Phase 3
Completed N=387
Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51
Source: ClinicalTrials.gov NCT00595465 ↗Enrolled (actual)
387
Serious AEs
0.8%
Results posted
Nov 2012
Primary outcomePrimary: Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody — 160.8; 188.2; 168.4 titers
Summary
The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody |
160.8; 188.2; 168.4 | — |
| SECONDARY Seroconversion Rate |
— | — |
| SECONDARY Safety and Adverse Events |
— | — |
Eligibility Criteria
Main 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
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 (NCT00595465). 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.