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

December 4, 2012 updated by: Sanofi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2004

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
  • 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
    • Florida
      • Miami, Florida, United States, 33173
      • Orlando, Florida, United States, 32809
      • Pembroke Pines, Florida, United States, 33024
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Kansas
      • Overland Park, Kansas, United States, 66212
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
    • Michigan
      • Livonia, Michigan, United States, 48152
    • Missouri
      • Sprnigfield, Missouri, United States, 65802
    • Nebraska
      • Omaha, Nebraska, United States, 68134
    • North Carolina
      • Winston Salem, North Carolina, United States, 27109
    • Texas
      • Fort Worth, Texas, United States, 76135

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • ChimeriVax™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 up to 30 days post-vaccination
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.
Day 0 up to 30 days post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Principal Investigator: Steven G Hull, MD, Vince and Associates Clinical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

April 11, 2006

First Submitted That Met QC Criteria

April 11, 2006

First Posted (Estimate)

April 13, 2006

Study Record Updates

Last Update Posted (Estimate)

December 6, 2012

Last Update Submitted That Met QC Criteria

December 4, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-040-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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