Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00314132
First received: April 11, 2006
Last updated: December 4, 2012
Last verified: December 2012
Results First Received: November 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Encephalitis
Japanese Encephalitis
Interventions: Biological: ChimeriVax-JE, Japanese Encephalitis vaccine
Biological: 0.9% Saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 2004 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.

Reporting Groups
  Description
Placebo Participants received a single injection of placebo on Day 0.
ChimeriVax™-JE 4 log10 PFU Vaccine Participants received a single injection of ChimeriVax™-JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0.

Participant Flow:   Overall Study
    Placebo     ChimeriVax™-JE 4 log10 PFU Vaccine  
STARTED     403     1601  
COMPLETED     395     1583  
NOT COMPLETED     8     18  
Lost to Follow-up                 3                 13  
Withdrawal by Subject                 3                 5  
Adverse Event                 1                 0  
Physician Decision                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Participants received a single injection of placebo on Day 0.
ChimeriVax™-JE 4 log10 PFU Vaccine Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
Total Total of all reporting groups

Baseline Measures
    Placebo     ChimeriVax™-JE 4 log10 PFU Vaccine     Total  
Number of Participants  
[units: participants]
  403     1601     2004  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     403     1601     2004  
>=65 years     0     0     0  
Age  
[units: Years]
Mean ± Standard Deviation
  34.8  ± 14.12     34.6  ± 14.25     34.7  ± 14.22  
Gender  
[units: participants]
     
Female     165     721     886  
Male     238     880     1118  
Region of Enrollment  
[units: Participants]
     
United States     263     1201     1464  
Australia     140     400     540  



  Outcome Measures
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1.  Primary:   Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo   [ Time Frame: Day 0 up to 30 days post-vaccination ]

2.  Primary:   Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo   [ Time Frame: Day 0 up to 30 days post-vaccination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
e-mail: RegistryContactUs@sanofipasteur.com


No publications provided by Sanofi

Publications automatically indexed to this study:

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00314132     History of Changes
Other Study ID Numbers: H-040-010
Study First Received: April 11, 2006
Results First Received: November 6, 2012
Last Updated: December 4, 2012
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration