Japanese EncephalitisPhase 2NCT00982137
Study of Live Attenuated Japanese Encephalitis Vaccine (ChimeriVax™-JE) and Yellow Fever Vaccine (STAMARIL®)
A Phase 2 study testing Live attenuated Japanese encephalitis virus; Yellow fever virus and Yellow fever virus; Live attenuated Japanese encephalitis virus in people with Japanese Encephalitis and Yellow Fever, run by Sanofi at 1 site in Australia.
Trial 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®. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Japanese Encephalitis, Yellow Fever
- What is being tested?
- Live attenuated Japanese encephalitis virus; Yellow fever virus and Yellow fever virus; Live attenuated Japanese encephalitis virus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2004to Mar 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official 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®)
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:
Read more
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®.
Read the detailed description
All participants will receive two injections, one to each arm on Days 0 and 30, respectively. Immunogenicity will be tested on Days 0, 15, 30, 45, and 60, and at Month 6.
- Conditions
- Japanese Encephalitis, Yellow Fever
- Being tested
- Live attenuated Japanese encephalitis virus; Yellow fever virus, Yellow fever virus; Live attenuated Japanese encephalitis virus
- Keywords
- Japanese Encephalitis, Yellow Fever, ChimeriVax™-JE, STAMARIL®, Adult
- Medical subject headings
- Encephalitis, Japanese, Yellow Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live attenuated Japanese encephalitis virus; Yellow fever virusBiological
Also called ChimeriVax-JE, STAMARIL®
ChimeriVax™-JE, 0.5 mL, Subcutaneous on Day 0; STAMARIL®, 0.5 mL, Subcutaneous on Day 30.
Yellow fever virus; Live attenuated Japanese encephalitis virusBiological
Also called STAMARIL®, ChimeriVax™-JE
STAMARIL®, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous on Day 30.
Live attenuated Japanese encephalitis virus; Yellow fever virusBiological
Also called ChimeriVax™-JE, STAMARIL®
ChimeriVax™-JE, 0.5 mL Subcutaneous and STAMARIL®, 0.5 mL, Subcutaneous on Day 0; Diluent 0.5 mL, Subcutaneous on Day 30.
Live attenuated Japanese encephalitis virus; Yellow fever virusBiological
Also called ChimeriVax™-JE, STAMARIL®
Diluent, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous and STAMARIL®, 0.5 mL Subcutaneous on Day 30.
| Study group | Role | What they receive |
|---|---|---|
| ChimeriVax™-JE then STAMARIL® | Experimental | Participants will receive ChimeriVax™-JE on Day 0 and STAMARIL® on Day 30 Receives: Biological: Live attenuated Japanese encephalitis virus; Yellow fever virus |
| STAMARIL® then ChimeriVax™-JE | Experimental | Participants will receive STAMARIL® on Day 0 and ChimeriVax™-JE on Day 30 Receives: Biological: Yellow fever virus; Live attenuated Japanese encephalitis virus |
| ChimeriVax™-JE and STAMARIL®, then Diluent | Experimental | Participants will receive ChimeriVax™-JE and STAMARIL® on Day 0 and diluent on Day 30. Receives: Biological: Live attenuated Japanese encephalitis virus; Yellow fever virus |
| Diluent then ChimeriVax™-JE and STAMARIL® | Experimental | Participants will receive Diluent on Day 0 and ChimeriVax™-JE and STAMARIL® on Day 30. Receives: Biological: Live attenuated Japanese encephalitis virus; Yellow fever virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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).
Measured: Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)
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.
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).
Measured: Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)
Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination
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.
Measured: Day 0 (Pre-vaccination) through Day 30 post-vaccination
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
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.
Measured: Day 0 up to Day 60 post-vaccination
Secondary outcomes (2)
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.
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)
Measured: Day 0 through 6 months post-vaccination
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
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).
Measured: Day 0 through 6 months post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startJul 2004
- Primary completionApr 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Japanese EncephalitisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982137
- Sponsor's protocol ID
- H-040-006
- Status last verified
- Sep 2012
- First submitted
- 21 Sep 2009
- Last updated
- 20 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Nasveld PE, Marjason J, Bennett S, Aaskov J, Elliott S, McCarthy K, Kanesa-Thasan N, Feroldi E, Reid M. Concomitant or sequential administration of live attenuated Japanese encephalitis chimeric virus vaccine and yellow fever 17D vaccine: randomized double-blind phase II evaluation of safety and immunogenicity. Hum Vaccin. 2010 Nov;6(11):906-14. doi: 10.4161/hv.6.11.12854. Epub 2010 Nov 1.
