A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX
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ClinicalTrials.gov Identifier: NCT00314145 |
Recruitment Status :
Completed
First Posted : April 13, 2006
Results First Posted : December 5, 2012
Last Update Posted : December 6, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Japanese Encephalitis | Biological: ChimeriVax™-JE Biological: JE-VAX® | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 820 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Multicentre, Randomized, Double-blind, Phase III Study of The Comparative Immunogenicity, Safety and Tolerability of Two Japanese Encephalitis Vaccines (ChimeriVax™-JE and JE-VAX®) |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | November 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: ChimeriVax™-JE
Participants received dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine and saline placebo into different arms.
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Biological: ChimeriVax™-JE
0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline) |
Active Comparator: JE-VAX®
Participants received 1 dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a dose of saline placebo into a different arm on Day 30.
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Biological: JE-VAX®
0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline) |
- Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination [ Time Frame: Up to Day 60 post-first vaccination ]Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10.
- Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax® [ Time Frame: Day 0 (Pre-vaccination) up to 60 days post-first vaccination ]
Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported.
Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash.
- Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination [ Time Frame: Up to Day 60 post-first vaccination ]Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).
- Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination [ Time Frame: Day 60 post-first vaccination ]Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314145
United States, Illinois | |
Chicago, Illinois, United States, 60610 | |
United States, Kansas | |
Shawnee Mission, Kansas, United States, 66216 | |
United States, Montana | |
Missoula, Montana, United States, 59802 | |
United States, Texas | |
Dallas, Texas, United States, 75231 | |
United States, Washington | |
Tacoma, Washington, United States, 98403 | |
Australia | |
Adelaide, Australia | |
Melbourne, Australia | |
New South Wales, Australia | |
Queensland, Australia | |
Victoria, Australia |
Principal Investigator: | Luis Angles, M.D. | Heart of America Research Institute |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00314145 |
Other Study ID Numbers: |
H-040-009 |
First Posted: | April 13, 2006 Key Record Dates |
Results First Posted: | December 5, 2012 |
Last Update Posted: | December 6, 2012 |
Last Verified: | December 2012 |
Encephalitis, Japanese Encephalitis Brain Diseases Central Nervous System Diseases Nervous System Diseases Encephalitis, Arbovirus Encephalitis, Viral Central Nervous System Viral Diseases Central Nervous System Infections |
Infections Infectious Encephalitis Arbovirus Infections Vector Borne Diseases Virus Diseases RNA Virus Infections Flavivirus Infections Flaviviridae Infections |