Trial record 6 of 55 for:
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.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
First received: October 23, 2009
Last updated: March 28, 2013
Last verified: March 2013
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).
- To describe the yearly persistence of humoral immune response to Japanese encephalitis after a single dose of JE-CV
||Observational Model: Cohort
Time Perspective: Prospective
||Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine in Toddlers in Thailand and the Philippines
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||October 2013 (Final data collection date for primary outcome measure)
Participants received a single dose of Japanese encephalitis chimeric virus vaccine (JE-CV) in Study JEC02 (NCT00735644)
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.
|Ages Eligible for Study:
||2 Years to 6 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Particpants received a single dose of the Japanese encephalitis chimeric virus vaccine (JE-CV) in Study JEC02 (NCT00735644)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001988
|Muntinlupa City, Philippines, 1781 |
|Bangkok, Thailand, 10330 |
|Bangkok, Thailand, 10400 |
|Khon Kaen, Thailand, 40002 |
Sanofi Pasteur, a Sanofi Company
||Sanofi Pasteur Inc.
No publications provided
||Sanofi ( Sanofi Pasteur, a Sanofi Company )
History of Changes
|Other Study ID Numbers:
||JEC05, UTN: U1111-1112-2127
|Study First Received:
||October 23, 2009
||March 28, 2013
||Philippines: Department of Health
Thailand: Food and Drug Administration
Keywords provided by Sanofi:
Japanese Encephalitis Chimeric Virus Vaccine
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 12, 2013
Central Nervous System Viral Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
RNA Virus Infections