Authorised Therapeutic use (Phase IV) 18-64 years old volunteers with general good health

Immune response to intradermally administered Ixiaro in healthy adults

EU CTIS ID: 2024-519876-17-00

What this study is testing

-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).

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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

You likely can't join if

  • 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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.