Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15357 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-04-30

Brief Summary

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This is a single-arm, non-randomized, open-label post-marketing safety observation study. The purpose of this study is to investigate the safety of JEV-I given with primary immunization in a large amount of healthy children aged 8 months and older.

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Detailed Description

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Healthy children aged 8 months and older who choose to receive the study vaccine for primary immunization at their own expense in Jiangsu Province will be invited to participate in this study. No study vaccine will be supplied or administered as part of this study, participants will be monitored following vaccine administration in clinical settings.

The primary immunization program with JEV-I requires 2 intramuscular doses administered 7-10 days apart. All participants will be observed for the incidence of any adverse events (AEs) within 30 minutes and from 30 minutes to 7 days after each vaccination, including local and systemic reactions. Additionally, all participants will be observed for unsolicited AEs within 30 days after after each vaccination.

Conditions

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Japanese Encephalitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Vero Cell-derived Inactivated Japanese Encephalitis Vaccine Group

Healthy children aged 8 months and above who choose to receive the study vaccine for primary immunization at their own expense in Jiangsu Province

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Healthy children who have received the inactivated Japanese encephalitis vaccine.
* Legal guardian of the participants voluntarily participates in the clinical trial and signs an informed consent form.
* Legal guardian of the subject has the ability to understand the procedures of the study and accept all scheduled visits.