Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51

Valneva

Status and phase: Completed; Phase 3

Conditions: Japanese Encephalitis

Treatments: Biological: IC51

Study type: Interventional

Funder types: Industry

Identifiers

NCT00595790

IC51-304

Details and patient eligibility

About

The study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51 (JE-PIV) in healthy subjects aged > or = 18 years

Full description

This is a multicenter, observer blinded, controlled, randomized phase 3 study. The study population consists of healthy male and female volunteers, aged at least 18 years.

Approximately 375 volunteers will be enrolled at approximately 2 to 3 sites.

Enrollment: 374 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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374 participants in 3 patient groups

IC51 2 x 6 mcg

Active Comparator group

Description:

2 x 6 mcg (microgram)

Treatment:

Biological: IC51

IC51 1 x 12 mcg

Active Comparator group

Description:

1 x 12 mcg (microgram)

Treatment:

Biological: IC51

IC51 1 x 6 mcg

Active Comparator group

Description:

1 x 6 mcg (microgram)

Treatment:

Biological: IC51