Phase 3
N=198
Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
Japanese Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT00595309 ↗Enrolled (actual)
198
Serious AEs
4.0%
Results posted
Jun 2012
Primary outcome: Primary: Seroconversion Rate — 98.5 percent
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
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seroconversion Rate |
98.5 | — |
| SECONDARY Safety and Adverse Events |
— | — |
| SECONDARY Seroconversion |
— | — |
| SECONDARY Geometric Mean Titer |
— | — |
Summary
The objective is to assess the effect of a booster vaccination on immunogenicity of IC51 in terms of seroconversion rate.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00595309). 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.