Japanese EncephalitisPhase 4NCT06331702
Immunogenicity of Japanese Encephalitis Vaccine Co-administered With Measles-Mumps-Rubella Vaccine (MMR)
A Phase 4 study testing Vero cell-drived inactive Japanese encephalitis vaccine and Measles-Mumps-Rubella Vaccine in people with Japanese Encephalitis and Measles, run by Liaoning Chengda Biotechnology CO., LTD at 1 site in China.
Trial summary
This is a phase IV, randomized, controlled, open-label study proceed in healthy children aged 8 months in China. The primary objective is to demonstrate the immunogenicity of simultaneous administration of JEV-I and MMR is not inferior to that of separate administration, as measured by seroconversion rates and… Read more about this study
- Who is it for?
- Ages 8 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis, Measles, Mumps
- What is being tested?
- Vero cell-drived inactive Japanese encephalitis vaccine and Measles-Mumps-Rubella Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2024to 11 Feb 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 8 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants aged 8 months to <12 months at the time of enrollment
- Participants are able to provide valid identification documents of themselves and/or their legal guardian (entrusted person).
- Legal guardian of the participants can understand requirements and processes of the study, voluntarily agree to participate in the clinical trial, provide informed consent, accept all scheduled visits.
Who cannot join
- Axillary temperature >37.0 ℃ at the time of enrollment.
- Participating in another clinical trial or planning to participate in another clinical trial during the course of this trial.
- Previous receipt of the Japanese encephalitis vaccine or the measles-mumps-rubella vaccine (or a vaccine containing any of these components), or plan to receive other vaccines of the same type or composition during the trial period.
- History of measles, mumps, rubella, or Japanese encephalitis infection (confirmed by clinical, serological, or microbiological methods).
- Received blood or blood products within 3 months before enrollment.
- History of allergies to any component of the experimental vaccine, or severe allergies to other vaccine or drugs administered in the past, such as anaphylactic shock, laryngeal edema, henoch-schonlein purpura, thrombocytopenic purpura, arthur reaction, dyspnea, angioneuroedema, systemic rash and/or urticaria.
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- History of attenuated live vaccine administration within 14 days prior to vaccination, or history of other non live vaccine administration within 7 days prior to vaccination.
- Acute febrile diseases (axillary body temperature ≥ 38.5 ℃) or in acute stage of chronic diseases, or taking antipyretics, analgesics, and anti-allergic agents within 3 days before vaccination.
- Primary or acquired immunodeficiency, such as human immunodeficiency virus infection (participants themselves or their mothers are infected with human immunodeficiency virus), systemic lupus erythematosus, guillain-barre syndrome, or other autoimmune diseases.
- Primary or acquired immune dysfunction (history of thyroid, pancreatic, liver, and spleen resection)
- Receipt of immunosuppressive therapy within 3 months prior to enrollment, such as cytotoxic therapy, steroid therapy (defined as continuous oral or intravenous infusion for more than 14 days, with a glucocorticoid dose of ≥0.5 mg/kg/day, unrestricted for inhaled and local steroids), or long-term other immunomodulatory drugs.
- Serious illness (acute or chronic), known or suspected, such as complicated diabetes, infectious, purulent, and allergic skin diseases, Down's syndrome, sickle cell anemia, cardiovascular and cerebrovascular diseases, liver and kidney diseases, respiratory diseases, malignant tumors, etc.
- Contraindications to intramuscular injection, such as diagnosed with thrombocytopenia, any coagulation disorders, or receiving anticoagulant treatment.
- History of convulsions, epilepsy, encephalopathy, mental illness or other neurological disorders, or a family history of mental illness.
- Plans to move out of the local area before the end of the experiment or leave the local area for a long time during the scheduled trial visit period.
- Any conditions that may interfere with the evaluation of the experimental purpose, as deemed by the researcher.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official title: A Phase Ⅳ, Randomized, Controlled, Open-label, Immunogenicity Study of Vero Cell-derived Inactivated Japanese Encephalitis Vaccine (JEV-I) Co-administered With Measles-Mumps-Rubella Vaccine (MMR)
This is a phase IV, randomized, controlled, open-label study proceed in healthy children aged 8 months in China. The primary objective is to demonstrate the immunogenicity of simultaneous administration of JEV-I and MMR is not inferior to that of separate administration, as measured by seroconversion rates and antibody titers against the four antigens. The secondary objective is to describe the safety of the vaccines when administered simultaneously or separately.
