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Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling

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: NCT00776230
Recruitment Status : Completed
First Posted : October 21, 2008
Results First Posted : January 23, 2014
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Japanese Encephalitis
Intervention Biological: IC51
Enrollment 304
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IC51 Cohort 1 IC51 Cohort 2 IC51 Cohort 3
Hide Arm/Group Description vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~12 months after filling; vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~18 months after filling; vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling;
Period Title: Overall Study
Started 99 103 102
Enrolled and Vaccinated at Day 0 98 103 102
Completed 96 100 97
Not Completed 3 3 5
Reason Not Completed
Lost to Follow-up             2             1             5
Not vaccinated at Day 0             1             0             0
Withdrawal by Subject             0             1             0
Subject missed Visit 4             0             1             0
Arm/Group Title IC51 Cohort 1 IC51 Cohort 2 IC51 Cohort 3 Total
Hide Arm/Group Description vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~12 months after filling; vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~18 months after filling; vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling; Total of all reporting groups
Overall Number of Baseline Participants 98 103 102 303
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants 103 participants 102 participants 303 participants
27.3  (7.6) 28.6  (10.7) 31.6  (10.7) 29.2  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 103 participants 102 participants 303 participants
Female
61
  62.2%
55
  53.4%
51
  50.0%
167
  55.1%
Male
37
  37.8%
48
  46.6%
51
  50.0%
136
  44.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 98 participants 103 participants 102 participants 303 participants
Caucasian/ White 93 98 102 293
Asian 5 5 0 10
Black or African American 0 0 0 0
Other 0 0 0 0
1.Primary Outcome
Title Primary: 1. Geometric Mean Titers (GMT) at Day 56
Hide Description [Not Specified]
Time Frame 56 days post 1st vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Intention To Treat Population, i.e., all subjects entered into the study who received at least one dose of study medication
Arm/Group Title IC51 Cohort 1 IC51 Cohort 2 IC51 Cohort 3
Hide Arm/Group Description:
vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~12 months after filling;
vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~18 months after filling;
vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling;
Overall Number of Participants Analyzed 98 103 102
Geometric Mean (95% Confidence Interval)
Unit of Measure: Geometric Mean Titer - Estimate
100.1
(78.9 to 127.0)
84.7
(66.3 to 108.2)
68.1
(54.4 to 85.4)
2.Secondary Outcome
Title Secondary: 1. Seroconversion Rate 2. GMTs Day 28, Month 6 and Month 12 3. Treatment Emergent Adverse Events 4. Systemic and Local Tolerability
Hide Description [Not Specified]
Time Frame see above
Outcome Measure Data Not Reported
Time Frame up to Day 56
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IC51 Cohort 1 IC51 Cohort 2 IC51 Cohort 3
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
IC51 Cohort 1 IC51 Cohort 2 IC51 Cohort 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
IC51 Cohort 1 IC51 Cohort 2 IC51 Cohort 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/98 (2.04%)   1/103 (0.97%)   0/102 (0.00%) 
Infections and infestations       
Subcutaneous abscess  1/98 (1.02%)  0/103 (0.00%)  0/102 (0.00%) 
Reproductive system and breast disorders       
Endometrial hyperplasia  1/98 (1.02%)  0/103 (0.00%)  0/102 (0.00%) 
