Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51

Valneva

Status and phase: Completed; Phase 3

Conditions: Japanese Encephalitis

Treatments: Biological: Japanese Encephalitis purified inactivated vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00595465

IC51-310

Details and patient eligibility

About

The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody

Enrollment: 389 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Male and female healthy adults 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: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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389 participants in 3 patient groups

IC51 Batch A

Active Comparator group

Treatment:

Biological: Japanese Encephalitis purified inactivated vaccine

IC51 Batch B

Active Comparator group

Treatment:

Biological: Japanese Encephalitis purified inactivated vaccine

IC51 Batch C

Active Comparator group

Treatment:

Biological: Japanese Encephalitis purified inactivated vaccine