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Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00621764
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : September 25, 2014
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Japanese Encephalitis
Hepatitis A
Interventions Biological: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)
Biological: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)
Enrollment 300
Recruitment Details The study participants were enrolled from 02 March 2008 to 06 January 2009 at 3 clinic centers in Thailand.
Pre-assignment Details A total of 300 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.
Arm/Group Title JE-CV/Hepatitis A (Group 1) Hepatitis A/JE-CV (Group 2) JE-CV/Hepatitis A (Group 3) Hepatitis A/JE-CV (Group 4)
Hide Arm/Group Description Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
Period Title: Overall Study
Started 50 50 101 99
Completed 50 50 101 98
Not Completed 0 0 0 1
Reason Not Completed
Protocol Violation             0             0             0             1
Arm/Group Title JE CV/Hepatitis A (Group 1) Hepatitis A/JE CV (Group 2) JE CV/Hepatitis A (Group 3) Hepatitis A/JE CV (Group 4) Total
Hide Arm/Group Description Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart Toddlers aged 12 to 24 months of age received one dose of JE CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart Total of all reporting groups
Overall Number of Baseline Participants 50 50 101 99 300
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 101 participants 99 participants 300 participants
<=18 years
50
 100.0%
50
 100.0%
101
 100.0%
99
 100.0%
300
 100.0%
Between 18 and 65 years
0
   0.0%
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%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 101 participants 99 participants 300 participants
2.4  (0.5) 2.5  (0.6) 1.4  (0.2) 1.3  (0.2) 1.7  (0.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 101 participants 99 participants 300 participants
Female
17
  34.0%
35
  70.0%
57
  56.4%
57
  57.6%
166
  55.3%
Male
33
  66.0%
15
  30.0%
44
  43.6%
42
  42.4%
134
  44.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Thailand Number Analyzed 50 participants 50 participants 101 participants 99 participants 300 participants
50 50 101 99 300
1.Primary Outcome
Title Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection
Hide Description

12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, >39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable.

2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, >39˚C; Headache, Malaise, and Myalgia, Prevents activities.

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, which includes all persons who received at least one dose of study vaccine.
Arm/Group Title JE-CV/Hepatitis A (Group 1) Hepatitis A/JE-CV (Group 2) JE-CV/Hepatitis A (Group 3) Hepatitis A/JE-CV (Group 4)
Hide Arm/Group Description:
Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
Overall Number of Participants Analyzed 50 50 101 99
Measure Type: Number
Unit of Measure: Participants
Injection site Pain (N=50,50,0,0) 15 13 NA [1]  NA [1] 
Grade 3 Injection site Pain (N=50,50,0,0) 0 0 NA [1]  NA [1] 
Injection site Tenderness (N=0,0,101,99) NA [1]  NA [1]  43 19
Grade 3 Injection site Tenderness (N=0,0,101,99) NA [1]  NA [1]  0 0
Injection site Erythema (N=50,50,101,99) 7 9 23 16
Grade 3 Injection site Erythema (N=50,50,101,99) 0 0 0 0
Injection site Swelling (N=50,50,101,99) 4 5 6 8
Grade 3 Swelling (N=50,50,101,99) 0 0 0 0
Fever (N=50,50,101,99) 8 8 14 18
Grade 3 Fever (N=50,50,101,99) 1 0 0 0
Headache (N=50,50,0,0) 7 7 NA [1]  NA [1] 
Grade 3 Headache (N=50,50,0,0) 0 0 NA [1]  NA [1] 
Malaise (N=50,50,0,0) 15 13 NA [1]  NA [1] 
Grade 3 Malaise (N=50,50,0,0) 0 0 NA [1]  NA [1] 
Myalgia (N=50,50,0,0) 14 8 NA [1]  NA [1] 
Grade 3 Myalgia (N=50,50,0,0) 0 0 NA [1]  NA [1] 
Vomiting (N=0,0,101,99) NA [1]  NA [1]  21 21
Grade 3 Vomiting (N=0,0,101,99) NA [1]  NA [1]  1 0
Crying abnormal (N=0,0,101,99) NA [1]  NA [1]  24 20
Grade 3 Crying abnormal (N=0,0,101,99) NA [1]  NA [1]  0 0
Drowsiness (N=0,0,101,99) NA [1]  NA [1]  22 13
Grade 3 Drowsiness (N=0,0,101,99) NA [1]  NA [1]  0 0
Appetite lost (N=0,0,101,99) NA [1]  NA [1]  28 32
Grade 3 Appetite lost (N=0,0,101,99) NA [1]  NA [1]  0 2
Irritability (N=0,0,101,99) NA [1]  NA [1]  32 24
Grade 3 Irritability (N=0,0,101,99) NA [1]  NA [1]  0 0
[1]
This safety event was not solicited for this group
2.Primary Outcome
Title Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection
Hide Description

12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, >39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable.

2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, >39˚C; Headache, Malaise, and Myalgia, Prevents activities.

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, which includes all persons who received at least one dose of study vaccine. A participant in Group 1 was given JE-CV vaccine as the second vaccination in error; and counted for Group 2 for the safety outcome for the second injection.
Arm/Group Title JE-CV/Hepatitis A (Group 1) Hepatitis A/JE-CV (Group 2) JE-CV/Hepatitis A (Group 3) Hepatitis A/JE-CV (Group 4)
Hide Arm/Group Description:
Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
Overall Number of Participants Analyzed 48 51 101 98
Measure Type: Number
Unit of Measure: Participants
Injection site Pain (N=48,51,0,0) 15 9 NA [1]  NA [1] 
Grade 3 Injection site Pain (N=48,51,0,0) 0 0 NA [1]  NA [1] 
Injection site Tenderness (N=0,0,100,98) NA [1]  NA [1]  35 20
Grade 3 Injection site Tenderness (N=0,0,100,98) NA [1]  NA [1]  1 0
Injection site Erythema (N=48,51,100,98) 8 7 23 22
Grade 3 Injection site Erythema (N=48,51,100,98) 0 0 0 0
Injection site Swelling (N=48,51,100,98) 8 4 6 11
Grade 3 Swelling (N=48,51,100,98) 0 0 0 0
Fever (N=48,51,100,98) 5 14 23 28
Grade 3 Fever (N=48,51,100,98) 1 0 1 2
Headache (N=48,51,0,0) 7 14 NA [1]  NA [1] 
Grade 3 Headache (N=48,51,0,0) 0 0 NA [1]  NA [1] 
Malaise (N=48,51,0,0) 13 18 NA [1]  NA [1] 
Grade 3 Malaise (N=48,51,0,0) 0 0 NA [1]  NA [1] 
Myalgia (N=48,51,0,0) 7 10 NA [1]  NA [1] 
Grade 3 Myalgia (N=48,51,0,0) 0 0 NA [1]  NA [1] 
Vomiting (N=0,0,100,98) NA [1]  NA [1]  23 19
Grade 3 Vomiting (N=0,0,100,98) NA [1]  NA [1]  1 1
Crying abnormal (N=0,0,100,98) NA [1]  NA [1]  19 21
Grade 3 Crying abnormal (N=0,0,100,98) NA [1]  NA [1]  2 0
Drowsiness (N=0,0,100,98) NA [1]  NA [1]  17 14
Grade 3 Drowsiness (N=0,0,100,98) NA [1]  NA [1]  0 0
Appetite lost (N=0,0,100,98) NA [1]  NA [1]  26 24
Grade 3 Appetite lost (N=0,0,100,98) NA [1]  NA [1]  2 1
Irritability (N=0,0,100,98) NA [1]  NA [1]  22 24
Grade 3 Irritability (N=0,0,100,98) NA [1]  NA [1]  1 0
[1]
This safety event was not solicited for this group
3.Secondary Outcome
Title Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination
Hide Description JE virus neutralizing antibody measurement was assessed by 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 4-fold increase from pre- to post-vaccination.
Time Frame Day 0 (pre-vaccination) and Day 28 after final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion to the JE-CV vaccine antigens was assessed in the Per-Protocol Analysis Set.
Arm/Group Title JE-CV/Hepatitis A (Group 1) Hepatitis A/JE-CV (Group 2) JE-CV/Hepatitis A (Group 3) Hepatitis A/JE-CV (Group 4)
Hide Arm/Group Description:
Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart.
