N/A
Completed N=3,258
Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51
Source: ClinicalTrials.gov NCT00596102 ↗Enrolled (actual)
3,258
Serious AEs
1.1%
Results posted
Jul 2014
Primary outcomePrimary: Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) — 81.8 percentage of subjects
Summary
The study investigates the long term safety and immunogenicity of the Japanese Encephalitis vaccine IC51 up to month 60.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) |
— | — |
| SECONDARY Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) |
— | — |
| SECONDARY Geometric Mean Titers |
— | — |
| SECONDARY Adverse Events |
— | — |
Eligibility Criteria
Inclusion Criteria
- Healthy subjects at least 18 years of age
- Written informed consent obtained prior to study entry
- Subjects correctly included and having completed clinical studies IC51-301 (NCT00604708) and IC51-302 (NCT00605085) with at least one vaccination
Exclusion Criteria
- Inability or unwillingness to provide informed consent and to abide the requirements of the study
Data sourced from ClinicalTrials.gov (NCT00596102). 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. Informational only — not medical advice.