Immunogenicity Study of the Japanese Encephalitis Vaccine IC51

Valneva

Status and phase

Completed

Phase 3

Conditions

Japanese Encephalitis

Treatments

Biological: IC51

Biological: JE-VAX

Study type

Interventional

Funder types

Industry

Identifiers

NCT00604708

IC51-301

Details and patient eligibility

About

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

Enrollment

867 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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