Ability of the new Vero-cell-derived inactivated Japanese encephalitis vaccine (IXIARO) to elicit a booster response in travellers previously vaccinated with traditional mouse-brain derived vaccine (JE-MB)
- Conditions
- The study subjects are healthy travelers and have no major chronic illnesses.
- Registration Number
- EUCTR2010-023300-27-FI
- Lead Sponsor
- Helsinki University Central Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
- male and female travelers over 18 years of age
- general good health
- written informed consent
- ability to attend all visits scheduled in the study
- travelers who have previously received a primary series of 2 or 3 doses of JE-MB and are now given a booster vaccination with Japanese Encephalitis Vaccine - GCC or IXIARO because of their upcoming trip to Asia
OR
- travelers who are previously unvaccinated against JE and are given the primary vaccination series with IXIARO at the travel clinic because of their upcoming trip to Asia
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
- age below 18 years
- acute disease at the enrollment
- pregnancy or lactation
- known immunodeficiency or immune suppressive treatment
- any chronic illness that might interfere with the immune response
- alcohol or drug abuse
- any clinically significant history of known or suspected anaphylaxis or hypersensitivity based on the judgement of the investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of the trial is to compare immunological responses induced by a booster vaccination with IXIARO and Japanese Encephalitis Vaccine-GCC in travellers who have previously received a primary vaccination series against Japanese encephalitis with Japanese Encephalitis Vaccine-GCC. These immune responses are measured in volunteers receiving Japanese encephalitis vaccine as a part of their pretravel councelling.;Secondary Objective: - to compare the above mentioned serological responses to the ones that are found in travellers who have received only a primary series of IXIARO or Japanese Encephalitis Vaccine-GCC ;Primary end point(s): - seroconversion rates and levels of neutralizing antibodies
- Secondary Outcome Measures
Name Time Method