Read the detailed description
According to current immunization programs in China, there is an overlap in the vaccination schedules for JEV-I and MMR. Children are recommended to receive 2 doses of JEV-I at 8 months of age, with an interval of 7-10 days. The MMR vaccine is also recommended for administration at 8 months of age. Administering JEV-I and MMR vaccines simultaneously at 8 months of age may facilitate adherence to vaccination programs, reduce the burden of medical treatment for parents and children who receive both vaccines separately, and improve the efficiency of vaccination work.
This is a phase IV, randomized, controlled, open-label study proceed in healthy children aged 8 months in China. The primary objective is to demonstrate the immunogenicity of simultaneous administration of JEV-I and MMR is not inferior to that of separate administration, as measured by seroconversion rates and antibody titers against the four antigens. The secondary objective is to describe the safety of the vaccines when administered simultaneously or separately.
The children aged 8 months who have not received any Japanese encephalitis vaccine or MMR (or vaccines containing related ingredients) will be recruited and randomly assigned to one of three study groups (1:1:1 ratio): Group 1, Group 2 and Group 3. Participants in Group 1 will receive JEV-I (dose 1) and MMR simultaneously for the first time. Participants in Group 2 will receive JEV-I only. Participants in Group 3 will receive MMR only.
Blood will be collected pre-vaccination (Day 0) and 30 days post vaccination to evaluate seroconversion rates and antibody titers against the four antigens.
After each vaccination, all participants will be observed at the clinical site for at least 30 minutes for immediate reactions and will be monitored for solicited adverse events (AEs) for 7 days post vaccination. All participants will be monitored for unsolicited AEs and serious adverse events within 30 days of post vaccination.
- Conditions
- Japanese Encephalitis, Measles, Mumps, Rubella
- Being tested
- Vero cell-drived inactive Japanese encephalitis vaccine, Measles-Mumps-Rubella Vaccine
- 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.
Vero cell-drived inactive Japanese encephalitis vaccineBiological
Also called JEV-I
0.5ml for each dose, manufactured by Liaoning Chengda Biotechnology CO., LTD, administered in the deltoid area of lateral arm by intramuscular injection.
Measles-Mumps-Rubella VaccineBiological
Also called MMR
0.5ml for each dose (after dissolving), manufactured by Shanghai Institute of Biological Products CO., LTD, administered in the lower part of the deltoid area of lateral arm, by subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (JEV-I and MMR co-administration group) | Experimental | Participants will receive 1 dose of JEV-I and 1 dose of MMR concurrently on Day 0, with each vaccine administered on a different side of the body, and a second dose of JEV-I 7-10 days later. Blood sampling will be performed on Day 0 and 30 days after the second dose of JEV-I. Receives: Biological: Vero cell-drived inactive Japanese encephalitis vaccine; Biological: Measles-Mumps-Rubella Vaccine |
| Group 2 (JEV-I administered separately) | Active comparator | Participants will receive 2 doses of JEV-I (7-10 days apart). Blood sampling will be performed on Day 0 and 30 days after the second dose of JEV-I. Receives: Biological: Vero cell-drived inactive Japanese encephalitis vaccine |
| Group 3 (MMR administered separately) | Active comparator | Participants will receive 1 doses of MMR. Blood sampling will be performed on Day 0 and Day 30. Receives: Biological: Measles-Mumps-Rubella Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody Titer for Post Vaccination
The serum neutralizing antibody titer against Japanese encephalitis virus is measured by plaque reduction neutralization test (PRNT). The immunoglobulin (IgG) antibody titers against measles virus, mumps virus, and rubella virus are measured using enzyme-linked immunosorbent assay (ELISA).
Measured: 30 days after the last dose of vaccination
Seroconversion Rate for Post Vaccination
The seroconversion rate for JEV-I post vaccination is defined as the percentage of participants with a change in serum anti-JE neutralizing antibody from PRNT titer <1:10 at baseline to titer ≥1:10 30 days after the last dose of vaccination or a 4-fold rise from baseline. The seroconversion rate for MMR post vaccination is defined as the percentage of participants with a change in serum measles IgG antibody from titer <200 milli international units (mIU)/mL at baseline to titer ≥200 mIU/mL post vaccination or a 4-fold rise from baseline, and serum mumps IgG antibody from titer <100 international units (IU)/mL to titer ≥100 IU/mL or a 4-fold rise from baseline, and serum rubella IgG antibody from titer <20 IU/mL to titer ≥20 IU/mL or a 4-fold rise from baseline, as measured by ELISA.
