Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
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ClinicalTrials.gov Identifier: NCT00314132 |
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 |
---|---|---|
Encephalitis Japanese Encephalitis | Biological: ChimeriVax-JE, Japanese Encephalitis vaccine Biological: 0.9% Saline | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2004 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Randomised, Double Blind, Multicentre, Placebo Controlled Phase III Study of the Safety and Tolerability Following Administration of Live Attenuated JE Vaccine (ChimeriVax™-JE) |
Study Start Date : | October 2005 |
Actual Primary Completion Date : | November 2006 |
Actual Study Completion Date : | November 2006 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
All subjects received a single injection of placebo on Day 0.
|
Biological: 0.9% Saline
0.5 mL, Subcutaneous |
Experimental: ChimeriVax™ JE 4 log10 PFU Vaccine
All participants received a single injection of ChimeriVax™ JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0.
|
Biological: ChimeriVax-JE, Japanese Encephalitis vaccine
0.5 mL, Subcutaneous
Other Name: ChimeriVax™ |
- Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo [ Time Frame: Day 0 up to 30 days post-vaccination ]Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30.
- Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo [ Time Frame: Day 0 up to 30 days post-vaccination ]
Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported.
Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported.

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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:
- Informed consent obtained from the subject.
- Aged 18 years or above at screening.
- In good general health
- Subject available for the study duration
- For female subjects (of child bearing potential) a negative pregnancy tests at Screening and Day 0.
Exclusion Criteria:
- A history of vaccination against or infection with JE.
- Known or suspected immunodeficiency, use of immunosuppressive or antineoplastic drugs.
- History of thymoma, thymic surgery (removal) or myasthenia gravis.
- Clinically significant abnormalities on laboratory assessment
- Anaphylaxis or other serious adverse reactions characterised by urticaria or angioedema to foods, Hymenoptera (bee family) stings, or drugs including vaccines).
- Transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit or up to Day 30.
- Administration of another vaccine or antiviral within 30 days preceding the Screening visit or up to Day 30.
- Physical examination indicating any clinically significant medical condition.
- Oral temperature >38°C (100.4°F) or acute illness within 3 days prior to inoculation.
- Intention to travel out of the area for an extended period that may affect the subjects ability to attend clinic visits prior to the study visit up to Day 30.
- Seropositive to hepatitis C virus (HCV) or HIV or positive for Hepatitis B Surface Antigen.
- Lactation or intended pregnancy in female subjects.
- Excessive alcohol consumption, drug abuse, significant psychiatric illness.
- A known or suspected physiological or structural condition that compromises the integrity of the blood-brain barrier (e.g. cerebrovascular disease, multiple sclerosis, trauma, infection, inflammation of the brain or meninges).
- Participation in another clinical study within 30 days of the screening visit for this study.
- Employee of the study site, Sponsor or Clinical Research Organization (CRO) involved with the management of the study.
- Any other reasons, which in the investigator's opinion, makes the subject unsuitable to participate in the study.

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): NCT00314132
United States, California | |
Burbank, California, United States, 92505 | |
Costa Mesa, California, United States, 92708 | |
Davis, California, United States, 95616 | |
San Francisco, California, United States, 94102 | |
Vallejo, California, United States, 94589 | |
United States, Florida | |
Miami, Florida, United States, 33173 | |
Orlando, Florida, United States, 32809 | |
Pembroke Pines, Florida, United States, 33024 | |
United States, Iowa | |
Iowa City, Iowa, United States, 52242 | |
United States, Kansas | |
Overland Park, Kansas, United States, 66212 | |
United States, Kentucky | |
Bardstown, Kentucky, United States, 40004 | |
United States, Michigan | |
Livonia, Michigan, United States, 48152 | |
United States, Missouri | |
Sprnigfield, Missouri, United States, 65802 | |
United States, Nebraska | |
Omaha, Nebraska, United States, 68134 | |
United States, North Carolina | |
Winston Salem, North Carolina, United States, 27109 | |
United States, Texas | |
Fort Worth, Texas, United States, 76135 | |
Australia | |
Darlinghurst, Australia, NSW 2010 | |
Enoggera, Australia, QLD 4051 | |
Heidelbeg West, Australia, VIC 3081 | |
Kippa-Ring, Australia, QLD 4021 | |
Mill Park, Australia, VIC 3082 | |
Toorak Gardens, Australia, SA 5056 |
Principal Investigator: | Steven G Hull, MD | Vince and Associates Clinical Research |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00314132 |
Other Study ID Numbers: |
H-040-010 |
First Posted: | April 13, 2006 Key Record Dates |
Results First Posted: | December 5, 2012 |
Last Update Posted: | December 6, 2012 |
Last Verified: | December 2012 |
Japanese Encephalitis Encephalitis virus ChimeriVax™-JE Vaccine |
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 |