NCT07502560 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
| NCT ID | NCT07502560 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | GlaxoSmithKline |
| Condition | Herpes Zoster |
| Study Type | INTERVENTIONAL |
| Enrollment | 33,609 participants |
| Start Date | 2026-03-31 |
| Primary Completion | 2030-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 33,609 participants in total. It began in 2026-03-31 with a primary completion date of 2030-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the effect of the recombinant zoster vaccine on the risk of new diagnosis of dementia among adults aged 76 years or older in Finland. Participants will be enrolled and randomized in a 3:1 ratio to receive either recombinant zoster vaccine or placebo.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07502560 clinical trial?
This trial is open to participants of all sexes, aged 76 Years or older, studying Herpes Zoster. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07502560 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07502560 currently recruiting?
Yes, NCT07502560 is actively recruiting participants. Contact the research team at GSKClinicalSupportHD@gsk.com for enrollment information.
Where is the NCT07502560 trial being conducted?
This trial is being conducted at Espoo, Finland, Helsinki, Finland, Jarvenpaa, Finland, Kokkola, Finland and 4 additional locations.
Who is sponsoring the NCT07502560 clinical trial?
NCT07502560 is sponsored by GlaxoSmithKline. The trial plans to enroll 33,609 participants.