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.

Randomized controlled, investigator blinded, single center trial in Thailand in approximately 140 subjects aged 20-30 months whom had been primed with any live attenuated JE vaccine at least 12-18 months before booster dose of vaccine. Subjects will be randomized into 2 arms

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20220412006

Enrollment

140

Registered

2022-04-12

Start date

2022-04-24

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Immungenicity of booster dose of inactivated or live attenuated JE vaccine in children 20-30 month whom had primed with any live attenuated JE vaccine to ensure prevention of Japanese Encephalitis. Japanese encephalitis, JE vaccine, inactivated JE vaccine, live attenuated JE vaccine, , immunogenicity, safety

Interventions

Approximately 70 subjects aged 20-30 months who primed with any live attenuated JE vaccine at least 12-18 months before booster doses, Inactivated vero-cell-derived JE vaccine.,Approximately 70 subjec

Experimental Biological/Vaccine,Active Comparator Biological/Vaccine

Inactivated vero-cell-derived JE vaccine,Live attenuated JE vaccine

Eligibility

Sex/Gender

All

Age

20 Months to 30 Months

Inclusion criteria

Inclusion criteria: 1.Children (any gender) aged 20-30 months on day of enrollment, 2.History of recieved 1 dose of IMOJEV or CD JEVAX as primary JE vaccination at 12-18 months prior to enrollment for booster dose, 3.In good general health at enrollment, 4.Informed consent by parent(s) or legal gardian(s), 5.Able to follow up for 1 year (+1 month) after enrollment

Exclusion criteria

Exclusion criteria: 1.Acute febrile illness on day of vaccination (Body temperature is equal or more than 38 degree Celsius), 2.Had been recieved any JE vaccine before (except IMOJEV or CD JEVAX for 1 dose only), 3.Reciept of blood products in the past 3 months or plan to recieve blood product within 1 month after enrollment, 4.Known hypersensitivity of vaccine component, 5.Any confirmed or suspected immunosuppress or immunodeficient condition, by medical history or physical examination, 6.Had been recieved any vaccine within 30 days prior study vaccine, 7.Planned to recieve any vaccine within 30 days after enrollment, 8.Not participating in any clinical trial for drug or vaccine 30 days before and after enrollment.

Design outcomes

Primary

Measure	Time frame
Immunogenicity at baseline and at 42 and 365 days after booster in both arms The geometric mean titer (GMT) of JE neutralizing antibody,Rate of seroprotective level of JE neutralizing antiboy 30 minutes after booster and 7 days and 42 days after vaccination Occurrence of MedDRA, time to onset, intensity, duration related to vaccination of any unsolicited systemic adverse events	—

Secondary

Measure	Time frame
Safety 30 minutes after booster and 7 days and 42 days after vaccination Occurrence of MedDRA, time to onset, intensity, duration related to vaccination of any unsolicited systemic adverse events	—

Countries

Thailand

Contacts

Public ContactTawee Chotpitayasunondh

Ministry of Health

cctawee@gmail.com023548400

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026