Japanese Encephalitis Clinical Trial
— JECEVAX-3Official title:
Evaluate the Safety and Immunogenicity of a Vero Cell - Derived Inactivated Japanese Encephalitis Vaccine (JECEVAX) Produced by VABIOTECH (Vietnam) in Vietnamese Children Aged 9-24 Months
Verified date | September 2018 |
Source | National Institute of Hygiene and Epidemiology, Vietnam |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 vaccine compares to licenced vaccine. Two hundred and twenty children are enrolled and randomly assigned into 2 groups (110 children/group), each of which receive 2 doses of study / control vaccine subcutaneously, at 28-34 days interval. Safety data included immediate reaction at the injection site and systemic reaction within 30 min of administration, solicited and unsolicited adverse events occurs from the 1st dose to 28-34 days after first dose and from the second dose to 28-34 days after 2nd dose. SAE (from start of first dose to 28-34 days after second dose).
Status | Completed |
Enrollment | 655 |
Est. completion date | April 8, 2018 |
Est. primary completion date | February 6, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 9 Months to 24 Months |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Vietnam | Hoa Binh City Health Center | Hòa Bình | Hoa Binh |
Vietnam | Hoa Binh Provincial Preventive Medicine Center | Hòa Bình | Hoa Binh |
Vietnam | District Health Center | Thanh Son | Phu Tho |
Vietnam | Phu Tho Preventive Medicine Center | Viet tri | Phu Tho |
Lead Sponsor | Collaborator |
---|---|
National Institute of Hygiene and Epidemiology, Vietnam | Company for vaccine and biological production No 1, Ministry of Health, Vietnam, Ministry of Science and Technology, Vietnam |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of participants with treatment-related adverse events during study period. | Percent of participants with solicited and unsolicited adverse events after each dose of vaccine: immediately injection site and systemic AEs after vaccination (within 30 min), solicited AEs within 7 days after each dose, unsolicited AEs from date 1st dose 1 to date of dose 2 and from date of 2nd dose to 28-34 day post 2nd dose (3rd visit), as assessed by CTCAE v.4.0. | Up to 28-34 days after 2nd dose | |
Primary | Percent of participants who has antibody sero-conversion in study group and control group at 28-34 days post dose 2. | Serum samples will be taken before 1 dose and 28-34 days post 2nd dose to be tested for JE antibody by PRNT. | Up to 28-34 days after 2nd dose | |
Secondary | Frequencies of participants with treatment-related SAE during study period | Frequencies of participants with treatment-related SAE during study period of JECEVAX compared to that of JEVAX, as assessed by CTCAE ver 4.0 | Up to 28-34 days after the 2nd dose (3rd visit) |
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