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    Clinical Trial Results:
    A Controlled Study of the Safety and Immunogenicity of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children

    Summary
    EudraCT number
    		 2015-005193-38
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 May 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Feb 2016
    First version publication date
    18 Feb 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    JEC01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00621764
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon Cedex 07, France, F-69367
    Public contact
    Medical Director, Sanofi Pasteur SA, 33 4 37 37 5843, Emmanuel.Feroldi@sanofipasteur.com
    Scientific contact
    Medical Director, Sanofi Pasteur SA, 33 4 37 37 5843, Emmanuel.Feroldi@sanofipasteur.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Oct 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 May 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To describe the safety of a single dose of JE CV in comparison with hepatitis A control vaccine in two age cohorts: children aged 2 to 5 years previously vaccinated with two doses of a mouse-brain-derived inactivated JE vaccine according to the national immunization schedule, and toddlers aged 12 to 24 months previously not vaccinated with any JE vaccine
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    02 Mar 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Thailand: 301
    Worldwide total number of subjects
    301
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    200
    Children (2-11 years)
    101
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study subjects were enrolled from 02 March 2008 to 06 January 2009 at 3 clinic centers in Thailand.

    Pre-assignment
    Screening details
    		 A total of 301 subjects who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study, except for 1 subject in Group 2 who was not vaccinated.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 JE-CV/Hepatitis A (Group 1)
    Arm 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Japanese encephalitis vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    3.0 mL, subcutaneous, 1 injection on Day 0

    Investigational medicinal product name
    Hepatitis A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, 1 injection 28 days after JE-CV vaccine

    Arm title
    		 Hepatitis A/JE-CV (Group 2)
    Arm description
    		 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.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hepatitis A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, 1 injection on Day 0

    Investigational medicinal product name
    Japanese encephalitis vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    3.0 mL, subcutaneous, 1 injection 28 days after Hepatitis A vaccine

    Arm title
    		 JE-CV/Hepatitis A (Group 3)
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Japanese encephalitis vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    3.0 mL, subcutaneous, 1 injection on Day 0

    Investigational medicinal product name
    Hepatitis A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, 1 injection 28 days after JE-CV vaccine

    Arm title
    		 Hepatitis A/JE-CV (Group 4)
    Arm description
    		 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.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hepatitis A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, 1 injection on Day 0

    Investigational medicinal product name
    Japanese encephalitis vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    3.0 mL, subcutaneous, 1 injection 28 days after Hepatitis A vaccine

    Number of subjects in period 1
    		JE-CV/Hepatitis A (Group 1) Hepatitis A/JE-CV (Group 2) JE-CV/Hepatitis A (Group 3) Hepatitis A/JE-CV (Group 4)
    Started
    50
    51
    101
    99
    Completed
    50
    50
    101
    98
    Not completed
    0
    1
    0
    1
         Not vaccinated
    -
    1
    -
    -
         Protocol deviation
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    JE-CV/Hepatitis A (Group 1)
    Reporting 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.

    Reporting group title
    Hepatitis A/JE-CV (Group 2)
    Reporting group description
    		 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.

    Reporting group title
    JE-CV/Hepatitis A (Group 3)
    Reporting group description
    		 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.

    Reporting group title
    Hepatitis A/JE-CV (Group 4)
    Reporting group description
    		 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.

    Reporting group values
    		 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
    Number of subjects
    		 50 51 101 99 301
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 101 99 200
        Children (2-11 years)
    		 50 51 0 0 101
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 2.4 ± 0.5 2.5 ± 0.6 1.4 ± 0.2 1.3 ± 0.2 -
    Gender categorical
    Units: Subjects
        Female
    		 17 36 57 57 167
        Male
    		 33 15 44 42 134

    End points

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    End points reporting groups
    Reporting group title
    JE-CV/Hepatitis A (Group 1)
    Reporting 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.

    Reporting group title
    Hepatitis A/JE-CV (Group 2)
    Reporting group description
    		 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.

