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