CompletedPhase 4

Long-term Immunogenicity After Receipt of JE Vaccine and Antibody Response and Safety to a Booster Dose

561 participantsStarted 2015-07-30

Plain-language summary

This study aims to understand the persistence of the Japanese encephalitis (JE) antibody response in previously vaccinated children. The proposed study will enrol Bangladeshi children who had previously participated in a lot to lot consistency study (JEV05; NCT01567865) of JE live attenuated SA 14-14-2 vaccine (CD-JEV).

Who can participate

Age range43 Months – 51 Months

SexALL

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Inclusion Criteria: * Participant in JEV05 study (NCT01567865) and received one dose of CD-JEV. * Resides in the Matlab or Mirpur study area. * At least one parent or guardian willing to provide written informed consent. Exclusion Criteria: * Received a second dose of Japanese encephalitis vaccine within the past three years. * Received immunoglobulins and/or any blood products within 90 days prior to enrollment. * Been diagnosed with a primary or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection within the past three years.

What they're measuring

Seroprotection Rate Three and Four Years After Initial Vaccination With CD-JEV

Timeframe: 3 years after initial vaccination (Study Day 1) and 4 years after initial vaccination (Study Day 365)

Geometric Mean Titer of Anti-JE Neutralizing Antibodies Three and Four Years After Initial Vaccination With CD-JEV

Timeframe: 3 years after initial vaccination (Study Day 1) and 4 years after initial vaccination (Study Day 365)

Trial details

NCT IDNCT02514746

SponsorPATH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12-15

Results submitted2020-09-17

View on ClinicalTrials.gov More Encephalitis, Japanese trials