Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03204227 |
Date of registration:
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27/06/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Safety of Vero Cell - Derived Inactivated Japanese Encephalitis Vaccine (JECEVAX) in Children From 9-24 Months of Age
JECEVAX-2B |
Scientific title:
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Evaluate the Safety of a Vero Cell - Derived Inactivated Japanese Encephalitis Vaccine (JECEVAX) Produced by The Company for Vaccine and Biological Production No.1 in Vietnamese Children Aged 9-24 Months |
Date of first enrolment:
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June 2, 2017 |
Target sample size:
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220 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03204227 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Vietnam
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Contacts
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Name:
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Thiem D Vu, MD., PhD. |
Address:
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Telephone:
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Email:
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Affiliation:
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National Institute of Hygiene and Epidemiology, Vietnam |
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Key inclusion & exclusion criteria
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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
Age minimum:
9 Months
Age maximum:
24 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Japanese Encephalitis
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Intervention(s)
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Biological: JEVAX
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Biological: JECEVAX
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Primary Outcome(s)
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Percent of participants with treatment-related adverse events during study period.
[Time Frame: Up to 28-34 days after 2nd dose]
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Secondary Outcome(s)
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Frequencies of participants with treatment-related SAE during study period
[Time Frame: Up to 28-34 days after the 2nd dose (3rd visit)]
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Secondary ID(s)
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2017-JECEVAX-2B
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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