Phase 3
N=304
Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling
Japanese Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT00776230 ↗Enrolled (actual)
304
Serious AEs
1.0%
Results posted
Jan 2014
Primary outcome: Primary: Primary: 1. Geometric Mean Titers (GMT) at Day 56 — 100.1; 84.7; 68.1 Geometric Mean Titer - Estimate
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IC51 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Valneva Austria GmbH
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary: 1. Geometric Mean Titers (GMT) at Day 56 |
100.1; 84.7; 68.1 | — |
| SECONDARY Secondary: 1. Seroconversion Rate 2. GMTs Day 28, Month 6 and Month 12 3. Treatment Emergent Adverse Events 4. Systemic and Local Tolerability |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00776230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.