Phase 3
N=820
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX
Japanese Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT00314145 ↗Enrolled (actual)
820
Serious AEs
0.6%
Results posted
Dec 2012
Primary outcome: Primary: Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination — NA; 324; 273; 343 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ChimeriVax™-JE (Biological); JE-VAX® (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Jun 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination |
NA; 324; 273; 343 | — |
| PRIMARY Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® |
262; 105; 123; 27; 107; 29 | — |
| SECONDARY Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination |
NA; 312.3; 37.4; 1391.7 | — |
| SECONDARY Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination |
63; 3; 29; 0; 51; 4 | — |
Summary
The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain after completion of vaccination course.
Eligibility Criteria
Inclusion Criteria
- Subjects aged 18 or above
- Subjects in good general health.
- Females must have negative pregnancy test and be using adequate form of contraception
Exclusion Criteria
- History of vaccination/infection with JE or Yellow fever or other flaviviruses
- History of residence/travel to flavivirus endemic regions
- History of anaphylaxis/serious adverse reactions
- Administration of vaccine within 30 days of study or during treatment period
- Clinically significant physical exam/medical history/lab abnormalities
- Pregnancy
- Excessive alcohol/drug abuse
- Hypersensitivity to constituents of JE-VAX®
- Blood transfusion/treatment with blood product within 6months of study and during study treatment period
- Known/suspected immunodeficiency
- Compromised blood brain barrier
- Employees of Clinical Research Organization (CRO)/study site staff
- Any other condition which would exclude subject.
Data sourced from ClinicalTrials.gov (NCT00314145). 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.