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Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Toddlers

NCT01001988 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 596

Last updated 2017-11-29

Study results available
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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

Conditions

Interventions

OTHER

Blood sample

Blood sample for immunogenicity assessment

BIOLOGICAL

JE-CV administered in Study JEC02

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

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-07
Primary Completion
2013-10-16
Completion
2013-10-16
FDA Drug
Yes

Countries

  • Philippines
  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01001988 on ClinicalTrials.gov