Last updated: 12/04/2024 10:40:23
Targeted safety study to assess the real-world safety of Recombinant zoster vaccine (RZV) in adults aged 50 and older in the United States (US)
GSK study ID
209452
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
Official title: A targeted safety study, EPI-ZOSTER-030 VS US DB, to evaluate the safety of Shingrix in adults ≥ 50 years of age in the United States
Trial description: Post-authorization safety study to assess the real-world safety of Recombinant zoster vaccine (RZV) in the US using a large distributed data network with a focus on specific health outcomes of interest in adults aged 50 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 after RZV vaccination using a Self-controlled Risk Interval (SCRI) design
Timeframe: Within 42 days after RZV vaccination
The risk of new-onset gout within 30 days after RZV vaccination using an SCRI design
Timeframe: Within 30 days after RZV vaccination
The risk of new-onset Polymyalgia Rheumatica (PMR) within 183 days after RZV vaccination using a cohort design
Timeframe: Within 183 days after RZV vaccination
The risk of new-onset Giant Cell Arteritis (GCA) within 183 days after RZV vaccination using a cohort design
Timeframe: Within 183 days after RZV vaccination
Secondary outcomes:
The risk of new-onset Supraventricular Tachycardia (SVT) within 30 days after RZV vaccination using an SCRI design
Timeframe: Within 30 days after RZV vaccination
The risk of new-onset Ischemic Optic Neuropathy (ION) within 183 days after RZV vaccination using a cohort design
Timeframe: Within 183 days after RZV vaccination
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2025-30-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Harvard Pilgrim Health Care Institute
Study date(s)
September 2020 to April 2026
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
Yes
- Inclusion criteria:
- Age ≥ 50 years of age at time of qualifying visit (i.e. RZV vaccination for RZV recipients or preventative care visit date for cohort study comparators).
Inclusion and exclusion criteria
Inclusion criteria:
- Age ≥ 50 years of age at time of qualifying visit (i.e. RZV vaccination for RZV recipients or preventative care visit date for cohort study comparators). For the SCRI analyses:
- First-in-365-days case of the health outcome of interest (HOI) in the risk or control interval (i.e., definition of an incident case).
- 365 days (1 year) of continuous enrolled time, allowing 45-days gap, prior to RZV receipt for GBS and SVT, and the secondary definition of gout.
- 730 days (2 years) of continuous enrolled time, allowing a 45-days gap, prior to RZV receipt for gout.
- Continuous enrollment (without gaps) through the end of the respective control interval during a period when data for the respective Research Partner are determined to be ≥ 90% complete for the outcomes of gout and SVT.
- Continuous enrollment (without gaps) through the end of the respective control interval plus 14 days during a period when data for the respective Research Partner are determined to be ≥ 90% complete for the outcome of GBS. For the cohort analyses:
- RZV vaccination or eligible preventive care visit with 365 days of enrolled time, allowing 45-days gap, before the index date (vaccination or preventive care visit) during a period when data for the respective Research Partner are determined to be ≥ 90% complete.
- 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. Exclusion criteria: Administrative Service Only (ASO) enrollees will be excluded, as their medical records may not be available for review; however, ASO enrollees may be considered for inclusion on an as-needed basis, if allowable and medical records are available.
Inclusion criteria:
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
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