Measured: 30 days after the last dose of vaccination
Secondary outcomes (3)
Incidence of Any Local and Systemic Adverse Events Within 30 Minutes of Each Vaccination
Participants will be observed at the clinical site for 30 minutes after each dose of vaccine. Any adverse events at the vaccination site (local) and non vaccination site (systemic) are collected. Adverse Events (AEs) are defined as all adverse medical events that occur in participants after receiving the investigational drug, which can manifest as symptoms, signs, diseases, or abnormal laboratory tests, but may not necessarily have a causal relationship with the investigational drug.
Measured: 30 minutes following each vaccination
Incidence of Solicited Local and Systemic Adverse Events Within 7 Days of Each Vaccination
Parents use a structured diary card to record the following solicited (pre-listed) local and system reactions from 30 minutes through 7 days following vaccination:
Local reactions:
- Induration
- Swelling
- Rash
- Tenderness
Systemic reactions:
- Fever
- Diarrhea
- Constipation
- Dysphagia
- Anorexia
- Sickness
- Vomiting
- Syncope
- Convulsions
- Cough
- Pruritus
- Irritability or Sleepiness
- Skin and mucosal abnormalities
- Fatigue
- Acute Allergic Reactions
Measured: 30 minutes through 7 days following each vaccination
Incidence of Unsolicited Adverse Events and Serious Adverse Events Within 30 Days of Post Vaccination
Unsolicited adverse events and serious adverse events within 30 days of post vaccination will be collected through a combination of telephone visits by researchers and active reporting by participants.
Serious adverse events are those meeting one of the following conditions:
- Death
- Life threatening
- Resulted in a persistent or significant disability or incapacity
- Required inpatient hospitalization or prolongation of existing hospitalization.
- Congenital abnormalities or birth defects.
Measured: 30 days of post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start2 Mar 2024
- Primary completion11 Feb 2025
- Study completion11 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Japanese EncephalitisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaoning Chengda Biotechnology CO., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huanyu Wang, Study director, Liaoning Chengda Biotechnology CO., LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331702
- Sponsor's protocol ID
- CDBJEIV2023001
- Status last verified
- Aug 2025
- First submitted
- 19 Mar 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅳ, Randomized, Controlled, Open-label, Immunogenicity Study of Vero Cell-derived Inactivated Japanese Encephalitis Vaccine (JEV-I) Co-administered With Measles-Mumps-Rubella Vaccine (MMR)
- ClinicalTrials.gov ID
- NCT06331702
- Acronym / sponsor ID
- CDBJEIV2023001
- Conditions
- Japanese Encephalitis, Measles, Mumps, Rubella
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Liaoning Chengda Biotechnology CO., LTDIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2024 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase IV, randomized, controlled, open-label study proceed in healthy children aged 8 months in China. The primary objective is to demonstrate the immunogenicity of simultaneous administration of JEV-I and MMR is not inferior to that of separate administration, as measured by seroconversion rates and antibody titers against the four antigens. The secondary objective is to describe the safety of the vaccines when administered simultaneously or separately.
Detailed description
According to current immunization programs in China, there is an overlap in the vaccination schedules for JEV-I and MMR. Children are recommended to receive 2 doses of JEV-I at 8 months of age, with an interval of 7-10 days. The MMR vaccine is also recommended for administration at 8 months of age. Administering JEV-I and MMR vaccines simultaneously at 8 months of age may facilitate adherence to vaccination programs, reduce the burden of medical treatment for parents and children who receive both vaccines separately, and improve the efficiency of vaccination work.
This is a phase IV, randomized, controlled, open-label study proceed in healthy children aged 8 months in China. The primary objective is to demonstrate the immunogenicity of simultaneous administration of JEV-I and MMR is not inferior to that of separate administration, as measured by seroconversion rates and antibody titers against the four antigens. The secondary objective is to describe the safety of the vaccines when administered simultaneously or separately.
The children aged 8 months who have not received any Japanese encephalitis vaccine or MMR (or vaccines containing related ingredients) will be recruited and randomly assigned to one of three study groups (1:1:1 ratio): Group 1, Group 2 and Group 3. Participants in Group 1 will receive JEV-I (dose 1) and MMR simultaneously for the first time. Participants in Group 2 will receive JEV-I only. Participants in Group 3 will receive MMR only.
Blood will be collected pre-vaccination (Day 0) and 30 days post vaccination to evaluate seroconversion rates and antibody titers against the four antigens.
