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    Clinical Trial Results:
    Long-Term Safety Follow-Up of Thai Children Who Were Included in an Efficacy Study of a Tetravalent Dengue Vaccine

    Summary
    EudraCT number
    		 2014-001737-88
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date

    Results information
    Results version number
    		 v1
    This version publication date
    19 May 2016
    First version publication date
    19 May 2016
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CYD57
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01983553
    WHO universal trial number (UTN)
    		 U1111-1127-7380
    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 Thailand, Sanofi Pasteur SA, 66 2264 8813, Danaya.chansinghakul@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur Thailand, Sanofi Pasteur SA, 66 2264 8813, Danaya.chansinghakul@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?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    05 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Sep 2014
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study is to evaluate the continuous long-term follow-up of hospitalized dengue and safety of subjects who received CYD dengue vaccine in study CYD23 (EudraCT No. 2014-001710-25) including retrospective data collection (i.e., including the blood samples collected from March 05th, 2012 to September 9th, 2013) and prospective data collection from CYD57 study start (September 10th, 2013) until the end of the study, and the following activities will be performed. 1) To describe the incidence of virologically-confirmed hospitalized dengue cases. 2) To characterize hospitalized dengue cases. 3) To evaluate the occurrence of related and fatal SAEs.
    Protection of trial subjects
    Subjects were vaccinated in a previous study, CYD23. No vaccination was administered as part of this study.
    Background therapy
    		 In study CYD23, subjects age 4 to 11 were randomized to receive 3 injections of either CYD dengue vaccine or control, 1 each at 0, 6, and 12 months. Those that received at least one injection were eligible to be included in this follow-up study.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    10 Sep 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 4 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Thailand: 3203
    Worldwide total number of subjects
    3203
    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)
    3203
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study subjects were enrolled in the original study CYD23 from 10 September 2013 to 29 November 2013 at 1 clinic center in Thailand.

    Pre-assignment
    Screening details
    		 Of the 3997 subjects who were treated in the original study, CYD23 a total of 3203 subjects were included in the 4-year safety follow-up CYD57 study.

    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, Monitor, Assessor
    Blinding implementation details
    Subjects and site staff remained blinded to the treatment allocation in CYD23 until the end of the study (CYD57) to avoid any bias in the safety follow-up (detection of dengue cases) until the second year of the follow-up study. In the event of an emergency (i.e., serious adverse event), the code of CYD57 could be broken by the Investigator as explained in the code-breaking procedures described in the Operating Guidelines.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CYD Dengue Vaccine Group
    Arm description
    		 Subjects received 3 injections of CYD dengue vaccine, 1 injection each at 0, 6, and 12 months in study CYD23.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CYD Dengue 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
    0.5 mL, subcutaneous, 1 injection each at 0, 6, and 12 months in the initial CYD23 study

    Arm title
    		 Control Group
    Arm description
    		 Subjects received either Rabies vaccine (Verorab®) or placebo control as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the original CYD23 study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Rabies vaccine (Verorab®)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, 1 injection of either Verorab or placebo as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the original CYD23 study

    Investigational medicinal product name
    Placebo (sodium chloride)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, 1 injection of either Verorab or placebo as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the original CYD23 study

    Number of subjects in period 1
    		CYD Dengue Vaccine Group Control Group
    Started
    2131
    1072
    Completed
    2131
    1072

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CYD Dengue Vaccine Group
    Reporting group description
    		 Subjects received 3 injections of CYD dengue vaccine, 1 injection each at 0, 6, and 12 months in study CYD23.

    Reporting group title
    Control Group
    Reporting group description
    		 Subjects received either Rabies vaccine (Verorab®) or placebo control as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the original CYD23 study.

    Reporting group values
    		 CYD Dengue Vaccine Group Control Group Total
    Number of subjects
    		 2131 1072 3203
    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)
    		 2131 1072 3203
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.11 ± 2.02 8.15 ± 2.06 -
    Gender categorical
    Units: Subjects
        Female
    		 1118 579 1697
        Male
    		 1013 493 1506

    End points

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    End points reporting groups
    Reporting group title
    CYD Dengue Vaccine Group
    Reporting group description
    		 Subjects received 3 injections of CYD dengue vaccine, 1 injection each at 0, 6, and 12 months in study CYD23.

    Reporting group title
    Control Group
    Reporting group description
    		 Subjects received either Rabies vaccine (Verorab®) or placebo control as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the original CYD23 study.

