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

No results posted yet for this study

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06331702 on ClinicalTrials.gov