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

Phase 3

Completed

• Conditions: Japanese Encephalitis
• Interventions: Biological: IC51; Biological: HAVRIX; Other: Placebo

• Registration Number: NCT00596271
• Lead Sponsor: Valneva Austria GmbH

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2006-07
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-16
• Study Completion: 2008-08
• Results First Submitted: 2013-11-12
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-09
• Last Update Submitted: 2014-04-09
• Results First Posted: 2014-05-13
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IC51 and Placebo	IC51	6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
IC51 and Placebo	Placebo	6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
HAVRIX and placebo	HAVRIX	HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
HAVRIX and placebo	Placebo	HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
IC51 and HAVRIX	IC51	IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
IC51 and HAVRIX	HAVRIX	IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies	Day 56	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
GMT for Hepatitis A Virus (HAV) Antibody at Day 28	Day 28

Secondary Outcome Measures

Name	Time	Method
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	until 6 month after last vaccination	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)