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Trial record 1 of 1 for:    JEC05
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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
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Encephalitis
Japanese Encephalitis
Interventions Other: Blood sample
Biological: JE-CV administered in Study JEC02
Enrollment 596
Recruitment Details Study participants were enrolled at 3 sites in Thailand and 2 sites in the Philippines.
Pre-assignment Details 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.
Arm/Group Title Study Group
Hide Arm/Group Description Participants received a single dose of JE-CV in Study JEC02 (NCT00735644)
Period Title: Overall Study
Started 596
Completed 479
Not Completed 117
Reason Not Completed
Protocol Violation             84
Withdrawal by Subject             18
Lost to Follow-up             15
Arm/Group Title Study Group
Hide Arm/Group Description Participants received a single dose of JE-CV in Study JEC02
Overall Number of Baseline Participants 585
Hide Baseline Analysis Population Description
The baseline analysis population includes all participants in the Per Protocol Analysis Set at Year 1 of JEC05
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 585 participants
<=18 years
585
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 585 participants
26.2  (1.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 585 participants
Female
272
  46.5%
Male
313
  53.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 585 participants
Philippines 229
Thailand 356
1.Primary Outcome
Title Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Dose of JE-CV
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection was analyzed in the Per Protocol Analysis Set.
Arm/Group Title Study Group
Hide Arm/Group Description:
Participants received a single dose of Japanese encephalitis chimeric virus vaccine (JE-CV) in Study JEC02 (NCT00735644)
Overall Number of Participants Analyzed 585
Measure Type: Number
Unit of Measure: Percentage of participants
Day 0 (pre-vaccination) Number Analyzed 583 participants
2.6
Day 28 post-vaccination Number Analyzed 574 participants
100.0
Year 1 post-vaccination Number Analyzed 584 participants
88.2
Year 2 post-vaccination Number Analyzed 541 participants
90.0
Year 3 post-vaccination Number Analyzed 505 participants
93.1
Year 4 post-vaccination Number Analyzed 484 participants
87.6
Year 5 post-vaccination Number Analyzed 478 participants
85.4
2.Primary Outcome
Title Summary of Geometric Mean Titers of Japanese Encephalitis Virus Antibodies Following a Single Dose of a JE-CV
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the Per Protocol Analysis Set.
Arm/Group Title Study Group
Hide Arm/Group Description:
Participants received a single dose of Japanese encephalitis chimeric virus vaccine (JE-CV) in Study JEC02 (NCT00735644)
Overall Number of Participants Analyzed 585
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dil)
Day 0 (pre-vaccination) Number Analyzed 583 participants
5.13
(5.06 to 5.21)
Day 28 post-vaccination Number Analyzed 574 participants
252
(224 to 284)
Year 1 post-vaccination Number Analyzed 584 participants
76.8
(67.4 to 87.6)
Year 2 post-vaccination Number Analyzed 541 participants
81.4
(71.7 to 92.6)
Year 3 post-vaccination Number Analyzed 505 participants
132
(114 to 153)
Year 4 post-vaccination Number Analyzed 484 participants
85.8
(74.7 to 98.6)
Year 5 post-vaccination Number Analyzed 478 participants
63.3
(54.8 to 73.0)
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Group
Hide Arm/Group Description Participants received a single dose of JE-CV in Study JEC02 (NCT00735644)
All-Cause Mortality
Study Group
Affected / at Risk (%)
Total   0/591 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Study Group
Affected / at Risk (%)
Total   0/591 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Study Group
Affected / at Risk (%)
Total   0/591 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur
Phone: 800-633-1610
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01001988     History of Changes
Other Study ID Numbers: JEC05
U1111-1112-2127 ( Other Identifier: WHO )
First Submitted: October 23, 2009
First Posted: October 27, 2009
Results First Submitted: September 18, 2017
Results First Posted: November 29, 2017
Last Update Posted: November 29, 2017