Immunogenicity Study of the Japanese Encephalitis Vaccine IC51 (NCT00604708) | Clinical Trial Compass
CompletedPhase 3
Immunogenicity Study of the Japanese Encephalitis Vaccine IC51
867 participantsStarted 2005-09
Plain-language summary
The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51 compared to JE-VAX in healthy subjects aged \> or = 18 years
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At least 18 years of age
* Written informed consent obtained prior to study entry
Exclusion Criteria:
* History of clinical manifestation of any flavivirus infection
* History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer \>= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis)
* Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
* Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
* A family history of congenital or hereditary immunodeficiency
* History of autoimmune disease
* Any acute infections within 4 weeks prior to enrollment
* Infection with HIV, Hepatitis B or Hepatitis C
* Pregnancy, lactation or unreliable contraception in female subjects
What they're measuring
1
SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56
Timeframe: Day 56
2
GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56