Overall Number of Participants Analyzed 49 48 87 95
Measure Type: Number
Unit of Measure: Percentage of participants
Homologous virus (N=49,48,83,88) 89.8 95.8 100.0 93.2
Genotype I (N=49,48,81,91) 83.7 93.8 98.8 95.6
Genotype II (N=49,48,81,91) 83.7 93.8 96.3 95.6
Genotype III (N=49,48,81,93) 87.8 91.7 100.0 94.6
Genotype IV (N=49,48,81,90) 89.8 91.7 74.1 65.6
4.Secondary Outcome
Title Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination
Hide Description JE virus neutralizing antibody measurement was assessed by the PRNT50 assay.
Time Frame Day 0 (pre-vaccination) and Day 28 after final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers against the JE-CV vaccine antigens were assessed in the Per-Protocol Analysis Set.
Arm/Group Title JE-CV/Hepatitis A (Group 1) Hepatitis A/JE-CV (Group 2) JE-CV/Hepatitis A (Group 3) Hepatitis A/JE-CV (Group 4)
Hide Arm/Group Description:
Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
Overall Number of Participants Analyzed 49 48 87 95
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Homologous virus (pre-vaccination; N=49,48,86,90)
49.5
(33.9 to 72.1)
40.6
(26.4 to 62.4)
5.78
(5.25 to 6.37)
5.08
(4.92 to 5.24)
Homologous virus (post-vaccination; N=49,48,84,93)
1957
(1227 to 3120)
3568
(2361 to 5394)
500
(353 to 708)
167
(120 to 233)
Genotype I (pre-vaccination; N=49,48,83,91)
55.2
(36.0 to 84.6)
55.3
(35.3 to 86.7)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Genotype I (post-vaccination; N=49,48,82,94)
1016
(703 to 1467)
1988
(1427 to 2770)
170
(130 to 223)
155
(117 to 206)
Genotype II (pre-vaccination; N=49,48,83,91)
46.5
(31.9 to 67.9)
34.2
(22.7 to 51.4)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Genotype II (post-vaccination; N=49,48,82,94)
921
(625 to 1356)
1566
(1090 to 2250)
157
(119 to 206)
121
(93.7 to 156)
Genotype III (pre-vaccination; N=49,48,83,93)
39.2
(27.0 to 57.0)
40.6
(25.7 to 64.0)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Genotype III (post-vaccination; N=49,48,82,94)
1107
(726 to 1689)
2089
(1405 to 3105)
189
(140 to 255)
98.2
(73.2 to 132)
Genotype IV (pre-vaccination; N=49,48,83,90)
25.2
(18.1 to 35.1)
20.0
(13.8 to 28.9)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Genotype IV (post-vaccination; N=49,48,82,94)
604
(387 to 944)
829
(575 to 1195)
25.3
(19.1 to 33.5)
17.0
(13.6 to 21.3)
5.Other Pre-specified Outcome
Title Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination
Hide Description Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.
Time Frame Day 0 (pre-vaccination) up to 5 years after final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Persistence of seroprotection to JE-CV antigens was assessed in the Full Analysis Set.
