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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: April 1, 2014
Last verified: April 2014
  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:


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 ]

Enrollment: 591
Study Start Date: August 2009
Estimated Study Completion Date: July 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: April 1, 2014
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, Japanese
Encephalitis
Arbovirus Infections
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Flaviviridae Infections
Flavivirus Infections
Nervous System Diseases
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014