Back to resultsImmunogenicity Study of the Japanese Encephalitis Vaccine IC51
Primary Purpose
Japanese Encephalitis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
IC51
JE-VAX
Sponsored by
About this trial
This is an interventional prevention trial for Japanese Encephalitis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IC51
JE-VAX
Arm Description
6 mcg (microgram) i.m. (intramuscular) on Day0, 14 and 28
given s.c. on Day 0, 7 and 28
Outcomes
Primary Outcome Measures
SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56
SCR: anti-JEV neutralizing antibody titer ≥1:10
GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56
GMT: geometric mean of PRNT50
Secondary Outcome Measures
Safety and Adverse Events
Immunogenicity at Day 28
Immunogenicity at Day 56 for North America vs. Europe
Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00604708
Brief Title
Immunogenicity Study of the Japanese Encephalitis Vaccine IC51
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valneva Austria GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Japanese Encephalitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
867 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IC51
Arm Type
Experimental
Arm Description
6 mcg (microgram) i.m. (intramuscular) on Day0, 14 and 28
Arm Title
JE-VAX
Arm Type
Active Comparator
Arm Description
given s.c. on Day 0, 7 and 28
Intervention Type
Biological
Intervention Name(s)
IC51
Other Intervention Name(s)
Japanese Encephalitis purified inactivated vaccine
Intervention Description
IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
Intervention Type
Biological
Intervention Name(s)
JE-VAX
Intervention Description
JE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28
Primary Outcome Measure Information:
Title
SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56
Description
SCR: anti-JEV neutralizing antibody titer ≥1:10
Time Frame
Day 56
Title
GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56
Description
GMT: geometric mean of PRNT50
Time Frame
Day 56
Secondary Outcome Measure Information:
Title
Safety and Adverse Events
Time Frame
until Day 56
Title
Immunogenicity at Day 28
Time Frame
Day 28
Title
Immunogenicity at Day 56 for North America vs. Europe
Time Frame
Day 56
Title
Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age
Time Frame
Day 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astrid Kaltenboeck, Ph.D.
Organizational Affiliation
Valneva Austria GmbH
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity Study of the Japanese Encephalitis Vaccine IC51
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