EncephalitisPhase 3NCT00314132
Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
A Phase 3 study testing ChimeriVax-JE, Japanese Encephalitis vaccine and 0.9% Saline in people with Encephalitis and Japanese Encephalitis, run by Sanofi at 22 sites in 2 countries.
Trial summary
The purpose of this study is to assess whether ChimeriVax™ JE vaccine (a new vaccine to be used for vaccination against Japanese encephalitis) is safe and well tolerated when compared to placebo (dummy) vaccination. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Encephalitis, Japanese Encephalitis
- What is being tested?
- ChimeriVax-JE, Japanese Encephalitis vaccine and 0.9% Saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,004 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Oct 2005to Nov 2006
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States16 sites
Study site
Bardstown, Kentucky, 40004
Study site
Burbank, California, 92505
Study site
Costa Mesa, California, 92708
Study site
Davis, California, 95616
Study site
Fort Worth, Texas, 76135
Study site
Iowa City, Iowa, 52242
Study site
Livonia, Michigan, 48152
Study site
Miami, Florida, 33173
Study site
Omaha, Nebraska, 68134
Study site
Orlando, Florida, 32809
Study site
Overland Park, Kansas, 66212
Study site
Pembroke Pines, Florida, 33024
Study site
San Francisco, California, 94102
Study site
Sprnigfield, Missouri, 65802
Study site
Vallejo, California, 94589
Study site
Winston-Salem, North Carolina, 27109
Australia6 sites
Study site
Darlinghurst, NSW 2010
Study site
Enoggera, QLD 4051
Study site
Heidelbeg West, VIC 3081
Study site
Kippa-Ring, QLD 4021
Study site
Mill Park, VIC 3082
Study site
Toorak Gardens, SA 5056
About this study
Official title: Randomised, Double Blind, Multicentre, Placebo Controlled Phase III Study of the Safety and Tolerability Following Administration of Live Attenuated JE Vaccine (ChimeriVax™-JE)
The purpose of this study is to assess whether ChimeriVax™ JE vaccine (a new vaccine to be used for vaccination against Japanese encephalitis) is safe and well tolerated when compared to placebo (dummy) vaccination.
- Conditions
- Encephalitis, Japanese Encephalitis
- Being tested
- ChimeriVax-JE, Japanese Encephalitis vaccine, 0.9% Saline
- Keywords
- Japanese Encephalitis, Encephalitis virus, ChimeriVax™-JE Vaccine
- Medical subject headings
- Encephalitis, Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChimeriVax-JE, Japanese Encephalitis vaccineBiological
Also called ChimeriVax™
0.5 mL, Subcutaneous
0.9% SalineBiological
0.5 mL, Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | All subjects received a single injection of placebo on Day 0. Receives: Biological: 0.9% Saline |
| ChimeriVax™ JE 4 log10 PFU Vaccine | Experimental | All participants received a single injection of ChimeriVax™ JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0. Receives: Biological: ChimeriVax-JE, Japanese Encephalitis vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30.
Measured: Day 0 up to 30 days post-vaccination
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported.
Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported.
Measured: Day 0 up to 30 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2006 (estimated)
- Study startOct 2005
- Primary completionNov 2006
- Study completionNov 2006
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 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven G Hull, MD, Principal investigator, Vince and Associates Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314132
- Sponsor's protocol ID
- H-040-010
- Status last verified
- Dec 2012
- First submitted
- 11 Apr 2006
- Last updated
- 6 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Torresi J, McCarthy K, Feroldi E, Meric C. Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: Randomised controlled phase 3 trials. Vaccine. 2010 Nov 23;28(50):7993-8000. doi: 10.1016/j.vaccine.2010.09.035. Epub 2010 Oct 8.
PubMed 20934459
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double Blind, Multicentre, Placebo Controlled Phase III Study of the Safety and Tolerability Following Administration of Live Attenuated JE Vaccine (ChimeriVax™-JE)
- ClinicalTrials.gov ID
- NCT00314132
- Acronym / sponsor ID
- H-040-010
- Conditions
- Encephalitis, Japanese Encephalitis
- Keywords
- Japanese Encephalitis, Encephalitis virus, ChimeriVax™-JE Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,004 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 13 Apr 2006 (estimated)
- Results
- Posted 5 Dec 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 assess whether ChimeriVax™ JE vaccine (a new vaccine to be used for vaccination against Japanese encephalitis) is safe and well tolerated when compared to placebo (dummy) vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: 0.9% SalineAll subjects received a single injection of placebo on Day 0. |
| ChimeriVax™ JE 4 log10 PFU Vaccine | Experimental | Biological: ChimeriVax-JE, Japanese Encephalitis vaccineAll participants received a single injection of ChimeriVax™ JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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).
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 |
|---|---|---|
| ChimeriVax-JE, Japanese Encephalitis vaccineAlso: ChimeriVax™0.5 mL, Subcutaneous | Biological | ChimeriVax™ JE 4 log10 PFU Vaccine |
| 0.9% Saline0.5 mL, Subcutaneous | Biological | Placebo |
Primary outcome
Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo
Time frame: Day 0 up to 30 days post-vaccination
Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30.
Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo
Time frame: Day 0 up to 30 days post-vaccination
Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported. Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20934459Torresi J, McCarthy K, Feroldi E, Meric C. Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: Randomised controlled phase 3 trials. Vaccine. 2010 Nov 23;28(50):7993-8000. doi: 10.1016/j.vaccine.2010.09.035. Epub 2010 Oct 8.
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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.
Steven G Hull, MD principal investigator
Vince and Associates Clinical Research
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ChimeriVax-JE, Japanese Encephalitis vaccine and 0.9% Saline in people with Encephalitis and Japanese Encephalitis, run by Sanofi at 22 sites in 2 countries.
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 5 inclusion and 17 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 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 5 Dec 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 Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo (time frame: Day 0 up to 30 days post-vaccination). The study lists 2 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 NCT00314132, 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 6 Dec 2012.