Immunogenicity of Japanese Encephalitis Vaccine Co-administered With Measles-Mumps-Rubella Vaccine (MMR)
NCT06331702 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 408
Last updated 2025-08-28
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
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
Liaoning Chengda Biotechnology CO., LTD
lead INDUSTRY
Principal Investigators
-
Huanyu Wang · Liaoning Chengda Biotechnology CO., LTD
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 8 Months
- Max Age
- 12 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-03-02
- Primary Completion
- 2025-02-11
- Completion
- 2025-02-11
Countries
- China
Study Locations
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