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Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population

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ClinicalTrials.gov Identifier: NCT01041573
Recruitment Status : Completed
First Posted : December 31, 2009
Results First Posted : February 27, 2014
Last Update Posted : May 6, 2016
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Encephalitis
Interventions Biological: IC51 Japanese Encephalitis
Biological: Havrix®720
Biological: Prevnar
Enrollment 1869
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IC51 0.5 mL IC51 0.25 mL Havrix 720 Prevnar
Hide Arm/Group Description Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28 Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28 Havrix®720 0.5 ml i.m. at day 0 and month 7 Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day 56 and month 7-13
Period Title: Overall Study
Started 540 871 394 64
Completed 535 858 387 62
Not Completed 5 13 7 2
Reason Not Completed
Withdrawal by Subject             2             5             2             0
Death             1             0             0             0
Lost to Follow-up             0             1             2             1
Adverse Event             0             2             0             0
relocation             1             4             3             1
further blood extraction             0             1             0             0
positive to anti-HCV             1             0             0             0
Arm/Group Title IC51 0.5 mL IC51 0.25 mL Havrix 720 Prevnar Total
Hide Arm/Group Description Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28 Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28 Havrix®720 0.5 ml i.m. at day 0 and month 7 Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day56 and month 7-13 Total of all reporting groups
Overall Number of Baseline Participants 540 871 394 64 1869
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 540 participants 871 participants 394 participants 64 participants 1869 participants
2 months - < 1 year 0 131 0 64 195
1 year - < 3 years 0 640 213 0 853
3 years - < 12 years 300 100 101 0 501
12 years - < 18 years 240 0 80 0 320
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 540 participants 871 participants 394 participants 64 participants 1869 participants
Female
249
  46.1%
449
  51.5%
197
  50.0%
30
  46.9%
925
  49.5%
Male
291
  53.9%
422
  48.5%
197
  50.0%
34
  53.1%
944
  50.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Philippines Number Analyzed 540 participants 871 participants 394 participants 64 participants 1869 participants
540 871 394 64 1869
1.Primary Outcome
Title Rate of Subjects With Serious Adverse Events and Medically Attended Adverse Events Until Day 56 After First Vaccination
Hide Description Comparing study participants 1 year and above receiving IC51 0.25mL, IC51 0.5 mL and Havrix
Time Frame until Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IC51, Subjects Aged >= 1 Year IC51, Subjects Aged >= 2 Months to <1 Year Havrix 720 Prevnar
Hide Arm/Group Description:
IC51 Japanese Encephalitis: 6 mcg or 3 mcg im. at day 0 and day 28
Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28
Havrix®720 0.5 ml im. at day 0 and month 7
  • Subjects aged ≥ 2 to < 6 months: 4 intramuscular vaccinations, Days 0, 28, 56 and Month 7‐13 (subjects aged ≥ 2 to < 6 months were to receive the fourth Prevnar® vaccination when 12‐15 months old, i.e., the vaccination was to be performed outside the study, depending on the subject´s age at day of first vaccination).
  • Subjects aged ≥ 6 months to < 1 year: 3 intramuscular vaccinations, Days 0, 56 and Month 7.
Overall Number of Participants Analyzed 1280 131 394 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
16.1
(14.1 to 18.2)
38.2
(29.8 to 47.1)
14.2
(10.9 to 18.1)
42.2
(29.9 to 55.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IC51, Subjects Aged >= 2 Months to <1 Year, Prevnar
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.641
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IC51, Subjects Aged >= 1 Year, Havrix 720
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Geometric Mean Titers (GMT) for JEV Neutralizing Antibodies and SCR at Days 0, 56 and at Month 7
Hide Description [Not Specified]
Time Frame Day 0, 56 and at Month 7
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Rate of Subjects With SAEs and Medically Attended AEs up to Month 7
Hide Description [Not Specified]
Time Frame up to Month 7
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Rate of Subjects With Solicited Local and Systemic AEs
Hide Description [Not Specified]
Time Frame study duration
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7
Hide Description [Not Specified]
Time Frame Day 56 and up to Month 7
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Rate of Subjects With Abnormal Laboratory Parameters
Hide Description [Not Specified]
Time Frame study duration
Outcome Measure Data Not Reported
Time Frame 7 months after first vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IC51 0.5 mL IC51 0.25 mL Havrix 720 Prevnar
Hide Arm/Group Description Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28 Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28 Havrix®720 0.5 ml i.m. at day 0 and month 7 Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day 56 and month 7-13
All-Cause Mortality
IC51 0.5 mL IC51 0.25 mL Havrix 720 Prevnar
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IC51 0.5 mL IC51 0.25 mL Havrix 720 Prevnar
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/540 (1.30%)      16/871 (1.84%)      10/394 (2.54%)      1/64 (1.56%)    
Blood and lymphatic system disorders         
Disseminated Intravascular Coagulation  1/540 (0.19%)  1 0/871 (0.00%)  0 0/394 (0.00%)  0 0/64 (0.00%)  0
Congenital, familial and genetic disorders         
Familial Periodic Paralysis  0/540 (0.00%)  0 0/871 (0.00%)  0 1/394 (0.25%)  1 0/64 (0.00%)  0
Eye disorders         
Strabismus  1/540 (0.19%)  1 0/871 (0.00%)  0 0/394 (0.00%)  0 0/64 (0.00%)  0
Infections and infestations         
Pneumonia  1/540 (0.19%)  1 3/871 (0.34%)  3 2/394 (0.51%)  2 0/64 (0.00%)  0
Bronchopneumonia  0/540 (0.00%)  0 2/871 (0.23%)  2 1/394 (0.25%)  1 0/64 (0.00%)  0
Dengue Fever  1/540 (0.19%)  1 1/871 (0.11%)  1 1/394 (0.25%)  1 0/64 (0.00%)  0
Gastroenteritis  0/540 (0.00%)  0 2/871 (0.23%)  2 1/394 (0.25%)  1 0/64 (0.00%)  0
Cellulitis  0/540 (0.00%)  0 1/871 (0.11%)  1 0/394 (0.00%)  0 0/64 (0.00%)  0
Hepatitis A  0/540 (0.00%)  0 1/871 (0.11%)  1 0/394 (0.00%)  0 0/64 (0.00%)  0
Meningitis Bacterial  1/540 (0.19%)  1 0/871 (0.00%)  0 0/394 (0.00%)  0 0/64 (0.00%)  0
Pharyngotonsillitis  1/540 (0.19%)  1 0/871 (0.00%)  0 0/394 (0.00%)  0 0/64 (0.00%)  0
Typhoid Fever  1/540 (0.19%)  1 0/871 (0.00%)  0 0/394 (0.00%)  0 0/64 (0.00%)  0
Upper Respiratory Tract Infection  1/540 (0.19%)  1 0/871 (0.00%)  0 0/394 (0.00%)  0 0/64 (0.00%)  0
Urinary Tract Infection  0/540 (0.00%)  0 1/871 (0.11%)  1 0/394 (0.00%)  0 0/64 (0.00%)  0
Injury, poisoning and procedural complications         
Injury  1/540 (0.19%)  1 0/871 (0.00%)  0 0/394 (0.00%)  0 0/64 (0.00%)  0
Metabolism and nutrition disorders         
