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Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children (JE0153)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pornthep Chanthavanich, Mahidol University
ClinicalTrials.gov Identifier:
NCT01408537
First received: August 2, 2011
Last updated: November 14, 2014
Last verified: November 2014
History of Changes
Results First Received: April 23, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Encephalitis, Japanese B
Intervention: Biological: JEVAC

  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 enrollment took place in 2 sites (Department of Tropical Pediatrics, Faculty of Tropical Medicine and Nopparat Rajathanee Hospital) from 3rd May 2010 to 10th August 2010. One hundred and fifty two subjects who illegible for the inclusion and exclusion criteria were enrolled in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was no subject who did not get the study vaccine after informed consent was signed.

Reporting Groups
  Description
JEVAC JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).

Participant Flow:   Overall Study
    JEVAC  
STARTED     152  
COMPLETED     144  
NOT COMPLETED     8  
Withdrawal by Subject                 2  
Protocol Violation                 3  
Lost to Follow-up                 3  



  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
JEVAC JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).

Baseline Measures
    JEVAC  
Number of Participants  
[units: participants]
 		  152  
Age  
[units: participants]
 		 
<=18 years     152  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation) 		  1.2  (0.32)  
Gender  
[units: participants]
 		 
Female     73  
Male     79  



  Outcome Measures
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1.  Primary:   Seroconversion Rate After Primary Vaccination   [ Time Frame: 28 days after second dose of JEVAC ]
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2.  Secondary:   Geometric Mean Titer of NT After Primary and Booster Vaccination   [ Time Frame: 28 days after second vaccination, before and 28 days after booster vaccination with JEVAC ]
  Show Outcome Measure 2

3.  Secondary:   Adverse Events of Vaccine   [ Time Frame: 7, 14, 28 days after each vaccination and throughout the study period for local, solicited systemic, unsolicited systemic and serious adverse events, respectively ]
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4.  Secondary:   Neutralizing Antibody Persistence One Year After the Primary Vaccination   [ Time Frame: 1 year after primary vaccination ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Pornthep Chanthavanich
Organization: Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Thailand
phone: 6623549161
e-mail: tmpct@mahidol.ac.th



Responsible Party: Pornthep Chanthavanich, Mahidol University
ClinicalTrials.gov Identifier: NCT01408537     History of Changes
Other Study ID Numbers: JE0153
Study First Received: August 2, 2011
Results First Received: April 23, 2013
Last Updated: November 14, 2014
Health Authority: Thailand: Ministry of Public Health