- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04223037
Purified Inactivated Japanese Encephalitis Vaccine
Phase III Clinical Trial of Purified Inactivated Japanese Encephalitis Vaccine
Study Overview
Status
Conditions
Detailed Description
The clinical study used randomized, blind method, commercialize inactivated Japanese encephalitis vaccine as control. In Infants at 6-23 months of age were injected with experimental vaccine with 0,7 days and 0,28 days vaccination schedule to evaluate immunogenicity and safety of the experimental vaccine and the effectiveness of different vaccination schedule. Participates were assigned to three groups (350 per group): group 1 with experimental vaccine using 0,7 days vaccination schedule; group 2 with control vaccine using 0, 7 days vaccination schedule; group 3 with experimental vaccine using 0, 28 vaccination schedule.
Blood samples were collected before immunization and 30 days after immunization, and the neutralization antibody of Japanese encephalitis was detected by plaque reduction neutralization test. Medical observation was conducted 30 minutes after each injection. Body temperature of participates was continuously measured for 7 days, and any adverse events were observed and recorded from the first dose to 30 days after the whole vaccination. Serious adverse events were collected within 6 months after the first dose.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Inner Mongolia Autonomous Region
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Hohhot, Inner Mongolia Autonomous Region, China, 010031
- Disease prevention and control center of Inner Mongolia autonomous region
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 6-23 months old infants, no vaccination history of JE vaccine, no vaccination contraindication.
- informed consent of guardian / lawful written guardian, and signed informed consent;
- the guardian and family can comply with the requirements of the clinical trial scheme.
- there was no immunization history of immunoglobulins within three months, and there was no history of live vaccination within 14 days.
- the axillary temperature ≤ 37℃.
Exclusion Criteria:
- Allergy to any ingredient in the vaccine (any previous history of vaccine allergy); There are allergic, convulsive, epileptic, encephalopathy and psychiatric symptoms or signs.
- People with known or suspected (or high-risk) impairment or abnormality of immune function, such as those receiving immunosuppressive or immunopotentiator therapy, receiving blood products or plasma extracts within three months, or having an immunodeficiency virus infection or related disease in the mother or child.
- A history of thrombocytopenia or other coagulation disorders clearly diagnosed by the medical department, or a history of hemorrhagic constitution or prolonged bleeding time;
- Infected patients with known or suspected to have respiratory diseases, acute infections or active chronic diseases and are receiving antibiotic or antiviral treatment;
- In the past 3 days, fever (axillary body temperature≥38℃), oral or steroid hormones were given.
- Infectious or allergic skin diseases.
- Participating in another clinical researcher; or any situation that the researcher considers likely to affect the evaluation of the trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Day 0,7 immunization shedule
Japanese Encephalitis Vaccine produced by Institute of Medical Biology, Chinese Academy of Medical Sciences (IMBCAMS) and Japanese Encephalitis Vaccine produced by Liaoning Chenda CO.,LTD Dosage form: 0.5mL/vial Two Dose injection with 7 days interval
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Dosage form: 0.5mL/vial
Dosage form: 0.5mL/vial
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Experimental: Day 0,28 immunization shedule
Japanese Encephalitis Vaccine produced by IMBCAMS Dosage form: 0.5mL/vial Two Dose injection with 28 days interval
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Dosage form: 0.5mL/vial
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local and systemic adverse reactions
Time Frame: Within 6 months after immunization
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The main endpoint of safety observation was 30 days after 2 doses vaccination.
If serious adverse reactions related to vaccines occur during the observation period, or the adverse reactions of grade 3 and above reached 10%, or three symptoms similar to grade 3 and above occur within 24 hours, the trial should be suspended and vaccine-related adverse reactions occurred.
The death of the subjects will be terminated at any time.
Follow up and collection of serious adverse events within 6 months after first dose immunization via close monitoring or diary card.
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Within 6 months after immunization
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Immunogenecity detected by plaque reduction neutralization test
Time Frame: 1 month after immunization
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Blood samples were collected from all subjects before and 30 days after the whole course of immunization, and neutralizing antibody was detected by plaque reduction neutralization test.
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1 month after immunization
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Collaborators and Investigators
Investigators
- Principal Investigator: Shaohong Yan, Disease prevention and control center of Inner Mongolia autonomous region
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Infections
- Encephalitis, Arbovirus
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- Arbovirus Infections
- Vector Borne Diseases
- Flavivirus Infections
- Flaviviridae Infections
- Encephalitis, Japanese
- Encephalitis
- Virus Diseases
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- 074201504
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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