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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
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE April 11, 2006
First Posted Date  ICMJE April 13, 2006
Results First Submitted Date  ICMJE November 6, 2012
Results First Posted Date  ICMJE December 5, 2012
Last Update Posted Date December 6, 2012
Study Start Date  ICMJE October 2005
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2012)
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00314132 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
Official Title  ICMJE Randomised, Double Blind, Multicentre, Placebo Controlled Phase III Study of the Safety and Tolerability Following Administration of Live Attenuated JE Vaccine (ChimeriVax™-JE)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Encephalitis
  • Japanese Encephalitis
Intervention  ICMJE
  • Biological: ChimeriVax-JE, Japanese Encephalitis vaccine
    0.5 mL, Subcutaneous
    Other Name: ChimeriVax™
  • Biological: 0.9% Saline
    0.5 mL, Subcutaneous
Study Arms  ICMJE
  • 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
Publications * 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2012)
2004
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00314132
Other Study ID Numbers  ICMJE H-040-010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steven G Hull, MD Vince and Associates Clinical Research
PRS Account Sanofi
Verification Date December 2012

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