Japanese EncephalitisPhase 3NCT01188343
Study of Japanese Encephalitis Chimeric Virus Vaccine Given With Measles-Mumps-Rubella Vaccine in Taiwanese Toddlers
A Phase 3 study testing Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus in people with Japanese Encephalitis and Measles, run by Sanofi Pasteur, a Sanofi Company at 3 sites in Taiwan.
Trial summary
This study is designed to compare the immunogenicity of Japanese encephalitis chimeric virus vaccine (JE-CV) and measles-mumps-rubella (MMR)vaccine when given together or when given at separate visits 6 weeks apart in toddlers aged 12 to 18 months. 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, Measles, Mumps
- What is being tested?
- Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 542 participants
- Where
- 3 sitesTaiwan
- Study dates
- Aug 2010to Dec 2012
- 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 .
- Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg.
- Subject in good health based on medical history and physical examination.
- Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by an independent witness if the parents or legally acceptable representative cannot read.
- Subject and parent/legally acceptable representative or delegate able to attend all scheduled visits and comply with all trial procedures.
Who cannot join
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination except for pandemic influenza vaccination, which may be received at least two weeks before the study vaccines.
- Planned receipt of any vaccine up to the 6 weeks following the last trial vaccination except for pandemic influenza vaccine. In the event of a local or national immunization program with a pandemic influenza vaccine, participants who receive a pandemic influenza vaccine at any time during the trial will not be withdrawn from the trial.
- Previous vaccination against measles, measles-mumps-rubella (MMR), or flavivirus disease, including Japanese encephalitis (JE).
- Receipt of blood in the past 6 months that might interfere with the assessment of the immune response
Show all 17Show fewer
- Receipt of intravenous injection of plasma, platelet product, or high dose of intravenous immunoglobulin in the past 11 months
- Receipt of intramuscular treatment of immunoglobulin or Hepatitis B immunoglobulin in the past 3 months
- 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 history of human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C seropositivity.
- History of measles, mumps, rubella, or flavivirus infection confirmed either clinically, serologically, or microbiologically.
- 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 .
- Known systemic hypersensitivity to gelatin, eggs, or anaphylactic/anaphylactoid reaction to neomycin.
- Known history of thrombocytopenia.
- Administration of any anti-viral within 2 months preceding first vaccination and up to the 6 weeks following the last trial vaccination.
- History of central nervous system disorder or disease, including seizures and febrile seizures.
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: Immunogenicity and Safety of Japanese Encephalitis Chimeric Virus Vaccine (JE CV) Concomitantly Administered With Measles, Mumps, and Rubella (MMR) Vaccine in Toddlers in Taiwan.
This study is designed to compare the immunogenicity of Japanese encephalitis chimeric virus vaccine (JE-CV) and measles-mumps-rubella (MMR)vaccine when given together or when given at separate visits 6 weeks apart in toddlers aged 12 to 18 months.
Primary objective:
Read more
- To demonstrate the non-inferiority of the antibody responses in terms of seroconversion of the concomitant administration of JE-CV and MMR compared to the antibody responses after the single administration of JE-CV and MMR vaccine.
Secondary objectives:
- To describe the immune response to JE CV and MMR before and after one dose of JE CV and MMR vaccine, respectively.
- To describe the safety of a single dose of JE-CV and MMR vaccine (given separately at a 6-week interval and the safety of the concomitant administration of JE-CV and MMR vaccine in all subjects up to 6 months after last vaccination.
Read the detailed description
All participants will receive Japanese encephalitis chimeric virus vaccine and measles-mumps-rubella vaccine and will be monitored for safety throughout the study.
- Conditions
- Japanese Encephalitis, Measles, Mumps, Rubella
- Being tested
- Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus
- Keywords
- Japanese Encephalitis, Japanese encephalitis chimeric virus vaccine, Measles, Mumps, Rubella
- Medical subject headings
- Encephalitis, Japanese, Measles, Mumps, Rubella
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virusBiological
Also called JE-CV, MMR II®
0.5 mL each; Subcutaneous (SC)
Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virusBiological
Also called JE-CV, MMR II®
0.5 mL each, Subcutaneous (SC)
Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virusBiological
Also called JE-CV, MMR II®
0.5 mL each, subcutaneous (SC)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants will receive the Japanese encephalitis chimeric virus vaccine (JE-CV) on Day 0 and Measles, mumps, and rubella live attenuated virus vaccine (MMR) on Day 42 Receives: Biological: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus |
| Group 2 | Experimental | Participants will receive Measles, mumps, and rubella live attenuated virus vaccine (MMR) on Day 0, and the Japanese encephalitis chimeric virus vaccine (JE-CV) on Day 42. Receives: Biological: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus |
| Group 3 | Experimental | Participants will receive the Measles, mumps, and rubella live attenuated virus vaccine (MMR) and the Japanese encephalitis chimeric virus vaccine (JE-CV) on Day 0 Receives: Biological: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination
JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml.
