Safety and Tolerability of the Japanese Encephalitis Vaccine IC51

Valneva

Status and phase: Completed; Phase 3

Conditions: Japanese Encephalitis

Treatments: Biological: Placebo; Biological: Japanese Encephalitis purified inactivated vaccine (IC51)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00605085

IC51-302

Details and patient eligibility

About

The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged > or = 18 years

Enrollment: 2,675 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

• 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
• History of any previous JE vaccination (e.g. JE-VAX®)
• Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
• A family history of congenital or hereditary immunodeficiency
• History of autoimmune disease
• Any acute infections within 2 weeks prior to enrollment
• Known or suspected HIV Infection
• Pregnancy, lactation or unreliable contraception in female subjects

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,675 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

IC51

Treatment:

Biological: Japanese Encephalitis purified inactivated vaccine (IC51)

2

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Placebo