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

Primary Purpose

Encephalitis, Japanese Encephalitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ChimeriVax-JE, Japanese Encephalitis vaccine
0.9% Saline
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Encephalitis focused on measuring Japanese Encephalitis, Encephalitis virus, ChimeriVax™-JE Vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

ChimeriVax™ JE 4 log10 PFU Vaccine

Arm Description

All subjects received a single injection of placebo on Day 0.

All participants received a single injection of ChimeriVax™ JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0.

Outcomes

Primary Outcome Measures

Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
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
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.

Secondary Outcome Measures

Full Information

First Posted
April 11, 2006
Last Updated
December 4, 2012
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00314132
Brief Title
Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encephalitis, Japanese Encephalitis
Keywords
Japanese Encephalitis, Encephalitis virus, ChimeriVax™-JE Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2004 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
All subjects received a single injection of placebo on Day 0.
Arm Title
ChimeriVax™ JE 4 log10 PFU Vaccine
Arm Type
Experimental
Arm Description
All participants received a single injection of ChimeriVax™ JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0.
Intervention Type
Biological
Intervention Name(s)
ChimeriVax-JE, Japanese Encephalitis vaccine
Other Intervention Name(s)
ChimeriVax™
Intervention Description
0.5 mL, Subcutaneous
Intervention Type
Biological
Intervention Name(s)
0.9% Saline
Intervention Description
0.5 mL, Subcutaneous
Primary Outcome Measure Information:
Title
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Description
Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30.
Time Frame
Day 0 up to 30 days post-vaccination
Title
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Description
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.
Time Frame
Day 0 up to 30 days post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven G Hull, MD
Organizational Affiliation
Vince and Associates Clinical Research
Official's Role
Principal Investigator
Facility Information:
City
Burbank
State/Province
California
ZIP/Postal Code
92505
Country
United States
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92708
Country
United States
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States
City
Sprnigfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27109
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
City
Darlinghurst
ZIP/Postal Code
NSW 2010
Country
Australia
City
Enoggera
ZIP/Postal Code
QLD 4051
Country
Australia
City
Heidelbeg West
ZIP/Postal Code
VIC 3081
Country
Australia
City
Kippa-Ring
ZIP/Postal Code
QLD 4021
Country
Australia
City
Mill Park
ZIP/Postal Code
VIC 3082
Country
Australia
City
Toorak Gardens
ZIP/Postal Code
SA 5056
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
20934459
Citation
Torresi J, McCarthy K, Feroldi E, Meric 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.
Results Reference
derived

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

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