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    Clinical Trial Results:
    Safety of ChimeriVax™ Dengue Tetravalent Vaccine in Subjects Aged 2 to 45 Years in Mexico

    Summary
    EudraCT number
    2014-001706-17
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    27 Aug 2007

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Feb 2016
    First version publication date
    22 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CYD06
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    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
    Director, Clinical Development, Sanofi Pasteur SA, 33 (0)437 65 60 60, remi.forrat@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (0)437 65 60 60, remi.forrat@sanofipasteur.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-001201-PIP01-11
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Feb 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Aug 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To describe the safety of each injection of ChimeriVax™ Dengue Tetravalent Vaccine in four age groups of subjects: adults (18 to 45), adolescents (12 to 17), children (6 to 11), and children (2 to 5). - To describe viremia after each injection of ChimeriVax™ Dengue Tetravalent Vaccine in the four age groups of subjects. - To describe the humoral immune response against dengue before injection, and after each injection of ChimeriVax™ Dengue Tetravalent Vaccine in the four age groups of subjects.
    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
    -
    Actual start date of recruitment
    24 Jan 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Mexico: 126
    Worldwide total number of subjects
    126
    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)
    0
    Children (2-11 years)
    72
    Adolescents (12-17 years)
    36
    Adults (18-64 years)
    18
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Study subjects were enrolled from 02 February 2006 to 23 July 2007 at 2 clinical centers in Mexico.

    Pre-assignment
    Screening details
    A total of 126 subjects who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    The blind observer method was used for the first vaccination. The delegate study personnel(s)/pharmacist, independent of the safety evaluation and other evaluations, prepared and administered the vaccine. The subjects, Investigator or designated study personnel in charge of safety assessment did not know which treatment or product being administered. Labels on the secondary packaging were also designed to prevent the treatment from being identified.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Study Group 1
    Arm description
    Subjects who received Sanofi Pasteur’s ChimeriVax™ Dengue Tetravalent Vaccine (serotypes 1, 2, 3, and 4) as first, second, and third injections on Day 0, Day 0 + 3.5 months, and Day 0 + 12 months.
    Arm type
    Experimental

    Investigational medicinal product name
    ChimeriVax Dengue Tetravalent Vaccine
    Investigational medicinal product code
    323
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL dose, subcutaneous, administered on Day 0 (1st injection), Day 0 + 3.5 months (2nd injection), and Day 0 + 12 months (3rd injection).

    Arm title
    Study Group 2
    Arm description
    Subjects received Stamaril Pasteur® (Yellow Fever vaccine) as first injection on Day 0 and sanofi pasteur’s CYD Dengue vaccine (serotypes 1, 2, 3, and 4) as second injection (Day 0 + 3.5 months ) and third injection (Day 0 + 12 months).
    Arm type
    Experimental

    Investigational medicinal product name
    ChimeriVax Dengue Tetravalent Vaccine
    Investigational medicinal product code
    323
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL dose, subcutaneous, administered on Day 0 (1st injection), Day 0 + 3.5 months (2nd injection), and Day 0 + 12 months (3rd injection).

    Investigational medicinal product name
    Sanofi Pasteur live attenuated YF vaccine (Stamaril Pasteur®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection into the deltoid region on Day 0 as the first injection

    Number of subjects in period 1
    Study Group 1 Study Group 2
    Started
    84
    42
    Completed
    73
    35
    Not completed
    11
    7
         Protocol deviation
             1
             3
         Adverse event, non-fatal
             4
             3
         Consent withdrawn by subject
             3
             -
         Lost to follow-up
             2
             -
         Serious adverse event
             1
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study Group 1
    Reporting group description
    Subjects who received Sanofi Pasteur’s ChimeriVax™ Dengue Tetravalent Vaccine (serotypes 1, 2, 3, and 4) as first, second, and third injections on Day 0, Day 0 + 3.5 months, and Day 0 + 12 months.

    Reporting group title
    Study Group 2
    Reporting group description
    Subjects received Stamaril Pasteur® (Yellow Fever vaccine) as first injection on Day 0 and sanofi pasteur’s CYD Dengue vaccine (serotypes 1, 2, 3, and 4) as second injection (Day 0 + 3.5 months ) and third injection (Day 0 + 12 months).

    Reporting group values
    Study Group 1 Study Group 2 Total
    Number of subjects
    84 42 126
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    48 24 72
        Adolescents (12-17 years)
    24 12 36
        Adults (18-64 years)
    12 6 18
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    12.1 ± 9.2 11.6 ± 7.3 -
    Gender categorical
    Units: Subjects
        Female
    49 21 70
        Male
    35 21 56
    Study sub-groups by age
    Study subjects were also categorized into 4 sub-groups based on their age as adults, adolescents, and 2 children groups.
    Units: Subjects
        Adults (age 18 to 45 years)
    12 6 18
        Adolescents (age 12 to 17 years)
    24 12 36
        Children (age 6 to 11 years)
    24 12 36
        Children (age 2 to 5 years)
    24 12 36

    End points

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    End points reporting groups
    Reporting group title
    Study Group 1
    Reporting group description
    Subjects who received Sanofi Pasteur’s ChimeriVax™ Dengue Tetravalent Vaccine (serotypes 1, 2, 3, and 4) as first, second, and third injections on Day 0, Day 0 + 3.5 months, and Day 0 + 12 months.

    Reporting group title
    Study Group 2
    Reporting group description
    Subjects received Stamaril Pasteur® (Yellow Fever vaccine) as first injection on Day 0 and sanofi pasteur’s CYD Dengue vaccine (serotypes 1, 2, 3, and 4) as second injection (Day 0 + 3.5 months ) and third injection (Day 0 + 12 months).

    Primary: Number of Subjects Reporting a Solicited Injection-site or Systemic Reactions Following the First Vaccination with Sanofi Pasteur's CYD Dengue Vaccine or Yellow Fever Vaccine (Stamaril Pasteur®)

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    End point title
    Number of Subjects Reporting a Solicited Injection-site or Systemic Reactions Following the First Vaccination with Sanofi Pasteur's CYD Dengue Vaccine or Yellow Fever Vaccine (Stamaril Pasteur®) [1]
    End point description
    Solicited injection site: Pain, Erythema, and Edema. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection site reactions: Pain – Incapacitating, unable to perform usual activities; Erythema and Edema - ≥5 cm. Grade 3 Solicited systemic reactions: Fever - ≥39˚C axillary; Headache, Malaise, Myalgia, and Asthenia – Prevents daily activity.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 14 post-first 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
    Study Group 1 Study Group 2
    Number of subjects analysed
    84
    40
    Units: Number of subjects
    number (not applicable)
        Inj. site Pain; Adults (18-45 y)
    1
    1
        Inj. site Pain; Adolescents (12-17 y)
    5
    1
        Inj. site Pain; Children (6-11 y)
    10
    0
        Inj. site Pain; Children (2-5 y)
    6
    5
        All Grade 3 Inj. site Pain
    0
    0
        Inj. site Erythema; Adults (18-45 y)
    3
    1
        Inj. site Erythema; Adolescents (12-17 y)
    0
    0
        Inj. site Erythema; Children (6-11 y)
    1
    1
        Inj. site Erythema; Children (2-5 y)
    2
    1
        All Grade 3 Inj. site Erythema
    0
    0
        Inj. site Edema; Adults (18-45 y)
    3
    1
        Inj. site Edema; Adolescents (12-17 y)
    0
    0
        Inj. site Edema; Children (6-11 y)
    1
    0
        Inj. site Edema; Children (2-5 y)
    1
    1
        All Grade 3 Inj. site Edema
    1
    0
        Inj. site Fever; Adults (18-45 y)
    0
    0
        Inj. site Fever; Adolescents (12-17 y)
    3
    1
        Inj. site Fever; Children (6-11 y)
    2
    2
        Inj. site Fever; Children (2-5 y)
    3
    1
        All Grade 3 Inj. site Fever
    3
    0
        Inj. site Headache; Adults (18-45 y)
    6
    3
        Inj. site Headache; Adolescents (12-17 y)
    13
    6
        Inj. site Headache; Children (6-11 y)
    9
    2
        Inj. site Headache; Children (2-5 y)
    4
    2
        All Grade 3 Inj. site Headache
    1
    0
        Inj. site Malaise; Adults (18-45 y)
    0
    1
        Inj. site Malaise; Adolescents (12-17 y)
    3
    1
        Inj. site Malaise; Children (6-11 y)
    2
    1
        Inj. site Malaise; Children (2-5 y)
    3
    3
        All Grade 3 Inj. site Malaise
    0
    0
        Inj. site Myalgia; Adults (18-45 y)
    5
    2
        Inj. site Myalgia; Adolescents (12-17 y)
    7
    4
        Inj. site Myalgia; Children (6-11 y)
    7
    2
        Inj. site Myalgia; Children (2-5 y)
    5
    3
        All Grade 3 Inj. site Myalgia
    0
    0
        Inj. site Asthenia; Adults (18-45 y)
    3
    3
        Inj. site Asthenia; Adolescents (12-17 y)
    8
    2
        Inj. site Asthenia; Children (6-11 y)
    2
    1
        Inj. site Asthenia; Children (2-5 y)
    4
    2
        All Grade 3 Inj. site Asthenia
    2
    0
    No statistical analyses for this end point

    Primary: Number of Subjects Reporting a Solicited Injection-site or Systemic Reactions Following the Second Vaccination with Sanofi Pasteur's CYD Dengue Vaccine

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    End point title
    Number of Subjects Reporting a Solicited Injection-site or Systemic Reactions Following the Second Vaccination with Sanofi Pasteur's CYD Dengue Vaccine [2]
    End point description
    Solicited injection site: Pain, Erythema, and Edema. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection site reactions: Pain – Incapacitating, unable to perform usual activities; Erythema and Edema - ≥5 cm. Grade 3 Solicited systemic reactions: Fever - ≥39˚C axillary; Headache, Malaise, Myalgia, and Asthenia – Prevents daily activity.
    End point type
    Primary
    End point timeframe
    Day 0 to Day 14 post-second vaccination
    Notes
    [2] - 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
    Study Group 1 Study Group 2
    Number of subjects analysed
    79
    35
    Units: Number of subjects
    number (not applicable)
        Inj. site Pain; Adults (18-45 y)
    2
    3
        Inj. site Pain; Adolescents (12-17 y)
    9
    3
        Inj. site Pain; Children (6-11 y)
    6
    0
        Inj. site Pain; Children (2-5 y)
    3
    2
        All Grade 3 Inj. site Pain
    0
    1
        Inj. site Erythema; Adults (18-45 y)
    2
    0
        Inj. site Erythema; Adolescents (12-17 y)
    4
    0
        Inj. site Erythema; Children (6-11 y)
    3
    1
        Inj. site Erythema; Children (2-5 y)
    1
    1
        All Grade 3 Inj. site Erythema
    1
    0
        Inj. site Edema; Adults (18-45 y)
    0
    0
        Inj. site Edema; Adolescents (12-17 y)
    1
    1
        Inj. site Edema; Children (6-11 y)
    4
    1
        Inj. site Edema; Children (2-5 y)
    0
    1
        All Grade 3 Inj. site Edema
    0
    0
        Inj. site Fever; Adults (18-45 y)
    2
    1
        Inj. site Fever; Adolescents (12-17 y)
    1
    0
        Inj. site Fever; Children (6-11 y)
    2
    1
        Inj. site Fever; Children (2-5 y)
    6
    0
        All Grade 3 Inj. site Fever
    1
    0
        Inj. site Headache; Adults (18-45 y)
    4
    3
        Inj. site Headache; Adolescents (12-17 y)
    7
    3
        Inj. site Headache; Children (6-11 y)
    7
    1
        Inj. site Headache; Children (2-5 y)
    5
    0
        All Grade 3 Inj. site Headache
    1
    1
        Inj. site Malaise; Adults (18-45 y)
    3
    3
        Inj. site Malaise; Adolescents (12-17 y)
    2
    2
        Inj. site Malaise; Children (6-11 y)
    3
    0
        Inj. site Malaise; Children (2-5 y)
    4
    2
        All Grade 3 Inj. site Malaise
    0
    1
        Inj. site Myalgia; Adults (18-45 y)
    2
    3
        Inj. site Myalgia; Adolescents (12-17 y)
    4
    3
        Inj. site Myalgia; Children (6-11 y)
    5
    0
        Inj. site Myalgia; Children (2-5 y)
    2
    1
        All Grade 3 Inj. site Myalgia
    0
    1
        Inj. site Asthenia; Adults (18-45 y)
    2
    2
        Inj. site Asthenia; Adolescents (12-17 y)
    6
    1
        Inj. site Asthenia; Children (6-11 y)
    2
    0
        Inj. site Asthenia; Children (2-5 y)
    4
    0
        All Grade 3 Inj. site Asthenia
    0
    1
    No statistical analyses for this end point

    Primary: Number of Subjects Reporting a Solicited Injection-site or Systemic Reactions Following the Third Vaccination with Sanofi Pasteur's CYD Dengue Vaccine

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    End point title
    Number of Subjects Reporting a Solicited Injection-site or Systemic Reactions Following the Third Vaccination with Sanofi Pasteur's CYD Dengue Vaccine [3]
    End point description
    Solicited injection site: Pain, Erythema, and Edema. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection site reactions: Pain – Incapacitating, unable to perform usual activities; Erythema and Edema - ≥5 cm. Grade 3 Solicited systemic reactions: Fever - ≥39˚C axillary; Headache, Malaise, Myalgia, and Asthenia – Prevents daily activity.
    End point type
    Primary
    End point timeframe
    Day 0 to Day 14 post-third vaccination
    Notes
    [3] - 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
    Study Group 1 Study Group 2
    Number of subjects analysed
    73
    35
    Units: Number of subjects
    number (not applicable)
        Inj. site Pain
    26
    8
        Grade 3 Inj. site Pain
    0
    1
        Inj. site Erythema
    7
    2
        Grade 3 Inj. site Erythema
    0
    0
        Inj. site Edema
    5
    3
        Grade 3 Inj. site Edema
    0
    0
        Fever
    4
    2
        Grade 3 Fever
    0
    0
        Headache
    15
    7
        Grade 3 Headache
    1
    2
        Malaise
    10
    7
        Grade 3 Malaise
    1
    2
        Myalgia
    14
    7
        Grade 3 Myalgia
    1
    1
        Asthenia
    11
    3
        Grade 3 Asthenia
    1
    1
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Non-serotype Specific CYD Viremia by Flavivirus Reverse Transcriptase Polymerase Chain Reaction After the First Vaccination with Sanofi Pasteur's CYD Dengue Vaccine and Yellow Fever Vaccine (Stamaril Pasteur®)

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    End point title
    Percentage of Subjects with Non-serotype Specific CYD Viremia by Flavivirus Reverse Transcriptase Polymerase Chain Reaction After the First Vaccination with Sanofi Pasteur's CYD Dengue Vaccine and Yellow Fever Vaccine (Stamaril Pasteur®) [4]
    End point description
    CYD Dengue vaccine and Yellow Fever vaccine virus were assessed using the flavivirus reverse transcriptase-polymerase chain reaction (RT-PCR).
    End point type
    Primary
    End point timeframe
    Day 0 (V01; pre-vaccination) and Day 7 (V01+7) and Day 14 (V01+14) post-first vaccination
    Notes
    [4] - 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
    Study Group 1 Study Group 2
    Number of subjects analysed
    84
    42
    Units: Percentage of subjects
    number (not applicable)
        All subjects; Detected viremia (V01)
    0
    0
        All subjects; Detected viremia (V01+7)
    4.9
    2.4
        All subjects; Detected viremia (V01+14)
    2.4
    0
        Adults (18-45 y); Detected viremia (V01)
    0
    0
        Adults (18-45 y); Detected viremia (V01+7)
    8.3
    0
        Adults (18-45 y); Detected viremia (V01+14)
    8.3
    0
        Adolescents (12-17 y); Detected viremia (V01)
    0
    0
        Adolescents (12-17 y); Detected viremia (V01+7)
    4.2
    8.3
        Adolescents (12-17 y); Detected viremia (V01+14)
    4.2
    0
        Children (6-11 y); Detected viremia (V01)
    0
    0
        Children (6-11 y); Detected viremia (V01+7)
    8.7
    0
        Children (6-11 y); Detected viremia (V01+14)
    0
    0
        Children (2-5 y); Detected viremia (V01)
    0
    0
        Children (2-5 y); Detected viremia (V01+7)
    0
    0
        Children (2-5 y); Detected viremia (V01+14)
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Non-serotype Specific CYD Viremia by Flavivirus Reverse Transcriptase-Polymerase Chain Reaction After the Second Vaccination with Sanofi Pasteur's CYD Dengue Vaccine

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    End point title
    Percentage of Subjects with Non-serotype Specific CYD Viremia by Flavivirus Reverse Transcriptase-Polymerase Chain Reaction After the Second Vaccination with Sanofi Pasteur's CYD Dengue Vaccine [5]
    End point description
    CYD Dengue Vaccine and Yellow Fever vaccine antibodies were assessed using the flavivirus reverse transcriptase-polymerase chain reaction (RT-PCR).
    End point type
    Primary
    End point timeframe
    Day 0 (V06; pre-second vaccination) and Day 7 (V06+7) and Day 14 (V06+14) post-second vaccination
    Notes
    [5] - 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
    Study Group 1 Study Group 2
    Number of subjects analysed
    79
    39
    Units: Percentage of subjects
    number (not applicable)
        All subjects; Detected viremia (V06)
    0
    0
        All subjects; Detected viremia (V06+7)
    2.5
    10.5
        All subjects; Detected viremia (V06+14)
    0
    2.6
        Adults (18-45 y); Detected viremia (V06)
    0
    0
        Adults (18-45 y); Detected viremia (V06+7)
    8.3
    0
        Adults (18-45 y); Detected viremia (V06+14)
    0
    0
        Adolescents (12-17 y); Detected viremia (V06)
    0
    0
        Adolescents (12-17 y); Detected viremia (V06+7)
    0
    8.3
        Adolescents (12-17 y); Detected viremia (V06+14)
    0
    8.3
        Children (6-11 y); Detected viremia (V06)
    0
    0
        Children (6-11 y); Detected viremia (V06+7)
    0
    20
        Children (6-11 y); Detected viremia (V06+14)
    0
    0
        Children (2-5 y); Detected viremia (V06)
    0
    0
        Children (2-5 y); Detected viremia (V06+7)
    5
    10
        Children (2-5 y); Detected viremia (V06+14)
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Non-serotype Specific CYD Viremia by Yellow Fever Flavivirus Reverse Transcriptase-Polymerase Chain Reaction After the Second Vaccination with Sanofi Pasteur's CYD Dengue Vaccine

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    End point title
    Percentage of Subjects with Non-serotype Specific CYD Viremia by Yellow Fever Flavivirus Reverse Transcriptase-Polymerase Chain Reaction After the Second Vaccination with Sanofi Pasteur's CYD Dengue Vaccine [6]
    End point description
    Antibodies to CYD Dengue vaccine and Yellow Fever vaccine antigens were assessed using the Yellow Fever Flavivirus reverse transcriptase-polymerase chain reaction (RT-PCR).
    End point type
    Primary
    End point timeframe
    Day 0 (V06; pre-second vaccination) and Day 7 (V06+7) and Day 14 (V06+14) post-second 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
    Study Group 1 Study Group 2
    Number of subjects analysed
    79
    39
    Units: Percentage of subjects
    number (not applicable)
        All subjects; Detected viremia (V06)
    0
    0
        All subjects; Detected viremia (V06+7)
    2.5
    26.3
        All subjects; Detected viremia (V06+14)
    2.6
    12.8
        Adults (18-45 y); Detected viremia (V06)
    0
    0
        Adults (18-45 y); Detected viremia (V06+7)
    0
    50
        Adults (18-45 y); Detected viremia (V06+14)
    0
    0
        Adolescents (12-17 y); Detected viremia (V06)
    0
    0
        Adolescents (12-17 y); Detected viremia (V06+7)
    8.3
    33.3
        Adolescents (12-17 y); Detected viremia (V06+14)
    4.2
    16.7
        Children (6-11 y); Detected viremia (V06)
    0
    0
        Children (6-11 y); Detected viremia (V06+7)
    0
    20
        Children (6-11 y); Detected viremia (V06+14)
    4.3
    20
        Children (2-5 y); Detected viremia (V06)
    0
    0
        Children (2-5 y); Detected viremia (V06+7)
    0
    10
        Children (2-5 y); Detected viremia (V06+14)
    0
    9.1
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Non-serotype Specific CYD Viremia by Flavivirus Reverse Transcriptase-Polymerase Chain Reaction After the Third Vaccination with Sanofi Pasteur's CYD Dengue Vaccine

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    End point title
    Percentage of Subjects with Non-serotype Specific CYD Viremia by Flavivirus Reverse Transcriptase-Polymerase Chain Reaction After the Third Vaccination with Sanofi Pasteur's CYD Dengue Vaccine [7]
    End point description
    Antibodies to CYD Dengue vaccine and Yellow Fever vaccine antigens were assessed using the Yellow Fever Flavivirus reverse transcriptase-polymerase chain reaction (RT-PCR).
    End point type
    Primary
    End point timeframe
    Day 0 (V11; pre-third vaccination) and Day 7 (V11+7) post-third vaccination
    Notes
    [7] - 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
    Study Group 1 Study Group 2
    Number of subjects analysed
    73
    35
    Units: Percentage of subjects
    number (not applicable)
        All subjects; Detected viremia (V11)
    1.4
    0
        All subjects; Detected viremia (V11+7)
    2.8
    8.8
        Adults (18-45 y); Detected viremia (V11)
    0
    0
        Adults (18-45 y); Detected viremia (V11+7)
    8.3
    0
        Adolescents (12-17 y); Detected viremia (V11)
    4.2
    0
        Adolescents (12-17 y); Detected viremia (V11+7)
    0
    0
        Children (6-11 y); Detected viremia (V11)
    0
    0
        Children (6-11 y); Detected viremia (V11+7)
    5
    30
        Children (2-5 y); Detected viremia (V11)
    0
    0
        Children (2-5 y); Detected viremia (V11+7)
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Non-serotype Specific CYD Viremia by Yellow Fever Reverse Transcriptase-Polymerase Chain Reaction After the Third Vaccination with Sanofi Pasteur's CYD Dengue Vaccine

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    End point title
    Percentage of Subjects with Non-serotype Specific CYD Viremia by Yellow Fever Reverse Transcriptase-Polymerase Chain Reaction After the Third Vaccination with Sanofi Pasteur's CYD Dengue Vaccine [8]
    End point description
    Antibodies to CYD Dengue vaccine and Yellow Fever vaccine antigens were assessed using the Yellow Fever Flavivirus reverse transcriptase-polymerase chain reaction (RT-PCR).
    End point type
    Primary
    End point timeframe
    Day 0 (V11; pre-third vaccination) and Day 7 (V11+7) post-third vaccination
    Notes
    [8] - 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
    Study Group 1 Study Group 2
    Number of subjects analysed
    73
    35
    Units: Percentage of subjects
    number (not applicable)
        All subjects; Detected viremia (V11)
    1.4
    0
        All subjects; Detected viremia (V11+7)
    5.6
    26.5
        Adults (18-45 y); Detected viremia (V11)
    0
    0
        Adults (18-45 y); Detected viremia (V11+7)
    0
    33.3
        Adolescents (12-17 y); Detected viremia (V11)
    0
    0
        Adolescents (12-17 y); Detected viremia (V11+7)
    4.2
    12.5
        Children (6-11 y); Detected viremia (V11)
    5
    0
        Children (6-11 y); Detected viremia (V11+7)
    10
    20
        Children (2-5 y); Detected viremia (V11)
    0
    0
        Children (2-5 y); Detected viremia (V11+7)
    6.3
    40
    No statistical analyses for this end point

    Primary: Geometric Mean Titers of Neutralizing Antibodies Against Dengue Serotype Strain 1 Before and Following Each Injection with Sanofi Pasteur's CYD Dengue Vaccine and Yellow Fever Vaccine (Stamaril Pasteur®)

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    End point title
    Geometric Mean Titers of Neutralizing Antibodies Against Dengue Serotype Strain 1 Before and Following Each Injection with Sanofi Pasteur's CYD Dengue Vaccine and Yellow Fever Vaccine (Stamaril Pasteur®)
    End point description
    Neutralizing antibody levels against each of the four parental dengue virus serotype strains of ChimeriVax™ Dengue Tetravalent Vaccine constructs, and against the Thai Mahidol four dengue virus serotype strains were assessed by the Plaque Reduction Neutralization Test, (PRNT)
    End point type
    Primary
    End point timeframe
    Day 0 (pre-first, second, and third vaccination) and Day 28 post-first, second, and third post-vaccination
    End point values
    Study Group 1 Study Group 2
    Number of subjects analysed
    84
    42
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Parental Dengue 1 Strain; Pre-first vaccination
    5 (5 to 5)
    5 (5 to 5)
        Parental Dengue 1 Strain; Post-first vaccination
    6.17 (5.46 to 6.97)
    5.81 (4.99 to 6.77)
        Parental Dengue 1 Strain; Pre-second vaccination
    5.48 (4.98 to 6.04)
    5.71 (4.99 to 6.54)
        Parental Dengue 1 Strain; Post-second vaccination
    14.2 (10.6 to 19)
    15.2 (10.4 to 22)
        Parental Dengue 1 Strain; Pre-third vaccination
    6.6 (5.63 to 7.74)
    6.34 (5.21 to 7.71)
        Parental Dengue 1 Strain; Post-third vaccination
    35.6 (26.4 to 47.9)
    43.4 (29 to 64.9)
        Mahidol Dengue 1 Strain; Pre-first vaccination
    5 (5 to 5)
    5 (5 to 5)
        Mahidol Dengue 1 Strain; Post-first vaccination
    7.45 (6.1 to 9.1)
    5.65 (4.88 to 6.53)
        Mahidol Dengue 1 Strain; Pre-second vaccination
    7.04 (5.85 to 8.46)
    5.46 (4.82 to 6.2)
        Mahidol Dengue 1 Strain; Post-second vaccination
    17.5 (12.6 to 24.4)
    11.5 (7.81 to 16.9)
        Mahidol Dengue 1 Strain; Pre-third vaccination
    7.07 (5.86 to 8.54)
    8.14 (5.99 to 11.1)
        Mahidol Dengue 1 Strain; Post-third vaccination
    35.7 (24.8 to 51.6)
    31.7 (21 to 48)
    Statistical analysis title
    P-value test comparing GMT pre- and post-injection
    Statistical analysis description
    P-values for tests comparing GMTs after vaccinations between vaccine groups are adjusted on age groups. ANCOVA models performed on Log10 distributions after vaccinations adjusted on age groups and on Log10 distributions before vaccinations.
    Comparison groups
    Study Group 1 v Study Group 2
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    other [9]
    P-value
    = 0.5656 [10]
    Method
    ANCOVA
    Confidence interval
    Notes
    [9] - Intra-group comparisons were assessed in pre-first, second, and third injection (inj.) vs. post-first, second, and third inj.
    [10] - Grp 1; Parental: Pre-each inj. vs. Post-each inj. was P=0.5656, 0.9408; and 0.5194, respectively. Mahidol: P=0.0723, 0.3274, and 0.2250. Grp 2; Parental: P=0.5656, 0.9408, 0.5194. Mahidol: P=0.0723, 0.3274, and 0.2250.

    Primary: Geometric Mean Titers of Neutralizing Antibodies Against Dengue Serotype Strain 2 Before and Following Each Injection with Sanofi Pasteur's CYD Dengue Vaccine and Yellow Fever Vaccine (Stamaril Pasteur®)

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    End point title
    Geometric Mean Titers of Neutralizing Antibodies Against Dengue Serotype Strain 2 Before and Following Each Injection with Sanofi Pasteur's CYD Dengue Vaccine and Yellow Fever Vaccine (Stamaril Pasteur®)
    End point description
    Neutralizing antibody levels against each of the four parental dengue virus serotype strains of ChimeriVax™ Dengue Tetravalent Vaccine constructs, and against the Thai Mahidol four dengue virus serotype strains were assessed by the Plaque Reduction Neutralization Test, (PRNT).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-first, second, and third vaccination) and Day 28 post-first, second, and third post-vaccination
    End point values
    Study Group 1 Study Group 2
    Number of subjects analysed
    84
    42
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Parental Dengue 2 Strain; Pre-first vaccination
    5 (5 to 5)
    5.32 (4.69 to 6.04)
        Parental Dengue 2 Strain; Post-first vaccination
    11.2 (8.52 to 14.8)
    6.18 (4.84 to 7.9)
        Parental Dengue 2 Strain; Pre-second vaccination
    10.2 (8.11 to 12.7)
    5.62 (4.65 to 6.81)
        Parental Dengue 2 Strain; Post-second vaccination
    32.3 (23.9 to 43.7)
    23.5 (15.6 to 35.6)
        Parental Dengue 2 Strain; Pre-third vaccination
    10.9 (8.54 to 14)
    10.5 (7.24 to 15.2)
        Parental Dengue 2 Strain; Post-third vaccination
    53.6 (40.4 to 71.1)
    58 (37.6 to 89.6)
        Mahidol Dengue 2 Strain; Pre-first vaccination
    5 (5 to 5)
    5.29 (4.72 to 5.92)
        Mahidol Dengue 2 Strain; Post-first vaccination
    11.7 (8.57 to 16.1)
    6.69 (4.99 to 8.96)
        Mahidol Dengue 2 Strain; Pre-second vaccination
    6.48 (5.57 to 7.55)
    5.47 (4.56 to 6.56)
        Mahidol Dengue 2 Strain; Post-second vaccination
    9.32 (7.4 to 11.7)
    6.48 (4.76 to 8.83)
        Mahidol Dengue 2 Strain; Pre-third vaccination
    5.48 (5 to 6.01)
    6.18 (4.85 to 7.88)
        Mahidol Dengue 2 Strain; Post-third vaccination
    11.9 (9 to 15.7)
    9.6 (6.54 to 14.1)
    Statistical analysis title
    P-value test comparing GMT pre- and post-injection
    Statistical analysis description
    P-values for tests comparing GMTs after vaccinations between vaccine groups are adjusted on age groups. ANCOVA models performed on Log10 distributions after vaccinations adjusted on age groups and on Log10 distributions before vaccinations.
    Comparison groups
    Study Group 1 v Study Group 2
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    other [11]
    P-value
    = 0.0003 [12]
    Method
    ANCOVA
    Confidence interval
    Notes
    [11] - Intra-group comparisons were assessed in pre-first, second, and third injection (inj.) vs. post-first, second, and third inj.
    [12] - Grp 1; Parental: Pre-each inj. vs. Post-each inj. was P=0.0003, 0.6049; and 0.8375, respectively. Mahidol: P=0.0033, 0.1651, and 0.0759. Grp 2; Parental: P=0.0003, 0.6049, 0.8375. Mahidol: P=0.0033, 0.1651, and 0.0759.

    Primary: Geometric Mean Titers of Neutralizing Antibodies Against Dengue Serotype Strain 3 Before and Following Each Injection with Sanofi Pasteur's CYD Dengue Vaccine and Yellow Fever Vaccine (Stamaril Pasteur®)

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    End point title
    Geometric Mean Titers of Neutralizing Antibodies Against Dengue Serotype Strain 3 Before and Following Each Injection with Sanofi Pasteur's CYD Dengue Vaccine and Yellow Fever Vaccine (Stamaril Pasteur®)
    End point description
    Neutralizing antibody levels against each of the four parental dengue virus serotype strains of ChimeriVax™Dengue Tetravalent Vaccine constructs and against the Thai Mahidol four dengue virus serotype strains were assessed using the Plaque Reduction Neutralization Test (PRNT).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-first, second, and third vaccination) and Day 28 post-first, second, and third post-vaccination
    End point values
    Study Group 1 Study Group 2
    Number of subjects analysed
    84
    42
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Parental Dengue 3 Strain; Pre-first vaccination
    5.11 (4.96 to 5.26)
    5 (5 to 5)
        Parental Dengue 3 Strain; Post-first vaccination
    15.5 (11.5 to 20.9)
    5.7 (4.84 to 6.71)
        Parental Dengue 3 Strain; Pre-second vaccination
    11.2 (8.88 to 14.2)
    6.01 (4.98 to 7.26)
        Parental Dengue 3 Strain; Post-second vaccination
    26.8 (20.3 to 35.4)
    25.8 (17.4 to 38.3)
        Parental Dengue 3 Strain; Pre-third vaccination
    9.76 (7.84 to 12.1)
    6.93 (5.58 to 8.59)
        Parental Dengue 3 Strain; Post-third vaccination
    51.7 (41.5 to 64.4)
    48.3 (34.2 to 68.3)
        Mahidol Dengue 3 Strain; Pre-first vaccination
    5 (5 to 5)
    5.22 (4.78 to 5.71)
        Mahidol Dengue 3 Strain; Post-first vaccination
    11.6 (8.48 to 15.7)
    5.59 (4.91 to 6.36)
        Mahidol Dengue 3 Strain; Pre-second vaccination
    7.98 (6.53 to 9.74)
    5.1 (4.9 to 5.32)
        Mahidol Dengue 3 Strain; Post-second vaccination
    17 (13 to 22.2)
    10.6 (7.45 to 15.2)
        Mahidol Dengue 3 Strain; Pre-third vaccination
    6.56 (5.62 to 7.66)
    5.57 (5.01 to 6.2)
        Mahidol Dengue 3 Strain; Post-third vaccination
    24.2 (18.8 to 31.3)
    24.3 (16.1 to 36.7)
    Statistical analysis title
    P-value test comparing GMT pre- and post-injection
    Statistical analysis description
    P-values for tests comparing GMTs after vaccinations between vaccine groups are adjusted on age groups. ANCOVA models performed on Log10 distributions after vaccinations adjusted on age groups and on Log10 distributions before vaccinations.
    Comparison groups
    Study Group 1 v Study Group 2
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    other [13]
    P-value
    < 0.0001 [14]
    Method
    ANCOVA
    Confidence interval
    Notes
    [13] - Intra-group comparisons were assessed pre-first, second, and third injection (inj.) vs. post-first, second, and third inj.
    [14] - Grp 1; Parental: Pre-each inj. vs. Post-each inj. was P<0.0001, 0.2976; and 0.8712, respectively. Mahidol: P=0.0011, 0.5503, and 0.9928. Grp 2; Parental: P<0.0001, 0.2976, 0.8712. Mahidol: P=0.0011, 0.5503, and 0.9928.

