Immunogenicity Study of the Japanese Encephalitis Vaccine IC51

NCT ID: NCT00604708

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 867 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2006-09-30

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

Conditions

Japanese Encephalitis

Study Design

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

Study Groups

IC51

6 mcg (microgram) i.m. (intramuscular) on Day0, 14 and 28

Group Type: EXPERIMENTAL

IC51

Intervention Type: BIOLOGICAL

IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28

JE-VAX

given s.c. on Day 0, 7 and 28

Group Type: ACTIVE_COMPARATOR

JE-VAX

Intervention Type: BIOLOGICAL

JE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28

Interventions

IC51

IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28

Intervention Type: BIOLOGICAL

JE-VAX

JE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28

Intervention Type: BIOLOGICAL

Other Intervention Names

Japanese Encephalitis purified inactivated vaccine

Eligibility Criteria

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

• 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

IC51-301

Identifier Type: -

Identifier Source: org_study_id