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Study of Japanese Encephalitis Chimeric Virus Vaccine Given With Measles-Mumps-Rubella Vaccine in Taiwanese Toddlers

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ClinicalTrials.gov Identifier: NCT01188343
Recruitment Status : Completed
First Posted : August 25, 2010
Results First Posted : August 15, 2014
Last Update Posted : August 15, 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: None (Open Label);   Primary Purpose: Prevention
Conditions Japanese Encephalitis
Measles
Mumps
Rubella
Intervention Biological: Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus
Enrollment 542
Recruitment Details Study participants were enrolled from 14 August 2010 through 28 July 2011 at 5 clinic centers in Taiwan.
Pre-assignment Details A total of 550 participants who met all of the inclusion and none of the exclusion criteria were randomized, 542 were vaccinated and reported.
Arm/Group Title JE CV + MMR (Group 1) MMR + JE CV (Group 2) JE CV/MMR (Group 3)
Hide Arm/Group Description Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42 Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42 Participants 12 to 18 months of age received one dose each of MMR and JE CV vaccine on day 0
Period Title: Overall Study
Started 102 219 221
Completed 101 193 220
Not Completed 1 26 1
Reason Not Completed
Not vaccinated             0             2             1
Withdrawal by Subject             1             24             0
Arm/Group Title JE CV + MMR (Group 1) MMR + JE CV (Group 2) JE CV/MMR (Group 3) Total
Hide Arm/Group Description Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42 Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42 Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0 Total of all reporting groups
Overall Number of Baseline Participants 102 219 221 542
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 219 participants 221 participants 542 participants
<=18 years
102
 100.0%
219
 100.0%
221
 100.0%
542
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 102 participants 219 participants 221 participants 542 participants
13.1  (1.12) 13.0  (1.08) 13.1  (1.19) 13.1  (1.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 219 participants 221 participants 542 participants
Female
46
  45.1%
110
  50.2%
109
  49.3%
265
  48.9%
Male
56
  54.9%
109
  49.8%
112
  50.7%
277
  51.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 102 participants 219 participants 221 participants 542 participants
102 219 221 542
1.Primary Outcome
Title Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination
Hide Description JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml.
Time Frame Day 0 (pre-vaccination) and Day 42 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion was assessed in the Per Protocol Analysis Set with evaluable data.
Arm/Group Title JE-CV + MMR (Group 1) MMR + JE-CV (Group 2) JE-CV/MMR (Group 3)
Hide Arm/Group Description:
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42
Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
Overall Number of Participants Analyzed 95 176 197
Measure Type: Number
Unit of Measure: Percentage of Participants
JE-CV (N = 95, 0, 194) 97.9 NA [1]  96.9
Measles (N = 0, 170, 193) NA [2]  97.6 100
Mumps (N = 0, 173, 194) NA [2]  98.8 99.5
Rubella (N = 0, 154, 178) NA [2]  99.4 99.4
[1]
JE-CV was not administered on Day 0 in this group
[2]
MMR was not administered on Day 0 in this group.
2.Secondary Outcome
Title Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
Hide Description JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/m
Time Frame Pre-vaccination and Day 42 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion to JE-CV and to MMR vaccine antigen was assessed in all participants who were randomized, vaccinated, who performed all protocol defined activities and has evaluable data (Per-protocol Analysis Set).
Arm/Group Title JE-CV + MMR (Group 1) MMR + JE-CV (Group 2) JE-CV/MMR (Group 3)
Hide Arm/Group Description:
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42
Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
Overall Number of Participants Analyzed 95 176 197
Measure Type: Number
Unit of Measure: Percentage of Participants
JE-CV Pre-vaccination (N = 95, 158, 194) 0.0 0.0 0.0
JE-CV Post-vaccination (N = 95, 158, 194) 97.9 100.0 96.9
Measles Pre-vaccination (N = 94, 176, 196) 4.3 2.8 1.0
Measles Post-vaccination (N = 94, 176, 197) 97.9 97.7 100.0
Mumps Pre-vaccination (N = 94, 176, 196) 1.1 1.1 0.5
Mumps Post-vaccination (N = 94, 176, 197) 100.0 98.9 99.5
Rubella Pre-vaccination (N = 94, 176, 196) 9.6 11.9 8.7
Rubella Post-vaccination (N = 94, 176, 197) 100.0 99.4 99.5
3.Secondary Outcome
Title Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
Hide Description JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroprotection was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 (1/dil) and post-vaccination titer ≥1/10, (1/dil) or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 units/ml when pre-vaccination titer is <10 units/ml; and for Rubella, post-vaccination titer ≥1/10 IU/ml when pre-vaccination titer is <10 IU/m
Time Frame Pre-vaccination and up to Month 12 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection to JE-CV and to MMR vaccine antigen was assessed in all participants who were randomized, vaccinated and who performed all protocol defined activities the Full Analysis Set.
Arm/Group Title JE-CV + MMR (Group 1) MMR + JE-CV (Group 2) JE-CV/MMR (Group 3)
Hide Arm/Group Description:
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42
Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
Overall Number of Participants Analyzed 102 217 221
Measure Type: Number
Unit of Measure: Participants
JE-CV Pre-vaccination (N=102, 197, 221) 2 10 4
JE-CV 6 months Post-vaccination (N=96, 191, 217) 92 190 203
JE-CV 12 months Post-vaccination (N=89, 164, 193) 86 162 171
Measles Pre-vaccination (N = 101, 217, 219) 4 8 2
Measles 6 months Post-vaccination (N=96, 191, 217) 93 189 216
Measles 12 months Post-vaccination (N=89, 164, 193 87 163 192
Mumps Pre-vaccination (N=101, 217, 219) 1 2 2
Mumps 6 months Post-vaccination (N=96, 191, 217) 90 180 208
Mumps 12 months Post-vaccination (N=89, 164, 193) 82 153 176
Rubella Pre-vaccination (N=101, 217, 219) 10 23 19
Rubella 6 months Post-vaccination (N=96, 191, 217) 95 191 217
Rubella 12 months Post-vaccination (N=89, 164, 193 89 164 192
4.Secondary Outcome
Title Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
Hide Description JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA).
Time Frame Pre-vaccination and Day 42 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the Per Protocol Analysis Set population with evaluable data.
Arm/Group Title JE CV + MMR (Group 1) MMR + JE CV (Group 2) JE CV/MMR (Group 3)
Hide Arm/Group Description:
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
Overall Number of Participants Analyzed 95 176 197
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
JE-CV pre-vaccination (N = 95, 158, 194)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
JE-CV post-vaccination (N = 95, 158, 194)
510
(356 to 731)
581
(449 to 752)
332
(258 to 426)
Measles pre-vaccination (N = 94, 176, 196)
34.3
(31.5 to 37.3)
33.4
(31.4 to 35.5)
33.4
(32.0 to 35.0)
Measles post-vaccination (N = 94, 176, 197)
1835
(1536 to 2193)
1723
(1506 to 1971)
1924
(1753 to 2111)
Mumps pre-vaccination (N = 94, 176, 196)
2.59
(2.46 to 2.71)
2.63
(2.52 to 2.75)
2.55
(2.49 to 2.62)
Mumps Post-vaccination (N = 94, 176, 197)
81.1
(70.1 to 93.9)
87.5
(77.6 to 98.8)
89.2
(80.0 to 99.5)
Rubella pre-vaccination (N = 94, 176, 196)
3.90
(3.44 to 4.43)
3.97
(3.60 to 4.37)
3.60
(3.32 to 3.90)
Rubella post-vaccination (N = 94, 176, 197)
78.0
(68.3 to 89.2)
81.4
(73.7 to 89.9)
69.6
(63.6 to 76.0)
5.Secondary Outcome
Title Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine
Hide Description Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. 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 Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable.
Time Frame Day 0 up to Day14 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site and systemic events were assessed in all randomized and vaccinated participants, the Safety Analysis Set.
Arm/Group Title JE CV + MMR (Group 1) MMR + JE CV (Group 2) JE CV/MMR (Group 3)
Hide Arm/Group Description:
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
Overall Number of Participants Analyzed 102 196 220
Measure Type: Number
Unit of Measure: Participants
Injection site Pain (N = 102, 195, 219) 18 30 35
Grade 3 Pain (N = 102, 195, 219) 0 0 0
Injection site Erythema (N = 102, 195, 219) 11 21 24
Grade 3 Erythema (N = 102, 195, 219) 0 0 0
Injection site Swelling (N = 102, 195, 219) 2 11 3
Grade 3 Swelling (N = 102, 195, 219) 0 0 0
Solicited Fever (N = 102, 195, 219) 17 35 53
Grade 3 Fever (N = 102, 195, 219) 1 1 1
Solicited Vomiting (N = 102, 195, 219) 15 21 39
Grade 3 Vomiting (N = 102, 195, 219) 0 3 0
Solicited Crying Abnormal (N = 102, 195, 219) 24 56 79
Grade 3 Crying Abnormal (N = 102, 195, 219) 2 4 5
Solicited Drowsiness (N = 102, 195, 219) 26 45 67
Grade 3 Drowsiness (N = 102, 195, 219) 0 3 2
Solicited Appetite Lost (N = 102, 195, 219) 25 46 78
Grade 3 Appetite Lost (N = 102, 195, 219) 3 5 6
Solicited Irritability (N = 102, 195, 219) 28 39 72
Grade 3 Irritability (N = 102, 195, 219) 4 0 2
6.Secondary Outcome
Title Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine
Hide Description Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. 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 Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable.
Time Frame Day 0 up to Day 14 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site and systemic events were assessed in all randomized and vaccinated participants, the Safety Analysis Set.
Arm/Group Title JE CV + MMR (Group 1) MMR + JE CV (Group 2) JE CV/MMR (Group 3)
Hide Arm/Group Description:
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
Overall Number of Participants Analyzed 101 219 220
Measure Type: Number
Unit of Measure: Participants
Injection site Pain (N = 101, 211, 219) 16 32 36
Grade 3 Pain (N = 101, 211, 219) 0 0 0
Injection site Erythema (N = 101, 211, 219) 7 22 22
Grade 3 Erythema (N = 101, 211, 219) 0 0 0
Injection site Swelling (N = 101, 211, 219) 3 7 4
Grade 3 Swelling (N = 101, 211, 219) 0 0 0
Solicited Fever (N = 101, 211, 219) 21 48 53
Grade 3 Fever (N = 101, 211, 219) 1 4 1
Solicited Vomiting (N = 101, 210, 219) 12 32 39
Grade 3 Vomiting (N = 101, 210, 219) 0 2 0
Solicited Crying Abnormal (N = 101, 210, 219) 30 73 79
Grade 3 Crying Abnormal (N = 101, 210, 219) 4 7 5
Solicited Drowsiness (N = 101, 210, 219) 26 68 67
Grade 3 Drowsiness (N = 101, 210, 219) 1 4 2
Solicited Appetite Lost (N = 101, 210, 219) 29 80 78
Grade 3 Appetite Lost (N = 101, 210, 219) 0 10 6
Solicited Irritability (N = 101, 210, 219) 26 64 72
Grade 3 Irritability (N = 101, 210, 219) 4 3 2
7.Other Pre-specified Outcome
Title Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine
Hide Description Neutralizing antibodies levels against dengue were only evaluated on subjects ELISA positive for Immunoglobulin G (IgG) or Immunoglobulin M (IgM). Flavivirus positive was defined as antibodies against JE-CV virus ≥10 (l/dil) or antibodies against at least one dengue virus serotype ≥10 (l/dil); Flavivirus negative was defined as antibodies against JE CV virus < 10 (l/dil) and antibodies against the 4 dengue virus serotypes < 10 (l/dil).
Time Frame Day 0 (pre-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Serological status of Flavivirus infection was assessed in the Full Analysis Set.
Arm/Group Title JE CV + MMR (Group 1) MMR + JE CV (Group 2) JE CV/MMR (Group 3)
Hide Arm/Group Description:
Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
Overall Number of Participants Analyzed 102 197 221
Measure Type: Number
Unit of Measure: Participants
JE-CV virus/dengue serotypes FV Positive 2 18 5
JE CV virus/dengue serotypes FV Negative 100 179 216
JE CV virus 2 10 4
Any dengue serotype 0 8 1
Dengue serotype 1 0 7 1
Dengue serotype 2 0 0 0
Dengue serotype 3 0 0 0
Dengue serotype 4 0 3 0
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
Adverse Event Reporting Description The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
 
Arm/Group Title JE CV + MMR (Group 1) MMR + JE CV (Group 2) JE CV/MMR (Group 3)
Hide Arm/Group Description Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42 Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42 Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
All-Cause Mortality
JE CV + MMR (Group 1) MMR + JE CV (Group 2) JE CV/MMR (Group 3)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
JE CV + MMR (Group 1) MMR + JE CV (Group 2) JE CV/MMR (Group 3)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/102 (9.80%)      21/219 (9.59%)      13/220 (5.91%)    
Eye disorders       
Dacryostenosis acquired * 1  0/102 (0.00%)  0 1/219 (0.46%)  1 0/220 (0.00%)  0
Gastrointestinal disorders       
Enteritis * 1  0/102 (0.00%)  0 0/219 (0.00%)  0 1/220 (0.45%)  1
Gastritis * 1  0/102 (0.00%)  0 1/219 (0.46%)  1 0/220 (0.00%)  0
Hepatobiliary disorders       
Hepatitis * 1  0/102 (0.00%)  0 1/219 (0.46%)  1 0/220 (0.00%)  0
Infections and infestations       
Bronchiolitis * 1  1/102 (0.98%)  1 3/219 (1.37%)  3 0/220 (0.00%)  0
