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โ† Trials
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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

RecruitingPhase 4Ages 76 Years - anyAllGlaxoSmithKline
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Recombinant zoster vaccine
  • Placebo
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Where

8 sites
GSK Investigational Site
Espoo, Finland
GSK Investigational Site
Helsinki, Finland
GSK Investigational Site
Jarvenpaa, Finland
GSK Investigational Site
Kokkola, Finland
GSK Investigational Site
Oulu, Finland
GSK Investigational Site
Seinรคjoki, Finland
GSK Investigational Site
Tampere, Finland
GSK Investigational Site
Turku, Finland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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