Recombinant varicella zoster virus glycoprotein E for Herpes zoster|Major adverse cardiovascular events (MACE)|Dementia (including Alzheimer\u2019s disease and vascular dementia)

Inclusion criteria

• {"criterion_text":"- Age 65 years and above at the time of consent\n- Informed consent form has been signed and dated\n- Self-reported ability to understand written and spoken Danish or English"}

Exclusion criteria

• {"criterion_text":"- The study has the following exclusion criteria (self-reporting):\n- A prior diagnosis of dementia\n- Chronic inflammatory rheumatic disease and concomitant immunosuppressive therapy\n- Prior herpes zoster vaccination"}

Primary endpoints

• {"endpoint_text":"- Hospitalization for MACE\n- new dementia","definition_or_measurement_approach":"Time-to-event endpoints derived from Danish nationwide administrative health registries and medical record review. MACE defined as a composite of hospitalization for non-fatal myocardial infarction, non-fatal stroke and cardiovascular death. New dementia identified from registry/medical record diagnoses and coded as time-to-event."}

Secondary endpoints

• {"endpoint_text":"- The secondary endpoints of this trial are subdivided according to the dual primary endpoints of MACE and new dementia.\n- Composite of hospitalization for non-fatal acute coronary syndrome, non-fatal stroke, or cardiovascular death\n- Hospitalization for any cardiovascular disease\n- Hospitalization for stroke\n- Hospitalization for myocardial infarction\n- Cardiovascular death\n- Alzheimer’s dementia\n- Vascular dementia\n- Unspecified dementia","definition_or_measurement_approach":"Secondary endpoints are event-based and identified via Danish nationwide administrative health registries and hospitalisation records; subdivided into MACE-related events (hospitalisation/outcomes) and dementia subtypes identified in registries/medical records."}

Methods

• Invitation letter (document: K1_DAN-ZOSTER Invitation letter) — targeted at eligible adults aged 65 years and above in Denmark
• Website advertisement (documents: K1_Website advertisment_DK and K1_Website advertisment_ENG) — online recruitment targeting the Danish population aged 65+ (materials in Danish and English)
• Video (K1_video_transkript_DK and K1_Video script_ENG) — audiovisual recruitment material for Denmark
• Recruitment arrangement document (K1_recruitment_arrangement) describing local recruitment logistics in Denmark

Denmark

Earliest CTIS Part Ii Submission Date

26-02-2026

Latest Decision Or Authorization Date

04-03-2026

Processing Time Days

6

Number Of Sites

2

Number Of Participants

162000

Primary sponsor

Full Name

Gentofte Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"GCP-enheden ved Københavns Universitetshospital","duties_or_roles":"1","organisation_type":"Health care"}
• {"country":"Belgium","full_name":"GlaxoSmithKline Biologicals","duties_or_roles":"Source of monetary support","organisation_type":"Pharmaceutical company"}

Co-sponsors

• GlaxoSmithKline Biologicals