Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440

Study Overview
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Brief Summary
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The objective is to investigate the immunogenicity of the Japanese Encephalitis vaccine IC51 (JE-PIV) single and concomitant with HAVRIX® 1440

Detailed Description
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This is a randomized, controlled, multi-center, single-blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years. 192 subjects will be enrolled at 2 sites in Europe.

Official Title
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Safety and Immunogenicity of Concomitant Vaccination With IC51 and HARVIX® 1440 in Healthy Subjects. A Single-blind Randomized, Controlled Phase 3 Study

Conditions
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Japanese Encephalitis

Intervention / Treatment
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* Biological: IC51
* Biological: HAVRIX
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age In female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the study period and 30 days after the last vaccination by practicing reliable methods of contraception 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) History of any previous Hepatitis A vaccination and infection 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 Planned administration of another vaccine during the study period Immunodeficiency including post-organ-transplantation or immunosuppressive therapy A family history of congenital or hereditary immunodeficiency History of autoimmune disease Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. Any acute infections within 4 weeks prior to enrollment Infection with human immunodeficiency virus (HIV), Hepatitis B (HBsAg) or Hepatitis C

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IC51 and Placebo<br>6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0) | Biological: IC51<br> <br> * Other names: Japanese Encephalitis purified inactivated vaccine;Other: Placebo<br> <br> |
| Active Comparator: HAVRIX and placebo<br>HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28) | Biological: HAVRIX<br> <br> Other: Placebo<br> <br> |
| Active Comparator: IC51 and HAVRIX<br>IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0) | Biological: IC51<br> <br> * Other names: Japanese Encephalitis purified inactivated vaccine;Biological: HAVRIX<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies | anti-JEV Neutralizing Antibodies were tabulated for IC51 groups only; for HAV GMTs (co-primary endpoint GMT for Hepatitis A Virus (HAV) Antibody at Day 28), please refer to Outcome 2 within outcome measure section | Day 56 | 
| GMT for Hepatitis A Virus (HAV) Antibody at Day 28 |  | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28 |  | day 28 and 56 | 
| GMT and SCR for PRNT at Day 28 and HAV at Day 56 |  | day 28 and 56 | 
| Safety | Rate of Adverse Events (AEs), Serious Adverse Events (SAEs) and medically attended AEs, local and systemic tolerability, changes in safety laboratory parameters (hematology, serum chemistry, urinalysis) | until 6 month after last vaccination |