    Primary: Annual Incidence of Hospitalized Virologically-Confirmed Dengue Due to Any and Each Serotype Collected During the Year 1 and Year 2 Passive Surveillance Following Vaccination with Either CYD Dengue Vaccine or a Placebo in a Previous Study

    		 Close Top of page
    End point title
    		 Annual Incidence of Hospitalized Virologically-Confirmed Dengue Due to Any and Each Serotype Collected During the Year 1 and Year 2 Passive Surveillance Following Vaccination with Either CYD Dengue Vaccine or a Placebo in a Previous Study
    End point description
    Annual incidence rate was defined as the cases among the number of subjects present at the beginning of each period (M) multiplied by 100 converted in annual rate (Annual incidence rate = Cases among M*100).
    End point type
    Primary
    End point timeframe
    Year 1 and Year 2 post-vaccination
    End point values
    		 CYD Dengue Vaccine Group Control Group
    Number of subjects analysed
    2131
    1072
    Units: Annual incidence rate
    number (confidence interval 95%)
        Year 1: Any of the 4 Serotypes
    1.1 (0.7 to 1.7)
    1.1 (0.6 to 2)
        Year 1: Serotype 1
    0.3 (0.1 to 0.6)
    0.5 (0.2 to 1.2)
        Year 1: Serotype 2
    0.9 (0.5 to 1.4)
    0.4 (0.1 to 1)
        Year 1: Serotype 3
    0.1 (0 to 0.3)
    0.1 (0 to 0.6)
        Year 1: Serotype 4
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Unserotyped
    0 (0 to 0.2)
    0.2 (0 to 0.7)
        Year 2: Any of the 4 Serotypes
    0.8 (0.4 to 1.2)
    1.6 (0.9 to 2.5)
        Year 2: Serotype 1
    0.2 (0.1 to 0.5)
    0.3 (0.1 to 0.8)
        Year 2: Serotype 2
    0.2 (0.1 to 0.5)
    0.6 (0.2 to 1.2)
        Year 2: Serotype 3
    0.3 (0.1 to 0.6)
    0.3 (0.1 to 0.8)
        Year 2: Serotype 4
    0.1 (0 to 0.3)
    0.4 (0.1 to 1)
        Year 2: Unserotyped
    0 (0 to 0.2)
    0.1 (0 to 0.5)
    Statistical analysis title
    		 Relative risk; Year 1; Any of the 4 Serotypes
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 1 Any of the 4 Serotypes between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    1.006
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 2.3
    Notes
    [1] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative risk; Year 1; Serotype 1
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 1 Serotype 1 between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0.503
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.12
         upper limit
    		 2.19
    Notes
    [2] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative risk; Year 1; Serotype 2
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 1 Serotype 2 between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    2.138
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 8.73
    Statistical analysis title
    		 Relative risk; Year 1; Serotype 3
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 1 Serotype 3 between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0.503
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.01
         upper limit
    		 39.49
    Notes
    [3] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative risk; Year 1; Serotype 4
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 1 Serotype 4 between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Notes
    [4] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative risk; Year 1; Unserotyped
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 1 Unserotyped between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 2.68
    Notes
    [5] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative risk; Year 2; Any of the 4 Serotypes
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 2 Any of the 4 Serotypes between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Relative risk of annual incidence rate
    Point estimate
    0.473
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.22
         upper limit
    		 1
    Statistical analysis title
    		 Relative risk; Year 2; Serotype 1
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 2 Serotype 1 between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0.671
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.11
         upper limit
    		 4.58
    Notes
    [6] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative risk; Year 2; Serotype 2
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 2 Serotype 2 between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0.335
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.07
         upper limit
    		 1.41
    Notes
    [7] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative risk; Year 2; Serotype 3
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 1 Serotype 3 between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    1.006
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.21
         upper limit
    		 6.22
    Notes
    [8] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative risk; Year 2; Serotype 4
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 1 Serotype 4 between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0.252
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.02
         upper limit
    		 1.76
    Notes
    [9] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative risk; Year 2; Unserotyped
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 1 Unserotyped between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 19.62
    Notes
    [10] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.

    Primary: Number of Cases and Episodes of Hospitalized Virologically-Confirmed Dengue Due to Any and Each Serotype Collected During Year I and Year 2 Passive Surveillance Following Vaccination with Either CYD Dengue Vaccine or a Placebo in a Previous Study

