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

NCT06331702 | Completed Phase 4

• 1 other identifier: CDBJEIV2023001
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

Brief 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 antibody titers against the four antigens. The secondary objective is to describe the safety of the vaccines when administered simultaneously or separately.

Conditions

Japanese Encephalitis; Measles; Mumps; Rubella

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  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

  30 minutes following each vaccination

• Incidence of Solicited Local and Systemic Adverse Events Within 7 Days of Each Vaccination

  30 minutes through 7 days following each vaccination

• Incidence of Unsolicited Adverse Events and Serious Adverse Events Within 30 Days of Post Vaccination

  30 days of post vaccination

Study Arms (3)

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.

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.

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.

Biological: Measles-Mumps-Rubella Vaccine

Interventions

Vero cell-drived inactive Japanese encephalitis vaccine BIOLOGICAL

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

Group 1 (JEV-I and MMR co-administration group); Group 2 (JEV-I administered separately)

Measles-Mumps-Rubella Vaccine BIOLOGICAL

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

Group 1 (JEV-I and MMR co-administration group); Group 3 (MMR administered separately)

Eligibility Criteria

• Age: 8 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liaoning Chengda Biotechnology CO., LTD: lead

Study Sites (1)

Jiangsu Provincial Center for Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Encephalitis, Japanese; Measles; Mumps; Rubella

Interventions

Measles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Rubulavirus Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Rubivirus Infections; Togaviridae Infections

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine

Study Officials

• Huanyu Wang

  Liaoning Chengda Biotechnology CO., LTD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: March 2, 2024
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)