Immunogenicity of a Commercial Batch of the Japanese Encephalitis Vaccine IC51 up to Twenty-four Months Post Filling. An Open-label, Multicenter, Phase 3 Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Valneva Austria GmbH
- Enrollment
- 304
- Locations
- 3
- Primary Endpoint
- Primary: 1. Geometric Mean Titers (GMT) at Day 56
Study Overview
Brief Summary
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.
Detailed 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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
IC51 (~24 months post filling)
6 mcg (~24 months post filling)
Intervention: IC51 (Biological)
IC51 (~18 months post filling)
6 mcg (~18 months post filling)
Intervention: IC51 (Biological)
IC51 (~12 months post filling)
6 mcg (~12 months post filling)
Intervention: IC51 (Biological)
Outcomes
Primary Outcomes
Primary: 1. Geometric Mean Titers (GMT) at Day 56
Time Frame: 56 days post 1st vaccination
Secondary Outcomes
- Secondary: 1. Seroconversion Rate 2. GMTs Day 28, Month 6 and Month 12 3. Treatment Emergent Adverse Events 4. Systemic and Local Tolerability(see above)