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Determining Long-Term Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00412516
First Posted: December 18, 2006
Last Update Posted: October 13, 2014
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.
Information provided by (Responsible Party):
PATH
Results First Submitted: September 30, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Encephalitis, Japanese B
Intervention: Biological: Live attenuated SA 14-14-2 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1 SA 14-14-2 followed by measles vaccine one month later
Group 2

Measles and SA 14-14-2 given concurrently

Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)

Group 3 Measles vaccine followed by SA 14-14-2 one month later

Participant Flow:   Overall Study
    Group 1   Group 2   Group 3
STARTED   93   212   214 
COMPLETED   93   212   214 
NOT COMPLETED   0   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.
The baseline analysis population includes all subjects enrolled in the study

Reporting Groups
  Description
Group 1 SA 14-14-2 followed by measles vaccine one month later
Group 2 Measles and SA 14-14-2 given concurrently
Group 3 Measles vaccine followed by SA 14-14-2 one month later
Total Total of all reporting groups

Baseline Measures
   Group 1   Group 2   Group 3   Total 
Overall Participants Analyzed 
[Units: Participants]
 93   212   214   519 
Age 
[Units: Months]
Mean (Standard Deviation)
 20.6  (.4)   20.6  (.4)   20.6  (.4)   20.6  (.4) 
Gender 
[Units: Participants]
       
Female   46   114   117   277 
Male   47   98   97   242 
Weight (kg) 
[Units: Units on a scale]
Mean (Standard Deviation)
 10.2  (1.3)   10.2  (1.6)   10.2  (1.4)   10.2  (1.4) 
Height (cm) 
[Units: Cm]
Mean (Standard Deviation)
 78.7  (3.1)   77.8  (3.8)   78.1  (3.5)   78.0  (3.5) 


  Outcome Measures
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1.  Primary:   Measles Seropositivity at 24 and 36 Months   [ Time Frame: 24, 36 months post vaccination ]

2.  Secondary:   Measles Seropositivity at 12 Months   [ Time Frame: 12 months post vaccination ]

3.  Secondary:   Seropositive Rate for Japanese Encephalitis (JE) Antibody in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination.   [ Time Frame: 12 months, 24 months, and 36 months post vaccination ]

4.  Secondary:   Geometric Mean Neutralizing Antibody Titer to Japanese Encephalitis (JE) Virus in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination.   [ Time Frame: 12, 24, 36 months post-JE 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: Anthony A Marfin, Director Japanese Encephalitis Vaccine Introduction and Sustainability Project
Organization: PATH
phone: 2062853500
e-mail: aamarfin@path.org



Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT00412516     History of Changes
Other Study ID Numbers: JEV02
First Submitted: December 14, 2006
First Posted: December 18, 2006
Results First Submitted: September 30, 2014
Results First Posted: October 6, 2014
Last Update Posted: October 13, 2014