Trial record 1 of 1 for:
JEC07
A Study of Japanese Encephalitis Chimeric Virus Vaccine Compared With SA14-14-2 Vaccine in Infants and Toddlers
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01092507 |
Recruitment Status :
Completed
First Posted : March 25, 2010
Results First Posted : December 2, 2013
Last Update Posted : December 25, 2013
|
Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
Conditions |
Encephalitis Japanese Encephalitis |
Interventions |
Biological: Japanese encephalitis chimeric virus vaccine (JE-CV) Biological: Japanese encephalitis live vaccine (SA14-14-2 vaccine) (CD.JEVAX®) |
Enrollment | 300 |
Participant Flow
Recruitment Details | Participants were enrolled from 07 March 2010 to 27 April 2011 at 3 clinical centers in Thailand. |
Pre-assignment Details | A total of 300 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled; 299 were vaccinated. |
Arm/Group Title | Japanese Encephalitis Chimeric Vaccine (JE-CV) | Japanese Encephalitis Live Vaccine (SA14-14-2) |
---|---|---|
![]() |
Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0. | Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0. |
Period Title: Overall Study | ||
Started | 149 | 150 |
Completed | 147 | 150 |
Not Completed | 2 | 0 |
Reason Not Completed | ||
Withdrawal by Subject | 2 | 0 |
Baseline Characteristics
Arm/Group Title | Japanese Encephalitis Chimeric Vaccine (JE-CV) | Japanese Encephalitis Live Vaccine (SA14-14-2) | Total | |
---|---|---|---|---|
![]() |
Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0. | Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0. | Total of all reporting groups | |
Overall Number of Baseline Participants | 149 | 150 | 299 | |
![]() |
[Not Specified]
|
|||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 149 participants | 150 participants | 299 participants | |
<=18 years |
149 100.0%
|
150 100.0%
|
299 100.0%
|
|
Between 18 and 65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
>=65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Months |
||||
Number Analyzed | 149 participants | 150 participants | 299 participants | |
13.1 (2.11) | 13.2 (1.89) | 13.2 (2.00) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 149 participants | 150 participants | 299 participants | |
Female |
69 46.3%
|
75 50.0%
|
144 48.2%
|
|
Male |
80 53.7%
|
75 50.0%
|
155 51.8%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||||
Thailand | Number Analyzed | 149 participants | 150 participants | 299 participants |
149 | 150 | 299 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Results Point of Contact
Name/Title: | Medical Director |
Organization: | Sanofi Pasteur Inc. |
EMail: | RegistryContactUs@sanofipasteur.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
ClinicalTrials.gov Identifier: | NCT01092507 |
Other Study ID Numbers: |
JEC07 UTN: U1111-1112-2269 ( Other Identifier: WHO ) |
First Submitted: | March 23, 2010 |
First Posted: | March 25, 2010 |
Results First Submitted: | September 30, 2013 |
Results First Posted: | December 2, 2013 |
Last Update Posted: | December 25, 2013 |