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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00314132
First received: April 11, 2006
Last updated: December 4, 2012
Last verified: December 2012

April 11, 2006
December 4, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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.

Not Provided
Complete list of historical versions of study NCT00314132 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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. Epub 2010 Oct 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2004
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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT00314132
H-040-010
No
Sanofi
Sanofi
Not Provided
Principal Investigator: Steven G Hull, MD Vince and Associates Clinical Research
Sanofi
December 2012

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