NCT00604708CompletedPhase 3
Observer Blinded, Randomized Phase 3 Study to Investigate the Non-Inferiority of IC51 vs. JE-VAX as Vaccines for Japanese Encephalitis in Healthy Subjects
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Valneva Austria GmbH
- Enrollment
- 867
- Primary Endpoint
- SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
JE-VAX
Active Comparator
given s.c. on Day 0, 7 and 28
Intervention: JE-VAX (Biological)
IC51
Experimental
6 mcg (microgram) i.m. (intramuscular) on Day0, 14 and 28
Intervention: IC51 (Biological)
Outcomes
Primary Outcomes
SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56
Time Frame: Day 56
SCR: anti-JEV neutralizing antibody titer ≥1:10
GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56
Time Frame: Day 56
GMT: geometric mean of PRNT50
Secondary Outcomes
- Immunogenicity at Day 28(Day 28)
- Safety and Adverse Events(until Day 56)
- Immunogenicity at Day 56 for North America vs. Europe(Day 56)
- Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age(Day 56)
Investigators
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