Immunogenicity of Japanese Encephalitis Vaccine Co-administered With Measles-Mumps-Rubella Vaccin… (NCT06331702) | Clinical Trial Compass
CompletedPhase 4
Immunogenicity of Japanese Encephalitis Vaccine Co-administered With Measles-Mumps-Rubella Vaccine (MMR)
China408 participantsStarted 2024-03-02
Plain-language 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.
Who can participate
Age range8 Months – 12 Months
SexALL
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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 no…
What they're measuring
1
Antibody Titer for Post Vaccination
Timeframe: 30 days after the last dose of vaccination
2
Seroconversion Rate for Post Vaccination
Timeframe: 30 days after the last dose of vaccination