Measured: Day 0 (pre-vaccination) and Day 42 post-vaccination
Secondary outcomes (5)
Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/m
Measured: Pre-vaccination and Day 42 post-vaccination
Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroprotection was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 (1/dil) and post-vaccination titer ≥1/10, (1/dil) or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 units/ml when pre-vaccination titer is <10 units/ml; and for Rubella, post-vaccination titer ≥1/10 IU/ml when pre-vaccination titer is <10 IU/m
Measured: Pre-vaccination and up to Month 12 post-vaccination
Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA).
Measured: Pre-vaccination and Day 42 post-vaccination
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine
Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. Grade 3 systemic reactions: Fever - >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; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable.
Measured: Day 0 up to Day14 post-vaccination
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine
Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. Grade 3 systemic reactions: Fever - >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; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; 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 posted25 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2012
- Study completionDec 2012
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.
- 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
- None (open label)
- Enrolment
- 542 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188343
- Sponsor's protocol ID
- JEC04
- Other IDs
- UTN: U1111-1112-2143
- Status last verified
- Jul 2014
- First submitted
- 24 Aug 2010
- Last updated
- 15 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Japanese Encephalitis Chimeric Virus Vaccine (JE CV) Concomitantly Administered With Measles, Mumps, and Rubella (MMR) Vaccine in Toddlers in Taiwan.
- ClinicalTrials.gov ID
- NCT01188343
- Acronym / sponsor ID
- JEC04
- Conditions
- Japanese Encephalitis, Measles, Mumps, Rubella
- Keywords
- Japanese Encephalitis, Japanese encephalitis chimeric virus vaccine, Measles, Mumps, Rubella
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 542 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Aug 2010 (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 designed to compare the immunogenicity of Japanese encephalitis chimeric virus vaccine (JE-CV) and measles-mumps-rubella (MMR)vaccine when given together or when given at separate visits 6 weeks apart in toddlers aged 12 to 18 months.
Primary objective:
- To demonstrate the non-inferiority of the antibody responses in terms of seroconversion of the concomitant administration of JE-CV and MMR compared to the antibody responses after the single administration of JE-CV and MMR vaccine.
Secondary objectives:
- To describe the immune response to JE CV and MMR before and after one dose of JE CV and MMR vaccine, respectively.
- To describe the safety of a single dose of JE-CV and MMR vaccine (given separately at a 6-week interval and the safety of the concomitant administration of JE-CV and MMR vaccine in all subjects up to 6 months after last vaccination.
Detailed description
All participants will receive Japanese encephalitis chimeric virus vaccine and measles-mumps-rubella vaccine and will be monitored for safety throughout the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virusParticipants will receive the Japanese encephalitis chimeric virus vaccine (JE-CV) on Day 0 and Measles, mumps, and rubella live attenuated virus vaccine (MMR) on Day 42 |
| Group 2 | Experimental | Biological: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virusParticipants will receive Measles, mumps, and rubella live attenuated virus vaccine (MMR) on Day 0, and the Japanese encephalitis chimeric virus vaccine (JE-CV) on Day 42. |
| Group 3 | Experimental | Biological: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virusParticipants will receive the Measles, mumps, and rubella live attenuated virus vaccine (MMR) and the Japanese encephalitis chimeric virus vaccine (JE-CV) on Day 0 |
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 .
- Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg.
- Subject in good health based on medical history and physical examination.
- Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by an independent witness if the parents or legally acceptable representative cannot read.
- Subject and parent/legally acceptable representative or delegate able to attend all scheduled visits and comply with all trial procedures.
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 first trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination except for pandemic influenza vaccination, which may be received at least two weeks before the study vaccines.
- Planned receipt of any vaccine up to the 6 weeks following the last trial vaccination except for pandemic influenza vaccine. In the event of a local or national immunization program with a pandemic influenza vaccine, participants who receive a pandemic influenza vaccine at any time during the trial will not be withdrawn from the trial.
- Previous vaccination against measles, measles-mumps-rubella (MMR), or flavivirus disease, including Japanese encephalitis (JE).
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 chimeric virus: Measles, mumps, and rubella live attenuated virusAlso: JE-CV, MMR II®0.5 mL each; Subcutaneous (SC) | Biological | Group 1 |
| Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virusAlso: JE-CV, MMR II®0.5 mL each, Subcutaneous (SC) | Biological | Group 2 |
| Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virusAlso: JE-CV, MMR II®0.5 mL each, subcutaneous (SC) | Biological | Group 3 |
Primary outcome
Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination
Time frame: Day 0 (pre-vaccination) and Day 42 post-vaccination
JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml.
5 secondary outcomes
Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
Time frame: Pre-vaccination and Day 42 post-vaccination
Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
Time frame: Pre-vaccination and up to Month 12 post-vaccination
Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
Time frame: Pre-vaccination and Day 42 post-vaccination
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine
Time frame: Day 0 up to Day14 post-vaccination
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR 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 15 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus in people with Japanese Encephalitis and Measles, run by Sanofi Pasteur, a Sanofi Company at 3 sites in Taiwan.
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 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. 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 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?
Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination (time frame: Day 0 (pre-vaccination) and Day 42 post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2014.