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

NCT06372665 | Completed

• 1 other identifier: CDB-IV-JE-025202301
• Study Type: observational
• Target: 15,357
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Japanese Encephalitis

Outcome Measures

Primary Outcomes (1)

• 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)

  30 days following each vaccination

Study Arms (1)

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

Eligibility Criteria

• Age: 8 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy children aged 8 months and older who voluntarily receive the research vaccines within Jiangsu Province

You may qualify if:

• 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.

Sponsors & Collaborators

• Liaoning Chengda Biotechnology CO., LTD: lead

Study Sites (1)

Jiangsu Provincial Center for Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Encephalitis, Japanese

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Officials

• Huanyu Wang

  Liaoning Chengda Biotechnology CO., LTD

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: January 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

CN (1)