Phase 2
Completed N=60
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX
Source: ClinicalTrials.gov NCT00319592 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcomePrimary: Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine — 0; 7; 0; 16 Participants
Summary
The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVax™-JE and JE-VAX® to the respective homologous virus strain and several wild types strains after completion of vaccination course.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine |
0; 7; 0; 16; 18; 24 | — |
| PRIMARY Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE |
5.0; 5.0; 5.0; 15.2; 5.0; 36.5 | — |
| PRIMARY Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine. |
0; 0; 29; 23; 24; 7 | — |
| PRIMARY Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX® |
5.0; 5.0; 3115.9; 485.6; 1727.3; 44.4 | — |
| PRIMARY Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX® |
2; 1; 0; 0; 3; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent obtained.
- Aged ≥18 to <49 years.
- In good general health.
- Available for the study duration, including all planned follow-up visits.
- Females must have negative pregnancy test and be using adequate form of contraception
Exclusion Criteria
- Clinically significant abnormalities on laboratory and vital sign assessments.
- Anaphylaxis or other serious adverse reactions
- Administration of another vaccine within 30 days of study treatment period.
- Physical examination indicating any significant medical condition.
- Intention to travel out of the area prior to the study visit on Day 56.
- Seropositive to Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) or positive for Hepatitis B Surface Antigen.
- Pregnancy.
- Excessive alcohol consumption, drug abuse.
- Involvement in another clinical study within 60 days preceding the screening visit and during study treatment period.
Data sourced from ClinicalTrials.gov (NCT00319592). 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.