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

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: NCT01047839
Recruitment Status : Completed
First Posted : January 13, 2010
Results First Posted : December 19, 2014
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Encephalitis
Intervention Biological: IC51
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title >=2 Months to <3 Years >=3 to <12 Years >=12 to <18 Years
Hide Arm/Group Description IC51 0.25 ml, 2 intramuscular vaccinations at Day 0 and Day 28 IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28 IC51, 0.5 ml, 2 intramuscular vaccinations at Day 0 and 28
Period Title: Overall Study
Started 12 29 59
Completed 10 29 53
Not Completed 2 0 6
Arm/Group Title >=2 Months to <3 Years >=3 to <12 Years >=12 to <18 Years Total
Hide Arm/Group Description IC51 0.25 ml, 2 i.m.vaccinations at Day 0 and Day 28 IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28 IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28 Total of all reporting groups
Overall Number of Baseline Participants 12 29 59 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 29 participants 59 participants 100 participants
1.81  (0.811) 6.98  (2.417) 15.90  (1.176) 11.62  (5.605)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 29 participants 59 participants 100 participants
Female
5
  41.7%
12
  41.4%
36
  61.0%
53
  53.0%
Male
7
  58.3%
17
  58.6%
23
  39.0%
47
  47.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 29 participants 59 participants 100 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
  25.0%
5
  17.2%
5
   8.5%
13
  13.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   8.3%
2
   6.9%
0
   0.0%
3
   3.0%
White
8
  66.7%
22
  75.9%
53
  89.8%
83
  83.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   1.7%
1
   1.0%
1.Primary Outcome
Title Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title >=2 Months to <3 Years >=3 to <12 Years >=12 to <18 Years
Hide Arm/Group Description:
IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
Overall Number of Participants Analyzed 12 29 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
33.3
(9.9 to 65.1)
20.7
(8.0 to 39.7)
3.4
(0.4 to 11.7)
2.Secondary Outcome
Title Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination
Hide Description [Not Specified]
Time Frame up to Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IC51 0.25 mL IC51 0.5 mL
Hide Arm/Group Description:
0.25 mL i.m. vaccinations on Day 0 and Day 28 subjects aged >= 2 months to < 3years
0.5 mL i.m. vaccinations on Day 0 and Day 28 subjects >= 3 years to < 18 years
Overall Number of Participants Analyzed 12 88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
SAEs
0
(0.0 to 26.5)
3.4
(0.7 to 9.6)
medically attended AEs
33.3
(9.9 to 65.1)
18.2
(10.8 to 27.8)
3.Secondary Outcome
Title Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination
Hide Description [Not Specified]
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IC51 0.25 mL IC51 0.5 mL
Hide Arm/Group Description:
0.25 mL i.m. vaccinations on Day 0 and Day 28 subjects aged >= 2 months to < 3years
0.5 mL i.m. vaccinations on Day 0 and Day 28 subjects >= 3 years to < 18 years
Overall Number of Participants Analyzed 12 88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
any Local after 1st Vaccination
28.6
(2.1 to 48.4)
48.9
(38.1 to 59.8)
any Systemic after 1st Vaccination
33.3
(2.1 to 48.4)
46.0
(34.8 to 56.4)
any Local after 2nd Vaccination
22.2
(2.3 to 51.8)
29.4
(20.0 to 40.3)
any Systemic after 2nd Vaccination
28.6
(2.3 to 51.8)
22.6
(14.0 to 32.7)
4.Secondary Outcome
Title Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination
Hide Description [Not Specified]
Time Frame up to Day 56 and upt to Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IC51 0.25 mL IC51 0.5 mL
Hide Arm/Group Description:
0.25 mL i.m. vaccinations on Day 0 and Day 28 subjects aged >= 2 months to < 3years
0.5 mL i.m. vaccinations on Day 0 and Day 28 subjects >= 3 years to < 18 years
Overall Number of Participants Analyzed 12 88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
any unsolicited AE up to Day 56
83.3
(51.6 to 97.9)
29.5
(20.3 to 40.2)
any unsolicited AE up to Month 7
91.7
(61.5 to 99.8)
43.2
(32.7 to 54.2)
5.Secondary Outcome
Title Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination
Hide Description Laboratory parameters were assessed at the Day 28, Day 56 and Month 7 visit. Endpoint reflects abnormal laboratory parameters assessed as clinically significant by the investigator.
Time Frame up to Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
not from all subjects samples were collected, Overall number of participants analyzed were number of participants at Day 0
Arm/Group Title IC51 0.25 mL IC51 0.5 mL
Hide Arm/Group Description:
0.25 mL i.m. vaccinations on Day 0 and Day 28 subjects aged >= 2 months to < 3years
0.5 mL i.m. vaccinations on Day 0 and Day 28 subjects >= 3 years to < 18 years
Overall Number of Participants Analyzed 12 88
Measure Type: Count of Participants
Unit of Measure: Participants
White Blood cells on Day 28 Number Analyzed 8 participants 83 participants
1
  12.5%
0
   0.0%
Platelets on Day 28 Number Analyzed 8 participants 83 participants
0
   0.0%
1
   1.2%
6.Secondary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame at Day 56 and Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
number analyzed = number of subjects achieving seroconversion Overall number of participants analyzed were number of participants at Day 0
Arm/Group Title IC51 0.25 mL IC51 0.5 mL
Hide Arm/Group Description:
0.25 mL i.m. vaccinations on Day 0 and Day 28 subjects aged >= 2 months to < 3years
0.5 mL i.m. vaccinations on Day 0 and Day 28 subjects >= 3 years to < 18 years
Overall Number of Participants Analyzed 12 88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
SCR Day 56 Number Analyzed 5 participants 57 participants
100.0
(56.6 to 100.0)
100.0
(93.7 to 100.0)
SCR Month 7 Number Analyzed 2 participants 32 participants
100.0
(34.2 to 100.0)
90.6
(75.8 to 96.8)
7.Secondary Outcome
Title GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7
Hide Description [Not Specified]
Time Frame at Day 56 and Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IC51 0.25 mL IC51 0.5 mL
Hide Arm/Group Description:
0.25 mL i.m. vaccinations on Day 0 and Day 28 subjects aged >= 2 months to < 3years
0.5 mL i.m. vaccinations on Day 0 and Day 28 subjects >= 3 years to < 18 years
Overall Number of Participants Analyzed 5 59
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
GMT Day 56
216.18
(105.97 to 441.00)
340.74
(269.83 to 430.28)
GMT Month 7
47.96
(0.00 to 3214485.72)
57.12
(38.41 to 84.94)
8.Secondary Outcome
Title SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups
Hide Description [Not Specified]
Time Frame at Day 56 and Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
number analyzed = number of subjects achieving seroconversion Overall number of participants analyzed were number of participants at Day 0
Arm/Group Title >=2 Months to <3 Years >=3 to <12 Years >=12 to <18 Years
Hide Arm/Group Description:

IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28

IC51: 0.25 ml, 2 i.m. vaccinations at Day 0 and 28

IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28

IC51: 0.5 ml, 2 i.m. vaccinations at Day 0 and 28

IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28

IC51: 0.5 ml, 2 i.m. vaccinations at Day 0 and 28

Overall Number of Participants Analyzed 12 29 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
SCR Day 56 Number Analyzed 5 participants 15 participants 42 participants
100
(56.6 to 100.0)
100.0
(79.6 to 100.0)
100.0
(91.6 to 100.0)
SCR Month 7 Number Analyzed 2 participants 3 participants 29 participants
100.0
(34.2 to 100.0)
66.7
(20.8 to 93.9)
93.1
(78.0 to 98.1)
9.Secondary Outcome
Title GMTs at Day 56 and Month 7 Stratified According to Age Groups
Hide Description [Not Specified]
Time Frame at Day 56 and Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title >=2 Months to <3 Years >=3 to <12 Years >=12 to <18 Years
Hide Arm/Group Description:
IC51 0.25 ml, 2 intramuscular vaccinations at Day 0 and Day 28
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
IC51, 0.5 ml, 2 intramuscular vaccinations at Day 0 and 28
Overall Number of Participants Analyzed 5 15 42
Mean (95% Confidence Interval)
Unit of Measure: Titer
GMT Day 56
216.18
(105.97 to 441.0)
508.03
(267.76 to 963.90)
295.44
(235.96 to 369.90)
GMT Month 7
47.96
(0.00 to 3214485.72)
31.96
(0.48 to 2120.78)
60.65
(40.72 to 90.36)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title >=2 Months to <3 Years >=3 to <12 Years >=12 to <18 Years
Hide Arm/Group Description IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28 IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28 IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
All-Cause Mortality
>=2 Months to <3 Years >=3 to <12 Years >=12 to <18 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
>=2 Months to <3 Years >=3 to <12 Years >=12 to <18 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/29 (0.00%)      3/59 (5.08%)    
Metabolism and nutrition disorders       
Type 1 diabetes mellitus  0/12 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1
Nervous system disorders       
Dizziness  0/12 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1
Psychiatric disorders       
Intentional self-injury  0/12 (0.00%)  0 0/29 (0.00%)  0 1/59 (1.69%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
>=2 Months to <3 Years >=3 to <12 Years >=12 to <18 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/12 (91.67%)      22/29 (75.86%)      49/59 (83.05%)    
Blood and lymphatic system disorders       
Lymphadenopathy  2/12 (16.67%)  2 3/29 (10.34%)  4 0/59 (0.00%)  0
Ear and labyrinth disorders       
Ear Canal Erythema  1/12 (8.33%)  1 1/29 (3.45%)  1 0/59 (0.00%)  0
Gastrointestinal disorders       
Abdominal Pain Upper  1/12 (8.33%)  1 0/29 (0.00%)  0 3/59 (5.08%)  3
Diarrhoea  1/12 (8.33%)  1 0/29 (0.00%)  0 2/59 (3.39%)  2
Haematochezia  1/12 (8.33%)  1 0/29 (0.00%)  0 0/59 (0.00%)  0
