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Trial record 1 of 1 for:    JEC05
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Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Toddlers

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ClinicalTrials.gov Identifier: NCT01001988
Recruitment Status : Completed
First Posted : October 27, 2009
Results First Posted : November 29, 2017
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE October 23, 2009
First Posted Date  ICMJE October 27, 2009
Results First Submitted Date  ICMJE September 18, 2017
Results First Posted Date  ICMJE November 29, 2017
Last Update Posted Date November 29, 2017
Actual Study Start Date  ICMJE August 7, 2009
Actual Primary Completion Date October 16, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2017)
  • Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Dose of JE-CV [ Time Frame: Day 0 (pre-vaccination) from study JEC02, Day 28 post-vaccination from study JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination ]
    Seroprotection was defined as the proportion of participants with Japanese encephalitis virus neutralizing antibody titers ≥10 1/dil as measured by a JE 50% plaque reduction neutralization test (PRNT50).
  • Summary of Geometric Mean Titers of Japanese Encephalitis Virus Antibodies Following a Single Dose of a JE-CV [ Time Frame: Day 0 (pre-vaccination) from JEC02, Day 28 post-vaccination from JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination ]
    Geometric mean titers of Japanese encephalitis virus antibodies were assessed using the PRNT50 test.
Original Primary Outcome Measures  ICMJE
 (submitted: October 23, 2009)
To provide information concerning the immunogenicity of Japanese encephalitis chimeric virus vaccine (JE-CV) after primary vaccination. [ Time Frame: 1-5 years post-vaccination ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Toddlers
Official Title  ICMJE Long-term Follow-up of Immunogenicity of a Single Dose of JE-CV in Toddlers in Thailand and the Philippines
Brief 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
Detailed Description Persistence of immune response will be determined in participants who previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02 (NCT00735644). No vaccination will be given in this study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Encephalitis
  • Japanese Encephalitis
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Study group
Participants received a single dose of JE-CV administered in Study JEC02. In Study JEC05 there were yearly visits with blood samples taken for immunogenicity assessment.
Interventions:
  • Other: Blood sample
  • Biological: JE-CV administered in Study JEC02
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2017)
596
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2009)
700
Actual Study Completion Date  ICMJE October 16, 2013
Actual Primary Completion Date October 16, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • Participant who was vaccinated with JE-CV in JEC02 trial and had a pre-vaccination blood sample at baseline in JEC02 trial.
  • Participant 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 up to the first year of the follow-up in the present trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 3 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Philippines,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01001988
Other Study ID Numbers  ICMJE JEC05
U1111-1112-2127 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Original Responsible Party Medical Monitor, Sanofi Pasteur Inc.
Current Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Original Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP