Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    JEC05
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Encephalitis Japanese Encephalitis Other: Blood sample Biological: JE-CV administered in Study JEC02 Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 596 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Long-term Follow-up of Immunogenicity of a Single Dose of JE-CV in Toddlers in Thailand and the Philippines
Actual Study Start Date : August 7, 2009
Actual Primary Completion Date : October 16, 2013
Actual Study Completion Date : October 16, 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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).

  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01001988


Locations
Layout table for location information
Philippines
Muntinlupa, Philippines, 1781
Thailand
Bangkok, Thailand, 10330
Bangkok, Thailand, 10400
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Layout table for investigator information
Study Director: Medical Director Sanofi Pasteur Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01001988    
Other Study ID Numbers: JEC05
U1111-1112-2127 ( Other Identifier: WHO )
First Posted: October 27, 2009    Key Record Dates
Results First Posted: November 29, 2017
Last Update Posted: November 29, 2017
Last Verified: October 2017

Layout table for additional information
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
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Encephalitis
Japanese Encephalitis
Japanese Encephalitis Chimeric Virus Vaccine
Toddlers
Additional relevant MeSH terms:
Layout table for MeSH terms
Encephalitis, Japanese
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Central Nervous System Viral Diseases
Central Nervous System Infections
 Infections
Infectious Encephalitis
Arbovirus Infections
Vector Borne Diseases
Virus Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections