Immunogenicity of Japanese Encephalitis Vaccine Co-administered With Measles-Mumps-Rubella Vaccine (MMR)

August 21, 2025 updated by: Liaoning Chengda Biotechnology CO., LTD

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
408

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Provincial Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1 (JEV-I and MMR co-administration group)
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.
Biological: Vero cell-drived inactive Japanese encephalitis vaccine
0.5ml for each dose, manufactured by Liaoning Chengda Biotechnology CO., LTD, administered in the deltoid area of lateral arm by intramuscular injection.
Other Names:
  • JEV-I
Biological: Measles-Mumps-Rubella Vaccine
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.
Other Names:
  • MMR
Active Comparator: Group 2 (JEV-I administered separately)
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.
Biological: Vero cell-drived inactive Japanese encephalitis vaccine
0.5ml for each dose, manufactured by Liaoning Chengda Biotechnology CO., LTD, administered in the deltoid area of lateral arm by intramuscular injection.
Other Names:
  • JEV-I
Active Comparator: Group 3 (MMR administered separately)
Participants will receive 1 doses of MMR. Blood sampling will be performed on Day 0 and Day 30.
Biological: Measles-Mumps-Rubella Vaccine
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.
Other Names:
  • MMR

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
30 days after the last dose of vaccination
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.
30 days after the last dose of vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Any Local and Systemic Adverse Events Within 30 Minutes of Each Vaccination
Time Frame: 30 minutes following 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.
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

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
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

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.
30 days of post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Liaoning Chengda Biotechnology CO., LTD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Huanyu Wang, Liaoning Chengda Biotechnology CO., LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 11, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CDBJEIV2023001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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