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Safety and Tolerability 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: NCT00605085
Recruitment Status : Completed
First Posted : January 30, 2008
Results First Posted : November 20, 2012
Last Update Posted : November 20, 2012
Sponsor:
Information provided by:
Valneva Austria GmbH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Japanese Encephalitis
Interventions Biological: Japanese Encephalitis purified inactivated vaccine (IC51)
Biological: Placebo
Enrollment 2675
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IC51 Placebo
Hide Arm/Group Description IC51 Placebo
Period Title: Overall Study
Started 2012 663
Completed 1962 638
Not Completed 50 25
Reason Not Completed
Withdrawal by Subject             8             5
Adverse Event             9             5
Pregnancy             2             0
Protocol Violation             3             2
Lost to Follow-up             10             5
administrative reasons             18             8
Arm/Group Title IC51 Placebo Total
Hide Arm/Group Description IC51 Placebo Total of all reporting groups
Overall Number of Baseline Participants 1993 657 2650
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1993 participants 657 participants 2650 participants
33.9  (13.3) 33.4  (13) 33.8  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1993 participants 657 participants 2650 participants
Female
1088
  54.6%
378
  57.5%
1466
  55.3%
Male
905
  45.4%
279
  42.5%
1184
  44.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1993 participants 657 participants 2650 participants
Australia 294 100 394
Europe 1236 406 1642
United States 463 151 614
1.Primary Outcome
Title Safety and Tolerability up to Day 56
Hide Description calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)
Time Frame Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title IC51 Placebo
Hide Arm/Group Description:
IC51
Placebo
Overall Number of Participants Analyzed 1993 657
Measure Type: Number
Unit of Measure: percentage of participants with AEs
58.9 56.6
2.Secondary Outcome
Title Rates of Serious Adverse Events and Medically Attended Adverse Events
Hide Description [Not Specified]
Time Frame until Day 56
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Changes in Laboratory Parameters
Hide Description [Not Specified]
Time Frame until Day 56
Outcome Measure Data Not Reported
4.Secondary Outcome
Title SCR and GMT of Subjects With Concomitant Vaccinations
Hide Description [Not Specified]
Time Frame until Day 56
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description

Safet population (N = 2650): All subjects who entered the study and received at least one vaccination. All analyses based on the safety population were carried out using the actual treatment received.

The safety population was used for all safety and tolerability analyses and for the analysis of demographic and background data.

 
Arm/Group Title IC51 Placebo
Hide Arm/Group Description IC51 Placebo
All-Cause Mortality
IC51 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IC51 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   10/1993 (0.50%)   6/657 (0.91%) 
Cardiac disorders     
Acute Coronary Syndrome  0/1993 (0.00%)  1/657 (0.15%) 
Gastrointestinal disorders     
Proctalgia  0/1993 (0.00%)  1/657 (0.15%) 
Rectal Haemorrhage  1/1993 (0.05%)  0/657 (0.00%) 
General disorders     
Chest Pain  1/1993 (0.05%)  0/657 (0.00%) 
Infections and infestations     
Abscess Limb  1/1993 (0.05%)  0/657 (0.00%) 
Appendicitis  1/1993 (0.05%)  2/657 (0.30%) 
Injury, poisoning and procedural complications     
Face Injury  1/1993 (0.05%)  0/657 (0.00%) 
Facial Bones Fracture  1/1993 (0.05%)  0/657 (0.00%) 
Ulna Fracture  1/1993 (0.05%)  0/657 (0.00%) 
Renal and urinary disorders     
Calculus Urinary  0/1993 (0.00%)  1/657 (0.15%) 
Reproductive system and breast disorders     
Adnexa Uteri Pain  1/1993 (0.05%)  0/657 (0.00%) 
Ovarian Cyst Ruptured  1/1993 (0.05%)  0/657 (0.00%) 
Ovarian Torsion  1/1993 (0.05%)  0/657 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatomyositis  1/1993 (0.05%)  0/657 (0.00%) 
Vascular disorders     
Curculatory Collapse  0/1993 (0.00%)  1/657 (0.15%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
IC51 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   917/1993 (46.01%)   292/657 (44.44%) 
Gastrointestinal disorders     
Nausea  131/1993 (6.57%)  49/657 (7.46%) 
General disorders     
Fatigue  227/1993 (11.39%)  77/657 (11.72%) 
Influenza Like Illness  248/1993 (12.44%)  78/657 (11.87%) 
Pyrexia  64/1993 (3.21%)  20/657 (3.04%) 
Infections and infestations     
Nasopharyngitis  94/1993 (4.72%)  26/657 (3.96%) 
Musculoskeletal and connective tissue disorders     
Myalgia  311/1993 (15.60%)  102/657 (15.53%) 
Nervous system disorders     
Headache  559/1993 (28.05%)  173/657 (26.33%) 
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: Intercell AG
ClinicalTrials.gov Identifier: NCT00605085     History of Changes
Other Study ID Numbers: IC51-302
First Submitted: January 4, 2008
First Posted: January 30, 2008
Results First Submitted: June 1, 2012
Results First Posted: November 20, 2012
Last Update Posted: November 20, 2012