CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 596 enrolled
Drug / intervention
JE-CV administered in Study JEC02 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01001988
NCT01001988Phase 3Completed
CompareCT.gov

Long-term Follow-up of Immunogenicity of a Single Dose of JE-CV in Toddlers in Thailand and the Philippines

Sanofi Pasteur, a Sanofi Company·interventional·Posted Oct 27, 2009·Updated Nov 29, 2017

In Brief

A Phase 3 clinical trial evaluating Blood sample and JE-CV administered in Study JEC02 for Encephalitis and Japanese Encephalitis. Completed, enrolled 596 participants across 4 sites in 2 countries.

Detailed Summary

This is a long-term follow-up of the persistence of immune response in participants who previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02 (NCT00735644) . No vaccination was administered during the present long-term follow-up study. Primary Objective: * To describe the yearly persistence of humoral immune response to Japanese encephalitis after a single dose of JE-CV

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEncephalitis, Japanese Encephalitis
CountriesPhilippines, Thailand
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 27, 2009
Enrollment StartAug 7, 2009
Primary CompletionOct 16, 2013
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 16.7 years ago

Interventions

Blood sampleother

Blood sample for immunogenicity assessment

JE-CV administered in Study JEC02biological

Participants received a single dose of JE-CV at 12 to 18 months of age in Study JEC02. No vaccination was administered in Study JEC05