Japanese Encephalitis Clinical Trial
Official title:
Observer Blinded, Randomized Phase 3 Study to Investigate the Non-Inferiority of IC51 vs. JE-VAX as Vaccines for Japanese Encephalitis in Healthy Subjects
Verified date | March 2024 |
Source | Valneva Austria GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 867 |
Est. completion date | September 2006 |
Est. primary completion date | September 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Valneva Austria GmbH |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56 | SCR: anti-JEV neutralizing antibody titer =1:10 | Day 56 | |
Primary | GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56 | GMT: geometric mean of PRNT50 | Day 56 | |
Secondary | Safety and Adverse Events | until Day 56 | ||
Secondary | Immunogenicity at Day 28 | Day 28 | ||
Secondary | Immunogenicity at Day 56 for North America vs. Europe | Day 56 | ||
Secondary | Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age | Day 56 |
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