Trial record 1 of 1 for:
JEC05
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
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
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Study Type | Interventional |
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Study Design | Allocation: N/A; 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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
Arm/Group Title | Study Group | |
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Participants received a single dose of JE-CV in Study JEC02 | |
Overall Number of Baseline Participants | 585 | |
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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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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 585 participants | |
<=18 years |
585 100.0%
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Between 18 and 65 years |
0 0.0%
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>=65 years |
0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Months |
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Number Analyzed | 585 participants | |
26.2 (1.86) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 585 participants | |
Female |
272 46.5%
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Male |
313 53.5%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 585 participants |
Philippines | 229 | |
Thailand | 356 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Medical Director |
Organization: | Sanofi Pasteur |
Phone: | 800-633-1610 |
EMail: | RegistryContactUS@sanofi.com |
Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
ClinicalTrials.gov Identifier: | NCT01001988 |
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 |