Trial record 1 of 1 for:
H-040-010
Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
|
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: NCT00314132 |
|
Recruitment Status :
Completed
First Posted : April 13, 2006
Results First Posted : December 5, 2012
Last Update Posted : December 6, 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 |
| Conditions |
Encephalitis Japanese Encephalitis |
| Interventions |
Biological: ChimeriVax-JE, Japanese Encephalitis vaccine Biological: 0.9% Saline |
| Enrollment | 2004 |
Participant Flow
| Recruitment Details | Participants were enrolled and vaccinated from 10 October 2005 to 30 March 2006 at 6 clinical centers in Australia and 16 clinical centers in the US. |
| Pre-assignment Details | A total of 2004 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated. |
| Arm/Group Title | Placebo | ChimeriVax™-JE 4 log10 PFU Vaccine |
|---|---|---|
 Arm/Group Description |
Participants received a single injection of placebo on Day 0. | Participants received a single injection of ChimeriVax™-JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0. |
| Period Title: Overall Study | ||
| Started | 403 | 1601 |
| Completed | 395 | 1583 |
| Not Completed | 8 | 18 |
| Reason Not Completed | ||
| Lost to Follow-up | 3 | 13 |
| Withdrawal by Subject | 3 | 5 |
| Adverse Event | 1 | 0 |
| Physician Decision | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Placebo | ChimeriVax™-JE 4 log10 PFU Vaccine | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
Participants received a single injection of placebo on Day 0. | Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 403 | 1601 | 2004 | |
|
Baseline Analysis Population Description |
[Not Specified]
|
|||
|
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 403 participants | 1601 participants | 2004 participants | |
| <=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
| Between 18 and 65 years |
403 100.0%
|
1601 100.0%
|
2004 100.0%
|
|
| >=65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
|
Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
| Number Analyzed | 403 participants | 1601 participants | 2004 participants | |
| 34.8 (14.12) | 34.6 (14.25) | 34.7 (14.22) | ||
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 403 participants | 1601 participants | 2004 participants | |
| Female |
165 40.9%
|
721 45.0%
|
886 44.2%
|
|
| Male |
238 59.1%
|
880 55.0%
|
1118 55.8%
|
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 403 participants | 1601 participants | 2004 participants |
| United States | 263 | 1201 | 1464 | |
| Australia | 140 | 400 | 540 | |
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 |
| ClinicalTrials.gov Identifier: | NCT00314132 |
| Other Study ID Numbers: |
H-040-010 |
| First Submitted: | April 11, 2006 |
| First Posted: | April 13, 2006 |
| Results First Submitted: | November 6, 2012 |
| Results First Posted: | December 5, 2012 |
| Last Update Posted: | December 6, 2012 |