Trial record 1 of 1 for:
H-040-004
Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age
![]() |
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: NCT00441259 |
Recruitment Status :
Completed
First Posted : February 28, 2007
Results First Posted : August 27, 2012
Last Update Posted : August 27, 2012
|
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
- 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 |
Condition |
Japanese Encephalitis |
Interventions |
Biological: ChimeriVax™-JE Biological: Japanese Encephalitis Inactivated Mouse Brain Vaccine |
Enrollment | 96 |
Participant Flow
Recruitment Details | Participants were enrolled and vaccinated from 03 January 2007 to 13 January 2009 at 3 clinical centers in India. |
Pre-assignment Details | A total of 96 participants who met the inclusion and exclusion criteria were enrolled and vaccinated. |
Arm/Group Title | ChimeriVax™-JE | Mouse Brain Derived Vaccine |
---|---|---|
![]() |
Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14. | Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14. |
Period Title: Overall Study | ||
Started | 48 | 48 |
Completed | 48 | 48 |
Not Completed | 0 | 0 |
Baseline Characteristics
Arm/Group Title | ChimeriVax™-JE | Mouse Brain Derived Vaccine | Total | |
---|---|---|---|---|
![]() |
Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14. | Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14. | Total of all reporting groups | |
Overall Number of Baseline Participants | 48 | 48 | 96 | |
![]() |
[Not Specified]
|
|||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 48 participants | 48 participants | 96 participants | |
<=18 years |
48 100.0%
|
48 100.0%
|
96 100.0%
|
|
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: Years |
||||
Number Analyzed | 48 participants | 48 participants | 96 participants | |
3.8 (2.98) | 3.7 (2.89) | 3.7 (2.52) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 48 participants | 48 participants | 96 participants | |
Female |
27 56.3%
|
21 43.8%
|
48 50.0%
|
|
Male |
21 43.8%
|
27 56.3%
|
48 50.0%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||||
India | Number Analyzed | 48 participants | 48 participants | 96 participants |
48 | 48 | 96 |
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 |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00441259 |
Other Study ID Numbers: |
H-040-004 |
First Submitted: | February 27, 2007 |
First Posted: | February 28, 2007 |
Results First Submitted: | June 6, 2012 |
Results First Posted: | August 27, 2012 |
Last Update Posted: | August 27, 2012 |