Trial record 2 of 2 for:
JEC02
Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines
![]() |
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: NCT00735644 |
Recruitment Status :
Completed
First Posted : August 15, 2008
Results First Posted : August 15, 2014
Last Update Posted : April 21, 2015
|
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: Single (Outcomes Assessor); Primary Purpose: Prevention |
Conditions |
Japanese Encephalitis Hepatitis A |
Interventions |
Biological: Japanese encephalitis vaccine Biological: Japanese encephalitis vaccine (Acambis) Biological: Hepatitis A vaccine |
Enrollment | 1200 |
Participant Flow
Recruitment Details | The study participants were enrolled from 02 August 2008 through 27 March 2009 at 3 clinic sites in Thailand and 5 clinic sites in the Philippines. |
Pre-assignment Details | A total of 1200 participants who met all of the inclusion and none of the exclusion criteria were randomized, 1199 were vaccinated in this study. |
Arm/Group Title | JE-CV GPO MBP (Lot 1) | JE-CV GPO MBP (Lot 2) | JE-CV GPO MBP (Lot 3) | JE-CV WRAIR | Hepatitis A |
---|---|---|---|---|---|
![]() |
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1. | Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2 | Participants 12 to 18 months of age received one dose of JE- CV from GPO MBP Lot 3 | Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR) | Participants 12 to 18 months of age received the Hepatitis A vaccine |
Period Title: Overall Study | |||||
Started | 303 | 300 | 296 | 199 | 102 |
Completed | 303 | 298 | 295 | 198 | 102 |
Not Completed | 0 | 2 | 1 | 1 | 0 |
Reason Not Completed | |||||
Did not receive study vaccine | 0 | 1 | 0 | 0 | 0 |
Withdrawal by Subject | 0 | 1 | 1 | 1 | 0 |
Baseline Characteristics
Arm/Group Title | JE CV GPO MBP (Lot 1) | JE-CV GPO MBP (Lot 2) | JE-CV GPO MBP (Lot 3) | JE-CV WRAIR | Hepatitis A | Total | |
---|---|---|---|---|---|---|---|
![]() |
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously | Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2 | Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3 | Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR) | Participants 12 to 18 months of age received Hepatitis A vaccine | Total of all reporting groups | |
Overall Number of Baseline Participants | 303 | 299 | 296 | 199 | 102 | 1199 | |
![]() |
The baseline analysis population represents the participants who have received the trial vaccine or control vaccine (safety analysis set). Data on participants were analyzed and presented according to the vaccine they actually received.
|
||||||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
|||||||
Number Analyzed | 303 participants | 299 participants | 296 participants | 199 participants | 102 participants | 1199 participants | |
<=18 years |
303 100.0%
|
299 100.0%
|
296 100.0%
|
199 100.0%
|
102 100.0%
|
1199 100.0%
|
|
Between 18 and 65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
>=65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Months |
|||||||
Number Analyzed | 303 participants | 299 participants | 296 participants | 199 participants | 102 participants | 1199 participants | |
14.3 (1.91) | 14.5 (1.84) | 14.4 (1.88) | 14.3 (1.81) | 14.3 (1.93) | 14.4 (1.87) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
|||||||
Number Analyzed | 303 participants | 299 participants | 296 participants | 199 participants | 102 participants | 1199 participants | |
Female |
155 51.2%
|
138 46.2%
|
143 48.3%
|
94 47.2%
|
45 44.1%
|
575 48.0%
|
|
Male |
148 48.8%
|
161 53.8%
|
153 51.7%
|
105 52.8%
|
57 55.9%
|
624 52.0%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 303 participants | 299 participants | 296 participants | 199 participants | 102 participants | 1199 participants |
Thailand | 123 | 122 | 121 | 82 | 42 | 490 | |
Philippines | 180 | 177 | 175 | 117 | 60 | 709 |
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 of Results:
Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
ClinicalTrials.gov Identifier: | NCT00735644 |
Other Study ID Numbers: |
JEC02 |
First Submitted: | August 14, 2008 |
First Posted: | August 15, 2008 |
Results First Submitted: | June 25, 2014 |
Results First Posted: | August 15, 2014 |
Last Update Posted: | April 21, 2015 |