Bronchopneumonia * 1  1/102 (0.98%)  1 2/219 (0.91%)  2 3/220 (1.36%)  3
Croup infectious * 1  0/102 (0.00%)  0 1/219 (0.46%)  1 1/220 (0.45%)  1
Diarrhea infectious * 1  1/102 (0.98%)  1 0/219 (0.00%)  0 0/220 (0.00%)  0
Exanthema subitum * 1  1/102 (0.98%)  1 0/219 (0.00%)  0 0/220 (0.00%)  0
Gastroenteritis * 1  2/102 (1.96%)  2 3/219 (1.37%)  3 1/220 (0.45%)  1
Gastroenteritis norovirus * 1  0/102 (0.00%)  0 0/219 (0.00%)  0 1/220 (0.45%)  1
Gastroenteritis rotavirus * 1  1/102 (0.98%)  1 0/219 (0.00%)  0 0/220 (0.00%)  0
Gastroenteritis salmonella * 1  0/102 (0.00%)  0 1/219 (0.46%)  1 0/220 (0.00%)  0
Hand foot and mouth disease * 1  0/102 (0.00%)  0 0/219 (0.00%)  0 1/220 (0.45%)  1
Herpangina * 1  1/102 (0.98%)  1 5/219 (2.28%)  5 2/220 (0.91%)  2
Influenza * 1  0/102 (0.00%)  0 1/219 (0.46%)  1 0/220 (0.00%)  0
Lobar pneumonia * 1  0/102 (0.00%)  0 2/219 (0.91%)  2 0/220 (0.00%)  0
Oral herpes * 1  0/102 (0.00%)  0 1/219 (0.46%)  1 0/220 (0.00%)  0
Otitis media acute * 1  0/102 (0.00%)  0 1/219 (0.46%)  1 0/220 (0.00%)  0
Periorbital cellulitis * 1  0/102 (0.00%)  0 0/219 (0.00%)  0 1/220 (0.45%)  1
Pharyngitis * 1  0/102 (0.00%)  0 0/219 (0.00%)  0 2/220 (0.91%)  2
Pneumonia * 1  2/102 (1.96%)  2 2/219 (0.91%)  2 2/220 (0.91%)  2
Pneumonia pneumococcal * 1  1/102 (0.98%)  1 0/219 (0.00%)  0 0/220 (0.00%)  0
Respiratory syncytial virus bronchiolitis * 1  0/102 (0.00%)  0 0/219 (0.00%)  0 1/220 (0.45%)  1
Injury, poisoning and procedural complications       
Overdose * 1  0/102 (0.00%)  0 1/219 (0.46%)  1 0/220 (0.00%)  0
Thermal burn * 1  1/102 (0.98%)  1 0/219 (0.00%)  0 0/220 (0.00%)  0
Nervous system disorders       
Febrile convulsion * 1  0/102 (0.00%)  0 2/219 (0.91%)  2 0/220 (0.00%)  0
Renal and urinary disorders       
Hydronephrosis * 1  1/102 (0.98%)  1 0/219 (0.00%)  0 0/220 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
JE CV + MMR (Group 1) MMR + JE CV (Group 2) JE CV/MMR (Group 3)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/102 (29.41%)      80/219 (36.53%)      79/220 (35.91%)    
Gastrointestinal disorders       
Vomiting  1  12/101 (11.88%)  12 32/210 (15.24%)  32 39/220 (17.73%)  39
General disorders       
Injection site Pain  1  18/102 (17.65%)  18 30/195 (15.38%)  30 35/220 (15.91%)  35
Injection site Erythema  1  11/102 (10.78%)  11 21/195 (10.77%)  21 24/220 (10.91%)  24
Injection site Swelling  1  2/102 (1.96%)  2 11/195 (5.64%)  11 3/220 (1.36%)  3
Fever  1  21/101 (20.79%)  21 48/211 (22.75%)  48 53/220 (24.09%)  53
Metabolism and nutrition disorders       
Appetite Lost  1  29/101 (28.71%)  29 80/210 (38.10%)  80 78/220 (35.45%)  78
Nervous system disorders       
Somnolence  1  26/102 (25.49%)  26 45/196 (22.96%)  45 67/220 (30.45%)  67
Drowsiness  1  26/101 (25.74%)  26 68/210 (32.38%)  68 67/220 (30.45%)  67
Psychiatric disorders       
Crying Abnormal  1  30/101 (29.70%)  30 73/210 (34.76%)  73 79/220 (35.91%)  79
Irritability  1  26/101 (25.74%)  26 64/210 (30.48%)  64 72/220 (32.73%)  72
Skin and subcutaneous tissue disorders       
Rash * 1  1/102 (0.98%)  1 2/196 (1.02%)  2 12/220 (5.45%)  12
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
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
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Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
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Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01188343    
Other Study ID Numbers: JEC04
UTN: U1111-1112-2143 ( Other Identifier: WHO )
First Submitted: August 24, 2010
First Posted: August 25, 2010
Results First Submitted: June 25, 2014
Results First Posted: August 15, 2014
Last Update Posted: August 15, 2014