Hyponatraemia  0/540 (0.00%)  0 0/871 (0.00%)  0 1/394 (0.25%)  1 0/64 (0.00%)  0
Nervous system disorders         
Febrile Convulsion  0/540 (0.00%)  0 5/871 (0.57%)  5 3/394 (0.76%)  3 1/64 (1.56%)  1
Pregnancy, puerperium and perinatal conditions         
Stillbirth  1/540 (0.19%)  1 0/871 (0.00%)  0 0/394 (0.00%)  0 0/64 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  0/540 (0.00%)  0 0/871 (0.00%)  0 1/394 (0.25%)  1 0/64 (0.00%)  0
Vascular disorders         
Haematoma  0/540 (0.00%)  0 1/871 (0.11%)  1 0/394 (0.00%)  0 0/64 (0.00%)  0
Kawasaki´s Disease  1/540 (0.19%)  1 0/871 (0.00%)  0 0/394 (0.00%)  0 0/64 (0.00%)  0
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IC51 0.5 mL IC51 0.25 mL Havrix 720 Prevnar
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   300/540 (55.56%)      691/871 (79.33%)      252/394 (63.96%)      57/64 (89.06%)    
Gastrointestinal disorders         
Diarrhoea  3/540 (0.56%)  3 30/871 (3.44%)  32 10/394 (2.54%)  10 5/64 (7.81%)  5
Vomiting  1 [1]  10/540 (1.85%)  11 58/871 (6.66%)  69 13/394 (3.30%)  14 5/63 (7.94%)  5
Diarrhea  1 [1]  6/540 (1.11%)  6 94/871 (10.79%)  113 13/394 (3.30%)  13 6/63 (9.52%)  7
General disorders         
Pyrexia  35/540 (6.48%)  36 122/871 (14.01%)  127 36/394 (9.14%)  40 8/64 (12.50%)  10
Injection Site Pain  1 [2]  65/532 (12.22%)  74 15/256 (5.86%)  17 20/228 (8.77%)  20 0/0  0
Tenderness  1 [3]  48/540 (8.89%)  55 38/871 (4.36%)  40 27/394 (6.85%)  27 8/63 (12.70%)  10
Hardening  1 [4]  8/540 (1.48%)  8 10/871 (1.15%)  10 2/394 (0.51%)  2 5/63 (7.94%)  6
Swelling  1 [4]  14/540 (2.59%)  15 34/871 (3.90%)  35 12/394 (3.05%)  15 5/63 (7.94%)  6
Redness  1 [4]  22/540 (4.07%)  22 81/871 (9.30%)  93 25/394 (6.35%)  25 23/63 (36.51%)  30
Flu-like symptoms  1 [1]  16/532 (3.01%)  17 21/268 (7.84%)  23 16/235 (6.81%)  16 0/0  0
Fever  1 [1]  61/540 (11.30%)  76 244/871 (28.01%)  316 49/394 (12.44%)  53 24/63 (38.10%)  31
Irritability  1 [5]  6/540 (1.11%)  9 87/871 (9.99%)  111 16/394 (4.06%)  17 9/63 (14.29%)  16
Excessive Fatigue  1 [1]  12/540 (2.22%)  14 28/871 (3.21%)  32 5/394 (1.27%)  5 5/63 (7.94%)  7
Infections and infestations         
Upper Respiratory Tract Infection  67/540 (12.41%)  72 326/871 (37.43%)  414 97/394 (24.62%)  115 33/64 (51.56%)  50
Gastroenteritis  3/540 (0.56%)  3 58/871 (6.66%)  61 14/394 (3.55%)  14 9/64 (14.06%)  12
Nasopharyngitis  14/540 (2.59%)  16 77/871 (8.84%)  89 27/394 (6.85%)  27 5/64 (7.81%)  6
Rhinitis  8/540 (1.48%)  8 45/871 (5.17%)  48 17/394 (4.31%)  19 3/64 (4.69%)  5
Metabolism and nutrition disorders         
Loss of appetite  1 [1]  11/540 (2.04%)  14 65/871 (7.46%)  78 13/394 (3.30%)  16 6/63 (9.52%)  12
Nervous system disorders         
Headache  1 [1]  31/531 (5.84%)  37 10/233 (4.29%)  10 10/219 (4.57%)  10 0/0  0
Skin and subcutaneous tissue disorders         
Heat Rash  4/540 (0.74%)  4 9/871 (1.03%)  10 4/394 (1.02%)  4 4/64 (6.25%)  5
Rash  1 [1]  5/540 (0.93%)  5 49/871 (5.63%)  57 6/394 (1.52%)  6 9/63 (14.29%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
[1]
solicited systemic
[2]
pain without touching, solicited local
[3]
pain upon touching, solicited local
[4]
solicited local
[5]
solicitec systemic
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: Valneva Austria GmbH
Phone: +43 1 206 20 ext 1175
Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT01041573     History of Changes
Other Study ID Numbers: IC51-323
First Submitted: December 30, 2009
First Posted: December 31, 2009
Results First Submitted: January 16, 2014
Results First Posted: February 27, 2014
Last Update Posted: May 6, 2016