Japanese EncephalitisPhase 3NCT00735644
Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines
A Phase 3 study testing Japanese encephalitis vaccine, Japanese encephalitis vaccine (Acambis) and Hepatitis A vaccine in people with Japanese Encephalitis and Hepatitis A, run by Sanofi Pasteur, a Sanofi Company at 8 sites in 2 countries.
Trial summary
This study is to assess the safety and immunogenicity of three consecutive lots of JE-CV in toddlers aged 12-18 months. Primary objective: To demonstrate the bio-equivalence of three lots of JE-CV vaccine manufactured by sanofi pasteur. Secondary objective: To describe the safety of vaccination in all subjects Read more about this study
- Who is it for?
- Ages 12 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis, Hepatitis A
- What is being tested?
- Japanese encephalitis vaccine, Japanese encephalitis vaccine (Acambis) and Hepatitis A vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Aug 2008to Aug 2009
- 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 12 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 12 to 18 months on the day of inclusion.
- In good general health, without significant medical history.
- Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations.
- Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
- Completion of vaccinations according to the national immunization schedule.
Who cannot join
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing any of the same substances.
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
- Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response.
Show all 17Show fewer
- Administration of any anti-viral within 2 months preceding V01.
- History of central nervous system disorder or disease, including seizures.
- Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
- Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
- Personal human immunodeficiency virus seropositivity in the blood sample taken at screening.
- Receipt of any JE vaccine or hepatitis A vaccine.
- Previous vaccination against flavivirus disease.
- History of flavivirus infection (confirmed either clinically, serologically or microbiologically)
- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination.
- Febrile illness (temperature ≥38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Philippines5 sites
Study site
Alabang
Study site
Bayanan
Study site
Buli
Study site
Cupang
Study site
Sucat
Thailand3 sites
Study site
Bangkok, 10330
Study site
Bangkok, 10400
Study site
Khon Kaen, 40002
About this study
Official title: Lot-to-lot Consistency, Bridging, and Safety Trial of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines
This study is to assess the safety and immunogenicity of three consecutive lots of JE-CV in toddlers aged 12-18 months.
Primary objective:
To demonstrate the bio-equivalence of three lots of JE-CV vaccine manufactured by sanofi pasteur.
Secondary objective:
To describe the safety of vaccination in all subjects
Read the detailed description
This is a Phase III trial in toddlers in Thailand and the Philippines.
- Conditions
- Japanese Encephalitis, Hepatitis A
- Being tested
- Japanese encephalitis vaccine, Japanese encephalitis vaccine (Acambis), Hepatitis A vaccine
- Keywords
- Japanese encephalitis, Hepatitis A, Inactivated Mouse-Brain
- Medical subject headings
- Encephalitis, Japanese, Hepatitis A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Japanese encephalitis vaccineBiological
Also called ChimeriVax™-JE
0.5 mL, Subcutaneous
Japanese encephalitis vaccineBiological
Also called ChimeriVax™-JE
0.5 mL, Subcutaneous
Japanese encephalitis vaccineBiological
Also called ChimeriVax™-JE
0.5 mL, Subcutaneous
Japanese encephalitis vaccine (Acambis)Biological
0.5 mL, Subcutaneous
Hepatitis A vaccineBiological
Also called Avaxim® 80U Pediatric
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| JE-CV GPO MBP (Lot 1) | Experimental | Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1. Receives: Biological: Japanese encephalitis vaccine |
| JE-CV GPO MBP (Lot 2) | Experimental | Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 2. Receives: Biological: Japanese encephalitis vaccine |
| JE-CV GPO MBP (Lot 3) | Experimental | Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 3. Receives: Biological: Japanese encephalitis vaccine |
| JE-CV WRAIR (Group 4) | Active comparator | Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR) Receives: Biological: Japanese encephalitis vaccine (Acambis) |
| Hepatitis A (Group 5) | Sham comparator | Participants 12 to 18 months of age randomized to receive Hepatitis A vaccine Receives: Biological: Hepatitis A vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots
Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 1/dil and post-vaccination titer ≥ 10 1/dil, or participants with pre-vaccination titer ≥ 10 1/dil and 4-fold increase from pre- to post-vaccination.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Secondary outcomes (4)
Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV
Anti-Japanese Encephalitis Chimeric Virus antibodies were measured using the 50% plaque reduction neutralization test (PRNT50) assay.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV
Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the PRNT50 assay. Seroprotection was defined as the proportion of subjects with a JE CV virus PRNT50 neutralizing antibody titer ≥10 1/dilution (dil).
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine
Anti Japanese encephalitis chimeric virus antibodies were measured using the PRNT50 assay.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine.
Solicited injection site: Tenderness, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Tenderness, cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling ≥5 cm. Grade 3 systemic reactions: Fever, temperature >39.5˚C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal, >3 hours; Drowsiness, sleeping most of the time or difficult to wake up; Appetite Lost, refuses ≥3 or most feeds/meals; and Irritability, inconsolable.
Measured: Day 0 up to Day 14 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2009
- Study completionAug 2009
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 (2)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 Sanofi Pasteur, a Sanofi CompanyThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735644
- Sponsor's protocol ID
- JEC02
- Status last verified
- Apr 2015
- First submitted
- 14 Aug 2008
- Last updated
- 21 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Feroldi E, Pancharoen C, Kosalaraksa P, Watanaveeradej V, Phirangkul K, Capeding MR, Boaz M, Gailhardou S, Bouckenooghe A. Single-dose, live-attenuated Japanese encephalitis vaccine in children aged 12-18 months: randomized, controlled phase 3 immunogenicity and safety trial. Hum Vaccin Immunother. 2012 Jul;8(7):929-37. doi: 10.4161/hv.20071. Epub 2012 Jul 1.
