Japanese EncephalitisNCT06372665
Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization
An observational study of Japanese Encephalitis, run by Liaoning Chengda Biotechnology CO., LTD at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 months and olderHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis
- Type of treatment
- Vaccines
- How many people
- 15,357 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy children aged 8 months and older who voluntarily receive the research vaccines within Jiangsu Province
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official title: 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 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.
Read the detailed description
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
- Japanese Encephalitis
- Medical subject headings
- Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Pain
- Induration
- Ecchymosis (Redness)
- Pruritus
- Rash
Systemic reactions:
- Headache
- Courbature (not from injection site)
- Diarrhea
- Dysphagia
- Anorexia
- Vomiting
- Sickness
- Cough
- Dyspnea
- Irritability
- Sleepiness
- Acute allergic reaction
- Pain (not from injection site)
Measured: 30 days following each vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Jan 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Japanese EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15,357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaoning Chengda Biotechnology CO., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huanyu Wang, Study director, Liaoning Chengda Biotechnology CO., LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372665
- Sponsor's protocol ID
- CDB-IV-JE-025202301
- Status last verified
- Aug 2025
- First submitted
- 15 Apr 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41980877
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06372665
- Acronym / sponsor ID
- CDB-IV-JE-025202301
- Conditions
- Japanese Encephalitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,357 participants (actual)
- Lead sponsor
- Liaoning Chengda Biotechnology CO., LTDIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 8 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy children aged 8 months and older who voluntarily receive the research vaccines within Jiangsu Province
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants Reporting Solicited Local and Systemic Adverse Events, and Unsolicited Adverse Events
Time frame: 30 days following each vaccination
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: * Pain * Induration * Ecchymosis (Redness) * Pruritus * Rash Systemic reactions: * Headache * Courbature (not from injection site) * Diarrhea * Dysphagia * Anorexia * Vomiting * Sickness * Cough * Dyspnea * Irritability * Sleepiness * Acute allergic reaction * Pain (not from injection site)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Derived from this study: PubMed 41980877Liu 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huanyu Wang study director
Liaoning Chengda Biotechnology CO., LTD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Japanese Encephalitis, run by Liaoning Chengda Biotechnology CO., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Solicited Local and Systemic Adverse Events, and Unsolicited Adverse Events (time frame: 30 days following each vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06372665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.