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    End point title
    		 Number of Cases and Episodes of Hospitalized Virologically-Confirmed Dengue Due to Any and Each Serotype Collected During Year I and Year 2 Passive Surveillance Following Vaccination with Either CYD Dengue Vaccine or a Placebo in a Previous Study [11]
    End point description
    Cases were defined as the number of subjects with at least one hospitalized virologically-confirmed dengue episode. Episodes were defined as the number of hospitalized virologically-confirmed dengue episodes.
    End point type
    Primary
    End point timeframe
    Year 1 and Year 2 post-vaccination
    Notes
    [11] - 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
    		 CYD Dengue Vaccine Group Control Group
    Number of subjects analysed
    2131
    1072
    Units: Number of cases and episodes of dengue
    number (not applicable)
        Year 1 Cases; Any of the 4 Serotypes
    22
    11
        Year 1 Episodes; Any of the 4 Serotypes
    22
    11
        Year 1 Cases; Serotype 1
    5
    5
        Year 1 Episodes; Serotype 1
    5
    5
        Year 1 Cases; Serotype 2
    17
    4
        Year 1 Episodes; Serotype 2
    17
    4
        Year 1 Cases; Serotype 3
    1
    1
        Year 1 Episodes; Serotype 3
    1
    1
        Year 1 Cases; Serotype 4
    0
    0
        Year 1 Episodes; Serotype 4
    0
    0
        Year 1 Cases; Unserotyped
    0
    2
        Year 1 Episodes; Unserotyped
    0
    2
        Year 2 Cases; Any of the 4 Serotypes
    16
    17
        Year 2 Episodes; Any of the 4 Serotypes
    16
    17
        Year 2 Cases; Serotype 1
    4
    3
        Year 2 Episodes; Serotype 1
    4
    3
        Year 2 Cases; Serotype 2
    4
    6
        Year 2 Episodes; Serotype 2
    4
    6
        Year 2 Cases; Serotype 3
    6
    3
        Year 2 Episodes; Serotype 3
    6
    3
        Year 2 Cases; Serotype 4
    2
    4
        Year 2 Episodes; Serotype 4
    2
    4
        Year 2 Cases; Unserotyped
    0
    1
        Year 2 Episodes; Unserotyped
    0
    1
    No statistical analyses for this end point

    Primary: Annual Incidence of Hospitalized Virologically-Confirmed Dengue Due to Any and Each Serotype Collected By Age Group During the Year I and Year 2 Passive Surveillance Following Vaccination with Either CYD Dengue Vaccine or a Placebo in a Previous Study

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    End point title
    		 Annual Incidence of Hospitalized Virologically-Confirmed Dengue Due to Any and Each Serotype Collected By Age Group During the Year I and Year 2 Passive Surveillance Following Vaccination with Either CYD Dengue Vaccine or a Placebo in a Previous Study
    End point description
    Annual incidence rate was defined as the cases among the number of subjects present at the beginning of each period (M) multiplied by 100 converted in annual rate (Annual incidence rate = Cases among M*100).
    End point type
    Primary
    End point timeframe
    Year 1 and Year 2 post-vaccination
    End point values
    		 CYD Dengue Vaccine Group Control Group
    Number of subjects analysed
    2131
    1072
    Units: Annual incidence rate
    number (confidence interval 95%)
        Year 1, 4 to 5 Years: Any of the 4 Serotypes
    1.4 (0.5 to 3.2)
    0.6 (0 to 3.1)
        Year 1, 6 to 11 Years: Any of the 4 Serotypes
    1.1 (0.6 to 1.7)
    1.2 (0.6 to 2.3)
        Year 1, 4 to 5 Years: Serotype 1
    0.6 (0.1 to 2)
    0 (0 to 2.1)
        Year 1, 6 to 11 Years: Serotype 1
    0.2 (0 to 0.5)
    0.6 (0.2 to 1.4)
        Year 1, 4 to 5 Years: Serotype 2
    1.1 (0.3 to 2.8)
    0 (0 to 2.1)
        Year 1, 6 to 11 Years: Serotype 2
    0.8 (0.4 to 1.4)
    0.5 (0.1 to 1.3)
        Year 1, 4 to 5 Years: Serotype 3
    0 (0 to 1)
    0 (0 to 2.1)
        Year 1, 6 to 11 Years: Serotype 3
    0.1 (0 to 0.3)
    0.1 (0 to 0.7)
        Year 1, 4 to 5 Years: Serotype 4
    0 (0 to 1)
    0 (0 to 2.1)
        Year 1, 6 to 11 Years: Serotype 4
    0 (0 to 0.2)
    0 (0 to 0.5)
        Year 1, 4 to 5 Years: Unserotyped
    0 (0 to 1)
    0.6 (0 to 3.1)
        Year 1, 6 to 11 Years: Unserotyped
    0 (0 to 0.2)
    0.1 (0 to 0.7)
        Year 2, 4 to 5 Years: Any of the 4 Serotypes
    1.3 (0.4 to 2.9)
    1.6 (0.3 to 4.5)
        Year 2, 6 to 11 Years: Any of the 4 Serotypes
    0.6 (0.3 to 1.1)
    1.6 (0.9 to 2.7)
        Year 2, 4 to 5 Years: Serotype 1
    1 (0.3 to 2.6)
    0 (0 to 1.9)
        Year 2, 6 to 11 Years: Serotype 1
    0 (0 to 0.2)
    0.3 (0.1 to 1)
        Year 2, 4 to 5 Years: Serotype 2
    0 (0 to 0.9)
    0.5 (0 to 2.9)
        Year 2, 6 to 11 Years: Serotype 2
    0.2 (0.1 to 0.6)
    0.6 (0.2 to 1.3)
        Year 2, 4 to 5 Years: Serotype 3
    0.3 (0 to 1.4)
    0.5 (0 to 2.9)
        Year 2, 6 to 11 Years: Serotype 3
    0.3 (0.1 to 0.7)
    0.2 (0 to 0.8)
        Year 2, 4 to 5 Years: Serotype 4
    0 (0 to 0.9)
    0 (0 to 1.9)
        Year 2, 6 to 11 Years: Serotype 4
    0.1 (0 to 0.4)
    0.5 (0.1 to 1.2)
        Year 2, 4 to 5 Years: Unserotyped
    0 (0 to 0.9)
    0.5 (0 to 2.9)
        Year 2, 6 to 11 Years: Unserotyped
    0 (0 to 0.2)
    0 (0 to 0.4)
    Statistical analysis title
    		 Relative Risk; Yr 1; 4 to 5 years; Any Serotype
    Statistical analysis description
    Relative risk (RR) analysis of the annual incidence rate at Year 1 Any of the 4 Serotypes (4 to 5 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [12]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    2.443
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.27
         upper limit
    		 115.54
    Notes
    [12] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 1; 6 to 11 years; Any Serotype
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 1 Any of the 4 Serotypes (6 to 11 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0.861
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 2.1
    Notes
    [13] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 1; 4 to 5 years; Serotype 1
    Statistical analysis description
    Relative risk (RR) analysis of the annual incidence rate at Year 1 Serotype 1 (4 to 5 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [14]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Notes
    [14] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 1; 6 to 11 years; Serotype 1
    Statistical analysis description
    Relative risk (RR) analysis of the annual incidence rate at Year 1 Serotype 1 (6 to 11 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0.304
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.05
         upper limit
    		 1.56
    Notes
    [15] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 1; 4 to 5 years; Serotype 2
    Statistical analysis description
    Relative risk (RR) analysis of the annual incidence rate at Year 1 Serotype 2 (4 to 5 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [16]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Notes
    [16] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 1; 6 to 11 years; Serotype 2
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 1 Serotype 2 (6 to 11 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [17]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    1.646
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 6.93
    Notes
    [17] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 1; 4 to 5 years; Serotype 3
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 1 Serotype 3 (4 to 5 year) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [18]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Notes
    [18] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 1; 6 to 11 years; Serotype 3
    Statistical analysis description
    Relative risk (RR) analysis of the annual incidence rate at Year 1 Serotype 3 (6 to 11 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [19]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0.506
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.01
         upper limit
    		 39.75
    Notes
    [19] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 1; 4 to 5 years; Serotype 4
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 1 Serotype 4 (4 to 5 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [20]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Notes
    [20] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 1; 6 to 11 years; Serotype 4
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 1 Serotype 4 (6 to 11 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [21]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Notes
    [21] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 1; 4 to 5 years; Unserotyped
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 1 Unserotyped (4 to 5 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [22]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 19.05
    Notes
    [22] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 1; 6 to 11 years; Unserotyped
    Statistical analysis description
    Relative risk (RR) analysis of the annual incidence rate at Year 1 Unserotyped (6 to 11 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [23]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 19.75
    Notes
    [23] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 2; 4 to 5 years; Any Serotype
    Statistical analysis description
    Relative risk (RR) analysis of the annual incidence rate at Year 2 Any of the 4 Serotypes (4 to 5 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [24]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0.814
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.16
         upper limit
    		 5.24
    Notes
    [24] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 2; 6 to 11 years; Any Serotype
    Statistical analysis description
    Relative risk (RR) analysis of the annual incidence rate at Year 2 Any of the 4 Serotypes (6 to 11 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [25]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0.398
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.16
         upper limit
    		 0.94
    Notes
    [25] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 2; 4 to 5 years; Serotype 1
    Statistical analysis description
    Relative risk (RR) analysis of the annual incidence rate at Year 2 Serotype 1 (4 to 5 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [26]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Notes
    [26] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 2; 6 to 11 years; Serotype 1
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 2 Serotype 1 (6 to 11 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [27]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 1.23
    Notes
    [27] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 2; 4 to 5 years; Serotype 2
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 2 Serotype 2 (4 to 5 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [28]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 19.05
    Notes
    [28] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 2; 6 to 11 years; Serotype 2
    Statistical analysis description
    Relative risk (RR) analysis of the annual incidence rate at Year 2 Serotype 2 (6 to 11 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [29]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0.405
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.08
         upper limit
    		 1.88
    Notes
    [29] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 2; 4 to 5 years; Serotype 3
    Statistical analysis description
    Relative risk (RR) analysis of the annual incidence rate at Year 2 Serotype 3 (4 to 5 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [30]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0.489
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.01
         upper limit
    		 38.35
    Notes
    [30] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 2; 6 to 11 years; Serotype 3
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 2 Serotype 3 (6 to 11 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    Control Group v CYD Dengue Vaccine Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [31]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    1.266
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.21
         upper limit
    		 13.29
    Notes
    [31] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 2; 4 to 5 years; Serotype 4
    Statistical analysis description
    Relative risk (RR) analysis of the annual incidence rate at Year 2 Serotype 4 (4 to 5 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [32]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Notes
    [32] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 2; 6 to 11 years; Serotype 4
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 2 Serotype 4 (6 to 11 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [33]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0.253
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.02
         upper limit
    		 1.77
    Notes
    [33] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 2; 4 to 5 years; Unserotyped
    Statistical analysis description
    Relative risk (RR) analysis of the annual incidence rate at Year 2 Unserotyped (4 to 5 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [34]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 19.05
    Notes
    [34] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 2; 6 to 11 years; Unserotyped
    Statistical analysis description
    Relative risk analysis of the annual incidence rate at Year 2 Unserotyped (6 to 11 years) between the CYD Dengue vaccine group and the Control group.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [35]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Notes
    [35] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.

