onset Polymyalgia Rheumatica (PMR) within 183 days following RZV vaccination using a cohort design
Timeframe: Within 183 days following RZV vaccination
The risk of new onset Giant Cell Arteritis (GCA) within 183 days following RZV vaccination using a cohort design
Timeframe: Within 183 days following RZV vaccination
Secondary outcomes:
The risk of new onset Supraventricular Tachycardia (SVT) within 30 days following RZV vaccination using a SCRI design
Timeframe: Within 30 days following RZV vaccination
The risk of new onset Ischemic Optic Neuropathy (ION) within 183 days following RZV vaccination using a cohort design
Timeframe: Within 183 days following RZV vaccination
Interventions:
Not applicable
Enrollment:
723000
Primary completion date:
2025-27-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
University of Maryland Baltimore (UMB)
Study date(s)
September 2020 to May 2025
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
65+ years
Accepts healthy volunteers
Yes
- Age 65 and older at the date of the RZV vaccination or preventive care visit for the RZV unvaccinated comparator
- Enrolled in Medicare due to age or End-Stage Renal Disease (ESRD) as the original and current qualifying reason
- Continuously enrolled only in Medicare Part C in the baseline period
- Enrolled in Medicare due to disability as the original qualifying reason for enrollment.
Inclusion and exclusion criteria
Inclusion criteria:
- Enrolled in Medicare due to age or End-Stage Renal Disease (ESRD) as the original and current qualifying reason
- Continuously enrolled in Medicare Parts A, B, and D fee-for-service for at least 365 days preceding the date of RZV vaccination or preventive care visit for the RZV unvaccinated comparator. Continuous enrollment is determined by Medicare enrollment in the month of the RZV vaccination or preventative care visit and enrollment in at least 11 of the 12 preceding months. For the cohort analyses:
- For a preventive care visit to be eligible as a comparator, the person must not have had RZV at any time (in available history) prior to the visit or on the day of the visit
- Absence of outcome (PMR, GCA, ION) at any point in the whole baseline period prior to vaccination or the preventive care visit in order to exclude prevalent cases of the outcome prior to the index date.
Age 65 and older at the date of the RZV vaccination or preventive care visit for the RZV unvaccinated comparator
Exclusion criteria:
- Enrolled in Medicare due to disability as the original qualifying reason for enrollment.
Continuously enrolled only in Medicare Part C in the baseline period
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
Recruitment complete
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website