Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
162,000
Countries
1
Sites
2
Herpes Zoster
This trial has two dual-primary objectives: 1) To evaluate the effect of Shingrix® on the risk of MACE, defined as a composite of hospitalization for non-fatal myocardial infarction, non-fatal stroke and cardiovascular death, in adults aged 65 years and older 2) To evaluate the effect of Shingrix® on the risk of new de…
Key facts
- Sponsor
- Gentofte Hospital, GlaxoSmithKline Biologicals
- Participant type
- Healthy volunteers
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 28 Apr 2026 → ongoing
- Decision date (initial)
- 2026-03-04
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- GSK
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Prophylaxis
This trial has two dual-primary objectives:
1) To evaluate the effect of Shingrix® on the risk of MACE, defined as a composite of hospitalization for non-fatal myocardial infarction, non-fatal stroke and cardiovascular death, in adults aged 65 years and older
2) To evaluate the effect of Shingrix® on the risk of new dementia in adults aged 65 years and older.
Secondary objectives 2
- The secondary objectives of this trial are subdivided according to the dual primary endpoints of new dementia and MACE. 1) MACE related secondary objectives To evaluate the effect of Shingrix® on the risk of the following endpoints: -Composite of hospitalization for non-fatal acute coronary syndrome, non-fatal stroke, or cardiovascular death -Hospitalization for any cardiovascular disease -Hospitalization for stroke -Hospitalization for myocardial infarction -Cardiovascular death
- New dementia related secondary objectives To evaluate the effect of Shingrix® on the risk of the following endpoints: – Alzheimer’s dementia – Vascular dementia – Unspecified dementia
Conditions and MedDRA coding
Herpes Zoster
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10019974 | Herpes zoster | 100000004862 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Age 65 years and above at the time of consent
- Informed consent form has been signed and dated
- Self-reported ability to understand written and spoken Danish or English
Exclusion criteria 1
- The study has the following exclusion criteria (self-reporting): 1. A prior diagnosis of dementia 2. Chronic inflammatory rheumatic disease and concomitant immunosuppressive therapy 3. Prior herpes zoster vaccination
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- In line with the study’s primary objective of evaluating the effect of Shingrix® on the risk of MACE and new dementia in adults aged 65 years and older, this trial includes the following dual primary time-to-event endpoints: 1) Hospitalization for MACE 2) new dementia
Secondary endpoints 2
- The secondary endpoints of this trial are subdivided according to the dual primary endpoints of MACE and new dementia.
- MACE-related secondary endpoints The MACE related secondary endpoints are as follows: -Composite of hospitalization for non-fatal acute coronary syndrome, non-fatal stroke, or cardiovascular death -Hospitalization for any cardiovascular disease -Hospitalization for stroke -Hospitalization for myocardial infarction -Cardiovascular death Dementia-related secondary endpoints The new dementia related endpoints are as follows: – Alzheimer’s dementia – Vascular dementia – Unspecified dementia
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD5987176 · Product
- Active substance
- Recombinant Varicella Zoster Virus Glycoprotein E
- Substance synonyms
- GSK-1437173A, RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 mg milligram(s)
- Max total dose
- 2 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BK03 — -
- Marketing authorisation
- EU/1/18/1272/002
- MA holder
- GLAXOSMITHKLINE BIOLOGICALS S.A.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD5987272 · Product
- Active substance
- Recombinant Varicella Zoster Virus Glycoprotein E
- Substance synonyms
- GSK-1437173A, RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 mg milligram(s)
- Max total dose
- 2 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BK03 — -
- Marketing authorisation
- EU/1/18/1272/001
- MA holder
- GLAXOSMITHKLINE BIOLOGICALS S.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Gentofte Hospital
- Sponsor organisation
- Gentofte Hospital
- Address
- Gentofte Hospitalsvej 1
- City
- Hellerup
- Postcode
- 2900
- Country
- Denmark
Scientific contact point
- Organisation
- Gentofte Hospital
- Contact name
- Tor Biering-Sørensen
Public contact point
- Organisation
- Gentofte Hospital
- Contact name
- Tor Biering-Sørensen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| GCP-enheden ved Københavns Universitetshospital ORL-000002325
|
Frederiksberg, Denmark | On site monitoring |
GlaxoSmithKline Biologicals
- Sponsor organisation
- GlaxoSmithKline Biologicals
- Address
- Rue De L'Institut 89
- City
- Rixensart
- Postcode
- 1330
- Country
- Belgium
Sponsor responsibilities
- Article 77 compliance
- Gentofte Hospital
- Contact point sponsor
- Gentofte Hospital
- Article 77 implementation
- Gentofte Hospital
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 162,000 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2026-04-28 | 2026-04-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 25 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | DAN-ZOSTER_Protocol_2025-524944-37-00_TC | 1.3 |
| Protocol (for publication) | Protocol_DAN-ZOSTER_2025-524944-37-00 | 1.3 |
| Recruitment arrangements (for publication) | K1_DAN-ZOSTER Invitation letter | 1.4 |
| Recruitment arrangements (for publication) | K1_DAN-ZOSTER Invitation letter_TC | 1.4 |
| Recruitment arrangements (for publication) | K1_recruitment_arrangement | 1.4 |
| Recruitment arrangements (for publication) | K1_recruitment_arrangement_TC | 1.4 |
| Recruitment arrangements (for publication) | K1_Video script_ENG | 1.4 |
| Recruitment arrangements (for publication) | K1_Video script_ENG_TC | 1.4 |
| Recruitment arrangements (for publication) | K1_video_transkript_DK | 1.4 |
| Recruitment arrangements (for publication) | K1_video_transkript_DK_TC | 1.4 |
| Recruitment arrangements (for publication) | K1_Website advertisment_DK | 1.4 |
| Recruitment arrangements (for publication) | K1_Website advertisment_DK_TC | 1.4 |
| Recruitment arrangements (for publication) | K1_Website advertisment_ENG | 1.4 |
| Recruitment arrangements (for publication) | K1_Website advertisment_ENG_TC | 1.4 |
| Subject information and informed consent form (for publication) | L1_DAN-ZOSTER_deltagerinformation_DK | 1.4 |
| Subject information and informed consent form (for publication) | L1_DAN-ZOSTER_deltagerinformation_TC | 1.4 |
| Subject information and informed consent form (for publication) | L1_DAN-ZOSTER_Informed_Consent_Form_TC | 1.1 |
| Subject information and informed consent form (for publication) | L1_DAN-ZOSTER_Participant Information sheet | 1.4 |
| Subject information and informed consent form (for publication) | L1_DAN-ZOSTER_Participant Information sheet_TC | 1.4 |
| Subject information and informed consent form (for publication) | L1_DAN-ZOSTER_Samtykkeerklring_TC | 1.1 |
| Subject information and informed consent form (for publication) | L1_Informed_Consent_Form_ENG | 1.1 |
| Subject information and informed consent form (for publication) | L1_Samtykkeerklring | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Shingrix | 1.0 |
| Synopsis of the protocol (for publication) | D1_DAN-ZOSTER Protocol-synopsis | 1.2 |
| Synopsis of the protocol (for publication) | D1_DAN-ZOSTER Protocol-synopsis_TC | 1.2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-09 | Denmark | Acceptable 2026-03-03
|
2026-03-04 |