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Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51

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ClinicalTrials.gov Identifier: NCT00595465
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : November 20, 2012
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Japanese Encephalitis
Intervention Biological: Japanese Encephalitis purified inactivated vaccine
Enrollment 389
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IC51 Batch IC51/07E/006A IC51 Batch IC51/07E/007A IC51 Batch IC51/07E/008A
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
Period Title: Overall Study
Started 130 129 128
Completed 124 125 121
Not Completed 6 4 7
Reason Not Completed
Adverse Event             4             3             3
Pregnancy             0             0             1
Protocol Violation             2             1             0
Lost to Follow-up             0             0             2
administrative reason             0             0             1
Arm/Group Title IC51 Batch IC51/07E/006A IC51 Batch IC51/07E/007A IC51 Batch IC51/07E/008A Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 130 129 128 387
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 129 participants 128 participants 387 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
130
 100.0%
128
  99.2%
127
  99.2%
385
  99.5%
>=65 years
0
   0.0%
1
   0.8%
1
   0.8%
2
   0.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 130 participants 129 participants 128 participants 387 participants
29.3  (8.6) 28.9  (9.4) 30.2  (10.5) 29.5  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 129 participants 128 participants 387 participants
Female
71
  54.6%
83
  64.3%
74
  57.8%
228
  58.9%
Male
59
  45.4%
46
  35.7%
54
  42.2%
159
  41.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Europe Number Analyzed 130 participants 129 participants 128 participants 387 participants
130 129 128 387
1.Primary Outcome
Title Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody
Hide Description [Not Specified]
Time Frame Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population (PP Population, N= 364): includes all subjects randomized who received at least one dose of study medication without any major protocol violations identified at the blind data review meeting.
Arm/Group Title IC51 Batch IC51/07E/006A IC51 Batch IC51/07E/007A IC51 Batch IC51/07E/008A
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 124 121 119
Mean (Standard Deviation)
Unit of Measure: titers
160.8  (398.0) 188.2  (410.2) 168.4  (483.6)
2.Secondary Outcome
Title Seroconversion Rate
Hide Description [Not Specified]
Time Frame Day 56
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Safety and Adverse Events
Hide Description [Not Specified]
Time Frame Day 56
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description 389 subjects were randomized, 2 of them were not treated
 
Arm/Group Title IC51 Batch IC51/07E/006A IC51 Batch IC51/07E/007A IC51 Batch IC51/07E/008A
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
IC51 Batch IC51/07E/006A IC51 Batch IC51/07E/007A IC51 Batch IC51/07E/008A
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IC51 Batch IC51/07E/006A IC51 Batch IC51/07E/007A IC51 Batch IC51/07E/008A
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/130 (1.54%)   1/129 (0.78%)   0/128 (0.00%) 
Gastrointestinal disorders       
Abdominal Pain  0/130 (0.00%)  1/129 (0.78%)  0/128 (0.00%) 
Infections and infestations       
Tubo-Ovarian Abscess  1/130 (0.77%)  0/129 (0.00%)  0/128 (0.00%) 
Injury, poisoning and procedural complications       
Humerus Fracture  1/130 (0.77%)  0/129 (0.00%)  0/128 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
IC51 Batch IC51/07E/006A IC51 Batch IC51/07E/007A IC51 Batch IC51/07E/008A
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   64/130 (49.23%)   74/129 (57.36%)   74/128 (57.81%) 
Blood and lymphatic system disorders       
Lymphadenopathy  4/130 (3.08%)  1/129 (0.78%)  1/128 (0.78%) 
Ear and labyrinth disorders       
Vertigo  1/130 (0.77%)  4/129 (3.10%)  1/128 (0.78%) 
Gastrointestinal disorders       
Abdominal Pain  0/130 (0.00%)  1/129 (0.78%)  3/128 (2.34%) 
Abdominal Pain Upper  0/130 (0.00%)  0/129 (0.00%)  3/128 (2.34%) 
Diarrhoea  4/130 (3.08%)  4/129 (3.10%)  3/128 (2.34%) 
Nausea  12/130 (9.23%)  10/129 (7.75%)  9/128 (7.03%) 
Vomiting  2/130 (1.54%)  3/129 (2.33%)  4/128 (3.13%) 
General disorders       
Fatigue  17/130 (13.08%)  19/129 (14.73%)  14/128 (10.94%) 
Influenza Like Illness  19/130 (14.62%)  25/129 (19.38%)  25/128 (19.53%) 
Injection Site Haematoma  2/130 (1.54%)  4/129 (3.10%)  2/128 (1.56%) 
Injection Site Pain  4/130 (3.08%)  5/129 (3.88%)  1/128 (0.78%) 
Pyrexia  8/130 (6.15%)  3/129 (2.33%)  3/128 (2.34%) 
Infections and infestations       
Bronchitis  3/130 (2.31%)  4/129 (3.10%)  2/128 (1.56%) 
Gastroenteritis  1/130 (0.77%)  2/129 (1.55%)  3/128 (2.34%) 
Nasopharyngitis  7/130 (5.38%)  9/129 (6.98%)  7/128 (5.47%) 
Rhinitis  3/130 (2.31%)  3/129 (2.33%)  7/128 (5.47%) 
Musculoskeletal and connective tissue disorders       
Myalgia  14/130 (10.77%)  10/129 (7.75%)  15/128 (11.72%) 
Nervous system disorders       
Headache  23/130 (17.69%)  36/129 (27.91%)  38/128 (29.69%) 
Respiratory, thoracic and mediastinal disorders       
Cough  5/130 (3.85%)  0/129 (0.00%)  0/128 (0.00%) 
Pharyngolaryngeal Pain  3/130 (2.31%)  2/129 (1.55%)  6/128 (4.69%) 
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: NCT00595465     History of Changes
Other Study ID Numbers: IC51-310
First Submitted: January 4, 2008
First Posted: January 16, 2008
Results First Submitted: June 1, 2012
Results First Posted: November 20, 2012
Last Update Posted: May 16, 2014