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Study of a Single Primary Dose Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02492165
Recruitment Status : Completed
First Posted : July 8, 2015
Results First Posted : November 29, 2016
Last Update Posted : November 29, 2016
Sponsor:
Collaborator:
National Institute of Hygiene and Epidemiology, Vietnam
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Japanese Encephalitis
Intervention Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)
Enrollment 250
Recruitment Details Study participants were enrolled from 27 June 2015 to 24 August 2015 at 1 clinic center in Vietnam.
Pre-assignment Details A total of 250 participants who met all inclusion and no exclusion criteria were enrolled and vaccinated.
Arm/Group Title 9 Months to 4 Years 5 to 11 Years 12 to 17 Years 18 to 60 Years
Hide Arm/Group Description Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®). Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®). Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®). Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Period Title: Overall Study
Started 100 60 60 30
Completed 100 59 60 30
Not Completed 0 1 0 0
Reason Not Completed
Withdrawal by Subject             0             1             0             0
Arm/Group Title 9 Months to 4 Years 5 to 11 Years 12 to 17 Years 18 to 60 Years Total
Hide Arm/Group Description Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®). Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®). Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®). Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®). Total of all reporting groups
Overall Number of Baseline Participants 100 60 60 30 250
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 60 participants 60 participants 30 participants 250 participants
<=18 years
100
 100.0%
60
 100.0%
60
 100.0%
0
   0.0%
220
  88.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
30
 100.0%
30
  12.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Continuous Number Analyzed 100 participants 60 participants 60 participants 30 participants 250 participants
0.7  (0.6) 8.7  (1.5) 13.9  (1.4) 38.7  (10.0) 15.75  (3.375)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 60 participants 60 participants 30 participants 250 participants
Female
46
  46.0%
31
  51.7%
42
  70.0%
22
  73.3%
141
  56.4%
Male
54
  54.0%
29
  48.3%
18
  30.0%
8
  26.7%
109
  43.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Vietnam Number Analyzed 100 participants 60 participants 60 participants 30 participants 250 participants
100 60 60 30 250
1.Primary Outcome
Title Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Hide Description

Solicited injection-site: ≤ 23 months age: Tenderness, Erythema, and Swelling. For ≥ 2 years age: Pain, Erythema, and Swelling. Solicited systemic reactions: ≤ 23 months age, Fever (temperature) Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability, For ≥ 2 years age, Fever (temperature) Headache, Malaise, and Myalgia.

Grade 3: Tenderness, Cries when injected limb is moved; Pain, Incapacitating, unable to perform usual activities or Significant; prevents daily activity (≥ 12 years); Erythema and Swelling (≤23 months to 11 years), ≥50 mm or >100 mm (≥ 12 years).

Grade 3 Fever, > 39.5°C (≤ 23 months) or ≥39.0°C (≥ 2 years); Vomiting, ≥ 6 episodes per 24 hours; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time; Appetite loss, Refuses ≥ 3 feeds / meals; Irritability, Inconsolable. Headache, Malaise, and Myalgia, Significant; prevents daily activity.

Time Frame Day 0 up to Day 14 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site and solicited systemic reactions were assessed in the Safety Analysis Set.
Arm/Group Title 9 Months to 4 Years 5 to 11 Years 12 to 17 Years 18 to 60 Years
Hide Arm/Group Description:
Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Overall Number of Participants Analyzed 100 60 60 30
Measure Type: Number
Unit of Measure: Participants
Injection-site Tenderness/Pain 35 8 11 8
Grade 3 Injection-site Tenderness/Pain 0 0 0 0
Injection-site Erythema 6 3 0 0
Grade 3 Injection-site Erythema 0 0 0 0
Injection-site Swelling 1 1 0 0
Grade 3 Injection-site Swelling 0 0 0 0
Fever 14 0 0 0
Grade 3 Fever 2 1 0 0
Vomiting 12 NA [1]  NA [1]  NA [1] 
Grade 3 Vomiting 0 NA [1]  NA [1]  NA [1] 
Crying abnormal 20 NA [1]  NA [1]  NA [1] 
Grade 3 Crying abnormal 0 NA [1]  NA [1]  NA [1] 
Drowsiness 12 NA [1]  NA [1]  NA [1] 
Grade 3 Drowsiness 0 NA [1]  NA [1]  NA [1] 
Appetite loss 38 NA [1]  NA [1]  NA [1] 
Grade 3 Appetite loss 1 NA [1]  NA [1]  NA [1] 
Irritability 21 NA [1]  NA [1]  NA [1] 
Grade 3 Irritability 0 NA [1]  NA [1]  NA [1] 
Headache NA [1]  9 14 10
Grade 3 Headache NA [1]  0 0 0
Malaise 1 8 16 9
Grade 3 Malaise 0 0 0 0
Myalgia 0 5 9 5
Grade 3 Myalgia 0 0 0 0
[1]
Event was not solicited for this group
2.Primary Outcome
Title Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Hide Description Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroprotection was defined as antibody titer levels ≥10 (1/dil).
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection was assessed in the Per-Protocol Analysis Set.
Arm/Group Title 9 Months to 4 Years 5 to 11 Years 12 to 17 Years 18 to 60 Years
Hide Arm/Group Description:
Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Overall Number of Participants Analyzed 76 60 19 5
Measure Type: Number
Unit of Measure: Percentage of participants
Pre-vaccination (Day 0) 0.0 0.0 0.0 0.0
Post-vaccination (Day 28) 97.4 100.0 100.0 100.0
3.Primary Outcome
Title Percentage of Participants With Japanese Encephalitis Seroconversion Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Hide Description Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) and post-vaccination titer ≥10 (1/dil) or participants with pre vaccination titer ≥10 (1/dil) and a ≥4-fold increase from pre- to post-vaccination.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion was assessed in the Per-Protocol Analysis Set.
Arm/Group Title 9 Months to 4 Years 5 to 11 Years 12 to 17 Years 18 to 60 Years
Hide Arm/Group Description:
Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Overall Number of Participants Analyzed 76 60 19 5
Measure Type: Number
Unit of Measure: Percentage of participants
97.4 100.0 100.0 100.0
4.Primary Outcome
Title Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)
Hide Description Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50).
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the Per Protocol Analysis Set.
Arm/Group Title 9 Months to 4 Years 5 to 11 Years 12 to 17 Years 18 to 60 Years
Hide Arm/Group Description:
Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
Overall Number of Participants Analyzed 76 34 19 5
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dil)
Pre-vaccination (Day 0)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Post-vaccination (Day 28)
277
(192 to 399)
1738
(1055 to 2862)
1481
(762 to 2878)
970
(65.6 to 14352)
Time Frame Adverse event data were collected from Day 0 up to Day 28 post vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 9 Months to 4 Years 5 to 11 Years 12 to 17 Years 18 to 60 Years
Hide Arm/Group Description Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®). Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®). Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®). Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
All-Cause Mortality
9 Months to 4 Years 5 to 11 Years 12 to 17 Years 18 to 60 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
9 Months to 4 Years 5 to 11 Years 12 to 17 Years 18 to 60 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/100 (1.00%)      0/60 (0.00%)      1/60 (1.67%)      0/30 (0.00%)    
Nervous system disorders         
Syncope * 1  0/100 (0.00%)  0 0/60 (0.00%)  0 1/60 (1.67%)  1 0/30 (0.00%)  0
Skin and subcutaneous tissue disorders         
Dermatitis * 1  1/100 (1.00%)  1 0/60 (0.00%)  0 0/60 (0.00%)  0 0/30 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
9 Months to 4 Years 5 to 11 Years 12 to 17 Years 18 to 60 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/100 (38.00%)      9/60 (15.00%)      16/60 (26.67%)      10/30 (33.33%)    
Gastrointestinal disorders         
Diarrhea * 1  5/100 (5.00%)  7 0/60 (0.00%)  0 0/60 (0.00%)  0 0/30 (0.00%)  0
Vomiting  1  12/100 (12.00%)  12 0/0  0 0/0  0 0/0  0
General disorders         
Injection site Tenderness/Pain  1  34/100 (34.00%)  34 8/60 (13.33%)  8 11/60 (18.33%)  11 8/30 (26.67%)  8
Injection site Erythema  1  6/100 (6.00%)  6 3/60 (5.00%)  3 0/60 (0.00%)  0 0/30 (0.00%)  0
Fever  1  14/100 (14.00%)  14 7/60 (11.67%)  7 2/60 (3.33%)  2 1/30 (3.33%)  1
Malaise  1  0/100 (0.00%)  0 8/60 (13.33%)  8 16/60 (26.67%)  16 9/30 (30.00%)  9
Metabolism and nutrition disorders         
Appetite loss  1  38/100 (38.00%)  38 0/0  0 0/0  0 0/0  0
Musculoskeletal and connective tissue disorders         
Myalgia  1  0/100 (0.00%)  0 5/60 (8.33%)  5 9/60 (15.00%)  9 5/30 (16.67%)  5
Nervous system disorders         
Drowsiness  1  12/100 (12.00%)  12 0/0  0 0/0  0 0/0  0
Headache  1  0/100 (0.00%)  0 9/60 (15.00%)  9 14/60 (23.33%)  14 10/30 (33.33%)  10
Psychiatric disorders         
Crying abnormal  1  20/100 (20.00%)  20 0/0  0 0/0  0 0/0  0
Irritability  1  21/100 (21.00%)  21 0/0  0 0/0  0 0/0  0
Respiratory, thoracic and mediastinal disorders         
Cough * 1  7/100 (7.00%)  7 0/60 (0.00%)  0 0/60 (0.00%)  0 0/30 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
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: NCT02492165     History of Changes
Obsolete Identifiers: NCT02821221
Other Study ID Numbers: JEC13
U1111-1143-8142 ( Other Identifier: WHO )
First Submitted: July 5, 2015
First Posted: July 8, 2015
Results First Submitted: October 4, 2016
Results First Posted: November 29, 2016
Last Update Posted: November 29, 2016