    Primary: Number of Cases and Episodes of Hospitalized Virologically-Confirmed Dengue Due to Any and Each Serotype Collected By Age Group During Year I and Year 2 Passive Surveillance After Vaccination with Either CYD Dengue Vaccine or a Placebo in a Previous Study

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    End point title
    		 Number of Cases and Episodes of Hospitalized Virologically-Confirmed Dengue Due to Any and Each Serotype Collected By Age Group During Year I and Year 2 Passive Surveillance After Vaccination with Either CYD Dengue Vaccine or a Placebo in a Previous Study [36]
    End point description
    Cases were defined as the number of subjects with at least one hospitalized virologically-confirmed dengue episode. Episodes were defined as the number of hospitalized virologically-confirmed dengue episodes.
    End point type
    Primary
    End point timeframe
    Year 1 and Year 2 post-vaccination
    Notes
    [36] - 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
    		 CYD Dengue Vaccine Group Control Group
    Number of subjects analysed
    2131
    1072
    Units: Number of cases and episodes of dengue
    number (not applicable)
        Year 1, 4 to 5 years cases: Any of the 4 Serotypes
    5
    1
        Year 1, 4 to 5 yrs episodes:Any of the 4 Serotypes
    5
    1
        Year 1, 6 to 11 yrs cases: Any of the 4 Serotypes
    17
    10
        Yr 1, 6 to 11 yrs episodes: Any of the 4 Serotypes
    17
    10
        Year 1, 4 to 5 years cases: Serotype 1
    2
    0
        Year 1, 4 to 5 years episodes: Serotype 1
    2
    0
        Year 1, 6 to 11 years cases: Serotype 1
    3
    5
        Year 1, 6 to 11 years episodes: Serotype 1
    3
    5
        Year 1, 4 to 5 years cases: Serotype 2
    4
    0
        Year 1, 4 to 5 years episodes: Serotype 2
    4
    0
        Year 1, 6 to 11 years cases: Serotype 2
    13
    4
        Year 1, 6 to 11 years episodes: Serotype 2
    13
    4
        Year 1, 4 to 5 years cases: Serotype 3
    0
    0
        Year 1, 4 to 5 years episodes: Serotype 3
    0
    0
        Year 1, 6 to 11 years cases: Serotype 3
    1
    1
        Year 1, 6 to 11 years episodes: Serotype 3
    1
    1
        Year 1, 4 to 5 years cases: Serotype 4
    0
    0
        Year 1, 4 to 5 years episodes: Serotype 4
    0
    0
        Year 1, 6 to 11 years cases: Serotype 4
    0
    0
        Year 1, 6 to 11 years episodes: Serotype 4
    0
    0
        Year 1, 4 to 5 years cases: Unserotyped
    0
    1
        Year 1, 4 to 5 years episodes: Unserotyped
    0
    1
        Year 1, 6 to 11 years cases: Unserotyped
    0
    1
        Year 1, 6 to 11 years epsiodes: Unserotyped
    0
    1
        Year 2, 4 to 5 years cases: Any of the 4 Serotypes
    5
    3
        Year 2, 4 to 5 yrs episodes:Any of the 4 Serotypes
    5
    3
        Year 2, 6 to 11 yrs cases: Any of the 4 Serotypes
    11
    14
        Yr 2, 6 to 11 yrs episodes: Any of the 4 Serotypes
    11
    14
        Year 2, 4 to 5 years cases: Serotype 1
    4
    0
        Year 2, 4 to 5 years episodes: Serotype 1
    4
    0
        Year 2, 6 to 11 years cases: Serotype 1
    0
    3
        Year 2, 6 to 11 years episodes: Serotype 1
    0
    3
        Year 2, 4 to 5 years cases: Serotype 2
    0
    1
        Year 2, 4 to 5 years episodes: Serotype 2
    0
    1
        Year 2, 6 to 11 years cases: Serotype 2
    4
    5
        Year 2, 6 to 11 years episodes: Serotype 2
    4
    5
        Year 2, 4 to 5 years cases: Serotype 3
    1
    1
        Year 2, 4 to 5 years episodes: Serotype 3
    1
    1
        Year 2, 6 to 11 years cases: Serotype 3
    5
    2
        Year 2, 6 to 11 years episodes: Serotype 3
    5
    2
        Year 2, 4 to 5 years cases: Serotype 4
    0
    0
        Year 2, 4 to 5 years episodes: Serotype 4
    0
    0
        Year 2, 6 to 11 years cases: Serotype 4
    2
    4
        Year 2, 6 to 11 years episodes: Serotype 4
    2
    4
        Year 2, 4 to 5 years cases: Unserotyped
    0
    1
        Year 2, 4 to 5 years episodes: Unserotyped
    0
    1
        Year 2, 6 to 11 years cases: Unserotyped
    0
    0
        Year 2, 6 to 11 years episodes: Unserotyped
    0
    0
    No statistical analyses for this end point

