Observing the safety of the Japanese Encephalitis vaccine in children
Safety Observation of the Vero Cell-derived Inactivated Japanese Encephalitis Vaccine (JEV-I) Given With Primary Immunization in a Large Amount of Healthy Children Aged 8 Months and Older
This study looks at how safe the Japanese Encephalitis vaccine is for healthy children aged 8 months and older when they get it as part of their regular vaccinations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 28547 (estimated) |
| Ages | 8 Months and up |
| Sex | All |
| Sponsor | Liaoning Chengda Biotechnology CO., LTD Industry-sponsored |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06372665 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the safety of the Japanese Encephalitis Vaccine (JEV-I) when administered as part of a primary immunization program in healthy children aged 8 months and older. Participants will voluntarily receive the vaccine at their own expense and will be monitored for any adverse events following vaccination. The study will track both immediate and delayed reactions to the vaccine, ensuring comprehensive safety data is collected over a specified observation period. No vaccine will be provided by the study; instead, it will rely on the children's existing immunization choices.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy children aged 8 months and older who are receiving the Japanese Encephalitis vaccine for primary immunization.
Not a fit: Patients who are not receiving the Japanese Encephalitis vaccine or those with underlying health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable safety data that enhances the understanding of the Japanese Encephalitis vaccine's effects in children.
How similar studies have performed: While this study is observational and focuses on safety, similar studies have been conducted with vaccines that have shown positive safety profiles, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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. Exclusion Criteria: -
Where this trial is running
Nanjing, Jiangsu
- Jiangsu Provincial Center for Disease Control and Prevention — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Li Tong
- Email: 14877107@qq.com
- Phone: +86 15811315908
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.