A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX

This study has been completed.
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00319592
First received: April 28, 2006
Last updated: August 16, 2012
Last verified: August 2012
Results First Received: July 11, 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
Condition: Japanese Encephalitis
Interventions: Biological: ChimeriVax™-JE vaccine
Biological: JE-VAX® vaccine

  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 from 18 May 2005 to 07 September 2005 at 1clinical center in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 60 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.

Reporting Groups
  Description
ChimeriVax™-JE After Placebo Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
JE-VAX® Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.

Participant Flow:   Overall Study
    ChimeriVax™-JE After Placebo     JE-VAX®  
STARTED     30     30  
COMPLETED     29     29  
NOT COMPLETED     1     1  
Protocol Violation                 1                 0  
Physician Decision                 0                 1  



  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
ChimeriVax™-JE After Placebo Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
JE-VAX® Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
Total Total of all reporting groups

Baseline Measures
    ChimeriVax™-JE After Placebo     JE-VAX®     Total  
Number of Participants  
[units: participants]
  30     30     60  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     30     30     60  
>=65 years     0     0     0  
Age  
[units: Years]
Mean ± Standard Deviation
  32.7  ± 8.82     29.2  ± 9.14     31  ± 8.98  
Gender  
[units: participants]
     
Female     16     16     32  
Male     14     14     28  
Region of Enrollment  
[units: Participants]
     
United States     30     30     60  



  Outcome Measures
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1.  Primary:   Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine   [ Time Frame: Day 0 (pre-vaccination) and up to Day 56 post-vaccination ]

2.  Primary:   Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE   [ Time Frame: Day 0 up to Day 56 post-vaccination ]

3.  Primary:   Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine.   [ Time Frame: Day 0 (Pre-vaccination) and up to Month 12 After First Dose ]

4.  Primary:   Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX®   [ Time Frame: Day 0 (pre-vaccination) up to month 12 post-vaccination ]

5.  Primary:   Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®   [ Time Frame: Day 0 up to Day 6 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
No text entered.


  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


Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00319592     History of Changes
Other Study ID Numbers: H-040-008
Study First Received: April 28, 2006
Results First Received: July 11, 2012
Last Updated: August 16, 2012
Health Authority: United States: Food and Drug Administration