Back to resultsPurified Inactivated Japanese Encephalitis Vaccine
Primary Purpose
Japanese Encephalitis Virus Disease
Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Japanese Encephalitis Vaccine produced by IMBCAMS
Japanese Encephalitis Vaccine produced by Liaoning Chenda
Sponsored by
About this trial
This is an interventional prevention trial for Japanese Encephalitis Virus Disease focused on measuring Japanese Encephalitis Vaccine, Phase III Clinical Trial
Eligibility Criteria
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
Sites / Locations
- Disease prevention and control center of Inner Mongolia autonomous region
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Day 0，7 immunization shedule
Day 0，28 immunization shedule
Arm Description
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
Japanese Encephalitis Vaccine produced by IMBCAMS Dosage form: 0.5mL/vial Two Dose injection with 28 days interval
Outcomes
Primary Outcome Measures
Local and systemic adverse reactions
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.
Immunogenecity detected by plaque reduction neutralization test
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04223037
First Posted
January 6, 2020
Last Updated
March 8, 2022
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04223037
Brief Title
Purified Inactivated Japanese Encephalitis Vaccine
Official Title
Phase III Clinical Trial of Purified Inactivated Japanese Encephalitis Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
March 7, 2018 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluates the immunogenicity and safety of a purified inactivated JE vaccine compared to a commercialized JE vaccine. In this phase III, randomized, blind trial, infants at 6-23 months of age were randomly assigned to three groups to receive experimental vaccine or control vaccine with two different vaccination schedule respectively.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Japanese Encephalitis Virus Disease
Keywords
Japanese Encephalitis Vaccine, Phase III Clinical Trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1050 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Day 0，7 immunization shedule
Arm Type
Active Comparator
Arm Description
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
Arm Title
Day 0，28 immunization shedule
Arm Type
Experimental
Arm Description
Japanese Encephalitis Vaccine produced by IMBCAMS Dosage form: 0.5mL/vial Two Dose injection with 28 days interval
Intervention Type
Biological
Intervention Name(s)
Japanese Encephalitis Vaccine produced by IMBCAMS
Intervention Description
Dosage form: 0.5mL/vial
Intervention Type
Biological
Intervention Name(s)
Japanese Encephalitis Vaccine produced by Liaoning Chenda
Intervention Description
Dosage form: 0.5mL/vial
Primary Outcome Measure Information:
Title
Local and systemic adverse reactions
Description
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.
Time Frame
Within 6 months after immunization
Title
Immunogenecity detected by plaque reduction neutralization test
Description
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.
Time Frame
1 month after immunization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaohong Yan
Organizational Affiliation
Disease prevention and control center of Inner Mongolia autonomous region
Official's Role
Principal Investigator
Facility Information:
Facility Name
Disease prevention and control center of Inner Mongolia autonomous region
City
Hohhot
State/Province
Inner Mongolia Autonomous Region
ZIP/Postal Code
010031
Country
China
12. IPD Sharing Statement
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Purified Inactivated Japanese Encephalitis Vaccine
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