PubMed 22777096Bonaparte M, Dweik B, Feroldi E, Meric C, Bouckenooghe A, Hildreth S, Hu B, Yoksan S, Boaz M. Immune response to live-attenuated Japanese encephalitis vaccine (JE-CV) neutralizes Japanese encephalitis virus isolates from south-east Asia and India. BMC Infect Dis. 2014 Mar 21;14:156. doi: 10.1186/1471-2334-14-156.
PubMed 24656175
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lot-to-lot Consistency, Bridging, and Safety Trial of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines
- ClinicalTrials.gov ID
- NCT00735644
- Acronym / sponsor ID
- JEC02
- Conditions
- Japanese Encephalitis, Hepatitis A
- Keywords
- Japanese encephalitis, Hepatitis A, Inactivated Mouse-Brain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 15 Aug 2008 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to assess the safety and immunogenicity of three consecutive lots of JE-CV in toddlers aged 12-18 months.
Primary objective:
To demonstrate the bio-equivalence of three lots of JE-CV vaccine manufactured by sanofi pasteur.
Secondary objective:
To describe the safety of vaccination in all subjects
Detailed description
This is a Phase III trial in toddlers in Thailand and the Philippines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| JE-CV GPO MBP (Lot 1) | Experimental | Biological: Japanese encephalitis vaccineParticipants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1. |
| JE-CV GPO MBP (Lot 2) | Experimental | Biological: Japanese encephalitis vaccineParticipants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 2. |
| JE-CV GPO MBP (Lot 3) | Experimental | Biological: Japanese encephalitis vaccineParticipants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 3. |
| JE-CV WRAIR (Group 4) | Active comparator | Biological: Japanese encephalitis vaccine (Acambis)Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR) |
| Hepatitis A (Group 5) | Sham comparator | Biological: Hepatitis A vaccineParticipants 12 to 18 months of age randomized to receive Hepatitis A vaccine |
Who may qualify
- Ages
- 12 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 12 to 18 months on the day of inclusion.
- In good general health, without significant medical history.
- Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations.
- Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
- Completion of vaccinations according to the national immunization schedule.
Key exclusion criteria (17 listed)
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing any of the same substances.
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
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 |
|---|---|---|
| Japanese encephalitis vaccineAlso: ChimeriVax™-JE0.5 mL, Subcutaneous | Biological | JE-CV GPO MBP (Lot 1) |
| Japanese encephalitis vaccineAlso: ChimeriVax™-JE0.5 mL, Subcutaneous | Biological | JE-CV GPO MBP (Lot 2) |
| Japanese encephalitis vaccineAlso: ChimeriVax™-JE0.5 mL, Subcutaneous | Biological | JE-CV GPO MBP (Lot 3) |
| Japanese encephalitis vaccine (Acambis)0.5 mL, Subcutaneous | Biological | JE-CV WRAIR (Group 4) |
| Hepatitis A vaccineAlso: Avaxim® 80U Pediatric0.5 mL, Intramuscular | Biological | Hepatitis A (Group 5) |
Primary outcome
Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 1/dil and post-vaccination titer ≥ 10 1/dil, or participants with pre-vaccination titer ≥ 10 1/dil and 4-fold increase from pre- to post-vaccination.
4 secondary outcomes
Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine.
Time frame: Day 0 up to Day 14 post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22777096Feroldi E, Pancharoen C, Kosalaraksa P, Watanaveeradej V, Phirangkul K, Capeding MR, Boaz M, Gailhardou S, Bouckenooghe A. Single-dose, live-attenuated Japanese encephalitis vaccine in children aged 12-18 months: randomized, controlled phase 3 immunogenicity and safety trial. Hum Vaccin Immunother. 2012 Jul;8(7):929-37. doi: 10.4161/hv.20071. Epub 2012 Jul 1.
- Results publication: PubMed 24656175Bonaparte M, Dweik B, Feroldi E, Meric C, Bouckenooghe A, Hildreth S, Hu B, Yoksan S, Boaz M. Immune response to live-attenuated Japanese encephalitis vaccine (JE-CV) neutralizes Japanese encephalitis virus isolates from south-east Asia and India. BMC Infect Dis. 2014 Mar 21;14:156. doi: 10.1186/1471-2334-14-156.
- Related InfoLink provided by the sponsor.
Related trials for Japanese Encephalitis
Active, not recruitingPhase 4
Immunogenicity, Safety, and Antibody Persistence of Different Immunization Strategies Against Japanese Encephalitis
Japanese Encephalitis Vaccine
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
Not yet recruitingObservational study
Diagnostics and Surveillance of Acute Meningo-encephalitis Among Children in Cambodia With a Focus on Japanese Encephalitis Virus
Japanese Encephalitis
Active, not recruitingPhase 4
Monitoring JE Antibody Levels in Healthy Populations and Immunization Strategy in Low-Prevalence Areas
Japanese Encephalitis
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 Monitor study director
Sanofi Pasteur Inc.
8 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 Japanese encephalitis vaccine, Japanese encephalitis vaccine (Acambis) and Hepatitis A vaccine in people with Japanese Encephalitis and Hepatitis A, run by Sanofi Pasteur, a Sanofi Company at 8 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 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Philippines, Thailand. 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 15 Aug 2014). 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 Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots (time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination). 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 NCT00735644, which also lists 2 linked publications.
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 21 Apr 2015.