Recombinant zoster (Shingrix) to see if it lowers new dementia diagnoses in people 76 and older in Finland.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 randomized, placebo-controlled study enrolls Finnish adults aged 76 and older and randomizes them 3:1 to receive recombinant zoster vaccine (Shingrix) or placebo. Participants must be permanent residents of Finland without a prior dementia diagnosis or prior receipt of any herpes zoster vaccine and will provide consent to link their health register data. The primary outcome is occurrence of a new dementia diagnosis measured through Finnish health registers over follow-up after vaccination. As a post-licensure study sponsored by GlaxoSmithKline, it relies on registry-based outcomes to capture real-world diagnoses rather than intensive in-person cognitive testing.

Why it matters

Who can join: the full rules

Inclusion 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.
* Age 76 years or older at the time of signing the informed consent.

Exclusion Criteria:

* Prior receipt of a Herpes Zoster (HZ) vaccine.
* 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.
  * 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.
* 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.

Where it's running

• GSK Investigational Site
  Espoo, Finland Recruiting
• GSK Investigational Site
  Helsinki, Finland Recruiting
• GSK Investigational Site
  Jarvenpaa, Finland Recruiting
• GSK Investigational Site
  Kokkola, Finland Recruiting
• GSK Investigational Site
  Oulu, Finland Recruiting
• GSK Investigational Site
  Seinäjoki, Finland Recruiting

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.