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Study of a Booster Dose of IMOJEV® One Year After Primary Immunization in Healthy Children in South Korea

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ClinicalTrials.gov Identifier: NCT01900444
Recruitment Status : Completed
First Posted : July 16, 2013
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Japanese Encephalitis
Intervention Biological: IMOJEV
Enrollment 119
Recruitment Details Study participants were enrolled from 11 July 2013 to 27 September 2013 at 8 clinic centers in South Korea.
Pre-assignment Details A total of 119 participants who met all inclusion and no exclusion criteria were enrolled and vaccinated.
Arm/Group Title Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Hide Arm/Group Description Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Period Title: Overall Study
Started 119
Completed 116
Not Completed 3
Reason Not Completed
Protocol Violation             2
Lost to Follow-up             1
Arm/Group Title Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Hide Arm/Group Description Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Overall Number of Baseline Participants 119
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants
<=18 years
119
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 119 participants
2.62  (0.391)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants
Female
48
  40.3%
Male
71
  59.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
South Korea Number Analyzed 119 participants
119
1.Primary Outcome
Title Percentage of Participants With JE Seroprotection Before and Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
Hide Description JE virus neutralizing antibodies were measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before and after IMOJEV vaccination was defined as antibody titers ≥ 10 (1/dilution).
Time Frame Day 0 (pre-booster) and Day 28 post-booster injection
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection rates were assessed in the Per Protocol Analysis Set.
Arm/Group Title Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Hide Arm/Group Description:
Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: Percentage of participants
Pre-Booster 93.5
Post-Booster 100.0
2.Primary Outcome
Title Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
Hide Description JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4-fold increase of titers from pre- to post-vaccination.
Time Frame Day 28 post-booster injection
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion rates were assessed in the Per Protocol Analysis Set.
Arm/Group Title Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Hide Arm/Group Description:
Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: Percentage of participants
94.6
3.Primary Outcome
Title Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
Hide Description JE virus neutralizing antibodies were measured using PRNT50 test.
Time Frame Day 0 (pre-booster) and Day 28 post-booster injection
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers of JE virus antibodies were assessed in the Per Protocol Analysis Set.
Arm/Group Title Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Hide Arm/Group Description:
Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Overall Number of Participants Analyzed 92
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Pre-Booster
165
(116 to 235)
Post-Booster
8482
(6994 to 10286)
4.Primary Outcome
Title Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization
Hide Description JE virus neutralizing antibodies were measured using PRNT50.
Time Frame Day 0 (pre-booster) and Day 28 post-booster injection
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titer ratios of JE virus antibodies were assessed in the Per Protocol Analysis Set.
Arm/Group Title Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Hide Arm/Group Description:
Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Overall Number of Participants Analyzed 92
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
51.4
(37.3 to 71.0)
5.Primary Outcome
Title Percentage of Participants With JE Seroprotection Before and After a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization
Hide Description JE virus neutralizing antibodies were measured using PRNT50. Seroprotection was defined as neutralizing antibody titer ≥ 10 (1/dilution).
Time Frame Day 0 (pre-booster) and Day 28 post-booster injection
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection rates were assessed in the Per Protocol Analysis Set.
Arm/Group Title Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Hide Arm/Group Description:
Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: Percentage of participants
Pre-Booster; ≥12 months and <18 months Number Analyzed 53 participants
92.5
Post-Booster; ≥12 months and <18 months Number Analyzed 53 participants
100.0
Pre-Booster; ≥18 months and <24 months Number Analyzed 38 participants
94.7
Post-Booster; ≥18 months and <24 months Number Analyzed 38 participants
100.0
Pre-Booster; ≥24 months Number Analyzed 1 participants
100.0
Post-Booster; ≥24 months Number Analyzed 1 participants
100.0
6.Primary Outcome
Title Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization
Hide Description JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4 fold increase from pre- to post-vaccination.
Time Frame Day 28 post-booster injection
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion rates were assessed in the Per Protocol Analysis Set.
Arm/Group Title Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Hide Arm/Group Description:
Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: Percentage of participants
Post-Booster; ≥12 months and <18 months Number Analyzed 53 participants
96.2
Post-Booster; ≥18 months and <24 months Number Analyzed 38 participants
92.1
Post-Booster; ≥24 months Number Analyzed 1 participants
100.0
7.Primary Outcome
Title Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV At Different Intervals After Primary Immunization
Hide Description JE virus neutralizing antibodies were measured using PRNT50.
