Safety of Vero Cell - Derived Inactivated Japanese Encephalitis Vaccine (JECEVAX) in Children From 9-24 Months of Age
JECEVAX-2B
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
1 other identifier
interventional
220
1 country
4
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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2017
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 2, 2017
CompletedFirst Submitted
Initial submission to the registry
June 27, 2017
CompletedFirst Posted
Study publicly available on registry
June 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2017
CompletedSeptember 17, 2018
September 1, 2018
2 months
June 27, 2017
September 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Frequencies of participants with treatment-related SAE during study period
Up to 28-34 days after the 2nd dose (3rd visit)
Study Arms (2)
JECEVAX
EXPERIMENTALJECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days
JEVAX
ACTIVE COMPARATORJEVAX - VABIOTECH Vietnam Liquid form Composition: 1,0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hoa Binh Provincial Preventive Medicine Center
Hòa Bình, Hoa Binh, 350000, Vietnam
Hoa Binh City Health Center
Hòa Bình, Hoa Binh, 35000, Vietnam
District Health Center
Thanh Sơn, Phu Tho, Vietnam
Phu Tho Preventive Medicine Center
Việt Trì, Phu Tho, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thiem D Vu, MD., PhD.
National Institute of Hygiene and Epidemiology, Vietnam
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head, Department of Epidemiology
Study Record Dates
First Submitted
June 27, 2017
First Posted
June 29, 2017
Study Start
June 2, 2017
Primary Completion
August 12, 2017
Study Completion
August 12, 2017
Last Updated
September 17, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share
Individual data with identification removed are to be available for Ethical committee, Ministry of Health and National Foundation of Science and Technology Development to avoid misuse of data. Public shared data will be in the form of summarised tables and figures.