Phase 3
N=639
Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51
Japanese Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT00594958 ↗Enrolled (actual)
639
Serious AEs
1.6%
Results posted
Jan 2014
Primary outcome: Primary: GMT for Anti-JEV Neutralizing Antibody — 160.71; 272.24; 127.56 GMT
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
- Apr 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY GMT for Anti-JEV Neutralizing Antibody |
160.71; 272.24; 127.56 | — |
| SECONDARY Safety |
— | — |
| SECONDARY SCR for Anti-JEC Neutralizing Antibody Titer |
— | — |
Summary
The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.
Eligibility Criteria
Main Inclusion Criteria:
- Male and female 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 HIV, drug addiction including alcohol dependence
Data sourced from ClinicalTrials.gov (NCT00594958). 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.