Overview
Sponsor-declared trial summary
No medical condition, prophylactic vaccine against dengue fever
To assess whether the Qdenga vaccine cause significantly elevated levels of cross-reactive IgG antibody levels against TBEV, YFV, ZIKV and JE at day 90 after two doses of Qdenga compared to before vaccination.
Key facts
- Sponsor
- Region Vaesterbotten, Umea University
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Phenomena and Processes [G] - Immune System Phenomena [G13], Diseases [C] - Virus Diseases [C02], Phenomena and Processes [G] - Immune system processes [G12]
- Trial duration
- 11 Sep 2025 → ongoing
- Decision date (initial)
- 2025-05-14
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Diagnosis, Safety
To assess whether the Qdenga vaccine cause significantly elevated levels of cross-reactive IgG antibody levels against TBEV, YFV, ZIKV and JE at day 90 after two doses of Qdenga compared to before vaccination.
Conditions and MedDRA coding
No medical condition, prophylactic vaccine against dengue fever
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Able to participate in all parts of the study
- Signed written informed consent
- 18 years of age or older
- Negative pregnancy test (urine HCG) for women of childbearing potential
- Planning to travel to a dengue fever endemic country. The guidelines by the Swedish Society for Infectious Diseases Physicians will be used in a shared decision-making process when deciding on vaccination
Exclusion criteria 14
- Unable to provide signed written informed consent
- Previous vaccination with a dengue fever vaccine
- Pregnancy or breastfeeding
- Immunocompromised condition due to illness or medication which prevents vaccination with a live vaccine according to the view of the investigator
- Systemic cortisone treatment (inhaled corticosteroids are allowed)
- Previous or present hepatitis B, hepatitis C and/or HIV
- Chronic liver failure (Child-Pugh Class B or higher)
- Chronic kidney disease (CKD stage 3 or higher)
- Autoinflammatory disease (i.e. inflammatory bowel disease, rheumatological disease or dermatological disease)
- Cancer diagnosis with active treatment (excluding hormone treatment only)
- Allergy to a component of the Qdenga® vaccine
- Not suitable for participation in the study according to the view of the investigator
- Participation or recent participation (within 30 days from inclusion) in a clinical trial with an investigational medicinal product
- Previous participation in this trial
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- IgG antibody levels in serum against TBEV, YFV, ZIKV and JE at day 90 after two doses of Qdenga compared to before vaccination
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Qdenga powder and solvent for solution for injection Dengue tetravalent vaccine (live, attenuated)
PRD10110227 · Product
- Active substance
- Dengue Virus, Serotype 2, Live, Attenuated
- Substance synonyms
- TDV-2
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BX04 — -
- Marketing authorisation
- EU/1/22/1699/001
- MA holder
- TAKEDA GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Vaesterbotten
- Sponsor organisation
- Region Vaesterbotten
- Address
- Koksvagen 11, Alidhem Alidhem
- City
- Umea
- Postcode
- 907 37
- Country
- Sweden
Scientific contact point
- Organisation
- Region Vaesterbotten
- Contact name
- Martin Angelin
Public contact point
- Organisation
- Region Vaesterbotten
- Contact name
- Martin Angelin
Umea University
- Sponsor organisation
- Umea University
- Address
- Universitetstorget 4, Alidhem Alidhem
- City
- Umea
- Postcode
- 907 36
- Country
- Sweden
Scientific contact point
- Organisation
- Region Vaesterbotten
- Contact name
- Martin Angelin
Public contact point
- Organisation
- Region Vaesterbotten
- Contact name
- Martin Angelin
Sponsor responsibilities
- Article 77 compliance
- Region Vaesterbotten
- Contact point sponsor
- Region Vaesterbotten
- Article 77 implementation
- Region Vaesterbotten
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 30 | 1 |
| 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 |
|---|---|---|---|---|---|
| Sweden | 2025-09-11 | 2025-09-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | DenVacc Provningsprotokoll 2025-520655-92-00_for publication | 2 |
| Recruitment arrangements (for publication) | DenVacc Annonstext 2025-520655-92-00_for publication | 1 |
| Recruitment arrangements (for publication) | DenVacc Annonstext kort 2025-520655-92-00_for publication | 1 |
| Recruitment arrangements (for publication) | DenVacc Forfarande for rekrytering och samtyckesprocess 2025-520655-92-00 | 1 |
| Subject information and informed consent form (for publication) | DenVacc Information till forsoksperson 2025-520655-92-00_for publication | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | DenVacc SmPC Qdenga 2025-520655-92-00 | 1 |
| Synopsis of the protocol (for publication) | DenVacc Sv synopsis 2025-520655-92-00 | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-07 | Sweden | Acceptable 2025-05-13
|
2025-05-14 |