Last updated: 02/20/2024 09:11:14

A study to assess the long-term vaccine effectiveness of Shingrix vaccine given to adults 50 years of age or older in the United States (US)

GSK study ID
209570
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title:
Trial description: This study will evaluate the long-term Vaccine Effectiveness (VE) among individuals ≥ 50 Years who received RZV compared to individuals who did not receive RZV, followed for up to 10 years following the last dose of RZV.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The Vaccine Effectiveness (VE) of 2 doses of RZV in preventing Herpes Zoster (HZ), when the second dose is received 4 weeks to 6 months after the first dose in adults aged ≥ 50 years

Timeframe: During a 10-year follow up period post second dose of vaccination

The VE of 2 doses of RZV in preventing Post-Herpetic Neuralgia (PHN), when the second dose is received 4 weeks to 6 months after the first dose in adults aged ≥ 50 years

Timeframe: During a 10-year follow up period post second dose of vaccination

Secondary outcomes:

The VE of 2 doses of RZV in preventing HZ in adults aged ≥ 50 years stratified by age, by sex and by race/ethnicity, when the second dose is received 4 weeks to 6 months after the first dose

Timeframe: During a 10-year follow up period post second dose of vaccination

The VE of 2 doses of RZV in preventing PHN in adults aged ≥ 50 years stratified by age, by sex and by race/ethnicity, when the second dose is received 4 weeks to 6 months after the first dose

Timeframe: During a 10-year follow up period post second dose of vaccination

The VE of 2 doses of RZV in preventing HZ in adults aged ≥ 50 years by prevalent comorbidities at baseline (kidney disease, heart disease, lung disease, liver disease, diabetes), when the second dose is received 4 weeks to 6 months after the first dose

Timeframe: During a 10-year follow up period post second dose of vaccination

The VE of 2 doses of RZV in preventing HZ in adults aged ≥ 50 years by history of ZVL, when the second dose is received 4 weeks to 6 months after the first dose

Timeframe: During a 10-year follow up period post second dose of vaccination

The incidence of HZ in vaccinated (2 doses of RZV) and RZV unvaccinated adults ≥ 50 years, by prior history of HZ, when the second dose is received 4 weeks to 6 months after the first dose

Timeframe: During a 10-year follow up period post second dose of vaccination

The VE of 2 doses of RZV in preventing Herpes Zoster Ophthalmicus (HZO) in adults aged ≥ 50 years, when the second dose is received 4 weeks to 6 months after the first dose

Timeframe: During a 10-year follow up period post second dose of vaccination

The VE of 2 doses of RZV in preventing hospitalized Acute Myocardial Infarction (AMI), and hospitalized stroke in adults aged ≥ 50 years, when the second dose is received 4 weeks to 6 months after the first dose

Timeframe: During a 10-year follow up period post second dose of vaccination

The VE of 1 dose of RZV in preventing HZ in adults aged ≥ 50 years

Timeframe: During a 10-year follow up period post first dose of vaccination

The VE of 1 dose of RZV in preventing PHN in adults aged ≥ 50 years

Timeframe: During a 10-year follow up period post first dose of vaccination

Interventions:
Not applicable
Enrollment:
800000
Primary completion date:
2031-31-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Kaiser Permanente Southern California (KPSC) Research and Evaluation
Study date(s)
December 2020 to December 2031
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
Yes
  • Age 50 years or more at the index date for all study objectives
  • At least 1 year of continuous KPSC membership before the index date (allowing for a 31-day gap in membership)
  • Individuals who receive a second dose less than 4 weeks after the first dose, since Advisory Committee on Immunization Practices (ACIP) guidelines state that these individuals must repeat the second dose.
  • Individuals with an HZ diagnosis in the 6 months prior to index date.
Inclusion and exclusion criteria
Inclusion criteria:

    Age 50 years or more at the index date for all study objectives

    • At least 1 year of continuous KPSC membership before the index date (allowing for a 31-day gap in membership)
Exclusion criteria:

    Individuals who receive a second dose less than 4 weeks after the first dose, since Advisory Committee on Immunization Practices (ACIP) guidelines state that these individuals must repeat the second dose.

    • Individuals with an HZ diagnosis in the 6 months prior to index date.
    • Individuals with HZ occurring within 30 days after the index date for both exposed and unexposed groups.

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