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

Japanese Encephalitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596271
• Other study ID #: IC51-308
• Status: Completed
• Phase: Phase 3
• First received: January 4, 2008
• Last updated: April 9, 2014
• Start date: September 2005
• Est. completion date: August 2008

Study information

• Verified date: April 2014
• Source: Valneva Austria GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-InstitutAustria: Agency for Health and Food SafetyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: August 2008
• Est. primary completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis

Intervention

Biological:
• IC51

• HAVRIX

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Valneva Austria GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	GMT for Hepatitis A Virus (HAV) Antibody at Day 28		Day 28	No
Secondary	Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28		day 28 and 56	No
Secondary	GMT and SCR for PRNT at Day 28 and HAV at Day 56		day 28 and 56	No
Secondary	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	Yes