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

NCT ID: NCT00596271

Last Updated: 2014-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2008-08-31

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.

Conditions

Japanese Encephalitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

IC51 and Placebo

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

Group Type: ACTIVE_COMPARATOR

IC51

Intervention Type: BIOLOGICAL

Placebo

Intervention Type: OTHER

HAVRIX and placebo

HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)

Group Type: ACTIVE_COMPARATOR

HAVRIX

Intervention Type: BIOLOGICAL

Placebo

Intervention Type: OTHER

IC51 and HAVRIX

IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)

Group Type: ACTIVE_COMPARATOR

IC51

Intervention Type: BIOLOGICAL

HAVRIX

Intervention Type: BIOLOGICAL

Interventions

IC51

Intervention Type: BIOLOGICAL

HAVRIX

Intervention Type: BIOLOGICAL

Placebo

Intervention Type: OTHER

Other Intervention Names

Japanese Encephalitis purified inactivated vaccine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Valneva Austria GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Astrid Kaltenboeck, Ph.D.

Role: STUDY_DIRECTOR

Valneva Austria GmbH

Other Identifiers

IC51-308

Identifier Type: -

Identifier Source: org_study_id