    Primary: Annual Incidence of Clinically Severe Hospitalized Virologically-Confirmed Dengue Due to Any and Each Serotype Collected During the Year I and Year 2 Passive Surveillance After Vaccination with Either CYD Dengue Vaccine or a Placebo in a Previous Study

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    End point title
    		 Annual Incidence of Clinically Severe Hospitalized Virologically-Confirmed Dengue Due to Any and Each Serotype Collected During the Year I and Year 2 Passive Surveillance After Vaccination with Either CYD Dengue Vaccine or a Placebo in a Previous Study [37]
    End point description
    Annual incidence rate was defined as the cases among the number of subjects present at the beginning of each period (M) multiplied by 100 converted in annual rate (Annual incidence rate = Cases among M*100).
    End point type
    Primary
    End point timeframe
    Year 1 and Year 2 post-vaccination
    Notes
    [37] - 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
    		 CYD Dengue Vaccine Group Control Group
    Number of subjects analysed
    2131
    1072
    Units: Annual incidence rate
    number (confidence interval 95%)
        Year 1: Any of the 4 Serotypes
    0.2 (0.1 to 0.5)
    0 (0 to 0.4)
        Year 1: Serotype 1
    0.2 (0.1 to 0.5)
    0 (0 to 0.4)
        Year 1: Serotype 2
    0.1 (0 to 0.3)
    0 (0 to 0.4)
        Year 1: Serotype 3
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Serotype 4
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Unserotyped
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 2: Any of the 4 Serotypes
    0.1 (0 to 0.3)
    0.2 (0 to 0.7)
        Year 2: Serotype 1
    0.1 (0 to 0.3)
    0 (0 to 0.3)
        Year 2: Serotype 2
    0 (0 to 0.2)
    0.1 (0 to 0.5)
        Year 2: Serotype 3
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Serotype 4
    0 (0 to 0.2)
    0.1 (0 to 0.5)
        Year 2: Unserotyped
    0 (0 to 0.2)
    0 (0 to 0.3)
    No statistical analyses for this end point

    Primary: Number of Cases and Episodes of Clinically Severe Hospitalized Virologically-Confirmed Dengue Due to Any and Each Serotype Collected During the Year I and Year 2 Passive Surveillance After Vaccination with CYD Dengue Vaccine or Placebo in a Previous Study

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    End point title
    		 Number of Cases and Episodes of Clinically Severe Hospitalized Virologically-Confirmed Dengue Due to Any and Each Serotype Collected During the Year I and Year 2 Passive Surveillance After Vaccination with CYD Dengue Vaccine or Placebo in a Previous Study [38]
    End point description
    Cases were defined as the number of subjects with at least one hospitalized virologically-confirmed dengue episode. Episodes were defined as the number of hospitalized virologically-confirmed dengue episodes.
    End point type
    Primary
    End point timeframe
    Year 1 and Year 2 post-vaccination
    Notes
    [38] - 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
    		 CYD Dengue Vaccine Group Control Group
    Number of subjects analysed
    2131
    1072
    Units: Number of cases and episodes
    number (not applicable)
        Year 1 Cases: Any of the 4 Serotypes
    4
    0
        Year 1 Episodes: Any of the 4 Serotypes
    4
    0
        Year 1 Cases: Serotype 1
    4
    0
        Year 1 Episodes: Serotype 1
    4
    0
        Year 1 Cases: Serotype 2
    1
    0
        Year 1 Episodes: Serotype 2
    1
    0
        Year 1 Cases: Serotype 3
    0
    0
        Year 1 Episodes: Serotype 3
    0
    0
        Year 1 Cases: Serotype 4
    0
    0
        Year 1 Episodes: Serotype 4
    0
    0
        Year 1 Cases: Unserotyped
    0
    0
        Year 1 Episodes: Unserotyped
    0
    0
        Year 2 Cases: Any of the 4 Serotypes
    1
    2
        Year 2 Episodes: Any of the 4 Serotypes
    1
    2
        Year 2 Cases: Serotype 1
    1
    0
        Year 2 Episodes: Serotype 1
    1
    0
        Year 2 Cases: Serotype 2
    0
    1
        Year 2 Episodes: Serotype 2
    0
    1
        Year 2 Cases: Serotype 3
    0
    0
        Year 2 Episodes: Serotype 3
    0
    0
        Year 2 Cases: Serotype 4
    0
    1
        Year 2 Episodes: Serotype 4
    0
    1
        Year 2 Cases: Unserotyped
    0
    0
        Year 2 Episodes: Unserotyped
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects with Non-Serotype Specific Dengue Viremia Among Hospitalized Virologically-Confirmed Dengue Cases Occurring During the Year I and Year 2 Passive Surveillance After Vaccination with CYD Dengue Vaccine or Placebo in a Previous Study

