Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00441259
First received: February 27, 2007
Last updated: July 24, 2012
Last verified: July 2012
Results First Received: June 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
Condition: Japanese Encephalitis
Interventions: Biological: ChimeriVax™-JE
Biological: Japanese Encephalitis Inactivated Mouse Brain 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 and vaccinated from 03 January 2007 to 13 January 2009 at 3 clinical centers in India.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 96 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Reporting Groups
  Description
ChimeriVax™-JE Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
Mouse Brain Derived Vaccine Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.

Participant Flow:   Overall Study
    ChimeriVax™-JE     Mouse Brain Derived Vaccine  
STARTED     48     48  
COMPLETED     48     48  
NOT COMPLETED     0     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
ChimeriVax™-JE Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
Mouse Brain Derived Vaccine Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
Total Total of all reporting groups

Baseline Measures
    ChimeriVax™-JE     Mouse Brain Derived Vaccine     Total  
Number of Participants  
[units: participants]
  48     48     96  
Age  
[units: participants]
     
<=18 years     48     48     96  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: Years]
Mean ± Standard Deviation
  3.8  ± 2.98     3.7  ± 2.89     3.7  ± 2.52  
Gender  
[units: participants]
     
Female     27     21     48  
Male     21     27     48  
Region of Enrollment  
[units: Participants]
     
India     48     48     96  



  Outcome Measures
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1.  Primary:   Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine   [ Time Frame: Day 14 up to Day 42 Post-vaccination ]

2.  Primary:   Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine   [ Time Frame: Day 14 up to Day 42 Post-vaccination ]

3.  Primary:   Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine   [ Time Frame: Day 42 Post-vaccination ]

4.  Primary:   Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine   [ Time Frame: Day 42 Post Dose 1 ]

5.  Secondary:   Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine   [ Time Frame: Day 42 Post Dose 1 ]

6.  Secondary:   Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine   [ Time Frame: Day 42 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: NCT00441259     History of Changes
Other Study ID Numbers: H-040-004
Study First Received: February 27, 2007
Results First Received: June 6, 2012
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India