Arm/Group Title JE-CV/Hepatitis A (Group 1) Hepatitis A/JE-CV (Group 2) JE-CV/Hepatitis A (Group 3) Hepatitis A/JE-CV (Group 4)
Hide Arm/Group Description:
Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
Overall Number of Participants Analyzed 50 50 101 99
Measure Type: Number
Unit of Measure: Participants
Homologous virus (pre-vaccination; N=50,50,100,94) 45 41 15 2
Homologous virus (post-vaccination; N=49,50,98,96) 49 50 98 89
Homologous virus (post-6 months; N=48,49,99,98) 48 49 91 80
Homologous virus (post-1 year; N=48,45,91,89) 46 44 81 71
Homologous virus (post-2 years; N=43,41,85,79) 41 41 74 64
Homologous virus (post-3 years; N=40,38,68,56) 40 38 66 52
Homologous virus (post-4 years; N=41,36,63,56) 41 36 63 54
Homologous virus (post-5 years; N=40,38,60,50) 40 38 55 44
Genotype I (pre-vaccination; N=50,50,97,95) 40 41 8 3
Genotype I (post-vaccination; N=49,50,96,97) 49 50 95 93
Genotype I (post-6 months; N=47,48,99,98) 47 48 95 86
Genotype II (pre-vaccination; N=49,50,97,95) 39 39 9 2
Genotype II (post-vaccination; N=49,50,96,97) 49 50 93 93
Genotype II (post-6 months; N=47,48,99,98) 47 48 90 80
Genotype III (pre-vaccination; N=50,50,97,97) 41 38 5 1
Genotype III (post-vaccination; N=49,50,96,97) 49 50 96 92
Genotype III (post-6 months; N=48,48,99,98) 48 48 73 62
Genotype IV (pre-vaccination; N=49,50,97,94) 39 32 5 0
Genotype IV (post-vaccination; N=49,50,96,97) 48 50 73 65
Genotype IV (post-6 months; N=47,48,99,98) 47 48 68 46
6.Other Pre-specified Outcome
Title Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine
Hide Description Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.
Time Frame Day 0 (pre-vaccination) up to 5 years after final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Titers Against JE Antibodies were assessed in the Full Analysis Set.
Arm/Group Title JE-CV/Hepatitis A (Group 1) Hepatitis A/JE-CV (Group 2) JE-CV/Hepatitis A (Group 3) Hepatitis A/JE-CV (Group 4)
Hide Arm/Group Description:
Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
Overall Number of Participants Analyzed 50 50 101 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Homologous virus (pre-vaccination; N=50,50,100,94)
48.6
(33.5 to 70.4)
41.1
(27.2 to 62.2)
6.11
(5.51 to 6.78)
5.15
(4.94 to 5.37)
Homologous virus (post-vaccination; N=49,50,98,96)
1956.7
(1227.1 to 3120.0)
3722.2
(2489.2 to 5565.9)
517.6
(371.7 to 720.9)
167.1
(120.2 to 232.2)
Homologous virus (post-6 months; N=48,49,99,98)
892.1
(566.1 to 1405.8)
1244.3
(798.8 to 1938.3)
96.6
(71.4 to 130.9)
49.8
(36.8 to 67.4)
Homologous virus (post-1 year; N=48,45,91,89)
339
(216 to 531)
621
(382 to 1009)
78.8
(57.8 to 107)
49.0
(34.9 to 68.6)
Homologous virus (post-2 years; N=43,41,85,79)
414
(246 to 698)
662
(403 to 1088)
94.2
(66.0 to 134)
67.1
(46.3 to 97.3)
Homologous virus (post-3 years; N=40,38,68,56)
422
(273 to 654)
505
(339 to 751)
146
(102 to 208)
90.5
(62.6 to 131)
Homologous virus (post-4 years; N=41,36,63,56)
360
(223 to 582)
559
(306 to 1023)
137
(100 to 188)
110
(77.5 to 157)
Homologous virus (post-5 years; N=40,38,60,50)
222
(151 to 328)
287
(183 to 449)
68.8
(48.3 to 98.1)
58.2
(36.4 to 93.0)
Genotype I (pre-vaccination; N=50,50,97,95)
54.8
(36.1 to 83.3)
55.3
(35.2 to 86.9)
5.62
(5.18 to 6.11)
5.18
(4.96 to 5.41)
Genotype I (post-vaccination; N=49,50,96,97)
1015.8
(703.4 to 1466.9)
2116.7
(1519.8 to 2948.1)
186.8
(142.2 to 245.3)
163.1
(122.5 to 217.1)
Genotype I (6-months; N=47,48,99,98)
863.5
(573.9 to 1299.3)
981.0
(678.4 to 1418.4)
81.4
(62.8 to 105.5)
52.4
(40.2 to 68.2)
Genotype II (pre-vaccination; N=49,50,97,95)
46.5
(31.9 to 67.9)
33.3
(22.3 to 49.6)
5.75
(5.16 to 6.40)
5.20
(4.90 to 5.53)
Genotype II (post-vaccination; N=49,50,96,97)
920.6
(624.9 to 1356.2)
1763.4
(1199.3 to 2592.9)
163.2
(125.5 to 212.3)
126.8
(97.8 to 164.4)
Genotype II (post-6 months; N=47,48,99,98)
581.2
(402.9 to 838.3)
714.4
(520.4 to 980.7)
72.3
(54.4 to 96.1)
42.4
(31.7 to 56.8)
Genotype III (pre-vaccination; N=50,50,97,97)
37.6
(25.8 to 54.7)
41.1
(26.5 to 63.7)
5.39
(5.04 to 5.76)
5.08
(4.93 to 5.23)
Genotype III (post-vaccination; N=49,50,96,97)
1107.1
(725.8 to 1688.7)
2210.4
(1498.2 to 3261.0)
200.2
(151.5 to 264.6)
102.1
(75.8 to 137.6)
Genotype III (post-6 months; N=48,48,99,98)
513.1
(326.5 to 806.5)
645.7
(438.7 to 950.4)
31.1
(23.3 to 41.5)
20.2
(15.6 to 26.3)
Genotype IV (pre-vaccination; N=49,50,97,94)
25.2
(18.1 to 35.1)
19.7
(13.8 to 28.2)
5.31
(5.03 to 5.60)
5.00
(5.00 to 5.00)
Genotype IV (post-vaccination; N=49,50,96,97)
604.0
(386.6 to 943.6)
874.0
(610.0 to 1252.3)
28.5
(21.5 to 37.7)
18.1
(14.3 to 23.0)
Genotype IV (post-6 months; N=47,48,99,98)
279.4
(194.1 to 402.3)
363.4
(256.8 to 514.3)
21.0
(16.2 to 27.2)
12.6
(9.93 to 16.0)
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 JE CV/Hepatitis A (Group 1) Hepatitis A/JE CV (Group 2) JE CV/Hepatitis A (Group 3) Hepatitis A/JE CV (Group 4)
Hide Arm/Group Description Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart Toddlers aged 12 to 24 months of age received one dose of JE CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
All-Cause Mortality
JE CV/Hepatitis A (Group 1) Hepatitis A/JE CV (Group 2) JE CV/Hepatitis A (Group 3) Hepatitis A/JE CV (Group 4)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
JE CV/Hepatitis A (Group 1) Hepatitis A/JE CV (Group 2) JE CV/Hepatitis A (Group 3) Hepatitis A/JE CV (Group 4)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/50 (6.00%)      3/50 (6.00%)      11/101 (10.89%)      10/99 (10.10%)    
Infections and infestations         
Bronchiolitis * 1  0/50 (0.00%)  0 0/50 (0.00%)  0 0/101 (0.00%)  0 2/99 (2.02%)  2
Bronchitis * 1  1/50 (2.00%)  1 0/50 (0.00%)  0 1/101 (0.99%)  1 0/99 (0.00%)  0
Gastroenteritis * 1  0/50 (0.00%)  0 1/50 (2.00%)  1 4/101 (3.96%)  4 0/99 (0.00%)  0
Gastroenteritis rotavirus * 1  1/50 (2.00%)  1 0/50 (0.00%)  0 0/101 (0.00%)  0 1/99 (1.01%)  1
Herpangina * 1  0/50 (0.00%)  0 0/50 (0.00%)  0 0/101 (0.00%)  0 1/99 (1.01%)  1
Influenza * 1  0/50 (0.00%)  0 0/50 (0.00%)  0 0/101 (0.00%)  0 1/99 (1.01%)  1
Pharyngitis * 1  0/50 (0.00%)  0 0/50 (0.00%)  0 1/101 (0.99%)  1 1/99 (1.01%)  1
Pneumonia * 1  0/50 (0.00%)  0 1/50 (2.00%)  1 2/101 (1.98%)  2 1/99 (1.01%)  1
Pneumonia viral * 1  1/50 (2.00%)  1 0/50 (0.00%)  0 1/101 (0.99%)  1 1/99 (1.01%)  1
