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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01001988
First received: October 23, 2009
Last updated: March 28, 2013
Last verified: March 2013
History of Changes
  Purpose

This is a follow-up of Study JEC02 (NCT 00735644) designed to characterize the persistence of neutralizing antibodies in the five years after vaccination with Japanese encephalitis chimeric vaccine (JE-CV).

Primary Objective:

  • To describe the yearly persistence of humoral immune response to Japanese encephalitis after a single dose of JE-CV

Condition Phase
Encephalitis
Japanese Encephalitis
 Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine in Toddlers in Thailand and the Philippines

Resource links provided by NLM:

MedlinePlus related topics: Encephalitis
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of Japanese encephalitis chimeric virus vaccine (JE-CV) after primary vaccination. [ Time Frame: 1-5 years post-vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: August 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study Group
Participants received a single dose of Japanese encephalitis chimeric virus vaccine (JE-CV) in Study JEC02 (NCT00735644)

Detailed Description:

Immunogenicity persistence will be determined in a subset of participants that previously received a single dose of Japanese encephalitis chimeric virus vaccine at age 12 to 18 months in Study JEC02 (NCT 00735644). No vaccination will be given in this study.

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Particpants received a single dose of the Japanese encephalitis chimeric virus vaccine (JE-CV) in Study JEC02 (NCT00735644)

Criteria

Inclusion Criteria :

  • Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations.
  • Subject who was vaccinated with Japanese encephalitis chimeric vaccine (JE-CV) in JEC02 trial and had a pre-vaccination blood sample at baseline in JEC02 trial.
  • Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.

Exclusion Criteria :

  • Receipt of any JE vaccine other than JE-CV during JEC02 trial and during the period up to inclusion in JEC05 trial.
  • Planned participation in another clinical trial during the present trial period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001988

Locations
Philippines
Muntinlupa City, Philippines, 1781
Thailand
Bangkok, Thailand, 10330
Bangkok, Thailand, 10400
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01001988     History of Changes
Other Study ID Numbers: JEC05, UTN: U1111-1112-2127
Study First Received: October 23, 2009
Last Updated: March 28, 2013
Health Authority: Philippines: Department of Health
Thailand: Food and Drug Administration

Keywords provided by Sanofi:
Encephalitis
Japanese Encephalitis
Japanese Encephalitis Chimeric Virus Vaccine
Toddlers

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 19, 2013