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Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00735644
First received: August 14, 2008
Last updated: July 25, 2014
Last verified: July 2014
Results First Received: June 25, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Japanese Encephalitis
Hepatitis A
Interventions: Biological: Japanese encephalitis vaccine
Biological: Japanese encephalitis vaccine (Acambis)
Biological: Hepatitis A 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
The study participants were enrolled from 02 August 2008 through 27 March 2009 at 3 clinic sites in Thailand and 5 clinic sites in the Philippines.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1200 participants who met all of the inclusion and none of the exclusion criteria were randomized, 1199 were vaccinated in this study.

Reporting Groups
  Description
JE-CV GPO MBP (Lot 1) Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1.
JE-CV GPO MBP (Lot 2) Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
JE-CV GPO MBP (Lot 3) Participants 12 to 18 months of age received one dose of JE- CV from GPO MBP Lot 3
JE-CV WRAIR Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
Hepatitis A Participants 12 to 18 months of age received the Hepatitis A vaccine

Participant Flow:   Overall Study
    JE-CV GPO MBP (Lot 1)     JE-CV GPO MBP (Lot 2)     JE-CV GPO MBP (Lot 3)     JE-CV WRAIR     Hepatitis A  
STARTED     303     300     296     199     102  
COMPLETED     303     298     295     198     102  
NOT COMPLETED     0     2     1     1     0  
Did not receive study vaccine                 0                 1                 0                 0                 0  
Withdrawal by Subject                 0                 1                 1                 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.
The baseline analysis population represents the participants who have received the trial vaccine or control vaccine (safety analysis set). Data on participants were analyzed and presented according to the vaccine they actually received.

Reporting Groups
  Description
JE CV GPO MBP (Lot 1) Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
JE-CV GPO MBP (Lot 2) Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
JE-CV GPO MBP (Lot 3) Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
JE-CV WRAIR Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
Hepatitis A Participants 12 to 18 months of age received Hepatitis A vaccine
Total Total of all reporting groups

Baseline Measures
    JE CV GPO MBP (Lot 1)     JE-CV GPO MBP (Lot 2)     JE-CV GPO MBP (Lot 3)     JE-CV WRAIR     Hepatitis A     Total  
Number of Participants  
[units: participants]
  303     299     296     199     102     1199  
Age  
[units: participants]
           
<=18 years     303     299     296     199     102     1199  
Between 18 and 65 years     0     0     0     0     0     0  
>=65 years     0     0     0     0     0     0  
Age  
[units: Months]
Mean ± Standard Deviation
  14.3  ± 1.91     14.5  ± 1.84     14.4  ± 1.88     14.3  ± 1.81     14.3  ± 1.93     14.4  ± 1.87  
Gender  
[units: participants]
           
Female     155     138     143     94     45     575  
Male     148     161     153     105     57     624  
Region of Enrollment  
[units: Participants]
           
Thailand     123     122     121     82     42     490  
Philippines     180     177     175     117     60     709  



  Outcome Measures
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1.  Primary:   Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots   [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]

2.  Secondary:   Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV   [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]

3.  Secondary:   Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV   [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]

4.  Secondary:   Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine   [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]

5.  Secondary:   Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine.   [ Time Frame: Day 0 up to Day 14 post-vaccination ]

6.  Other Pre-specified:   Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine.   [ Time Frame: Day 0 (pre-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 ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00735644     History of Changes
Other Study ID Numbers: JEC02
Study First Received: August 14, 2008
Results First Received: June 25, 2014
Last Updated: July 25, 2014
Health Authority: Philippines: Department of Health
Thailand: Food and Drug Administration