A Study to Evaluate the Effect of Recombinant Zoster Vaccine on New Diagnosis of Dementia in an Older Adult Population Aged 76 Years or Older in Finland
Trial overview
Hazard ratio of incident dementia diagnosis
Timeframe: From first dose of study intervention (Day 1) until the date of first dementia diagnosis, death, loss to follow-up, or end of data availability, whichever occurs first, assessed up to 10 years
Hazard ratio of incident dementia diagnosis
Timeframe: From 1 month after second dose of study intervention (2 to 6 months after first dose of study intervention) until the date of first dementia diagnosis, death, loss to follow-up, or end of data availability, whichever occurs first, assessed up to 10 years
Hazard ratio of incident Alzheimer’s disease diagnosis
Timeframe: From first dose of study intervention (Day 1) until the date of first Alzheimer’s disease diagnosis, death, loss to follow-up, or end of data availability, whichever occurs first, assessed up to 10 years
Participation criteria
- Citizens living permanently in Finland, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure. Informed consent will include consent to access health register data for participants.
- Prior receipt of a Herpes Zoster (HZ) vaccine.
- History of dementia diagnosis prior to enrolment, including confirmed cases or those under investigation. This includes:
- Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure. Informed consent will include consent to access health register data for participants.
- Age 76 years or older at the time of signing the informed consent.
Citizens living permanently in Finland, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- History of dementia diagnosis prior to enrolment, including confirmed cases or those under investigation. This includes:
- History of a confirmed clinical diagnosis of dementia prior to enrolment.
- Prior or current use of medications intended to treat dementia.
- Severely immunocompromised individuals.
- Concurrently participating in another clinical trial, in which the participant has been or will be exposed to an investigational product or ongoing participation in trials focused on preventive dementia interventions.
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.
- Living in a nursing facility.
Prior receipt of a Herpes Zoster (HZ) vaccine.
Current or recent history of cognitive assessments for any memory deficit or suspected dementia before enrolment including investigations that are ongoing or that were inconclusive (but not those for which dementia was conclusively ruled out); mild cognitive impairment on its own without any other information to indicate cognitive decline or dementia will not result in exclusion.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.