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
  Purpose

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.


Condition Intervention Phase
Encephalitis
Japanese Encephalitis
Biological: ChimeriVax-JE, Japanese Encephalitis vaccine
Biological: 0.9% Saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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.



Enrollment: 2004
Study Start Date: October 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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™

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314132

Locations
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
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Steven G Hull, MD Vince and Associates Clinical Research
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00314132     History of Changes
Other Study ID Numbers: H-040-010
Study First Received: April 11, 2006
Results First Received: November 6, 2012
Last Updated: December 4, 2012
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Sanofi:
Japanese Encephalitis
Encephalitis virus
ChimeriVax™-JE Vaccine

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Encephalitis, Arbovirus
Encephalitis, Viral
Arbovirus Infections
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Flaviviridae Infections
Flavivirus Infections
Nervous System Diseases
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014