    Reporting group title
    JE-CV/Hepatitis A (Group 3)
    Reporting group description
    		 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.

    Reporting group title
    Hepatitis A/JE-CV (Group 4)
    Reporting group description
    		 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.

    Primary: Number of Subjects With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection

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    End point title
    		 Number of Subjects With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection [1]
    End point 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, >39.0°C; Headache, Malaise, and Myalgia, Prevents activities.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 14 post-vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 JE-CV/Hepatitis A (Group 1) Hepatitis A/JE-CV (Group 2) JE-CV/Hepatitis A (Group 3) Hepatitis A/JE-CV (Group 4)
    Number of subjects analysed
    50 [2]
    50 [3]
    101 [4]
    99 [5]
    Units: Number of subjects
    number (not applicable)
        Injection site Pain
    15
    13
    0
    0
        Grade 3 Injection site Pain
    0
    0
    0
    0
        Injection site Tenderness
    0
    0
    43
    19
        Grade 3 Injection site Tenderness
    0
    0
    0
    0
        Injection site Erythema
    7
    9
    23
    16
        Grade 3 Injection site Erythema
    0
    0
    0
    0
        Injection site Swelling
    4
    5
    6
    8
        Grade 3 Injection site Swelling
    0
    0
    0
    0
        Fever
    8
    8
    14
    18
        Grade 3 Fever
    1
    0
    0
    0
        Headache
    7
    7
    0
    0
        Grade 3 Headache
    0
    0
    0
    0
        Malaise
    15
    13
    0
    0
        Grade 3 Malaise
    0
    0
    0
    0
        Myalgia
    14
    8
    0
    0
        Grade 3 Myalgia
    0
    0
    0
    0
        Vomiting
    0
    0
    21
    21
        Grade 3 Vomiting
    0
    0
    1
    0
        Crying abnormal
    0
    0
    24
    20
        Grade 3 Crying abnormal
    0
    0
    0
    0
        Drowsiness
    0
    0
    22
    13
        Grade 3 Drowsiness
    0
    0
    0
    0
        Appetite lost
    0
    0
    28
    32
        Grade 3 Appetite lost
    0
    0
    0
    2
        Irritability
    0
    0
    32
    24
        Grade 3 Irritability
    0
    0
    0
    0
    Notes
    [2] - Tenderness, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability were not assessed
    [3] - Tenderness, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability were not assessed
    [4] - Due to the age, Injection site Pain, Headache, Malaise, and Myalgia were not assessed in this group.
    [5] - Due to the age, Injection site Pain, Headache, Malaise, and Myalgia were not assessed in this group.
    No statistical analyses for this end point

    Primary: Number of Subjects With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection

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    End point title
    		 Number of Subjects With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection [6]
    End point 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, >39.0°C; Headache, Malaise, and Myalgia, Prevents activities.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 14 post-vaccination
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 JE-CV/Hepatitis A (Group 1) Hepatitis A/JE-CV (Group 2) JE-CV/Hepatitis A (Group 3) Hepatitis A/JE-CV (Group 4)
    Number of subjects analysed
    48 [7]
    51 [8]
    101 [9]
    98 [10]
    Units: Number of subjects
    number (not applicable)
        Injection site Pain
    15
    9
    0
    0
        Grade 3 Injection site Pain
    0
    0
    0
    0
        Injection site Tenderness
    0
    0
    35
    20
        Grade 3 Injection site Tenderness
    0
    0
    1
    0
        Injection site Erythema
    8
    7
    23
    22
        Grade 3 Injection site Erythema
    0
    0
    0
    0
        Injection site Swelling
    8
    4
    6
    11
        Grade 3 Injection site Swelling
    0
    0
    0
    0
        Fever
    5
    14
    23
    28
        Grade 3 Fever
    1
    0
    1
    2
        Headache
    7
    14
    0
    0
        Grade 3 Headache
    0
    0
    0
    0
        Malaise
    13
    18
    0
    0
        Grade 3 Malaise
    0
    0
    0
    0
        Myalgia
    7
    10
    0
    0
        Grade 3 Myalgia
    0
    0
    0
    0
        Vomiting
    0
    0
    23
    19
        Grade 3 Vomiting
    0
    0
    1
    1
        Crying abnormal
    0
    0
    19
    21
        Grade 3 Crying abnormal
    0
    0
    2
    0
        Drowsiness
    0
    0
    17
    14
        Grade 3 Drowsiness
    0
    0
    0
    0
        Appetite lost
    0
    0
    26
    24
        Grade 3 Appetite lost
    0
    0
    2
    1
        Irritability
    0
    0
    22
    24
        Grade 3 Irritability
    0
    0
    1
    0
    Notes
    [7] - Tenderness, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability were not assessed
    [8] - Tenderness, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability were not assessed
    [9] - Due to the age, Injection site Pain, Headache, Malaise, and Myalgia were not assessed in this group.
    [10] - Due to the age, Injection site Pain, Headache, Malaise, and Myalgia were not assessed in this group.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination

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    End point title
    		 Percentage of Subjects With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination
    End point description
    JE virus neutralizing antibody measurement was assessed by plaque reduction neutralization test (PRNT50). Seroconversion was defined as subjects with a pre-vaccination titer <10 (1/dil) and post-vaccination titer ≥10 (1/dil), or subjects with pre-vaccination titer ≥10 (1/dil) and 4-fold increase from pre- to post-vaccination.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 28 after final vaccination
    End point values
    		 JE-CV/Hepatitis A (Group 1) Hepatitis A/JE-CV (Group 2) JE-CV/Hepatitis A (Group 3) Hepatitis A/JE-CV (Group 4)
    Number of subjects analysed
    49
    48
    87
    95
    Units: Percentage of subjects
    number (not applicable)
        Homologous virus
    89.8
    95.8
    100
    93.2
        Genotype I
    83.7
    93.8
    98.8
    95.6
        Genotype II
    83.7
    93.8
    96.3
    95.6
        Genotype III
    87.8
    91.7
    100
    94.6
        Genotype IV
    89.8
    91.7
    74.1
    65.6
    No statistical analyses for this end point

    Secondary: Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination

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    End point title
    		 Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination
    End point description
    JE virus neutralizing antibody measurement was assessed by the PRNT50 assay.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 28 after final vaccination
    End point values
    		 JE-CV/Hepatitis A (Group 1) Hepatitis A/JE-CV (Group 2) JE-CV/Hepatitis A (Group 3) Hepatitis A/JE-CV (Group 4)
    Number of subjects analysed
    49
    48
    87
    95
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Homologous virus (pre-vaccination)
    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)
    1957 (1227 to 3120)
    3568 (2361 to 5394)
    500 (353 to 708)
    167 (120 to 233)
        Genotype I (pre-vaccination)
    55.2 (36 to 84.6)
    55.3 (35.3 to 86.7)
    5 (5 to 5)
    5 (5 to 5)
        Genotype I (post-vaccination)
    1016 (703 to 1467)
    1988 (1427 to 2770)
    170 (130 to 223)
    155 (117 to 206)
        Genotype II (pre-vaccination)
    46.5 (31.9 to 67.9)
    34.2 (22.7 to 51.4)
    5 (5 to 5)
    5 (5 to 5)
        Genotype II (post-vaccination)
    921 (625 to 1356)
    1566 (1090 to 2250)
    157 (119 to 206)
    121 (93.7 to 156)
        Genotype III (pre-vaccination)
    39.2 (27 to 57)
    40.6 (25.7 to 64)
    5 (5 to 5)
    5 (5 to 5)
        Genotype III (post-vaccination)
    1107 (726 to 1689)
    2089 (1405 to 3105)
    189 (140 to 255)
    98.2 (73.2 to 132)
        Genotype IV (pre-vaccination)
    25.2 (18.1 to 35.1)
    20 (13.8 to 28.9)
    5 (5 to 5)
    5 (5 to 5)
        Genotype IV (post-vaccination)
    604 (387 to 944)
    829 (575 to 1195)
    25.3 (19.1 to 33.5)
    17 (13.6 to 21.3)
    No statistical analyses for this end point

