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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00982137




Registration number
NCT00982137
Ethics application status
Date submitted
21/09/2009
Date registered
22/09/2009
Date last updated
20/09/2012

Titles & IDs
Public title
Study of Live Attenuated Japanese Encephalitis Vaccine (ChimeriVax™-JE) and Yellow Fever Vaccine (STAMARIL®)
Scientific title
Randomised, Double-blind, Phase II Evaluation of the Safety and Immunogenicity Following Administration of Live Attenuated JE Vaccine (ChimeriVax™-JE) and Yellow Fever Vaccine (STAMARIL®)
Secondary ID [1] 0 0
H-040-006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Japanese Encephalitis 0 0
Yellow Fever 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 - Live attenuated Japanese encephalitis virus; Yellow fever virus
Treatment: Other - Yellow fever virus; Live attenuated Japanese encephalitis virus
Treatment: Other - Live attenuated Japanese encephalitis virus; Yellow fever virus
Treatment: Other - Live attenuated Japanese encephalitis virus; Yellow fever virus

Experimental: ChimeriVax™-JE then STAMARIL® - Participants will receive ChimeriVax™-JE on Day 0 and STAMARIL® on Day 30

Experimental: STAMARIL® then ChimeriVax™-JE - Participants will receive STAMARIL® on Day 0 and ChimeriVax™-JE on Day 30

Experimental: ChimeriVax™-JE and STAMARIL®, then Diluent - Participants will receive ChimeriVax™-JE and STAMARIL® on Day 0 and diluent on Day 30.

Experimental: Diluent then ChimeriVax™-JE and STAMARIL® - Participants will receive Diluent on Day 0 and ChimeriVax™-JE and STAMARIL® on Day 30.


Treatment: Other: Live attenuated Japanese encephalitis virus; Yellow fever virus
ChimeriVax™-JE, 0.5 mL, Subcutaneous on Day 0; STAMARIL®, 0.5 mL, Subcutaneous on Day 30.

Treatment: Other: Yellow fever virus; Live attenuated Japanese encephalitis virus
STAMARIL®, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous on Day 30.

Treatment: Other: Live attenuated Japanese encephalitis virus; Yellow fever virus
ChimeriVax™-JE, 0.5 mL Subcutaneous and STAMARIL®, 0.5 mL, Subcutaneous on Day 0; Diluent 0.5 mL, Subcutaneous on Day 30.

Treatment: Other: Live attenuated Japanese encephalitis virus; Yellow fever virus
Diluent, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous and STAMARIL®, 0.5 mL Subcutaneous on Day 30.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Japanese Encephalitis Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.
Timepoint [1] 0 0
Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)
Primary outcome [2] 0 0
Number of Participants With Yellow Fever Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL® or Placebo Vaccination.
Timepoint [2] 0 0
Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)
Primary outcome [3] 0 0
Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination
Timepoint [3] 0 0
Day 0 (Pre-vaccination) through Day 30 post-vaccination
Primary outcome [4] 0 0
Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo
Timepoint [4] 0 0
Day 0 up to Day 60 post-vaccination
Secondary outcome [1] 0 0
Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.
Timepoint [1] 0 0
Day 0 through 6 months post-vaccination
Secondary outcome [2] 0 0
Geometric Mean Titers to Yellow Fever (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo
Timepoint [2] 0 0
Day 0 through 6 months post-vaccination

Eligibility
Key inclusion criteria
Inclusion Criteria :

* All aspects of the protocol explained and written informed consent obtained from the participant.
* Aged = 18 to = 55 years at Day 0.
* In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results.
* Participant must be available for the study duration, including all planned follow-up visits.
* The participant must agree to take the following precautions to avoid insect bites for 7 days following vaccination: (a) wear long-sleeved shirts and trousers; (b) apply N,N-Diethyl-meta-toluamide (DEET)-containing insect repellents; (c) sleep in screened enclosures.
* Female participants of childbearing potential must have a negative serum pregnancy test. An efficacious hormonal method (i.e., oral, implantable or injectable) of contraception or an intrauterine contraceptive device (IUCD) must be used at least 1 month before Screening and at least 1 month after Day 60. These participants will sign an agreement that contraception will be practised during the specified periods and will specify the method used. Female participants unable to become pregnant must have this documented (e.g., tubal ligation or hysterectomy).
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria :

* A history of flavivirus infection or vaccination to Japanese encephalitis (JE) or yellow fever (YF). Previous vaccination will be determined by history (interview of subject) and/or by reviewing the participant's vaccination card or other official documentation (either a history of or documentation of vaccination fulfils the criterion for exclusion).
* Impaired immunity, including known or suspected immunodeficiency (e.g., human immunodeficiency virus [HIV] infection, primary immunodeficiency disorder, leukemia, lymphoma), use of immunosuppressive or antineoplastic drugs (including corticosteroids > 10 mg prednisone, or equivalent, for more than 14 days in the last three months).
* Clinically significant abnormal laboratory assessment results.
* Serious adverse reactions characterised by urticaria or angioedema to a prior vaccine, chicken or eggs or egg protein.
* 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 60.
* Administration of another vaccine within 28 days of receiving study vaccination.
* Physical examination indicating any clinically significant medical condition including any short-lived or long-standing illness which has become more severe.
* Body temperature >38.1°C (100.6°F) or acute illness within 3 days prior to inoculation (participant may be rescheduled).
* Intention to travel out of the area prior to the study visit on Day 60.
* Seropositive to hepatitis C virus (HCV) or HIV or positive for hepatitis B virus (HBV) (antigen).
* Lactation or intended pregnancy in female participants.
* 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., significant hypertensive cerebrovascular disease, trauma, ischaemia, infection, inflammation of the brain).

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 2
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
1/07/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2007
Sample size
Target
Accrual to date
Final
108
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
- Herston
Recruitment postcode(s) [1] 0 0
QLD 4006 - Herston

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
Medical Director
Address 0 0
Sanofi Pasteur Inc.
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

TypeCitations or Other Details
Journal Nasveld PE, Marjason J, Bennett S, Aaskov J, Ellio... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00982137