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    End point title
    		 Number of Subjects with Non-Serotype Specific Dengue Viremia Among Hospitalized Virologically-Confirmed Dengue Cases Occurring During the Year I and Year 2 Passive Surveillance After Vaccination with CYD Dengue Vaccine or Placebo in a Previous Study [39]
    End point description
    Quantified viremia was defined as ≥ lower limit of quantitation (log10 pfu/mL).
    End point type
    Primary
    End point timeframe
    Year 1, Year 2, and entire period post-vaccination at each of the following time points: Anytime, 0-3 days, 4-7 days, 0-7 days, After 7 days.
    Notes
    [39] - 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
    		 CYD Dengue Vaccine Group Control Group
    Number of subjects analysed
    2131
    1072
    Units: Number of subjects
    number (not applicable)
        Year 1, Cases - Anytime
    19
    9
        Year 1, Mean Viremia - Anytime
    3.98
    3.93
        Year 1, Cases - 0-3 days
    7
    3
        Year 1, Mean Viremia - 0-3 days
    4.34
    4.84
        Year 1, Cases - 4-7 days
    12
    5
        Year 1, Mean Viremia - 4-7 days
    3.77
    3.42
        Year 1, Cases - 0-7 days
    19
    8
        Year 1, Mean Viremia - 0-7 days
    3.98
    3.95
        Year 1, Cases - After 7 days
    0
    1
        Year 1, Mean Viremia - After 7 days
    0
    3.72
        Year 2, Cases - Anytime
    15
    16
        Year 2, Mean Viremia - Anytime
    3.75
    3.36
        Year 2, Cases - 0-3 days
    6
    5
        Year 2, Mean Viremia - 0-3 days
    4.64
    3.85
        Year 2, Cases - 4-7 days
    9
    10
        Year 2, Mean Viremia - 4-7 days
    3.16
    2.9
        Year 2, Cases - 0-7 days
    15
    15
        Year 2, Mean Viremia - 0-7 days
    3.75
    3.22
        Year 2, Cases - After 7 days
    0
    1
        Year 2, Mean Viremia - After 7 days
    0
    5.58
        Entire period, Cases - Anytime
    34
    25
        Entire period, Mean Viremia - Anytime
    3.88
    3.57
        Entire period, Cases - 0-3 days
    13
    8
        Entire period, Mean Viremia - 0-3 days
    4.48
    4.22
        Entire period, Cases - 4-7 days
    21
    15
        Entire period, Mean Viremia - 4-7 days
    3.51
    3.07
        Entire period, Cases - 0-7 days
    34
    23
        Entire period, Mean Viremia - 0-7 days
    3.88
    3.47
        Entire period, Cases - After 7 days
    0
    2
        Entire period, Mean Viremia - After 7 days
    0
    4.65
    No statistical analyses for this end point

    Primary: Annual Incidence of Hospitalized Virologically-Confirmed Dengue Cases Due to Any and Each Serotype and Meeting WHO 1997 Criteria Collected During Year I and Year 2 Passive Surveillance After Previous Vaccination with Either CYD Dengue Vaccine or Placebo

