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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Solicited Local and Systemic Adverse Events, and Unsolicited Adverse Events | Adverse events (AEs) are defined as all adverse medical events that occur in participants after receiving the investigational drug, which can manifest as symptoms, signs, diseases, or abnormal laboratory tests, but they may not necessarily have a causal relationship with the investigational drug. Unsolicited AEs will be collected within 30 days after each dose of vaccine administration, while solicited adverse reactions will be collected within 30 minutes and 30 minutes to 7 days after each dose of vaccine administration. A structured form (pre-listed) will be used to record the local and systemic reactions collected below. Local reactions:
Systemic reactions:
| 30 days following each vaccination |
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Inclusion Criteria:
Exclusion Criteria:
-
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Healthy children aged 8 months and older who voluntarily receive the research vaccines within Jiangsu Province
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| Name | Affiliation | Role |
|---|---|---|
| Huanyu Wang | Liaoning Chengda Biotechnology CO., LTD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Center for Disease Control and Prevention | Nanjing | Jiangsu | 210009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41980877 | Derived | Liu L, Zhang L, Hu R, Kang G, Yu J, Sun X, Wang Z. An active surveillance study of adverse events following to Japanese encephalitis inactivated vaccine (JE-I) in Jiangsu Province, China, 2024-2025. Expert Rev Vaccines. 2026 Dec;25(1):2653748. doi: 10.1080/14760584.2026.2653748. Epub 2026 Apr 14. |
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| ID | Term |
|---|---|
| D004672 | Encephalitis, Japanese |
| ID | Term |
|---|---|
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
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| D007239 | Infections |
| D000069544 | Infectious Encephalitis |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D012327 | RNA Virus Infections |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |