Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling

Valneva

Status and phase: Completed; Phase 3

Conditions: Japanese Encephalitis

Treatments: Biological: IC51

Study type: Interventional

Funder types: Industry

Identifiers

NCT00776230

IC51-314

Details and patient eligibility

About

The objective is to assess immunogenicity of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) in terms of Geometric Mean Titers (GMT) for anti-JEV neutralizing antibodies at Day 56 after the first vaccination.

Full description

Open-label, multicenter, phase 3 study assessing immunogenicity at various time points throughout the shelf-life of a commercial batch of IC51 (Batch IC51/07F/008) The study population consists of male and female healthy subjects, aged at least 18 years.

The study will be performed at 3 study centers in Germany and Austria. Three sequential cohorts, each containing 100 subjects, will be enrolled into the study at approximately 12, 18 and 24 months after filling of the commercial batch IC51/07F/008 of IC51

Enrollment: 304 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Exclusion criteria

• History of immunodeficiency or immunosuppressive therapy, known HIV infection, drug addiction including alcohol dependence, prior vaccination against JE

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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304 participants in 3 patient groups

IC51 (~12 months post filling)

Active Comparator group

Description:

6 mcg (\~12 months post filling)

Treatment:

Biological: IC51

IC51 (~18 months post filling)

Active Comparator group

Description:

6 mcg (\~18 months post filling)

Treatment:

Biological: IC51

IC51 (~24 months post filling)

Active Comparator group

Description:

6 mcg (\~24 months post filling)

Treatment:

Biological: IC51