    Other pre-specified: Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination

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    End point title
    		 Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination
    End point description
    Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) up to 5 years after final vaccination
    End point values
    		 JE-CV/Hepatitis A (Group 1) Hepatitis A/JE-CV (Group 2) JE-CV/Hepatitis A (Group 3) Hepatitis A/JE-CV (Group 4)
    Number of subjects analysed
    50
    50
    101
    99
    Units: Number of subjects
    number (not applicable)
        Homologous virus (pre-vaccination)
    45
    41
    15
    2
        Homologous virus (post-vaccination)
    49
    50
    98
    89
        Homologous virus (post-6 months)
    48
    49
    91
    80
        Homologous virus (post-1 year)
    46
    44
    81
    71
        Homologous virus (post-2 years)
    41
    41
    74
    64
        Homologous virus (post-3 years)
    40
    38
    66
    52
        Homologous virus (post-4 years)
    41
    36
    63
    54
        Homologous virus (post-5 years)
    40
    38
    55
    44
        Genotype I (pre-vaccination)
    40
    41
    8
    3
        Genotype I (post-vaccination)
    49
    50
    95
    93
        Genotype I (post-6 months)
    47
    48
    95
    86
        Genotype II (pre-vaccination)
    39
    39
    9
    2
        Genotype II (post-vaccination)
    49
    50
    93
    93
        Genotype II (post-6 months)
    47
    48
    90
    80
        Genotype III (pre-vaccination)
    41
    38
    5
    1
        Genotype III (post-vaccination)
    49
    50
    96
    92
        Genotype III (post-6 months)
    48
    48
    73
    62
        Genotype IV (pre-vaccination)
    39
    32
    5
    0
        Genotype IV (post-vaccination)
    48
    50
    73
    65
        Genotype IV (post-6 months)
    47
    48
    68
    46
    No statistical analyses for this end point

    Other pre-specified: Summary of Persistence of Neutralizing Antibody Titers to JE-CV Up To Five Years Following Vaccination

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    End point title
    		 Summary of Persistence of Neutralizing Antibody Titers to JE-CV Up To Five Years Following Vaccination
    End point description
    Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) up to 5 years after final vaccination
    End point values
    		 JE-CV/Hepatitis A (Group 1) Hepatitis A/JE-CV (Group 2) JE-CV/Hepatitis A (Group 3) Hepatitis A/JE-CV (Group 4)
    Number of subjects analysed
    50
    50
    101
    99
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Homologous virus (pre-vaccination)
    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)
    1956.7 (1227.1 to 3120)
    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)
    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)
    339 (216 to 531)
    621 (382 to 1009)
    78.8 (57.8 to 107)
    49 (34.9 to 68.6)
        Homologous virus (post-2 years)
    414 (246 to 698)
    662 (403 to 1088)
    94.2 (66 to 134)
    67.1 (46.3 to 97.3)
        Homologous virus (post-3 years)
    422 (273 to 654)
    505 (339 to 751)
    146 (102 to 208)
    90.5 (62.6 to 131)
        Homologous virus (post-4 years)
    360 (223 to 582)
    559 (306 to 1023)
    137 (100 to 188)
    110 (77.5 to 157)
        Homologous virus (post-5 years)
    222 (151 to 328)
    287 (183 to 449)
    68.8 (48.3 to 98.1)
    58.2 (36.4 to 93)
        Genotype I (pre-vaccination)
    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)
    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 (post-6 months)
    863.5 (573.9 to 1299.3)
    981 (678.4 to 1418.4)
    81.4 (62.8 to 105.5)
    52.4 (40.2 to 68.2)
        Genotype II (pre-vaccination)
    46.5 (31.9 to 67.9)
    33.3 (22.3 to 49.6)
    5.75 (5.16 to 6.4)
    5.2 (4.9 to 5.53)
        Genotype II (post-vaccination)
    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)
    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)
    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)
    1107.1 (725.8 to 1688.7)
    2210.4 (1498.2 to 3261)
    200.2 (151.5 to 264.6)
    102.1 (75.8 to 137.6)
        Genotype III (post-6 months)
    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)
    25.2 (18.1 to 35.1)
    19.7 (13.8 to 28.2)
    5.31 (5.03 to 5.6)
    5 (5 to 5)
        Genotype IV (post-vaccination)
    604 (386.6 to 943.6)
    874 (610 to 1252.3)
    28.5 (21.5 to 37.7)
    18.1 (14.3 to 23)
        Genotype IV (post-6 months)
    279.4 (194.1 to 402.3)
    363.4 (256.8 to 514.3)
    21 (16.2 to 27.2)
    12.6 (9.93 to 16)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    JE-CV/Hepatitis A (Group 1)
    Reporting 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.

    Reporting group title
    Hepatitis A/JE-CV (Group 2)
    Reporting group description
    		 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.

    Reporting group title
    JE-CV/Hepatitis A (Group 3)
    Reporting group description
    		 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.

    Reporting group title
    Hepatitis A/JE-CV (Group 4)
    Reporting group description
    		 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.

    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)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 50 (6.00%)
    3 / 51 (5.88%)
    11 / 101 (10.89%)
    10 / 99 (10.10%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Wound
         subjects affected / exposed [1]
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    1 / 101 (0.99%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed [2]
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    1 / 101 (0.99%)
    3 / 99 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed [3]
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 101 (0.00%)
    2 / 99 (2.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed [4]
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    1 / 101 (0.99%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed [5]
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    4 / 101 (3.96%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed [6]
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 101 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed [7]
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 101 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed [8]
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 101 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed [9]
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 101 (0.99%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed [10]
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    2 / 101 (1.98%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed [11]
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    1 / 101 (0.99%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed [12]
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 101 (0.99%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed [13]
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 101 (0.99%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-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)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 50 (30.00%)
    18 / 51 (35.29%)
    43 / 101 (42.57%)
    35 / 99 (35.35%)
    Nervous system disorders
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    22 / 101 (21.78%)
    14 / 98 (14.29%)
         occurrences all number
    0
    0
    22
    14
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed [15]
    7 / 48 (14.58%)
    14 / 51 (27.45%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    7
    14
    0
    0
    General disorders and administration site conditions
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed [16]
    8 / 50 (16.00%)
    14 / 51 (27.45%)
    23 / 100 (23.00%)
    28 / 98 (28.57%)
         occurrences all number
    8
    14
    23
    28
    Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed [17]
    8 / 48 (16.67%)
    9 / 50 (18.00%)
    23 / 100 (23.00%)
    22 / 98 (22.45%)
         occurrences all number
    8
    9
    23
    22
    Injection site Pain
    alternative assessment type: Systematic
         subjects affected / exposed [18]
    15 / 48 (31.25%)
    13 / 50 (26.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    15
    13
    0
    0
    Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [19]
    8 / 48 (16.67%)
    5 / 50 (10.00%)
    6 / 100 (6.00%)
    11 / 98 (11.22%)
         occurrences all number
    8
    5
    6
    11
    Injection site Tenderness
    alternative assessment type: Systematic
         subjects affected / exposed [20]
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    43 / 101 (42.57%)
    20 / 98 (20.41%)
         occurrences all number
    0
    0
    43
    20
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    15 / 50 (30.00%)
    18 / 51 (35.29%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    15
    18
    0
    0
    Pyrexia
         subjects affected / exposed [21]
    3 / 50 (6.00%)
    0 / 50 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Gastrointestinal disorders
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed [22]
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    23 / 100 (23.00%)
    21 / 99 (21.21%)
         occurrences all number
    0
    0
    23
    21
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed [23]