Upper respiratory tract infection * 1  0/50 (0.00%)  0 0/50 (0.00%)  0 1/101 (0.99%)  1 0/99 (0.00%)  0
Viral infection * 1  0/50 (0.00%)  0 0/50 (0.00%)  0 1/101 (0.99%)  1 0/99 (0.00%)  0
Injury, poisoning and procedural complications         
Wound * 1  0/50 (0.00%)  0 1/50 (2.00%)  1 1/101 (0.99%)  1 0/99 (0.00%)  0
Nervous system disorders         
Febrile convulsion * 1  0/50 (0.00%)  0 1/50 (2.00%)  1 1/101 (0.99%)  1 3/99 (3.03%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
JE CV/Hepatitis A (Group 1) Hepatitis A/JE CV (Group 2) JE CV/Hepatitis A (Group 3) Hepatitis A/JE CV (Group 4)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/50 (30.00%)      18/50 (36.00%)      43/101 (42.57%)      35/99 (35.35%)    
Gastrointestinal disorders         
Vomiting  1  0/0  0 0/0  0 23/100 (23.00%)  23 21/99 (21.21%)  21
General disorders         
Pyrexia * 1  3/50 (6.00%)  3 0/50 (0.00%)  0 0/101 (0.00%)  0 0/99 (0.00%)  0
Injection-site pain  1  15/48 (31.25%)  15 13/50 (26.00%)  13 0/0  0 0/0  0
Injection-site tenderness  1  0/0  0 0/0  0 43/101 (42.57%)  43 20/98 (20.41%)  20
Injection-site erythema  1  8/48 (16.67%)  8 9/50 (18.00%)  9 23/100 (23.00%)  23 22/98 (22.45%)  22
Injection-site swelling  1  8/48 (16.67%)  8 5/50 (10.00%)  5 6/100 (6.00%)  6 11/98 (11.22%)  11
Fever  1  8/50 (16.00%)  8 14/50 (28.00%)  14 23/100 (23.00%)  23 28/98 (28.57%)  28
Malaise  1  15/50 (30.00%)  15 18/50 (36.00%)  18 0/0  0 0/0  0
Infections and infestations         
Bronchitis * 1  3/48 (6.25%)  3 3/50 (6.00%)  3 0/101 (0.00%)  0 0/99 (0.00%)  0
Nasopharyngitis * 1  1/50 (2.00%)  1 5/50 (10.00%)  5 5/101 (4.95%)  5 11/99 (11.11%)  12
Upper respiratory tract infection * 1  8/50 (16.00%)  9 8/50 (16.00%)  8 35/101 (34.65%)  35 35/99 (35.35%)  39
Metabolism and nutrition disorders         
Appetite lost  1  0/0  0 0/0  0 28/101 (27.72%)  28 32/99 (32.32%)  32
Musculoskeletal and connective tissue disorders         
Myalgia  1  14/50 (28.00%)  14 10/50 (20.00%)  10 0/0  0 0/0  0
Nervous system disorders         
Headache  1  7/48 (14.58%)  7 14/50 (28.00%)  14 0/0  0 0/0  0
Drowsiness  1  0/0  0 0/0  0 22/101 (21.78%)  22 14/98 (14.29%)  14
Psychiatric disorders         
Crying abnormal  1  0/0  0 0/0  0 24/101 (23.76%)  24 21/98 (21.43%)  21
Irritability  1  0/0  0 0/0  0 32/101 (31.68%)  32 24/98 (24.49%)  24
Respiratory, thoracic and mediastinal disorders         
Cough * 1  4/50 (8.00%)  4 1/50 (2.00%)  1 0/101 (0.00%)  0 0/99 (0.00%)  0
Rhinorrhoea * 1  3/50 (6.00%)  3 1/50 (2.00%)  1 13/101 (12.87%)  16 11/99 (11.11%)  12
Skin and subcutaneous tissue disorders         
Heat rash * 1  3/48 (6.25%)  4 0/50 (0.00%)  0 0/101 (0.00%)  0 0/99 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 10.0
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
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00621764     History of Changes
Other Study ID Numbers: JEC01
First Submitted: February 12, 2008
First Posted: February 22, 2008
Results First Submitted: September 9, 2014
Results First Posted: September 25, 2014
Last Update Posted: October 2, 2014