After each vaccination, all participants will be observed at the clinical site for at least 30 minutes for immediate reactions and will be monitored for solicited adverse events (AEs) for 7 days post vaccination. All participants will be monitored for unsolicited AEs and serious adverse events within 30 days of post vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (JEV-I and MMR co-administration group) | Experimental | Biological: Vero cell-drived inactive Japanese encephalitis vaccine, Biological: Measles-Mumps-Rubella VaccineParticipants will receive 1 dose of JEV-I and 1 dose of MMR concurrently on Day 0, with each vaccine administered on a different side of the body, and a second dose of JEV-I 7-10 days later. Blood sampling will be performed on Day 0 and 30 days after the second dose of JEV-I. |
| Group 2 (JEV-I administered separately) | Active comparator | Biological: Vero cell-drived inactive Japanese encephalitis vaccineParticipants will receive 2 doses of JEV-I (7-10 days apart). Blood sampling will be performed on Day 0 and 30 days after the second dose of JEV-I. |
| Group 3 (MMR administered separately) | Active comparator | Biological: Measles-Mumps-Rubella VaccineParticipants will receive 1 doses of MMR. Blood sampling will be performed on Day 0 and Day 30. |
Who may qualify
- Ages
- 8 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Participants aged 8 months to <12 months at the time of enrollment
- Participants are able to provide valid identification documents of themselves and/or their legal guardian (entrusted person).
- Legal guardian of the participants can understand requirements and processes of the study, voluntarily agree to participate in the clinical trial, provide informed consent, accept all scheduled visits.
Key exclusion criteria (16 listed)
- Axillary temperature >37.0 ℃ at the time of enrollment.
- Participating in another clinical trial or planning to participate in another clinical trial during the course of this trial.
- Previous receipt of the Japanese encephalitis vaccine or the measles-mumps-rubella vaccine (or a vaccine containing any of these components), or plan to receive other vaccines of the same type or composition during the trial period.
- History of measles, mumps, rubella, or Japanese encephalitis infection (confirmed by clinical, serological, or microbiological methods).
- Received blood or blood products within 3 months before enrollment.
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 |
|---|---|---|
| Vero cell-drived inactive Japanese encephalitis vaccineAlso: JEV-I0.5ml for each dose, manufactured by Liaoning Chengda Biotechnology CO., LTD, administered in the deltoid area of lateral arm by intramuscular injection. | Biological | Group 1 (JEV-I and MMR co-administration group), Group 2 (JEV-I administered separately) |
| Measles-Mumps-Rubella VaccineAlso: MMR0.5ml for each dose (after dissolving), manufactured by Shanghai Institute of Biological Products CO., LTD, administered in the lower part of the deltoid area of lateral arm, by subcutaneous injection. | Biological | Group 1 (JEV-I and MMR co-administration group), Group 3 (MMR administered separately) |
Primary outcome
Antibody Titer for Post Vaccination
Time frame: 30 days after the last dose of vaccination
The serum neutralizing antibody titer against Japanese encephalitis virus is measured by plaque reduction neutralization test (PRNT). The immunoglobulin (IgG) antibody titers against measles virus, mumps virus, and rubella virus are measured using enzyme-linked immunosorbent assay (ELISA).
Seroconversion Rate for Post Vaccination
Time frame: 30 days after the last dose of vaccination
The seroconversion rate for JEV-I post vaccination is defined as the percentage of participants with a change in serum anti-JE neutralizing antibody from PRNT titer <1:10 at baseline to titer ≥1:10 30 days after the last dose of vaccination or a 4-fold rise from baseline. The seroconversion rate for MMR post vaccination is defined as the percentage of participants with a change in serum measles IgG antibody from titer <200 milli international units (mIU)/mL at baseline to titer ≥200 mIU/mL post vaccination or a 4-fold rise from baseline, and serum mumps IgG antibody from titer <100 international units (IU)/mL to titer ≥100 IU/mL or a 4-fold rise from baseline, and serum rubella IgG antibody from titer <20 IU/mL to titer ≥20 IU/mL or a 4-fold rise from baseline, as measured by ELISA.
3 secondary outcomes
Incidence of Any Local and Systemic Adverse Events Within 30 Minutes of Each Vaccination
Time frame: 30 minutes following each vaccination
Incidence of Solicited Local and Systemic Adverse Events Within 7 Days of Each Vaccination
Time frame: 30 minutes through 7 days following each vaccination
Incidence of Unsolicited Adverse Events and Serious Adverse Events Within 30 Days of Post Vaccination
Time frame: 30 days of post vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Huanyu Wang study director
Liaoning Chengda Biotechnology CO., LTD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vero cell-drived inactive Japanese encephalitis vaccine and Measles-Mumps-Rubella Vaccine in people with Japanese Encephalitis and Measles, run by Liaoning Chengda Biotechnology CO., LTD at 1 site in China.
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 3 inclusion and 16 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 28 Aug 2025. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Antibody Titer for Post Vaccination (time frame: 30 days after the last dose of 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?
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 28 Aug 2025.