Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00314132
Recruitment Status : Completed
First Posted : April 13, 2006
Results First Posted : December 5, 2012
Last Update Posted : December 6, 2012
Information provided by (Responsible Party):

April 11, 2006
April 13, 2006
November 6, 2012
December 5, 2012
December 6, 2012
October 2005
November 2006   (Final data collection date for primary outcome measure)
  • 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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Complete list of historical versions of study NCT00314132 on Archive Site
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Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
Randomised, Double Blind, Multicentre, Placebo Controlled Phase III Study of the Safety and Tolerability Following Administration of Live Attenuated JE Vaccine (ChimeriVax™-JE)
The purpose of this study is to assess whether ChimeriVax™ JE vaccine (a new vaccine to be used for vaccination against Japanese encephalitis) is safe and well tolerated when compared to placebo (dummy) vaccination.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Encephalitis
  • Japanese Encephalitis
  • Biological: ChimeriVax-JE, Japanese Encephalitis vaccine
    0.5 mL, Subcutaneous
    Other Name: ChimeriVax™
  • Biological: 0.9% Saline
    0.5 mL, Subcutaneous
  • Placebo Comparator: Placebo
    All subjects received a single injection of placebo on Day 0.
    Intervention: Biological: 0.9% Saline
  • 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.
    Intervention: Biological: ChimeriVax-JE, Japanese Encephalitis vaccine
Torresi J, McCarthy K, Feroldi E, Méric C. Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: Randomised controlled phase 3 trials. Vaccine. 2010 Nov 23;28(50):7993-8000. doi: 10.1016/j.vaccine.2010.09.035. Epub 2010 Oct 8.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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November 2006
November 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Australia,   United States
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Principal Investigator: Steven G Hull, MD Vince and Associates Clinical Research
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP