Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00314132




Registration number
NCT00314132
Ethics application status
Date submitted
11/04/2006
Date registered
13/04/2006
Date last updated
6/12/2012

Titles & IDs
Public title
Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
Scientific title
Randomised, Double Blind, Multicentre, Placebo Controlled Phase III Study of the Safety and Tolerability Following Administration of Live Attenuated JE Vaccine (ChimeriVax™-JE)
Secondary ID [1] 0 0
H-040-010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Encephalitis 0 0
Japanese Encephalitis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - ChimeriVax-JE, Japanese Encephalitis vaccine
Treatment: Other - 0.9% Saline

Placebo comparator: Placebo - All subjects received a single injection of placebo on Day 0.

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.


Treatment: Other: ChimeriVax-JE, Japanese Encephalitis vaccine
0.5 mL, Subcutaneous

Treatment: Other: 0.9% Saline
0.5 mL, Subcutaneous
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Timepoint [1] 0 0
Day 0 up to 30 days post-vaccination
Primary outcome [2] 0 0
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Timepoint [2] 0 0
Day 0 up to 30 days post-vaccination

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2006
Sample size
Target
Accrual to date
Final
2004
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment hospital [2] 0 0
- Enoggera
Recruitment hospital [3] 0 0
- Heidelbeg West
Recruitment hospital [4] 0 0
- Kippa-Ring
Recruitment hospital [5] 0 0
- Mill Park
Recruitment hospital [6] 0 0
- Toorak Gardens
Recruitment postcode(s) [1] 0 0
NSW 2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
QLD 4051 - Enoggera
Recruitment postcode(s) [3] 0 0
VIC 3081 - Heidelbeg West
Recruitment postcode(s) [4] 0 0
QLD 4021 - Kippa-Ring
Recruitment postcode(s) [5] 0 0
VIC 3082 - Mill Park
Recruitment postcode(s) [6] 0 0
SA 5056 - Toorak Gardens
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Steven G Hull, MD
Address 0 0
Vince and Associates Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00314132