Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT01047839
First received: January 12, 2010
Last updated: December 10, 2014
Last verified: September 2014
Results First Received: September 25, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Encephalitis
Intervention: Biological: IC51

  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
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Reporting Groups
  Description
>=2 Months to <3 Years IC51 0.25 ml, 2 intramuscular vaccinations at Day 0 and Day 28
>=3 to <12 Years IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
>=12 to <18 Years IC51, 0.5 ml, 2 intramuscular vaccinations at Day 0 and 28

Participant Flow:   Overall Study
    >=2 Months to <3 Years     >=3 to <12 Years     >=12 to <18 Years  
STARTED     12     29     59  
COMPLETED     10     29     53  
NOT COMPLETED     2     0     6  



  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.
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Reporting Groups
  Description
>=2 Months to <3 Years IC51 0.25 ml, 2 i.m.vaccinations at Day 0 and Day 28
>=3 to <12 Years IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
>=12 to <18 Years IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
Total Total of all reporting groups

Baseline Measures
    >=2 Months to <3 Years     >=3 to <12 Years     >=12 to <18 Years     Total  
Number of Participants  
[units: participants]
  12     29     59     100  
Age  
[units: years]
Mean ± Standard Deviation
  1.81  ± 0.811     6.98  ± 2.417     15.90  ± 1.176     11.62  ± 5.605  
Gender  
[units: participants]
       
Female     5     12     36     53  
Male     7     17     23     47  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     3     5     5     13  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     1     2     0     3  
White     8     22     53     83  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     1     1  



  Outcome Measures

1.  Primary:   Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination   [ Time Frame: until Day 56 ]

2.  Secondary:   Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination   [ Time Frame: up to Month 7 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination   [ Time Frame: 7 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination   [ Time Frame: up to Day 56 and upt to Month 7 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination   [ Time Frame: up to Day 56 and up to Month 7 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT)   [ Time Frame: at Day 56 and Month 7 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7   [ Time Frame: at Day 56 and Month 7 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

8.  Secondary:   SCRs and GMTs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups   [ Time Frame: at Day 56 and Month 7 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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: Senior Scientist Clinical Research
Organization: Valneva Austria GmbH
phone: +43 1 206 20 ext 1175
e-mail: katrin.dubischar-kastner@valneva.com


No publications provided


Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT01047839     History of Changes
Other Study ID Numbers: IC51-322
Study First Received: January 12, 2010
Results First Received: September 25, 2014
Last Updated: December 10, 2014
Health Authority: United States: Food and Drug Administration