    Primary: Geometric Mean Titers of Neutralizing Antibodies Against Yellow Fever Before and Following Vaccination with Sanofi Pasteur's CYD Dengue Vaccine and Yellow Fever Vaccine (Stamaril Pasteur®)

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    End point title
    Geometric Mean Titers of Neutralizing Antibodies Against Yellow Fever Before and Following Vaccination with Sanofi Pasteur's CYD Dengue Vaccine and Yellow Fever Vaccine (Stamaril Pasteur®) [15]
    End point description
    Neutralizing antibody levels against Yellow Fever antigens were assessed using the Plaque Reduction Neutralization Test (PRNT).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-first [V01] and second vaccination [V06]) and Day 28 post-first (V04) and second (V09) post-vaccination
    Notes
    [15] - 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
    Study Group 1 Study Group 2
    Number of subjects analysed
    81
    40
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        All; Pre-first inj. (V01)
    2.5 (2.5 to 2.5)
    2.5 (2.5 to 2.5)
        All; Post-first inj. (V04)
    2.88 (2.49 to 3.32)
    80.9 (53.6 to 122)
        All; Pre-second inj. (V06)
    2.66 (2.42 to 2.93)
    111 (69.5 to 178)
        All; Post-second inj. (V09)
    2.67 (2.41 to 2.95)
    176 (111 to 280)
        Adults (18-45 y); Pre-first inj. (V01)
    2.5 (2.5 to 2.5)
    2.5 (2.5 to 2.5)
        Adults (18-45 y); Post-first inj. (V04)
    2.5 (2.5 to 2.5)
    148 (69.8 to 313)
        Adults (18-45 y); Pre-second inj. (V06)
    2.5 (2.5 to 2.5)
    108 (54.7 to 212)
        Adults (18-45 y); Post-second inj. (V09)
    2.5 (2.5 to 2.5)
    147 (93.7 to 230)
        Adolescents (12-17 y); Pre-first inj. (V01)
    2.5 (2.5 to 2.5)
    2.5 (2.5 to 2.5)
        Adolescents (12-17 y); Post-first inj. (V04)
    2.69 (2.31 to 3.14)
    203 (114 to 359)
        Adolescents (12-17 y); Pre-second inj. (V06)
    2.5 (2.5 to 2.5)
    301 (169 to 536)
        Adolescents (12-17 y); Post-second inj. (V09)
    2.5 (2.5 to 2.5)
    321 (167 to 618)
        Children (6-11 y); Pre-first inj. (V01)
    2.5 (2.5 to 2.5)
    2.5 (2.5 to 2.5)
        Children (6-11 y); Post-first inj. (V04)
    2.5 (2.5 to 2.5)
    38.5 (17.2 to 86.2)
        Children (6-11 y); Pre-second inj. (V06)
    2.5 (2.5 to 2.5)
    95.7 (31.8 to 288)
        Children (6-11 y); Post-second inj. (V09)
    2.5 (2.5 to 2.5)
    167 (44.1 to 633)
        Children (2-5 y); Pre-first inj. (V01)
    2.5 (2.5 to 2.5)
    2.5 (2.5 to 2.5)
        Children (2-5 y); Post-first inj. (V04)
    3.95 (2.32 to 6.71)
    45.6 (19.1 to 109)
        Children (2-5 y); Pre-second inj. (V06)
    3.19 (2.16 to 4.72)
    43.7 (15 to 127)
        Children (2-5 y); Post-second inj. (V09)
    3.26 (2.12 to 5)
    93.7 (26.9 to 327)
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Antibody titer ≥ 10 (1/dil) Against Yellow Fever Antigen Before and Following Vaccination with Sanofi Pasteur's CYD Dengue Vaccine and Yellow Fever Vaccine (Stamaril Pasteur®)

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    End point title
    Percentage of Subjects with Antibody titer ≥ 10 (1/dil) Against Yellow Fever Antigen Before and Following Vaccination with Sanofi Pasteur's CYD Dengue Vaccine and Yellow Fever Vaccine (Stamaril Pasteur®) [16]
    End point description
    Neutralizing antibody levels against Yellow Fever antigens were assessed using the Plaque Reduction Neutralization Test (PRNT).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-first [V01] and second vaccination [V06]) and Day 28 post-first (V04) and second (V09) post-vaccination
    Notes
    [16] - 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
    Study Group 1 Study Group 2
    Number of subjects analysed
    81
    40
    Units: Percentage of subjects
    number (not applicable)
        All; Pre-first inj. (V01)
    0
    0
        All; Post-first inj. (V04)
    4.9
    95
        All; Pre-second inj. (V06)
    1.3
    92.3
        All; Post-second inj. (V09)
    1.3
    94.4
        Adults (18-45 y); Pre-first inj. (V01)
    0
    0
        Adults (18-45 y); Post-first inj. (V04)
    0
    100
        Adults (18-45 y); Pre-second inj. (V06)
    0
    100
        Adults (18-45 y); Post-second inj. (V09)
    0
    100
        Adolescents (12-17 y); Pre-first inj. (V01)
    0
    0
        Adolescents (12-17 y); Post-first inj. (V04)
    4.2
    100
        Adolescents (12-17 y); Pre-second inj. (V06)
    0
    100
        Adolescents (12-17 y); Post-second inj. (V09)
    0
    100
        Children (6-11 y); Pre-first inj. (V01)
    0
    0
        Children (6-11 y); Post-first inj. (V04)
    0
    91.7
        Children (6-11 y); Pre-second inj. (V06)
    0
    90
        Children (6-11 y); Post-second inj. (V09)
    0
    88.9
        Children (2-5 y); Pre-first inj. (V01)
    0
    0
        Children (2-5 y); Post-first inj. (V04)
    14.3
    90
        Children (2-5 y); Pre-second inj. (V06)
    5
    81.8
        Children (2-5 y); Post-second inj. (V09)
    5.3
    88.9
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against Dengue Serotype Strain 4 Before and Following Each Injection with Sanofi Pasteur's CYD Dengue Vaccine and Yellow Fever (YF) vaccine (Stamaril Pasteur®)

