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

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: NCT00441259
Recruitment Status : Completed
First Posted : February 28, 2007
Results First Posted : August 27, 2012
Last Update Posted : August 27, 2012
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Japanese Encephalitis
Interventions: Biological: ChimeriVax™-JE
Biological: Japanese Encephalitis Inactivated Mouse Brain Vaccine

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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

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

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



Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00441259     History of Changes
Other Study ID Numbers: H-040-004
First Submitted: February 27, 2007
First Posted: February 28, 2007
Results First Submitted: June 6, 2012
Results First Posted: August 27, 2012
Last Update Posted: August 27, 2012