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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1112-2127 | Other Identifier | WHO |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Other | Blood sample for immunogenicity assessment |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Dose of JE-CV | 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). | 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 |
| Summary of Geometric Mean Titers of Japanese Encephalitis Virus Antibodies Following a Single Dose of a JE-CV | Geometric mean titers of Japanese encephalitis virus antibodies were assessed using the PRNT50 test. | Day 0 (pre-vaccination) from JEC02, Day 28 post-vaccination from JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Muntinlupa | 1781 | Philippines | ||||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 596 participants received a single dose of JE-CV in JEC02 and came to Visit 1 (Year 1) in JEC05; 585 participants were included in the Per Protocol Analysis set.
Study participants were enrolled at 3 sites in Thailand and 2 sites in the Philippines.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | Participants received a single dose of JE-CV in Study JEC02 (NCT00735644) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| JE-CV administered in Study JEC02 |
| Biological |
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 |
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| Bangkok |
| 10330 |
| Thailand |
| Bangkok | 10400 | Thailand |
| Khon Kaen | 40002 | Thailand |
| COMPLETED |
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| NOT COMPLETED |
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The baseline analysis population includes all participants in the Per Protocol Analysis Set at Year 1 of JEC05
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | Participants received a single dose of JE-CV in Study JEC02 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Dose of JE-CV | 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). | Seroprotection was analyzed in the Per Protocol Analysis Set. | Posted | Number | Percentage of participants | 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 |
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| Primary | Summary of Geometric Mean Titers of Japanese Encephalitis Virus Antibodies Following a Single Dose of a JE-CV | Geometric mean titers of Japanese encephalitis virus antibodies were assessed using the PRNT50 test. | Geometric mean titers were assessed in the Per Protocol Analysis Set. | Posted | Geometric Mean | 95% Confidence Interval | Titers (1/dil) | Day 0 (pre-vaccination) from JEC02, Day 28 post-vaccination from JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination |
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Safety data were not collected in this trial as no vaccine was administered. Only serious adverse events (SAEs) related to the vaccination in study JEC02 were collected. Overall, no related SAEs (including death) were reported from 6 months to 5 years post-vaccination in JEC02.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Group | Participants received a single dose of JE-CV in Study JEC02 (NCT00735644) | 0 | 591 | 0 | 591 | 0 | 591 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur | 800-633-1610 | RegistryContactUS@sanofi.com |
| ID | Term |
|---|---|
| D004660 | Encephalitis |
| D004672 | Encephalitis, Japanese |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D000069544 | Infectious Encephalitis |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D012327 | RNA Virus Infections |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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| Year 1 post-vaccination |
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| Year 2 post-vaccination |
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| Year 3 post-vaccination |
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| Year 4 post-vaccination |
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| Year 5 post-vaccination |
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