Study Results
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Basic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2015-04-30
2015-11-30
Brief Summary
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Detailed Description
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However, mouse brain-derived JE vaccine production requires companies to compliance various requirements from WHO. Especially, WHO has a plan to replace the mouse brain-derived JE vaccines with Cell culture-derived JE vaccines.
Vero cell-derived vaccine technology shows many advantages compares to Mouse brain-derived vaccine technology. VABIOTECH has been approved and sponsored by the Ministry of Science and Technology to produce Vero cell - derived JE vaccine. The vaccine demonstrated a good safety and immunogenicity profile in animal models. The vaccine has been proven safety in volunteer adults.
In this study, a dose escalating study with 3 different dosing regimens of the studied vaccine (JECEVAX) and a licensed vaccine (JEVAX-VABIOTECH Vietnam) is conducted in Vietnamese children, aged 9-24 months to assess the safety and immunogenicity. Two hundred children are enrolled and randomly assigned into 4 groups (50 children/group), each of which receive 2 doses of investigate vaccines or control vaccine subcutaneously, at 10-12 days interval. Safety issues included immediate reaction at the site of injection and systemic reaction within 30 min of administration, solicited and unsolicited adverse events occurs from the first dose to 30 days after second dose; SAE (from start of first dose to 30 days after second dose), blood cell count, urea, ALT, AST. Immunogenicity outcomes include seroconversion of neutralizing antibodies (blood samples are taken prior to 1st dose and 20-22 days post 2nd dose).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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JECEVAX-1
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 1.0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12days
JECEVAX-1
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 1 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
JECEVAX-0.8
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.8 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
JECEVAX-0.8
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.8 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
JECEVAX-0.5
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
JECEVAX-0.5
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
JEVAX
JEVAX - VABIOTECH Vietnam Liquid form Composition: 1,0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
JEVAX
JEVAX - VABIOTECH Vietnam Liquid form Subcutaneous injection 0.5ml/dose, 2 doses, 10-12 days interval
Interventions
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JEVAX
JEVAX - VABIOTECH Vietnam Liquid form Subcutaneous injection 0.5ml/dose, 2 doses, 10-12 days interval
JECEVAX-1
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 1 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
JECEVAX-0.8
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.8 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
JECEVAX-0.5
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have not been vaccinated with JE vaccine;
* Not have any chronic disease;
* Parents/legal guardians agree to participate their children in this study and sign the informed consent.
Exclusion Criteria
* Currently has acute diseases;
* Use (orally or injection) with corticosteroid containing drug (\>1 mg / kg dose);
* Use of immunocompromised treatment within 4 weeks of enrollment;
* Being immunocompromised and autoimmune diseases (HIV, lupus);
* The family history of immunocompromised;
* History of febrile seizure;
* Allergic to any vaccine component;
* Fever (\>38 Celsius degree) within 3 days before vaccination or at enrollment;
* Malnourished (3rd grade or above);
* Blood disorder;
* Use of vaccines which have not been licenced 7 days before enrolment in this study
9 Months
24 Months
ALL
Yes
Sponsors
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Ministry of Science and Technology, Vietnam
OTHER_GOV
Ministry of Health, Vietnam
OTHER_GOV
National Institute of Hygiene and Epidemiology, Vietnam
OTHER
Responsible Party
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Vu Dinh Thiem
Head, Department of Epidemiology
Principal Investigators
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Thiem D Vu, MD., PhD.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Hygiene and Epidemiology, Vietnam
Locations
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District Health Center
Thanh Sơn, Phu Tho, Vietnam
Phu Tho Preventive Medicine Center
Việt Trì, Phu Tho, Vietnam
Countries
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Other Identifiers
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2015-JECEVAX-2R
Identifier Type: -
Identifier Source: org_study_id
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