The study subjects are healthy travelers and have no major chronic illnesses.
Conditions
Interventions
Trade Name: IXIARO
Product Name: IXIARO
Pharmaceutical Form: Suspension for injection
CAS Number: 0
Other descriptive name: JAPANESE ENCEPHALITIS VACCINE
Trade Name: Japanese Encephalitis Vaccine - G
Sponsors
Helsinki University Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Finland
Outcome results
None listed