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
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
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 |

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 |
- 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.

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.
Ages Eligible for Study: | 2 Years to 3 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
Philippines | |
Muntinlupa, Philippines, 1781 | |
Thailand | |
Bangkok, Thailand, 10330 | |
Bangkok, Thailand, 10400 | |
Khon Kaen, Thailand, 40002 |
Study Director: | Medical Director | Sanofi Pasteur Inc. |
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 |
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 |
Encephalitis Japanese Encephalitis Japanese Encephalitis Chimeric Virus Vaccine Toddlers |
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 |