An Observational Study Using Real-World Data to Assess the Association between Recombinant Zoster Vaccination and Cardiovascular Risk Reduction by Inflammatory Risk in United States Adults
Trial overview
Hazard ratio of hospitalized CVD events among any (≥1) RZV dose vaccinated and matched unvaccinated individuals, overall and by inflammatory risk group
Timeframe: From Day 1 after the index date [RZV Dose 1 date (vaccinated) & comparable matched index date (unvaccinated)] until the earliest of the outcome of interest or a censoring event
Dose-specific hazard ratio of hospitalized CVD events among RZV vaccinated and matched unvaccinated individuals, overall and by inflammatory risk group
Timeframe: From Day 1 after the index date [RZV Dose 1 date (vaccinated)&comparable matched index date (unvaccinated)] until the earliest of the outcome of interest or a censoring event,with person-time during follow-up classified by time-updated vaccination states
Dose-specific hazard ratio of hospitalized acute myocardial infarction (AMI) among RZV vaccinated and matched unvaccinated individuals, overall and by inflammatory risk group
Timeframe: From Day 1 after the index date [RZV Dose 1 date (vaccinated)&comparable matched index date (unvaccinated)] until the earliest of the outcome of interest or a censoring event,with person-time during follow-up classified by time-updated vaccination states
Dose-specific hazard ratio of hospitalized stroke (ischemic stroke, hemorrhagic stroke) in RZV vaccinated and matched unvaccinated individuals, overall and by inflammatory risk group
Timeframe: From Day 1 after the index date [RZV Dose 1 date (vaccinated)&comparable matched index date (unvaccinated)] until the earliest of the outcome of interest or a censoring event,with person-time during follow-up classified by time-updated vaccination states
Participation criteria
- Age >=50 YOA on index date.
- Continuous enrollment with medical and pharmacy benefits during baseline period, allowing for a <=30-day gap in enrolment.
- Most recent hsCRP test result >10 mg/L identified in the hsCRP identification period.
- Recent history of CVD event [myocardial infarction (MI) or stroke] in any setting in the 3 months prior to and including the index date. Claims identified for stroke with traumatic brain injury codes in the principal or primary diagnosis position will not be considered for exclusion.
- Continuous enrollment with medical and pharmacy benefits during baseline period, allowing for a <=30-day gap in enrolment.
- Occurrence of a valid hsCRP test result during the 1-year period prior to index date.
Age >=50 YOA on index date.
- Recent history of CVD event [myocardial infarction (MI) or stroke] in any setting in the 3 months prior to and including the index date. Claims identified for stroke with traumatic brain injury codes in the principal or primary diagnosis position will not be considered for exclusion.
- History of zoster vaccine live (ZVL) during baseline period.
- History of RZV in the period prior to index date (earliest date of study start is 01 January 2017, exclusion accounts for any receipt prior to 01 January 2018).
Most recent hsCRP test result >10 mg/L identified in the hsCRP identification period.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.