A Phase 4 interventional study of Vero cell-drived inactive Japanese encephalitis vaccine and Measles-Mumps-Rubella Vaccine in Japanese Encephalitis, Measles and Mumps, sponsored by Liaoning Chengda Biotechnology CO., LTD. Completed at 1 site in China. Open to participants aged 8 Months to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by Liaoning Chengda Biotechnology CO., LTD · Phase 4, Interventional, and Prevention
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.
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.
74 studies on the registry are indexed under Encephalitis, Japanese; 3 are open to participants now.
This study's enrollment of 408 is above the median of 300 across 65 interventional studies indexed under Encephalitis, Japanese.
Browse Encephalitis, Japanese studies →Liaoning Chengda Biotechnology CO., LTD is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Biological: Measles-Mumps-Rubella Vaccine
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
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, manufactured by Liaoning Chengda Biotechnology CO., LTD, administered in the deltoid area of lateral arm by intramuscular injection.
Also known as: JEV-I
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.
Also known as: MMR
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).
Time frame: 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.
Time frame: 30 days after the last dose of vaccination
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.
Time frame: 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
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
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.
Time frame: 30 days of post vaccination
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2024 to primary completion in Feb 2025, 11 months.
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Studies of the drug tested here: Measles-Mumps-Rubella Vaccine
Liaoning Chengda Biotechnology CO., LTD