PubMed 20864814
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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®)
- ClinicalTrials.gov ID
- NCT00982137
- Acronym / sponsor ID
- H-040-006
- Conditions
- Japanese Encephalitis, Yellow Fever
- Keywords
- Japanese Encephalitis, Yellow Fever, ChimeriVax™-JE, STAMARIL®, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Apr 2005 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Posted 20 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
Detailed description
All participants will receive two injections, one to each arm on Days 0 and 30, respectively. Immunogenicity will be tested on Days 0, 15, 30, 45, and 60, and at Month 6.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ChimeriVax™-JE then STAMARIL® | Experimental | Biological: Live attenuated Japanese encephalitis virus; Yellow fever virusParticipants will receive ChimeriVax™-JE on Day 0 and STAMARIL® on Day 30 |
| STAMARIL® then ChimeriVax™-JE | Experimental | Biological: Yellow fever virus; Live attenuated Japanese encephalitis virusParticipants will receive STAMARIL® on Day 0 and ChimeriVax™-JE on Day 30 |
| ChimeriVax™-JE and STAMARIL®, then Diluent | Experimental | Biological: Live attenuated Japanese encephalitis virus; Yellow fever virusParticipants will receive ChimeriVax™-JE and STAMARIL® on Day 0 and diluent on Day 30. |
| Diluent then ChimeriVax™-JE and STAMARIL® | Experimental | Biological: Live attenuated Japanese encephalitis virus; Yellow fever virusParticipants will receive Diluent on Day 0 and ChimeriVax™-JE and STAMARIL® on Day 30. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live attenuated Japanese encephalitis virus; Yellow fever virusAlso: ChimeriVax-JE, STAMARIL®ChimeriVax™-JE, 0.5 mL, Subcutaneous on Day 0; STAMARIL®, 0.5 mL, Subcutaneous on Day 30. | Biological | ChimeriVax™-JE then STAMARIL® |
| Yellow fever virus; Live attenuated Japanese encephalitis virusAlso: STAMARIL®, ChimeriVax™-JESTAMARIL®, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous on Day 30. | Biological | STAMARIL® then ChimeriVax™-JE |
| Live attenuated Japanese encephalitis virus; Yellow fever virusAlso: ChimeriVax™-JE, STAMARIL®ChimeriVax™-JE, 0.5 mL Subcutaneous and STAMARIL®, 0.5 mL, Subcutaneous on Day 0; Diluent 0.5 mL, Subcutaneous on Day 30. | Biological | ChimeriVax™-JE and STAMARIL®, then Diluent |
| Live attenuated Japanese encephalitis virus; Yellow fever virusAlso: ChimeriVax™-JE, STAMARIL®Diluent, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous and STAMARIL®, 0.5 mL Subcutaneous on Day 30. | Biological | Diluent then ChimeriVax™-JE and STAMARIL® |
Primary outcome
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.
Time frame: Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)
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).
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.
Time frame: Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)
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).
Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination
Time frame: Day 0 (Pre-vaccination) through Day 30 post-vaccination
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.
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
Time frame: Day 0 up to Day 60 post-vaccination
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.
2 secondary outcomes
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.
Time frame: Day 0 through 6 months post-vaccination
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
Time frame: Day 0 through 6 months post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20864814Nasveld PE, Marjason J, Bennett S, Aaskov J, Elliott S, McCarthy K, Kanesa-Thasan N, Feroldi E, Reid M. Concomitant or sequential administration of live attenuated Japanese encephalitis chimeric virus vaccine and yellow fever 17D vaccine: randomized double-blind phase II evaluation of safety and immunogenicity. Hum Vaccin. 2010 Nov;6(11):906-14. doi: 10.4161/hv.6.11.12854. Epub 2010 Nov 1.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Sanofi Pasteur Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Live attenuated Japanese encephalitis virus; Yellow fever virus and Yellow fever virus; Live attenuated Japanese encephalitis virus in people with Japanese Encephalitis and Yellow Fever, run by Sanofi at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00982137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2012.