A Phase 3 interventional study of Blood sample and JE-CV administered in Study JEC02 in Encephalitis and Japanese Encephalitis, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 4 sites in 2 countries. Open to participants aged 2 Years to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-29.
Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 3, Interventional, and Prevention
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.
77 studies on the registry are indexed under Encephalitis, Japanese; 4 are open to participants now.
This study's enrollment of 596 is above the median of 278 across 69 interventional studies indexed under Encephalitis, Japanese.
Browse Encephalitis, Japanese studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.
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Exclusion Criteria :
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 · Biological: JE-CV administered in Study JEC02
Blood sample for immunogenicity assessment
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
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).
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
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.
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
Study participants were enrolled at 3 sites in Thailand and 2 sites in the Philippines.
| Milestone | Study Group |
|---|---|
| Started | 596 |
| Completed | 479 |
| Not completed | 117 |
| Withdrew: Protocol violation | 84 |
| Withdrew: Withdrawal by subject | 18 |
| Withdrew: Lost to follow-up | 15 |
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).
| Percentage of participants | Study Group |
|---|---|
| Day 0 (pre-vaccination) | 2.6 |
| Day 28 post-vaccination | 100.0 |
| Year 1 post-vaccination | 88.2 |
| Year 2 post-vaccination | 90.0 |
| Year 3 post-vaccination | 93.1 |
| Year 4 post-vaccination | 87.6 |
| Year 5 post-vaccination | 85.4 |
Geometric mean titers of Japanese encephalitis virus antibodies were assessed using the PRNT50 test.
| Titers (1/dil) | Study Group |
|---|---|
| Day 0 (pre-vaccination) | 5.13 (5.06 to 5.21) |
| Day 28 post-vaccination | 252 (224 to 284) |
| Year 1 post-vaccination | 76.8 (67.4 to 87.6) |
| Year 2 post-vaccination | 81.4 (71.7 to 92.6) |
| Year 3 post-vaccination | 132 (114 to 153) |
| Year 4 post-vaccination | 85.8 (74.7 to 98.6) |
| Year 5 post-vaccination | 63.3 (54.8 to 73.0) |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Group | 0/591 (0%) | 0/591 (0%) | 0/591 (0%) |
The baseline analysis population includes all participants in the Per Protocol Analysis Set at Year 1 of JEC05
| Age, Categorical(Participants) | Study Group |
|---|---|
| <=18 years | 585 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(months) | Study Group |
|---|---|
| Mean | 26.2 ± 1.86 |
| Sex: Female, Male(Participants) | Study Group |
|---|---|
| Female | 272 |
| Male | 313 |
| Region of Enrollment(participants) | Study Group |
|---|---|
| Philippines | 229 |
| Thailand | 356 |
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Sanofi Pasteur, a Sanofi Company