A Study on the Occurrence of New Herpes Zoster (HZ) Cases, Complications, and Healthcare Utilization Prior to and Following the Introduction of Recombinant Zoster Vaccine (RZV) in the United States (US)
Trial overview
Temporal trends in HZ incidence in US adults aged ≥50 years, characterized descriptively
Timeframe: Across the pre-RZV introduction period (January 2007–October 2017) and the post-RZV introduction period (November 2017–March 2025)
Temporal trends in HZ incidence in US adults aged ≥50 years, assessed by using a regression-based approach
Timeframe: Across the pre-RZV introduction period (January 2007–October 2017) and the post-RZV introduction period (November 2017–March 2025)
Temporal trends in HZ complications in US adults aged ≥50 years, characterized descriptively and assessed by using a regression-based approach
Timeframe: Across the pre-RZV introduction period (January 2007–October 2017) and the post-RZV introduction period (November 2017–March 2025)
Temporal trends in HZ-related Healthcare resource utilization (HCRU) in US adults aged ≥50 years, characterized descriptively and assessed by using a regression-based approach
Timeframe: Across the pre-RZV introduction period (January 2007–October 2017) and the post-RZV introduction period (November 2017–March 2025)
Temporal trends in HZ incidence in US adults aged 40–49 years, characterized descriptively and assessed by using a regression-based approach
Timeframe: Across the pre-RZV introduction period (January 2007–October 2017) and the post-RZV introduction period (November 2017–March 2025)
Temporal trends in HZ complications in US adults aged 40–49 years, characterized descriptively and assessed by using a regression-based approach
Timeframe: Across the pre-RZV introduction period (January 2007–October 2017) and the post-RZV introduction period (November 2017–March 2025)
Temporal trends in HZ-related HCRU in US adults aged 40–49 years, characterized descriptively and assessed by using a regression-based approach
Timeframe: Across the pre-RZV introduction period (January 2007–October 2017) and the post-RZV introduction period (November 2017–March 2025)
Temporal trends in HZ incidence in US adults aged ≥50 years, characterized descriptively and assessed by using a regression-based approach within subgroups stratified by age group, insurance type, comorbidities and clinical conditions
Timeframe: Across the pre-RZV introduction period (January 2007–October 2017) and the post-RZV introduction period (November 2017–March 2025)
Temporal trends in HZ complications in US adults aged ≥50 years, characterized descriptively and assessed by using a regression-based approach within subgroups stratified by age group, insurance type, comorbidities and clinical conditions
Timeframe: Across the pre-RZV introduction period (January 2007–October 2017) and the post-RZV introduction period (November 2017–March 2025)
Temporal trends in HZ-related HCRU in US adults aged ≥50 years, characterized descriptively and assessed by using a regression-based approach within subgroups stratified by age group, insurance type, comorbidities and clinical conditions
Timeframe: Across the pre-RZV introduction period (January 2007–October 2017) and the post-RZV introduction period (November 2017–March 2025)
Temporal trends in HZ incidence in US adults aged 40–49 years, characterized descriptively and assessed by using a regression-based approach within subgroups stratified by insurance type, comorbidities and clinical conditions
Timeframe: Across the pre-RZV introduction period (January 2007–October 2017) and the post-RZV introduction period (November 2017–March 2025)
Temporal trends in HZ complications in US adults aged 40–49 years, characterized descriptively and assessed by using a regression-based approach within subgroups stratified by insurance type, comorbidities and clinical conditions
Timeframe: Across the pre-RZV introduction period (January 2007–October 2017) and the post-RZV introduction period (November 2017–March 2025)
Temporal trends in HZ-related HCRU in US adults aged 40–49 years, characterized descriptively and assessed by using a regression-based approach within subgroups stratified by insurance type, comorbidities and clinical conditions
Timeframe: Across the pre-RZV introduction period (January 2007–October 2017) and the post-RZV introduction period (November 2017–March 2025)
Participation criteria
- Primary monthly cohorts
- Aged ≥50 years as of the index date, defined as the first date of the corresponding calendar year-month.
- Not applicable
- Note: No exclusion criteria are applied during monthly cohort construction.
- Aged ≥50 years as of the index date, defined as the first date of the corresponding calendar year-month.
- Had at least 12 months of continuous enrollment prior to the index date (baseline period).
- Had at least one month of continuous enrollment from the index date for outcome assessment of HZ incidence, RZV uptake, and HZ-related HCRU. Patients who died within the corresponding monthly cohort will be retained to mitigate potential survival bias. Specifically, retaining these patients avoids conditioning the analysis on survival through the assessment window, which may lead to underestimation of HZ incidence, complications, and HZ-related HCRU, particularly among older or medically complex patients.
- Additional continuous enrollment requirement for HZ complication assessment among patients with HZ onset during the follow-up:
- When assessing postherpetic neuralgia (PHN) complications requiring a relatively longer identification window, a minimum of 7 months of continuous enrollment following the monthly cohort index date is required. Patients who died within 6 months after the end of the corresponding monthly cohort will be retained to mitigate potential survivor bias. Rationale: PHN is defined based on persistent PHN-related diagnoses or treatments occurring ≥90 days after HZ onset, with follow-up extending up to 6 months post-index. This enrollment requirement aligns with prior GSK HZ studies and published literature and ensures adequate observation time to capture PHN diagnoses or treatments that may occur later in disease course. Shorter follow-up windows may increase sample size but risk under-ascertainment of PHN burden.
- Aged 40–49 years as of the index date, defined as the first date of the corresponding calendar year-month.
- Had at least 12 months of continuous enrollment prior to the index date (baseline period).
- Had at least one month of continuous enrollment after the index date.
- For analyses assessing HZ complication outcomes, the same continuous enrollment requirement applied to the Primary cohort will be used for the Reference cohort. Individuals may enter multiple monthly Primary and Reference cohorts provided they meet inclusion criteria at each month’s index date. Individuals in the Reference cohort may subsequently enter the Primary cohort in later months if they meet age and cohort-specific eligibility criteria.
Primary monthly cohorts
When assessing ocular complications, a minimum of 2 months of continuous enrollment following the index date is required. Patients who died within 1 month after the end of the corresponding monthly cohort will be retained to mitigate potential survivor bias. Rationale: Ocular complications are defined based on related diagnosis within 30 days after HZ onset. Reference monthly cohorts
Not applicable Note: No exclusion criteria are applied during monthly cohort construction. Eligibility criteria specific to each outcome are addressed in the outcome definition. For example, potential misclassification of ongoing versus incident HZ episodes is addressed through outcome definitions, which apply a 6-month look-back period to identify incident or recurrent HZ episodes. For HZ complications, patients with diagnosis codes for HZ-related complications in the absence of an HZ diagnosis will not be classified as having HZ and will not contribute to HZ-related outcome analyses.
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.