NCT01954810

Brief Summary

This study has aim to describe the immune response to the second dose of Japanese encephalitis chimeric vaccine (JECV) in children previously vaccinated with one dose of JECV 5 years ago.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

2 months

First QC Date

September 26, 2013

Last Update Submit

October 6, 2013

Conditions

Japanese Encephalitis

Keywords

JECVIMOJEVBooster responseChildrenantibody responseDuration

Outcome Measures

Primary Outcomes (1)

  • Neutralizing antibody titers after JECV vaccination

    Neutralizing antibody titers before JECV booster (on D0), and after IMOJEV booster (on D28)

    28 days

Study Arms (1)

Japanese encephaltis chimerix vaccine

NO INTERVENTION

This is a single-arm study. Japanese encephalitis chimeric vaccine (JECV) will be administered to all subjects and check for antibody response 4 weeks after vaccination.

Biological: Japanese encephalitis chimeric vaccine (JECV)

Interventions

Japanese encephalitis chimeric vaccine (JECV)BIOLOGICAL

Japanese encephalitis chimeric vaccine (JECV)will be administered to every children in the study for one dose and check for antibody response 4 weeks after vaccination

Also known as: IMOJEV
Japanese encephaltis chimerix vaccine

Eligibility Criteria

Age72 Months - 80 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Subject who was vaccinated with 1 dose JE-CV in JEC02 and participated in 5 year follow-up in JEC05 trial and finished year 5 of follow-up.
  • Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative.
  • Subject and parent/legally acceptable representative or guardian able to attend all scheduled visits and to comply with all trial procedures
  • In good general health, based on medical history and physical examination

You may not qualify if:

  • Participation in another clinical trial investigating a vaccine which need to have vaccination or blood draw within the 4 weeks preceding the trial vaccination except JEC05
  • Planned participation in another clinical trial during the Day0-Day28 period
  • Receipt of live vaccine within 4 weeks preceding the trial vaccination
  • Planned receipt of any vaccine in the 4 weeks following the trial vaccination
  • Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
  • Chronic illness or any underlying illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, Faculty of Medicine, Khon Kaen University

Muang, Changwat Khon Kaen, 40002, Thailand

Location

MeSH Terms

Conditions

Encephalitis, Japanese

Condition Hierarchy (Ancestors)

Encephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisArbovirus InfectionsVector Borne DiseasesMosquito-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlavivirus InfectionsFlaviviridae InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Study Officials

  • Pope Kosalaraksa, M.D.

    Khon Kaen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pope Kosalaraksa, M.D.

CONTACT

+66-89-7112236pkosalaraksa@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 26, 2013

First Posted

October 7, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2013

Study Completion

May 1, 2014

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

TH(1)