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

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ClinicalTrials.gov Identifier: NCT01408537
Recruitment Status : Completed
First Posted : August 3, 2011
Results First Posted : November 18, 2014
Last Update Posted : November 18, 2014
Sponsor:
Information provided by (Responsible Party):
Pornthep Chanthavanich, Mahidol University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Encephalitis, Japanese B
Intervention: Biological: JEVAC

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

1.  Primary:   Seroconversion Rate After Primary Vaccination   [ Time Frame: 28 days after second dose of JEVAC ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 3

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


  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 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
First Submitted: August 2, 2011
First Posted: August 3, 2011
Results First Submitted: April 23, 2013
Results First Posted: November 18, 2014
Last Update Posted: November 18, 2014