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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/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®)
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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®)
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Secondary ID [1]
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H-040-006
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Japanese Encephalitis
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Yellow Fever
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Condition category
Condition code
Infection
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Other infectious diseases
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Live attenuated Japanese encephalitis virus; Yellow fever virus
Other interventions - Yellow fever virus; Live attenuated Japanese encephalitis virus
Other interventions - Live attenuated Japanese encephalitis virus; Yellow fever virus
Other interventions - 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.
Other interventions: 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.
Other interventions: 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.
Other interventions: 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.
Other interventions: 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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Neutralising antibody titer against homologous Japanese encephalitis (JE), yellow fever (YF), and other relevant wild type JE strains were determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion post-vaccination was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-vaccination (Day 0) and the post-vaccination samples.
The 30 Days post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).
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Timepoint [1]
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Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)
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Primary outcome [2]
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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.
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Assessment method [2]
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Neutralising antibody titer against yellow fever strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint ws defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titre between the pre-injection Day 0 and later post vaccination samples.
The Day 30 post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).
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Timepoint [2]
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Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)
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Primary outcome [3]
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Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination
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Assessment method [3]
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Neutralising antibody titer against homologous JE, YF, and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-injection Day 0 and post-vaccination samples.
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Timepoint [3]
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Day 0 (Pre-vaccination) through Day 30 post-vaccination
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Primary outcome [4]
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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
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Assessment method [4]
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Solicited Local Adverse Events: Injection Site Pain, Erythema, Swelling, Hemorrhage, Venipuncture site Hemorrhage. Solicited Systemic Adverse Events: Fatigue, Malaise, Pyrexia, Chills, Headache, Dizziness, Myalgia, Abdominal Pain, Diarrhea, Nausea, Pharyngolaryngeal Pain.
All solicited local reactions associated with ChimeriVax™-JE are presented in Group 1, those associated with STAMARIL® in Group 2, those associated with co-administered vaccines in Group 3, and those associated with diluent in Group 4. The solicited systemic adverse events are reported according to the participants' randomized study groups.
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Timepoint [4]
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Day 0 up to Day 60 post-vaccination
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Secondary outcome [1]
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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.
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Assessment method [1]
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Neutralising antibody titer against homologous Japanese encephalitis (JE) and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test.
Post-vaccination 15 (30) Days JE seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)
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Timepoint [1]
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Day 0 through 6 months post-vaccination
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Secondary outcome [2]
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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
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Assessment method [2]
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Neutralising antibody titer against homologous yellow fever was determined using a 50% serum dilution plaque reduction neutralisation test.
Post vaccination 15 (30) Days Yellow Fever seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).
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Timepoint [2]
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Day 0 through 6 months post-vaccination
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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).
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Minimum age
18
Years
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Maximum age
55
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2007
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Sample size
Target
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Accrual to date
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Final
108
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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- Herston
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Recruitment postcode(s) [1]
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QLD 4006 - Herston
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to obtain safety, tolerability, and immunogenicity data on the
co-administration or sequential administration of Chimeravax™-JE vaccine and STAMARIL®.
Objectives:
Safety:
- Obtain safety and tolerability data of a single, fixed dose of ChimeriVax™-JE
administered concurrently, one month before or one month after STAMARIL® to adult
volunteers (= 18 to = 55 years) without prior Japanese encephalitis (JE) or yellow fever
(YF) vaccination.
Immunogenicity:
- Obtain data on the antibody response to a single, fixed dose of ChimeriVax™-JE
administered concurrently, one month before or one month after STAMARIL® to adult
volunteers without prior JE (or YF) vaccination.
- Assess the durability of the immune response in adult volunteers 6 months after
administration of ChimeriVax™-JE and STAMARIL®.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00982137
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Sanofi Pasteur Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00982137
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