    4 / 50 (8.00%)
    1 / 50 (2.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    4
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed [24]
    3 / 50 (6.00%)
    1 / 50 (2.00%)
    13 / 101 (12.87%)
    11 / 99 (11.11%)
         occurrences all number
    3
    1
    16
    12
    Skin and subcutaneous tissue disorders
    Heat rash
         subjects affected / exposed [25]
    3 / 48 (6.25%)
    0 / 51 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Psychiatric disorders
    Crying abnormal
    alternative assessment type: Systematic
         subjects affected / exposed [26]
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    24 / 101 (23.76%)
    21 / 98 (21.43%)
         occurrences all number
    0
    0
    24
    21
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [27]
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    32 / 101 (31.68%)
    24 / 98 (24.49%)
         occurrences all number
    0
    0
    32
    24
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 50 (28.00%)
    10 / 51 (19.61%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    14
    10
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed [28]
    3 / 48 (6.25%)
    3 / 50 (6.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
         occurrences all number
    3
    3
    0
    0
    Nasopharyngitis
         subjects affected / exposed [29]
    1 / 50 (2.00%)
    5 / 50 (10.00%)
    5 / 101 (4.95%)
    11 / 99 (11.11%)
         occurrences all number
    1
    5
    5
    12
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 50 (16.00%)
    8 / 51 (15.69%)
    35 / 101 (34.65%)
    35 / 99 (35.35%)
         occurrences all number
    9
    8
    35
    39
    Metabolism and nutrition disorders
    Appetite lost
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    28 / 101 (27.72%)
    32 / 99 (32.32%)
         occurrences all number
    0
    0
    28
    32
    Notes
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 14 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 14 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 14 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 14 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 14 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 14 days after vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Nov 2007
    Exclusion criteria were revised such that children were allowed to receive oral polio vaccine in the 4 weeks preceding the first trial vaccination and hepatitis B serology was defined as hepatitis B surface antigen; results of study H-040-009 were updated as blind was opened: presentation of SAEs per vaccine group, and seroconversion rates given per vaccine group.
    30 Nov 2007
    Inclusion and exclusion criteria defining groups 1 and 2 were corrected to enlarge the JE primary vaccination period; a precision on the safety intensity scales were included (Mild -> Grade 1; Moderate -> Grade 2; Severe -> Grade 3).
    10 Jan 2008
    Clarification of the reconstitution procedure for the investigational product; change in the Sponsor representatives of the Safety Review Committee.
    07 Apr 2008
    Modification of assay methods for determination of flavivirus status at baseline (dengue and JE status were to be assessed by PRNT50 assays instead of ELISA); a first screening was performed by dengue ELISA and then only positive samples were to be further analyzed by dengue PRNT50; JE PRNT50 was performed on all samples as part of baseline immunogenicity assessment.
    21 Aug 2008
    Addition of a 5-year follow-up to evaluate yearly persistence of immune response to JE after one dose of JE-CV; addition of an observational objective for the characterization of JE-CV viruses by measurement of viral plaque size and RNA sequencing; adjustment of titer defining seroconversion from 20 (1/dil) to 10 (1/dil) for wild-type virus strains.
    30 Oct 2008
    Revision of the definition of the Per Protocol population; definition for the Other Immunogenicity set was added.
    04 Jun 2009
    Clarification of SAE reporting was updated such that any related SAEs occurring between the 6-month follow-up visit and the end of the study were reported to the Sponsor by the Investigator.
    11 Dec 2009
    Change in the exclusion criteria such that subjects were allowed to participate in another clinical trial from the second year of follow-up period onward.
    11 Dec 2010
    Extension of the time window for the coming yearly visits to +/- 60 days instead of +/- 30 days to facilitate the participation of yearly visits and to anticipate any unexpected circumstances.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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