Safety and Immunogenicity of JECEVAX in Young Children

• Register: ClinicalTrials.gov
• Last refreshed on: 4 July 2016
• Main ID: NCT02816554
• Date of registration: 23/06/2016
• Prospective Registration: No
• Primary sponsor: National Institute of Hygiene and Epidemiology, Vietnam
• Public title: Safety and Immunogenicity of JECEVAX in Young Children
• Scientific title: Safety and Immunogenicity of an Inactivated Japanese Encephalitis Vaccine (JECEVAX) in Vietnamese Children
• Date of first enrolment: April 2015
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02816554
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 2

Countries of recruitment

Vietnam

Contacts

• Name: Thiem D Vu, MD., PhD.
• Affiliation: National Institute of Hygiene and Epidemiology, Vietnam

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy children of both sexes, 9-24 months of age;

- 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 chronic diseases (cardiovascular, liver and spleen related etc);

- 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



Age minimum: 9 Months
Age maximum: 24 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Japanese Encephalitis

Intervention(s)

Biological: JECEVAX-0.5

Biological: JECEVAX-0.8

Biological: JECEVAX-1

Biological: JEVAX

Primary Outcome(s)

Number of participants have sero-conversion at 20-22 days post 2nd dose (compared to pre-vaccination) [Time Frame: Up to 20-22 days after the 2nd dose]

Number of participants with treatment-related adverse events during study period. [Time Frame: Up to 30 days after 2nd dose]

Secondary Outcome(s)

Number of participants with abnormal laboratory value. [Time Frame: Up to 20-22 days after the 2nd dose.]

Number of participants with treatment-related SAE during study period [Time Frame: Up to 30 days after the 2nd dose]

Secondary ID(s)

2015-JECEVAX-2R

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Company for vaccine and biological production No 1, Ministry of Health, Vietnam

Ministry of Science and Technology, Vietnam