Vascular disorders       
Hypertension  0/98 (0.00%)  1/103 (0.97%)  0/102 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
IC51 Cohort 1 IC51 Cohort 2 IC51 Cohort 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   66/98 (67.35%)   58/103 (56.31%)   61/102 (59.80%) 
Blood and lymphatic system disorders       
Lymphadenopathy  0/98 (0.00%)  2/103 (1.94%)  0/102 (0.00%) 
Cardiac disorders       
Tachycardia  1/98 (1.02%)  0/103 (0.00%)  0/102 (0.00%) 
Ear and labyrinth disorders       
Vertigo  2/98 (2.04%)  1/103 (0.97%)  2/102 (1.96%) 
Eye disorders       
Ocular Hyperaemia  1/98 (1.02%)  0/103 (0.00%)  0/102 (0.00%) 
Gastrointestinal disorders       
Abdominal Pain Upper  1/98 (1.02%)  0/103 (0.00%)  0/102 (0.00%) 
Dental Caries  1/98 (1.02%)  0/103 (0.00%)  0/102 (0.00%) 
Diarrhoea  0/98 (0.00%)  0/103 (0.00%)  3/102 (2.94%) 
Dry Mouth  0/98 (0.00%)  2/103 (1.94%)  0/102 (0.00%) 
Enteritis  1/98 (1.02%)  0/103 (0.00%)  0/102 (0.00%) 
Nausea  5/98 (5.10%)  5/103 (4.85%)  7/102 (6.86%) 
Toothache  1/98 (1.02%)  0/103 (0.00%)  1/102 (0.98%) 
General disorders       
Asthenia  1/98 (1.02%)  0/103 (0.00%)  0/102 (0.00%) 
Fatigue  3/98 (3.06%)  20/103 (19.42%)  10/102 (9.80%) 
Influenza Like Illness  13/98 (13.27%)  10/103 (9.71%)  15/102 (14.71%) 
Injection Site Erythema  1/98 (1.02%)  0/103 (0.00%)  0/102 (0.00%) 
Pyrexia  0/98 (0.00%)  2/103 (1.94%)  1/102 (0.98%) 
Infections and infestations       
Cystitis  1/98 (1.02%)  2/103 (1.94%)  0/102 (0.00%) 
Gastroenteritis  3/98 (3.06%)  0/103 (0.00%)  2/102 (1.96%) 
Nasopharyngitis  11/98 (11.22%)  7/103 (6.80%)  7/102 (6.86%) 
Rhinitis  5/98 (5.10%)  1/103 (0.97%)  2/102 (1.96%) 
Sinusitis  1/98 (1.02%)  1/103 (0.97%)  1/102 (0.98%) 
Subcutaneous Abscess  1/98 (1.02%)  0/103 (0.00%)  0/102 (0.00%) 
Tonsillitis  0/98 (0.00%)  2/103 (1.94%)  0/102 (0.00%) 
Urinary Tract Infection  2/98 (2.04%)  0/103 (0.00%)  2/102 (1.96%) 
Investigations       
Hepatic Enzyme Increased  1/98 (1.02%)  0/103 (0.00%)  0/102 (0.00%) 
Iron Deficiency  0/98 (0.00%)  2/103 (1.94%)  0/102 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1/98 (1.02%)  0/103 (0.00%)  0/102 (0.00%) 
Back Pain  2/98 (2.04%)  0/103 (0.00%)  0/102 (0.00%) 
Muscle Spasms  1/98 (1.02%)  0/103 (0.00%)  0/102 (0.00%) 
Myalgia  7/98 (7.14%)  9/103 (8.74%)  9/102 (8.82%) 
Rotator Cuff Syndrome  1/98 (1.02%)  0/103 (0.00%)  0/102 (0.00%) 
Nervous system disorders       
Disturbance In Attention  1/98 (1.02%)  1/103 (0.97%)  0/102 (0.00%) 
Dizziness  1/98 (1.02%)  3/103 (2.91%)  2/102 (1.96%) 
Headache  26/98 (26.53%)  24/103 (23.30%)  32/102 (31.37%) 
Paraesthesia  1/98 (1.02%)  0/103 (0.00%)  0/102 (0.00%) 
Renal and urinary disorders       
Dysuria  1/98 (1.02%)  0/103 (0.00%)  0/102 (0.00%) 
Reproductive system and breast disorders       
Endometrial Hyperplasia  1/98 (1.02%)  0/103 (0.00%)  0/102 (0.00%) 
Endometriosis  1/98 (1.02%)  0/103 (0.00%)  0/102 (0.00%) 
Menorrhagia  1/98 (1.02%)  0/103 (0.00%)  0/102 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal Pain  3/98 (3.06%)  3/103 (2.91%)  2/102 (1.96%) 
Skin and subcutaneous tissue disorders       
Pruritus  0/98 (0.00%)  2/103 (1.94%)  0/102 (0.00%) 
Rash  0/98 (0.00%)  0/103 (0.00%)  2/102 (1.96%) 
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
Layout table for Results Point of Contact information
Name/Title: Katrin Dubischar-Kastner
Organization: Valneva Austria GmbH
Phone: +43120620 ext 0
EMail: info@valneva.com
Layout table for additonal information
Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00776230    
Other Study ID Numbers: IC51-314
First Submitted: October 20, 2008
First Posted: October 21, 2008
Results First Submitted: December 5, 2013
Results First Posted: January 23, 2014
Last Update Posted: May 4, 2016