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    End point title
    Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against Dengue Serotype Strain 4 Before and Following Each Injection with Sanofi Pasteur's CYD Dengue Vaccine and Yellow Fever (YF) vaccine (Stamaril Pasteur®)
    End point description
    Neutralizing antibody levels against each of the four parental dengue virus serotype strains of ChimeriVax™ Dengue Tetravalent Vaccine constructs and against the Thai Mahidol four dengue virus serotype strains were assessed using the Plaque Reduction Neutralization Test (PRNT).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-first, second, and third vaccination) and Day 28 post-first, second, and third post-vaccination
    End point values
    Study Group 1 Study Group 2
    Number of subjects analysed
    84
    42
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Parental Dengue 4 Strain; Pre-first vaccination
    5 (5 to 5)
    5 (5 to 5)
        Parental Dengue 4 Strain; Post-first vaccination
    80.4 (49.2 to 131)
    6.74 (4.69 to 9.69)
        Parental Dengue 4 Strain; Pre-second vaccination
    21.9 (16 to 29.9)
    5.9 (4.88 to 7.14)
        Parental Dengue 4 Strain; Post-second vaccination
    47.2 (36 to 61.8)
    54.8 (28.5 to 105)
        Parental Dengue 4 Strain; Pre-third vaccination
    17.8 (13.3 to 23.9)
    16.7 (10.8 to 26)
        Parental Dengue 4 Strain; Post-third vaccination
    71.7 (54.7 to 93.9)
    85.1 (57.7 to 126)
        Mahidol Dengue 4 Strain; Pre-first vaccination
    5.48 (5.08 to 5.91)
    5.13 (4.87 to 5.41)
        Mahidol Dengue 4 Strain; Post-first vaccination
    155 (94 to 256)
    8.46 (5.45 to 13.1)
        Mahidol Dengue 4 Strain; Pre-second vaccination
    33.1 (23.6 to 46.5)
    5.83 (4.94 to 6.89)
        Mahidol Dengue 4 Strain; Post-second vaccination
    62.4 (46.6 to 83.5)
    58.7 (28.2 to 122)
        Mahidol Dengue 4 Strain; Pre-third vaccination
    20.7 (15.4 to 27.8)
    16.1 (10 to 25.7)
        Mahidol Dengue 4 Strain; Post-third vaccination
    82.4 (63.5 to 107)
    74.7 (50.8 to 110)
    Statistical analysis title
    P-value test comparing GMT pre- and post-injection
    Statistical analysis description
    P-values for tests comparing GMTS after vaccinations between vaccine groups are adjusted on age groups. ANCOVA models performed on Log10 distributions after vaccinations adjusted on age groups and on Log10 distributions before vaccinations.
    Comparison groups
    Study Group 1 v Study Group 2
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    other [17]
    P-value
    < 0.0001 [18]
    Method
    ANCOVA
    Confidence interval
    Notes
    [17] - Intra-group comparisons were assessed in pre-first, second, and third injection (inj.) vs. post-first, second, and third inj.
    [18] - Grp 1; Parental: Pre-each inj. vs. Post-each inj. was P<0.0001, 0.0183, and 0.4596, respectively. Mahidol: P<0.0001, 0.0094, and 0.7019. Grp 2; Parental: P<0.0001, 0.0183, 0.4596. Mahidol: P<0.0001, 0.0094, and 0.7019.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events data were collected from Day 0 up to 28 days after each vaccination.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    7.1
    Reporting groups
    Reporting group title
    CYD TV/CYD TV
    Reporting group description
    Subjects who received Sanofi Pasteur’s ChimeriVax™ dengue Tetravalent Vaccine (CYD TV; serotypes 1, 2, 3, and 4) as first, second, and third injections on Day 0, Day 0 + 3.5 months, and Day 0 + 12 months.

    Reporting group title
    YFV/CYD
    Reporting group description
    Stamaril Pasteur® as first injection on Day 0 and sanofi pasteur’s CYD TV (serotypes 1, 2, 3, and 4) as second and third injections on Day 0 + 3.5 months and Day 0 + 12 months, respectively.

    Serious adverse events
    CYD TV/CYD TV YFV/CYD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 84 (2.38%)
    2 / 42 (4.76%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Partial seizures
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Hepatitis A
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    CYD TV/CYD TV YFV/CYD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 84 (38.10%)
    11 / 42 (26.19%)
    Nervous system disorders
    Headache; Post-first vaccination
    alternative assessment type: Systematic
         subjects affected / exposed
    32 / 84 (38.10%)
    8 / 42 (19.05%)
         occurrences all number
    32
    8
    General disorders and administration site conditions
    Inj. site Pain; Post-third vaccination
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    26 / 73 (35.62%)
    8 / 35 (22.86%)
         occurrences all number
    26
    8
    Inj. site Erythema; Post-second vaccination
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    10 / 77 (12.99%)
    3 / 39 (7.69%)
         occurrences all number
    10
    3
    Inj. site Edema; Post-third vaccination
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    5 / 73 (6.85%)
    3 / 35 (8.57%)
         occurrences all number
    5
    3
    Fever; Post-second vaccination
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    11 / 77 (14.29%)
    4 / 39 (10.26%)
         occurrences all number
    11
    4
    Malaise; Post-first vaccination
    alternative assessment type: Systematic
         subjects affected / exposed
    21 / 84 (25.00%)
    7 / 42 (16.67%)
         occurrences all number
    21
    7
    Asthenia; Post-second vaccination
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    14 / 77 (18.18%)
    8 / 39 (20.51%)
         occurrences all number
    14
    8
    Musculoskeletal and connective tissue disorders
    Myalgia; Post-first vaccination
    alternative assessment type: Systematic
         subjects affected / exposed
    24 / 84 (28.57%)
    11 / 42 (26.19%)
         occurrences all number
    24
    11
    Notes
    [1] - 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 of 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.
    [2] - 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 of 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.
    [3] - 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 of 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.
    [4] - 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 of 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.
    [5] - 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 of 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.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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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