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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00604708
Other study ID # IC51-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2005
Est. completion date September 2006

Study information

Verified date March 2024
Source Valneva Austria GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

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

Study Design


Intervention

Biological:
IC51
IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
JE-VAX
JE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Valneva Austria GmbH

Outcome

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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