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
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.
- 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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
|Muntinlupa, Philippines, 1781|
|Bangkok, Thailand, 10330|
|Bangkok, Thailand, 10400|
|Khon Kaen, Thailand, 40002|
|Study Director:||Medical Director||Sanofi Pasteur Inc.|