Nausea  1/12 (8.33%)  2 0/29 (0.00%)  0 2/59 (3.39%)  3
Vomiting  1/12 (8.33%)  1 2/29 (6.90%)  2 3/59 (5.08%)  3
Nausea  [1]  0/12 (0.00%)  0 2/29 (6.90%)  2 3/59 (5.08%)  7
Diarrhoea  [1]  2/12 (16.67%)  3 1/29 (3.45%)  1 2/59 (3.39%)  2
General disorders       
Pyrexia  3/12 (25.00%)  5 2/29 (6.90%)  3 1/59 (1.69%)  1
Influenza like Illness  1/12 (8.33%)  1 0/29 (0.00%)  0 1/59 (1.69%)  1
Injection Site Pain  [2]  0/12 (0.00%)  0 3/29 (10.34%)  3 19/59 (32.20%)  25
Injection Site Itching  [2]  0/12 (0.00%)  0 1/29 (3.45%)  1 3/59 (5.08%)  3
Tenderness  [2]  1/12 (8.33%)  1 13/29 (44.83%)  19 31/59 (52.54%)  42
Hardening  [2]  1/12 (8.33%)  2 0/29 (0.00%)  0 4/59 (6.78%)  4
Redness  [2]  3/12 (25.00%)  3 2/29 (6.90%)  2 2/59 (3.39%)  2
Irritability  [1]  0/12 (0.00%)  0 5/29 (17.24%)  7 1/59 (1.69%)  1
Excessive Fatigue  [1]  0/12 (0.00%)  0 3/29 (10.34%)  3 7/59 (11.86%)  7
Muscle Pain  [1]  0/12 (0.00%)  0 4/29 (13.79%)  5 23/59 (38.98%)  29
Loss of appetite  [1]  1/12 (8.33%)  1 1/29 (3.45%)  1 0/59 (0.00%)  0
Fever  [1]  0/12 (0.00%)  0 1/29 (3.45%)  1 3/59 (5.08%)  3
Infections and infestations       
Nasopharyngitis  4/12 (33.33%)  4 4/29 (13.79%)  4 0/59 (0.00%)  0
Bronchitis  1/12 (8.33%)  1 0/29 (0.00%)  0 1/59 (1.69%)  1
Upper Respiratory Tract Infection  1/12 (8.33%)  2 2/29 (6.90%)  3 0/59 (0.00%)  0
Injury, poisoning and procedural complications       
Excoriation  1/12 (8.33%)  1 0/29 (0.00%)  0 0/59 (0.00%)  0
Investigations       
White Blood Cell Count Decreased  1/12 (8.33%)  1 0/29 (0.00%)  0 0/59 (0.00%)  0
Nervous system disorders       
Headache  0/12 (0.00%)  0 1/29 (3.45%)  1 3/59 (5.08%)  3
Headache  [1]  0/12 (0.00%)  0 3/29 (10.34%)  5 4/59 (6.78%)  8
Psychiatric disorders       
Initial Insomnia  1/12 (8.33%)  1 0/29 (0.00%)  0 0/59 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough  2/12 (16.67%)  2 3/29 (10.34%)  3 1/59 (1.69%)  1
Pharyngeal Erythema  1/12 (8.33%)  1 2/29 (6.90%)  2 1/59 (1.69%)  1
Asthma  0/12 (0.00%)  0 2/29 (6.90%)  3 0/59 (0.00%)  0
Nasal Congestion  0/12 (0.00%)  0 2/29 (6.90%)  2 0/59 (0.00%)  0
Orapharyngeal Pain  0/12 (0.00%)  0 1/29 (3.45%)  1 3/59 (5.08%)  3
Skin and subcutaneous tissue disorders       
Pruritus  1/12 (8.33%)  1 1/29 (3.45%)  2 0/59 (0.00%)  0
Rash Erythematous  1/12 (8.33%)  1 0/29 (0.00%)  0 0/59 (0.00%)  0
Rash  [1]  0/12 (0.00%)  0 3/29 (10.34%)  4 1/59 (1.69%)  1
Indicates events were collected by systematic assessment
[1]
solicited systemic
[2]
solicited local
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: Senior Scientist Clinical Research
Organization: Valneva Austria GmbH
Phone: +43 1 206 20 ext 1175
EMail: katrin.dubischar-kastner@valneva.com
Layout table for additonal information
Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT01047839    
Other Study ID Numbers: IC51-322
First Submitted: January 12, 2010
First Posted: January 13, 2010
Results First Submitted: September 25, 2014
Results First Posted: December 19, 2014
Last Update Posted: June 30, 2020