Trial record 1 of 1 for:
H-040-005
A Study of ChimeriVax™-JE Live Attenuated Vaccine in Healthy Adults
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ClinicalTrials.gov Identifier: NCT00981175 |
Recruitment Status :
Completed
First Posted : September 22, 2009
Results First Posted : April 29, 2011
Last Update Posted : July 16, 2012
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Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
Conditions |
Encephalitis Japanese Encephalitis |
Interventions |
Biological: Live attenuated Japanese encephalitis virus, then ChimeriVax diluent Biological: ChimeriVax diluent, then Live attenuated Japanese encephalitis virus |
Enrollment | 202 |
Participant Flow
Recruitment Details | Participants were enrolled and vaccinated from 14 April 2003 to 05 January 2004 at 1 clinical center in Australia. |
Pre-assignment Details | A total of 202 participants who met the inclusion/exclusion criteria were enrolled and vaccinated. A subset of the participants also received a booster vaccine at month 6. A report on all participants who received the primary and booster vaccination and the primary vaccination only are presented. |
Arm/Group Title | ChimeriVax™-JE Vaccine First, Then Placebo | Placebo First, Then ChimeriVax™-JE Vaccine |
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Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on day 28. | Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on day 28. |
Period Title: Primary Dose Vaccination | ||
Started | 101 | 101 |
Completed | 98 | 99 |
Not Completed | 3 | 2 |
Reason Not Completed | ||
Adverse Event | 1 | 0 |
Protocol Violation | 0 | 1 |
Lost to Follow-up | 2 | 1 |
Period Title: Booster Dose Vaccination | ||
Started | 55 [1] | 43 [1] |
Completed | 53 | 40 |
Not Completed | 2 | 3 |
Reason Not Completed | ||
Lost to Follow-up | 2 | 3 |
[1]
A sub-set of participants in the group received the booster ChimeriVax™-JE vaccine.
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Baseline Characteristics
Arm/Group Title | ChimeriVax™-JE Vaccine First , Then Placebo | Placebo First, Then ChimeriVax™-JE Vaccine | Booster ChimeriVax™-JE Vaccine | Total | |
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Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on Day 28. | Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on Day 28. | Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28 | Total of all reporting groups | |
Overall Number of Baseline Participants | 101 | 101 | 0 | 202 | |
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[Not Specified]
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Age Categorical
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 101 participants | 101 participants | 0 participants | 202 participants |
<=18 years | 0 | 0 | 0 | ||
Between 18 and 65 years | 101 | 101 | 202 | ||
>=65 years | 0 | 0 | 0 | ||
Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 101 participants | 101 participants | 0 participants | 202 participants | |
26.1 (7.36) | 27.7 (8.25) | 26.9 (7.84) | |||
Gender
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 101 participants | 101 participants | 0 participants | 202 participants |
Female | 13 | 15 | 28 | ||
Male | 88 | 86 | 174 | ||
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Australia | Number Analyzed | 101 participants | 101 participants | 0 participants | 202 participants |
101 | 101 | 202 |
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: | NCT00981175 |
Other Study ID Numbers: |
H-040-005 |
First Submitted: | September 21, 2009 |
First Posted: | September 22, 2009 |
Results First Submitted: | April 5, 2011 |
Results First Posted: | April 29, 2011 |
Last Update Posted: | July 16, 2012 |