Effect of a Booster Dose 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

NCT00595309

IC51-311

Details and patient eligibility

About

The objective is to assess the effect of a booster vaccination on immunogenicity of IC51 in terms of seroconversion rate.

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Healthy adults who completed the primary immunization in study IC51 309
• Male and female healthy subjects aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test

Main Exclusion Criteria:

• History of immunodeficiency or immunosuppressive therapy, known Human Immunodeficiency Virus (HIV), or drug addiction including alcohol dependence

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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198 participants in 1 patient group

A

Active Comparator group

Treatment:

Biological: IC51