Time Frame Day 0 (pre-booster) and Day 28 post-booster injection
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers of JE virus antibodies were assessed in the Per Protocol Analysis Set.
Arm/Group Title Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Hide Arm/Group Description:
Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Overall Number of Participants Analyzed 92
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Pre-Booster; ≥12 months and <18 months Number Analyzed 53 participants
131
(5.00 to 5120)
Post-Booster; ≥12 months and <18 months Number Analyzed 53 participants
8199
(320 to 20480)
Pre-Booster; ≥18 months and <24 months Number Analyzed 38 participants
239
(5.00 to 20480)
Post-Booster; ≥18 months and <24 months Number Analyzed 38 participants
8850
(160 to 20480)
Pre-Booster; ≥24 months Number Analyzed 1 participants
20.0
(20.0 to 20.0)
Post-Booster; ≥24 months Number Analyzed 1 participants
10240
(10240 to 10240)
8.Primary Outcome
Title Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization
Hide Description JE virus neutralizing antibodies were measured using PRNT50.
Time Frame Day 0 (pre-booster) and Day 28 post-booster injection
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titer ratios of JE virus antibodies were assessed in the Per Protocol Analysis Set.
Arm/Group Title Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Hide Arm/Group Description:
Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
Overall Number of Participants Analyzed 92
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Post-Booster; ≥12 months and <18 months Number Analyzed 53 participants
62.3
(2.00 to 1024)
Post-Booster; ≥18 months and <24 months Number Analyzed 38 participants
37.0
(1.00 to 1024)
Post-Booster; ≥24 months Number Analyzed 1 participants
512
(512 to 512)
Time Frame Solicited injection site reactions were collected from Day 0 to Day 7 and solicited systemic reactions from Day 0 to Day 14. Unsolicited AEs were collected from Day 0 to Day 28 for non-serious AEs and up to 6 months for serious AEs post-booster injection.
Adverse Event Reporting Description The following pre-defined solicited adverse reactions were collected: Injection Site Pain, Erythema, and Swelling, as well as Fever, Headache, Malaise, and Myalgia. Solicited reactions are prelisted in the eCRF and considered to be related to vaccination, while unsolicited AsE are AEs that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
 
Arm/Group Title Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Hide Arm/Group Description Participants 2 to 4 years of age received one booster dose of IMOJEV® 1 year after primary immunization.
All-Cause Mortality
Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Affected / at Risk (%)
Total   0/119 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Affected / at Risk (%) # Events
Total   4/119 (3.36%)    
Gastrointestinal disorders   
Ileus * 1  1/119 (0.84%)  1
Intestinal obstruction * 1  1/119 (0.84%)  1
Infections and infestations   
Cellulitis * 1  1/119 (0.84%)  1
Pneumonia * 1  1/119 (0.84%)  1
Injury, poisoning and procedural complications   
Forearm fracture * 1  1/119 (0.84%)  1
Respiratory, thoracic and mediastinal disorders   
Adenoidal hypertrophy * 1  1/119 (0.84%)  1
Skin and subcutaneous tissue disorders   
Henoch Schonlein purpura * 1  1/119 (0.84%)  1
1
Term from vocabulary, MedDRA 15
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Affected / at Risk (%) # Events
Total   48/119 (40.34%)    
General disorders   
Injection site Pain  1  34/119 (28.57%)  34
Injection site Erythema  1  17/119 (14.29%)  17
Injection site Swelling  1  10/119 (8.40%)  10
Fever  1  15/119 (12.61%)  15
Malaise  1  48/119 (40.34%)  48
Myalgia  1  32/119 (26.89%)  32
Infections and infestations   
Nasopharyngitis * 1  33/119 (27.73%)  36
Nervous system disorders   
Headache  1  22/119 (18.49%)  22
1
Term from vocabulary, MedDRA 15
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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: NCT01900444     History of Changes
Other Study ID Numbers: JEC22
U1111-1127-7153 ( Other Identifier: WHO )
First Submitted: July 11, 2013
First Posted: July 16, 2013
Results First Submitted: October 16, 2017
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017