Overview
Sponsor-declared trial summary
18-64 years old volunteers with general good health
-To study whether one dose of intradermally given Ixiaro elicits a noninferior immune response as compared to intramuscular administration of the same vaccine. The immune response is measured as levels of neutralizing serum antibodies (PRNT).
Key facts
- Sponsor
- HUS-Yhtymae
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Decision date (initial)
- 2025-01-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Helsinki University Central Hospital
External identifiers
- EU CT number
- 2024-519876-17-00
- EudraCT number
- 2013-001954-88
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
-To study whether one dose of intradermally given Ixiaro elicits a noninferior
immune response as compared to intramuscular administration
of the same vaccine. The immune response is measured as levels of
neutralizing serum antibodies (PRNT).
Secondary objectives 1
- - To study whether two doses of intradermally administered Ixiaro elicits a non-inferior immune response as compared to one dose of intramuscular administration of the same vaccine. - To compare the immune responses to one vs. two doses of intradermally administered Ixiaro - To study whether intradermally given Ixiaro has a non-inferior adverse event profile as compared to intramuscular administration of the same vaccine. - To study circulating plasmablasts (ELISPOT) and cell-mediated immune responses after intradermal vs. intramuscular Ixiaro.
Conditions and MedDRA coding
18-64 years old volunteers with general good health
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Male or female subjects aged 18-64 2. General good health as established by medical history and physical examination 3. Written informed consent 4. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable. 5. Available for all visits scheduled in this study. 6. No previous Japanese encephalitis vaccination
Exclusion criteria 1
- 1. Previous Japanese encephalitis vaccination 2. Chronic administration of immunosuppressants or other immunemodifying drugs within 6 months before the first dose of IMP; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed 3. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection 4. Pregnancy or lactation 5. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever (fever is defined as body temperature of ≥38 °C). 6. Alcohol or drug abuse 7. Suspected non-compliance 8. Use of any investigational drug or any investigational vaccine within 30 days preceding the study vaccine, or planned use during the study period 9. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator 10. Employee at the investigational site, relative or spouse of the investigator 11. Any other criteria which, in the investigator's opinion, would compromise the ability of the subject to participate in the study, the subject's well-being, or the outcome of the study E.5
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Measurement of levels of neutralizing serum antibodies (PRNT)..
Secondary endpoints 1
- -To study circulating plasmablasts (ELISPOT) and cell-mediated immuneresponses after intradermal vs. intramuscular Ixiaro. - To study adverse event profiles
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
IXIARO suspension for injection Japanese encephalitis vaccine (inactivated, adsorbed)
PRD681426 · Product
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRADERMAL USE
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 0.5 ml millilitre(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- J07BA02 — ENCEPHALITIS, JAPANESE, INACTIVATED, WHOLE VIRUS
- Marketing authorisation
- EU/1/08/501/001
- MA holder
- VALNEVA AUSTRIA GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
HUS-Yhtymae
- Sponsor organisation
- HUS-Yhtymae
- Address
- Stenbackinkatu 9
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Anu Kantele
Public contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Anu Kantele
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 240 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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) | Study_protocol_idIx_25012016 | 2.5 |
| Recruitment arrangements (for publication) | Transitio application blanko file | 1 |
| Subject information and informed consent form (for publication) | Id_Ixiaro_Suostumuskaavake_17032026 | 4 |
| Subject information and informed consent form (for publication) | Id_Ixiaro_Tutkittavan tiedote_17032016 | 4 |
| Subject information and informed consent form (for publication) | Selvitys tutkimuksen suostumusasiakirjoista_30Nov2024 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | ixiaro-epar-product-information_en | 1 |
| Synopsis of the protocol (for publication) | Synopsis_id_Ixiaro_25012016 | 3 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-02 | Finland | Acceptable 2025-01-09
|
2025-01-10 |