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Immunogenicity Study of the Japanese Encephalitis Vaccine IC51

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.
ClinicalTrials.gov Identifier: NCT00604708
Recruitment Status : Completed
First Posted : January 30, 2008
Results First Posted : November 29, 2012
Last Update Posted : June 2, 2016
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Japanese Encephalitis
Interventions Biological: IC51
Biological: JE-VAX
Enrollment 867
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IC51 JE-VAX
Hide Arm/Group Description IC51 JE-VAX
Period Title: Overall Study
Started 430 437
Completed 399 397
Not Completed 31 40
Reason Not Completed
Withdrawal by Subject             9             10
Protocol Violation             2             8
Lost to Follow-up             5             5
administrative reasons             9             11
Adverse Event             6             6
Arm/Group Title IC51 JE-VAX Total
Hide Arm/Group Description IC51 JE-VAX Total of all reporting groups
Overall Number of Baseline Participants 430 437 867
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 430 participants 437 participants 867 participants
41.6  (14.5) 41.1  (14.4) 41.3  (14.4)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 430 participants 437 participants 867 participants
Female 267 258 525
Male 161 177 338
Unknown 2 2 4
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 430 participants 437 participants 867 participants
Europe 100 103 203
North America 330 334 664
1.Primary Outcome
Title SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56
Hide Description SCR: anti-JEV neutralizing antibody titer ≥1:10
Time Frame Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population: all randomized subjects without any protocol deviations as defined in the Statistical Analysis Plan
Arm/Group Title IC51 JE-VAX
Hide Arm/Group Description:
IC51
JE-VAX
Overall Number of Participants Analyzed 365 370
Measure Type: Number
Unit of Measure: percentage of participants
96.4 93.6
2.Primary Outcome
Title GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56
Hide Description GMT: geometric mean of PRNT50
Time Frame Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population: All randomized subjects without any major protocol deviations as assessed during a Data Review Meeting. Subjects who were randomized incorrectly or took the wrong study medications were also excluded.
Arm/Group Title IC51 JE-VAX
Hide Arm/Group Description:
IC51
JE-VAX
Overall Number of Participants Analyzed 361 364
Geometric Mean (Standard Deviation)
Unit of Measure: titers
243.6  (1163.1) 102  (221)
3.Secondary Outcome
Title Safety and Adverse Events
Hide Description [Not Specified]
Time Frame until Day 56
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Immunogenicity at Day 28
Hide Description [Not Specified]
Time Frame Day 28
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Immunogenicity at Day 56 for North America vs. Europe
Hide Description [Not Specified]
Time Frame Day 56
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age
Hide Description [Not Specified]
Time Frame Day 56
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description numbers provided for safety population (N= 863)
 
Arm/Group Title IC51 JE-VAX
Hide Arm/Group Description IC51 JE-VAX
All-Cause Mortality
IC51 JE-VAX
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IC51 JE-VAX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/428 (0.23%)      0/435 (0.00%)    
Cardiac disorders     
Myocardial Infarction  1/428 (0.23%)  1 0/435 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
IC51 JE-VAX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   217/428 (50.70%)      213/435 (48.97%)    
Gastrointestinal disorders     
Nausea  29/428 (6.78%)  39/435 (8.97%) 
Diarrhoea  7/428 (1.64%)  9/435 (2.07%) 
General disorders     
Fatigue  54/428 (12.62%)  48/435 (11.03%) 
Influenza like Ilness  54/428 (12.62%)  55/435 (12.64%) 
Pyrexia  24/428 (5.61%)  21/435 (4.83%) 
Infections and infestations     
Nasopharyngitis  26/428 (6.07%)  33/435 (7.59%) 
Musculoskeletal and connective tissue disorders     
Myalgia  88/428 (20.56%)  69/435 (15.86%) 
Nervous system disorders     
Headache  113/428 (26.40%)  125/435 (28.74%) 
Respiratory, thoracic and mediastinal disorders     
Cough  10/428 (2.34%)  11/435 (2.53%) 
Pharyngolaryngeal Pain  12/428 (2.80%)  5/435 (1.15%) 
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.
 
Results Point of Contact
Name/Title: Senior Manager Clinical Research
Organization: Intercell AG
Phone: +43 1 206 20 ext 1175
Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00604708     History of Changes
Other Study ID Numbers: IC51-301
First Submitted: January 4, 2008
First Posted: January 30, 2008
Results First Submitted: May 24, 2012
Results First Posted: November 29, 2012
Last Update Posted: June 2, 2016