Immunogenicity Study of the Japanese Encephalitis Vaccine IC51

Phase 3

Completed

• Conditions: Japanese Encephalitis
• Interventions: Biological: IC51; Biological: JE-VAX

• Registration Number: NCT00604708
• Lead Sponsor: Valneva Austria GmbH

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-16
• Study First Posted: 2008-01-30
• Results First Submitted: 2012-05-24
• Results First Submitted QC: 2012-10-31
• Results First Posted: 2012-11-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 867

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IC51	IC51	6 mcg (microgram) i.m. (intramuscular) on Day0, 14 and 28
JE-VAX	JE-VAX	given s.c. on Day 0, 7 and 28

Primary Outcome Measures

Name	Time	Method
SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56	Day 56	SCR: anti-JEV neutralizing antibody titer ≥1:10
GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56	Day 56	GMT: geometric mean of PRNT50

Secondary Outcome Measures

Name	Time	Method
Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age	Day 56
Safety and Adverse Events	until Day 56
Immunogenicity at Day 56 for North America vs. Europe	Day 56
Immunogenicity at Day 28	Day 28