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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00314145




Registration number
NCT00314145
Ethics application status
Date submitted
11/04/2006
Date registered
13/04/2006
Date last updated
6/12/2012

Titles & IDs
Public title
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX
Scientific title
A Multicentre, Randomized, Double-blind, Phase III Study of The Comparative Immunogenicity, Safety and Tolerability of Two Japanese Encephalitis Vaccines (ChimeriVax™-JE and JE-VAX®)
Secondary ID [1] 0 0
H-040-009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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
Other interventions - ChimeriVax™-JE
Other interventions - JE-VAX®

Experimental: ChimeriVax™-JE - Participants received dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine and saline placebo into different arms.

Active Comparator: JE-VAX® - Participants received 1 dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a dose of saline placebo into a different arm on Day 30.


Other interventions: ChimeriVax™-JE
0.5 mL, Subcutaneous (ChimeriVax™-JE); 1.0 mL, (Saline)

Other interventions: JE-VAX®
0.5 mL, Subcutaneous (JE-Vax®); 1.0 mL, (Saline)
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Timepoint [1] 0 0
Up to Day 60 post-first vaccination
Primary outcome [2] 0 0
Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Timepoint [2] 0 0
Day 0 (Pre-vaccination) up to 60 days post-first vaccination
Secondary outcome [1] 0 0
Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Timepoint [1] 0 0
Up to Day 60 post-first vaccination
Secondary outcome [2] 0 0
Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Timepoint [2] 0 0
Day 60 post-first vaccination

Eligibility
Key inclusion criteria
- Subjects aged 18 or above

- Subjects in good general health.

- Females must have negative pregnancy test and be using adequate form of contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of vaccination/infection with JE or Yellow fever or other flaviviruses

- History of residence/travel to flavivirus endemic regions

- History of anaphylaxis/serious adverse reactions

- Administration of vaccine within 30 days of study or during treatment period

- Clinically significant physical exam/medical history/lab abnormalities

- Pregnancy

- Excessive alcohol/drug abuse

- Hypersensitivity to constituents of JE-VAX®

- Blood transfusion/treatment with blood product within 6months of study and during
study treatment period

- Known/suspected immunodeficiency

- Compromised blood brain barrier

- Employees of Clinical Research Organization (CRO)/study site staff

- Any other condition which would exclude subject.

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
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2006
Sample size
Target
Accrual to date
Final
820
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Melbourne
Recruitment hospital [3] 0 0
- New South Wales
Recruitment hospital [4] 0 0
- Queensland
Recruitment hospital [5] 0 0
- Victoria
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- New South Wales
Recruitment postcode(s) [4] 0 0
- Queensland
Recruitment postcode(s) [5] 0 0
- Victoria
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Montana
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine non-inferiority in seroconversion and to compare
the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous
virus strain after completion of vaccination course.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00314145
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Luis Angles, M.D.
Address 0 0
Heart of America Research Institute
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00314145