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Study of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) Compared to CD.JEVAX™ in Toddlers

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ClinicalTrials.gov Identifier: NCT01396512
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : April 25, 2014
Last Update Posted : April 25, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Japanese Encephalitis
Japanese Encephalitis Virus Disease
Interventions Biological: Live attenuated Japanese encephalitis chimeric virus vaccine
Biological: Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine)
Enrollment 274
Recruitment Details The study participants were enrolled from 12 July 2011 to 28 September 2012 at 10 clinic centers in South Korea.
Pre-assignment Details A total of 274 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.
Arm/Group Title IMOJEV™ Vaccine Group CD.JEVAX™ Vaccine Group
Hide Arm/Group Description Participants age 12 to 24 months received one dose of IMOJEV™ Participants age 12 to 24 months received one dose of CD.JEVAX™
Period Title: Overall Study
Started 137 137
Completed 137 136
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title IMOJEV™ Vaccine Group CD.JEVAX™ Vaccine Group Total
Hide Arm/Group Description Participants age 12 to 24 months received one dose of IMOJEV™ Participants age 12 to 24 months received one dose of CD.JEVAX™ Total of all reporting groups
Overall Number of Baseline Participants 137 137 274
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants 137 participants 274 participants
<=18 years
137
 100.0%
137
 100.0%
274
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 137 participants 137 participants 274 participants
14.0  (2.0) 14.3  (2.2) 14.2  (2.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants 137 participants 274 participants
Female
58
  42.3%
57
  41.6%
115
  42.0%
Male
79
  57.7%
80
  58.4%
159
  58.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
South Korea Number Analyzed 137 participants 137 participants 274 participants
137 137 274
1.Primary Outcome
Title Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Hide Description Immunogenicity assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). Seroconversion was defined as the percentage of participants who developed neutralizing antibody titers above 10 (1/dil) when seronegative at baseline (<1/10) or who presented a ≥4-fold rise in their neutralizing antibody titers when seropositive (≥1/10) at baseline.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion to JE-CV was assessed in the Per-Protocol Analysis Set.
Arm/Group Title IMOJEV™ Vaccine Group CD.JEVAX™ Vaccine Group
Hide Arm/Group Description:
Participants age 12 to 24 months received one dose of IMOJEV™
Participants age 12 to 24 months received one dose of CD.JEVAX™
Overall Number of Participants Analyzed 119 117
Measure Type: Number
Unit of Measure: Percentage of Participants
100 99.1
2.Secondary Outcome
Title Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Hide Description

Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).

JE-CV PRNT50 antibody titer >10 (1/dil, Day 0)

Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers against the JE-CV was assessed in the Per-Protocol Analysis Set.
Arm/Group Title IMOJEV™ Vaccine Group CD.JEVAX™ Vaccine Group
Hide Arm/Group Description:
Participants age 12 to 24 months received one dose of IMOJEV™
Participants age 12 to 24 months received one dose of CD.JEVAX™
Overall Number of Participants Analyzed 119 117
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
JE-CV PRNT50 antibody titer (pre-vaccination)
5.0
(5.0 to 5.0)
5.0
(5.0 to 5.0)
JE-CV PRNT50 antibody titer (post-vaccination)
908
(656 to 1256)
579
(427 to 784)
3.Secondary Outcome
Title Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Hide Description Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection against JE-CV was assessed in the Per-Protocol Analysis Set.
Arm/Group Title IMOJEV™ Vaccine Group CD.JEVAX™ Vaccine Group
Hide Arm/Group Description:
Participants age 12 to 24 months received one dose of IMOJEV™
Participants age 12 to 24 months received one dose of CD.JEVAX™
Overall Number of Participants Analyzed 119 117
Measure Type: Number
Unit of Measure: Participants
JE-CV PRNT50 antibody titer ≥10 (1/dil, Day 0) 0 0
JE-CV PRNT50 antibody titer ≥10 (1/dil, Day 28) 119 116
4.Secondary Outcome
Title Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Hide Description Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling longest diameter ≥50 mm. Grade 3 systemic reactions: Fever >39.5°C; Vomiting ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - sleeping most of the time or difficult to wake; Appetite Loss - refuses ≥3 feeds or most feeds; Irritability - inconsolable.
Time Frame Day 0 up to Day 14 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.
Arm/Group Title IMOJEV™ Vaccine Group CD.JEVAX™ Vaccine Group
Hide Arm/Group Description:
Participants age 12 to 24 months received one dose of IMOJEV™
Participants age 12 to 24 months received one dose of CD.JEVAX™
Overall Number of Participants Analyzed 137 137
Measure Type: Number
Unit of Measure: Participants
Injection site Pain (N = 137, 137) 35 38
Grade 3 Injection site Pain (N = 137, 137) 0 1
Injection site Erythema (N = 137, 137) 23 33
Grade 3 Injection site Erythema (N = 137, 137) 0 0
Injection site Swelling (N = 137, 137) 6 10
Grade 3 Injection site Swelling (N = 137, 137) 0 0
Fever (N = 134, 136) 33 34
Grade 3 Fever (N = 134, 136) 1 1
Vomiting (N = 137, 137) 9 14
Grade 3 Vomiting (N = 137, 137) 1 2
Crying Abnormal (N = 137, 137) 27 35
Grade 3 Crying Abnormal (N = 137, 137) 2 3
Drowsiness (N = 137, 137) 23 33
Grade 3 Drowsiness (N = 137, 137) 0 1
Appetite Loss (N = 137, 137) 38 40
Grade 3 Appetite Loss (N = 137, 137) 4 1
Irritability (N = 137, 137) 31 36
Grade 3 Irritability (N = 137, 137) 1 5
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IMOJEV™ Vaccine Group CD.JEVAX™ Vaccine Group
Hide Arm/Group Description Participants age 12 to 24 months received one dose of IMOJEV™ Participants age 12 to 24 months received one dose of CD.JEVAX™
All-Cause Mortality
IMOJEV™ Vaccine Group CD.JEVAX™ Vaccine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IMOJEV™ Vaccine Group CD.JEVAX™ Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/137 (12.41%)      18/137 (13.14%)    
Gastrointestinal disorders     
Intestinal obstruction * 1  1/137 (0.73%)  1 0/137 (0.00%)  0
Intussusception * 1  1/137 (0.73%)  1 0/137 (0.00%)  0
Stomatitis * 1  0/137 (0.00%)  0 1/137 (0.73%)  1
General disorders     
Pyrexia * 1  1/137 (0.73%)  1 2/137 (1.46%)  2
Hepatobiliary disorders     
Hepatitis * 1  0/137 (0.00%)  0 1/137 (0.73%)  1
Infections and infestations     
Bronchiolitis * 1  1/137 (0.73%)  1 1/137 (0.73%)  1
Bronchitis * 1  2/137 (1.46%)  2 1/137 (0.73%)  2
Croup infectious * 1  0/137 (0.00%)  0 1/137 (0.73%)  1
Gastroenteritis * 1  1/137 (0.73%)  1 3/137 (2.19%)  3
Hand foot and mouth disease * 1  0/137 (0.00%)  0 1/137 (0.73%)  1
Herpangina * 1  1/137 (0.73%)  1 0/137 (0.00%)  0
Lymph node abscess * 1  1/137 (0.73%)  1 0/137 (0.00%)  0
Meningitis aseptic * 1  1/137 (0.73%)  1 0/137 (0.00%)  0
Pharyngitis * 1  2/137 (1.46%)  2 1/137 (0.73%)  1
Pharyngotonsillitis * 1  1/137 (0.73%)  1 1/137 (0.73%)  1
Pneumonia * 1  5/137 (3.65%)  5 3/137 (2.19%)  3
Urinary tract infection * 1  0/137 (0.00%)  0 1/137 (0.73%)  2
Nervous system disorders     
Febrile convulsion * 1  0/137 (0.00%)  0 1/137 (0.73%)  1
Kawasaki's disease * 1  2/137 (1.46%)  2 1/137 (0.73%)  1
*
Indicates events were collected by non-systematic assessment
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 5.00%
IMOJEV™ Vaccine Group CD.JEVAX™ Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   74/137 (54.01%)      69/137 (50.36%)    
Gastrointestinal disorders     
Diarrhea * 1  9/137 (6.57%)  9 3/137 (2.19%)  3
Vomiting  1  9/137 (6.57%)  9 14/137 (10.22%)  14
General disorders     
Pyrexia * 1  8/137 (5.84%)  8 9/137 (6.57%)  9
Injection site Pain  1  35/137 (25.55%)  35 38/137 (27.74%)  38
Injection site Erythema  1  23/137 (16.79%)  23 33/137 (24.09%)  33
Injection site Swelling  1  6/137 (4.38%)  6 10/137 (7.30%)  10
Fever  1  33/134 (24.63%)  33 34/136 (25.00%)  34
Infections and infestations     
Bronchitis * 1  9/137 (6.57%)  9 6/137 (4.38%)  7
Gastroenteritis * 1  4/137 (2.92%)  4 7/137 (5.11%)  8
Nasopharyngitis * 1  42/137 (30.66%)  54 38/137 (27.74%)  44
Otitis media * 1  6/137 (4.38%)  7 8/137 (5.84%)  9
Upper respiratory tract infection * 1  11/137 (8.03%)  13 4/137 (2.92%)  5
Metabolism and nutrition disorders     
Appetite Loss  1  38/137 (27.74%)  38 40/137 (29.20%)  40
Nervous system disorders     
Drowsiness  1  23/137 (16.79%)  23 33/137 (24.09%)  33
Psychiatric disorders     
Crying Abnormal  1  27/137 (19.71%)  27 35/137 (25.55%)  35
Irritability  1  31/137 (22.63%)  31 36/137 (26.28%)  36
Respiratory, thoracic and mediastinal disorders     
Rhinorrhea * 1  5/137 (3.65%)  7 7/137 (5.11%)  8
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
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.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01396512     History of Changes
Other Study ID Numbers: JEC12
U1111-1117-7378 ( Other Identifier: WHO )
First Submitted: July 14, 2011
First Posted: July 18, 2011
Results First Submitted: March 24, 2014
Results First Posted: April 25, 2014
Last Update Posted: April 25, 2014