Health TrialsbyHealthPanel

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

ConditionHerpes Zoster
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age76+
SponsorGlaxoSmithKline

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Prior receipt of a Herpes Zoster (HZ) vaccine.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Recombinant zoster vaccine

    Biological/Vaccine

    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.

  • Placebo

    Drug

    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).

Treatment groups

33,609 Participants
are divided into 2 treatment groups
Group A: Recombinant zoster vaccine GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hazard ratio of incident dementia diagnosis

Dementia diagnosis is defined as the first-time diagnosis of dementia as identified during the follow-up period.

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

Secondary outcomes

1

Hazard ratio of incident dementia diagnosis

Dementia diagnosis is defined as the first-time diagnosis of dementia as identified during the follow-up period.

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
2

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Finnish Vaccine Research;

Collaborator

Dr Arto Palmu

Collaborator

Source ClinicalTrials.gov
Apply now