Safety and Immunogenicity of a booster dose of inactivated Vero-cell-derived Japanese Encephalitis vaccine (JEVAC) in children whom primed with live attenuated JE vaccine.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20190507007

Enrollment

150

Registered

2019-05-07

Start date

2019-04-27

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy children Japanese encephalitis Japanese encephalitis vaccine Immunogenicity Booster Inactivated JE vaccine

Interventions

The subject gets live&#45

attenuate JE vaccine (CD.JEVAX) as a primary dose and will get JEVAC as a booster dose. (Live CD. JEvax then killed vaccine),The subject gets live&#45

attenuate chimeric JE vaccine (IMOJEV) as a primary dose and will get JEVAC as a booster dose. (Live IMJEV then killed vaccine) ,The subject gets live&#45

attenuate JE vaccine (CD.JEVAX) OR chimeric JE vaccine (IMOJEV) as a primary dose and will get live&#45

attenuate JE vaccine (CD.JEVAX) OR chimeric JE vaccine (IMOJEV) as a booster dose. (Live then live vaccine)

Experimental Biological/Vaccine,Experimental Biological/Vaccine,Active Comparator Biological/Vaccine

JEVAC booster,live&#45

attenuate JE vaccine (CD.JEVAX) OR chimeric JE vaccine (IMOJEV),The subject gets live&#45

attenuate JE vaccine (CD.JEVAX) OR chimeric JE vaccine (IMOJEV) as a primary d

Eligibility

Sex/Gender

All

Age

20 Months to 30 Months

Inclusion criteria

Inclusion criteria: 1. Healthy 20-30 months old 2. Available vaccination record 3. Received live-attenuate JE vaccine (CD.JEVAX) OR chimeric JE vaccine (IMOJEV) as a primary dose 12-18 months 4. Be able to return for visit 3 times in a year for the follow-ups 5. Has not been vaccinated any vaccines one month prior the enrollment date

Exclusion criteria

Exclusion criteria: 1. No allergic reaction to any vaccine or any compartment in JE vaccine 2. Has fever or other symptoms diagnosed by physician on enrollment day 3. Plan to relocate by the end of the study 4. Has blood transfusion 3 months prior the enrollment date or expect to have blood transfusion within 1 month after vaccination 5. Suspected of having immunodeficiency, including severe liver disease, renal failure, growth disorders, cancer, autoimmune diseases, use of immunosuppressants, oral steroids (Except for respiratory spray steroid) 6. Parents or guardian refuse or unable to sign inform consent

Design outcomes

Primary

Measure	Time frame
Immunogenicity of a booster dose 365 days (+28days) GMT for JE antibody (PRNT),Reactogenicity 365 days (+28days) Occurrence of systemic and local side effect	—

Secondary

Measure	Time frame
Side effect of the vaccine 7 days after vaccination Diary Card	—

Countries

Thailand

Contacts

Public ContactTawee Chotpitayasunondh

Queen Sirikit National Institute of Child Health

cctawee@gmail.com081-8198172

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026

Safety and Immunogenicity of a booster dose of inactivated Vero&#45;cell&#45;derived Japanese Encephalitis vaccine (JEVAC) in children whom primed with live attenuated JE vaccine.