Status:
COMPLETED
Evaluate Safety and Immunogenicity of a Vero Cell-Derived JE Vaccine in 9-24 Months of Age Children in Vietnam
Lead Sponsor:
National Institute of Hygiene and Epidemiology, Vietnam
Collaborating Sponsors:
Ministry of Science and Technology, Vietnam
Ministry of Health, Vietnam
Conditions:
Japanese Encephalitis
Eligibility:
All Genders
9-24 years
Phase:
PHASE3
Brief Summary
A study of the study vaccine (JECEVAX- VABIOTECH-Vietnam) and a licensed vaccine (JEVAX-VABIOTECH-Vietnam) is conducted in Vietnamese children, aged 9 to 24 months to assess the safety of the study va...
Detailed Description
Mouse brain-derived Japanese Encephalitis (JE) vaccine was developed in Vietnam since 1989 with the support from WHO and BIKEN institute, Japan. It helped Viet Nam prevents Japanese Encephalitis outbr...
Eligibility Criteria
Inclusion
- Healthy children of both sexes, 9-24 months of age;
- Have not been vaccinated with JE vaccine;
- Parents/legally guardians agree their children to participate in the study and sign the paper informed consent.
Exclusion
- Currently has chronic diseases (cardiovascular, liver and spleen related etc);
- Currently has acute diseases;
- 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 (2nd grade or above);
- Blood disorder;
- Use of vaccines which have not been licenced 7 days before enrolment in this study
Key Trial Info
Start Date :
September 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2018
Estimated Enrollment :
655 Patients enrolled
Trial Details
Trial ID
NCT03282370
Start Date
September 30 2017
End Date
April 8 2018
Last Update
September 17 2018
Active Locations (4)
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1
Hoa Binh Provincial Preventive Medicine Center
Hòa Bình, Hoa Binh, Vietnam, 350000
2
Hoa Binh City Health Center
Hòa Bình, Hoa Binh, Vietnam, 35000
3
District Health Center
Thanh Sơn, Phu Tho, Vietnam
4
Phu Tho Preventive Medicine Center
Việt Trì, Phu Tho, Vietnam