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
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 76
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
Finland
GSK Investigational Site
RECRUITING
Espoo
GSK Investigational Site
RECRUITING
Helsinki
GSK Investigational Site
RECRUITING
Jarvenpaa
GSK Investigational Site
RECRUITING
Kokkola
GSK Investigational Site
RECRUITING
Oulu
GSK Investigational Site
RECRUITING
Seinäjoki
GSK Investigational Site
RECRUITING
Tampere
GSK Investigational Site
RECRUITING
Turku
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2026-03-31
Estimated Completion Date: 2037-03-31
Participants
Target number of participants: 33609
Treatments
Experimental: Recombinant zoster vaccine Group
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.
Placebo_comparator: Placebo Group
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).
Sponsors
Collaborators: Finnish Vaccine Research;, Dr Arto Palmu
Leads: GlaxoSmithKline