Herpes ZosterPhase 4NCT07502560
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
A Phase 4 study testing Recombinant zoster vaccine in people with Herpes Zoster, run by GlaxoSmithKline at 8 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 76 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Recombinant zoster vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33,609 participants
- Where
- 8 sitesFinland
- Study dates
- 31 Mar 2026to 31 Mar 2037
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 76 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Finland8 sites, 8 recruiting
- Recruiting
GSK Investigational Site
Espoo, 02230
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Helsinki, 00100
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Jarvenpaa, 04400
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Kokkola, 67100
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Oulu, 90220
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seinäjoki, 60100
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Tampere, 33100
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Turku, 20520
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Randomized, Placebo Controlled, Observer-blind, Phase IV Pragmatic Trial to Evaluate the Effect of Recombinant Zoster Vaccine (Shingrix) on Incident Dementia Diagnosis in an Older Adult Population Aged ≥76 Years in Finland
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.
- Conditions
- Herpes Zoster
- Being tested
- Recombinant zoster vaccine, Placebo
- Keywords
- Recombinant Zoster Vaccine, Shingrix, Herpes Zoster, Incident dementia, Alzheimer's Disease, Older adults, Finland
- Medical subject headings
- Herpes Zoster, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant zoster vaccineBiological
Also called Shingrix
Recombinant zoster vaccine administered intramuscularly, one dose at Visit 1 (Day 1) and one dose at Visit 2 (between 2 and 6 months after the first dose), according to the approved recombinant zoster vaccine dosing schedule.
PlaceboDrug
Placebo administered intramuscularly, one dose at Visit 1 (Day 1) and one dose at Visit 2 (between 2 and 6 months after the first dose).
| Study group | Role | What they receive |
|---|---|---|
| Recombinant zoster vaccine Group | Experimental | Participants in this group receive recombinant zoster vaccine, the first dose being administered at Visit 1 (Day 1) and the second dose at Visit 2 (between 2 and 6 months after the first dose), according to the approved recombinant zoster vaccine dosing schedule. Receives: Biological: Recombinant zoster vaccine |
| Placebo Group | Placebo comparator | Participants in this group receive placebo, the first dose being administered at Visit 1 (Day 1) and the second dose at Visit 2 (between 2 and 6 months after the first dose). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hazard ratio of incident dementia diagnosis
Dementia diagnosis is defined as the first-time diagnosis of dementia as identified during the follow-up period.
Measured: 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
Secondary outcomes (2)
Hazard ratio of incident dementia diagnosis
Dementia diagnosis is defined as the first-time diagnosis of dementia as identified during the follow-up period.
Measured: 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
Alzheimer's disease diagnosis is defined as the first-time diagnosis of Alzheimer's disease as identified during the follow-up period.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start31 Mar 2026
- Primary completion1 Apr 2030 (estimated)
- Study completion31 Mar 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33,609 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Finnish Vaccine Research;, Dr Arto Palmu
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502560
- Sponsor's protocol ID
- 300889
- Other IDs
- 2025-524598-17-00, 2025
- Status last verified
- May 2026
- First submitted
- 25 Mar 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://d3l8i7lo48obsd.cloudfront.net/gsk-patient-level-data-sharing-july2025-1-Bgwa1UthxvluYbWYTThw.pdf
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, Observer-blind, Phase IV Pragmatic Trial to Evaluate the Effect of Recombinant Zoster Vaccine (Shingrix) on Incident Dementia Diagnosis in an Older Adult Population Aged ≥76 Years in Finland
- ClinicalTrials.gov ID
- NCT07502560
- Acronym / sponsor ID
- 300889
- Conditions
- Herpes Zoster
- Keywords
- Recombinant Zoster Vaccine, Shingrix, Herpes Zoster, Incident dementia, Alzheimer's Disease, Older adults, Finland
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33,609 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Finnish Vaccine Research;, Dr Arto Palmu
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 31 Mar 2037 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant zoster vaccine Group | Experimental | Biological: Recombinant zoster vaccineParticipants in this group receive recombinant zoster vaccine, the first dose being administered at Visit 1 (Day 1) and the second dose at Visit 2 (between 2 and 6 months after the first dose), according to the approved recombinant zoster vaccine dosing schedule. |
| Placebo Group | Placebo comparator | Drug: PlaceboParticipants in this group receive placebo, the first dose being administered at Visit 1 (Day 1) and the second dose at Visit 2 (between 2 and 6 months after the first dose). |
Who may qualify
- Ages
- 76 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- Prior receipt of a Herpes Zoster (HZ) vaccine.
- History of dementia diagnosis prior to enrolment, including confirmed cases or those under investigation. This includes:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant zoster vaccineAlso: ShingrixRecombinant zoster vaccine administered intramuscularly, one dose at Visit 1 (Day 1) and one dose at Visit 2 (between 2 and 6 months after the first dose), according to the approved recombinant zoster vaccine dosing schedule. | Biological | Recombinant zoster vaccine Group |
| PlaceboPlacebo administered intramuscularly, one dose at Visit 1 (Day 1) and one dose at Visit 2 (between 2 and 6 months after the first dose). | Drug | Placebo Group |
Primary outcome
Hazard ratio of incident dementia diagnosis
Time frame: 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
Dementia diagnosis is defined as the first-time diagnosis of dementia as identified during the follow-up period.
2 secondary outcomes
Hazard ratio of incident dementia diagnosis
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://d3l8i7lo48obsd.cloudfront.net/gsk-patient-level-data-sharing-july2025-1-Bgwa1UthxvluYbWYTThw.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Recombinant zoster vaccine in people with Herpes Zoster, run by GlaxoSmithKline at 8 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hazard ratio of incident dementia diagnosis (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.