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    End point title
    		 Annual Incidence of Hospitalized Virologically-Confirmed Dengue Cases Due to Any and Each Serotype and Meeting WHO 1997 Criteria Collected During Year I and Year 2 Passive Surveillance After Previous Vaccination with Either CYD Dengue Vaccine or Placebo
    End point description
    Annual incidence rate was defined as the cases among the number of subjects present at the beginning of each period (M) multiplied by 100 converted in annual rate (Annual incidence rate = Cases among M*100).
    End point type
    Primary
    End point timeframe
    Year 1 and Year 2 post-vaccination
    End point values
    		 CYD Dengue Vaccine Group Control Group
    Number of subjects analysed
    2131
    1072
    Units: Annual incidence rate
    number (confidence interval 95%)
        Year 1: Any of the 4 Serotypes Any grade
    0.2 (0.1 to 0.5)
    0 (0 to 0.4)
        Year 1: Any of the 4 Serotypes Grade I
    0.1 (0 to 0.3)
    0 (0 to 0.4)
        Year 1: Any of the 4 Serotypes Grade II
    0.1 (0 to 0.3)
    0 (0 to 0.4)
        Year 1: Any of the 4 Serotypes Grade III
    0.1 (0 to 0.4)
    0 (0 to 0.4)
        Year 1: Any of the 4 Serotypes Grade IV
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Serotype 1 Any grade
    0.2 (0.1 to 0.5)
    0 (0 to 0.4)
        Year 1: Serotype 1 Grade I
    0.1 (0 to 0.3)
    0 (0 to 0.4)
        Year 1: Serotype 1 Grade II
    0.1 (0 to 0.3)
    0 (0 to 0.4)
        Year 1: Serotype 1 Grade III
    0.1 (0 to 0.4)
    0 (0 to 0.4)
        Year 1: Serotype 1 Grade IV
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Serotype 2 Any grade
    0.1 (0 to 0.3)
    0 (0 to 0.4)
        Year 1: Serotype 2 Grade I
    0.1 (0 to 0.3)
    0 (0 to 0.4)
        Year 1: Serotype 2 Grade II
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Serotype 2 Grade III
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Serotype 2 Grade IV
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Serotype 3 Any grade
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Serotype 3 Grade I
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Serotype 3 Grade II
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Serotype 3 Grade III
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Serotype 3 Grade IV
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Serotype 4 Any grade
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Serotype 4 Grade I
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Serotype 4 Grade II
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Serotype 4 Grade III
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Serotype 4 Grade IV
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Unserotyped Any grade
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Unserotyped Grade I
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Unserotyped Grade II
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Unserotyped Grade III
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 1: Unserotyped Grade IV
    0 (0 to 0.2)
    0 (0 to 0.4)
        Year 2: Any of the 4 Serotypes Any grade
    0.1 (0 to 0.3)
    0.2 (0 to 0.7)
        Year 2: Any of the 4 Serotypes Grade I
    0 (0 to 0.2)
    0.2 (0 to 0.7)
        Year 2: Any of the 4 Serotypes Grade II
    0.1 (0 to 0.3)
    0 (0 to 0.3)
        Year 2: Any of the 4 Serotypes Grade III
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Any of the 4 Serotypes Grade IV
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Serotype 1 Any grade
    0.1 (0 to 0.3)
    0 (0 to 0.3)
        Year 2: Serotype 1 Grade I
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Serotype 1 Grade II
    0.1 (0 to 0.3)
    0 (0 to 0.3)
        Year 2: Serotype 1 Grade III
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Serotype 1 Grade IV
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Serotype 2 Any grade
    0 (0 to 0.2)
    0.1 (0 to 0.5)
        Year 2: Serotype 2 Grade I
    0 (0 to 0.2)
    0.1 (0 to 0.5)
        Year 2: Serotype 2 Grade II
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Serotype 2 Grade III
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Serotype 2 Grade IV
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Serotype 3 Any grade
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Serotype 3 Grade I
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Serotype 3 Grade II
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Serotype 3 Grade III
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Serotype 3 Grade IV
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Serotype 4 Any grade
    0 (0 to 0.2)
    0.1 (0 to 0.5)
        Year 2: Serotype 4 Grade I
    0 (0 to 0.2)
    0.1 (0 to 0.5)
        Year 2: Serotype 4 Grade II
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Serotype 4 Grade III
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Serotype 4 Grade IV
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Unserotyped Any grade
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Unserotyped Grade I
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Unserotyped Grade II
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Unserotyped Grade III
    0 (0 to 0.2)
    0 (0 to 0.3)
        Year 2: Unserotyped Grade IV
    0 (0 to 0.2)
    0 (0 to 0.3)
    Statistical analysis title
    		 Relative Risk; Year 2; Any serotype; Any grade
    Statistical analysis description
    Relative risk (RR) analysis of the annual incidence rate at Year 2 Any of the 4 Serotypes Any grade between the CYD Dengue vaccine group and the Control group. The RR was not calculated for Year 1 and is reported for only those serotypes and grades calculated in Year 2.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [40]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0.252
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 4.83
    Notes
    [40] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 2; Any serotype; Grade I
    Statistical analysis description
    Relative risk (RR) analysis of the annual incidence rate at Year 2 Any of the 4 Serotypes Grade I between the CYD Dengue vaccine group and the Control group. The RR was not calculated for Year 1 and is reported for only those serotypes and grades calculated in Year 2.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [41]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 2.68
    Notes
    [41] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 2; Serotype 2; Any grade
    Statistical analysis description
    Relative risk (RR) analysis of the annual incidence rate at Year 2 Serotype 2 Any grade between the CYD Dengue vaccine group and the Control group. The RR was not calculated for Year 1 and is reported for only those serotypes and grades calculated in Year 2.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [42]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 19.62
    Notes
    [42] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 2; Serotype 2; Grade I
    Statistical analysis description
    Relative risk (RR) analysis of the annual incidence rate at Year 2 Serotype 2 Grade I between the CYD Dengue vaccine group and the Control group. The RR was not calculated for Year 1 and is reported for only those serotypes and grades calculated in Year 2.
    Comparison groups
    Control Group v CYD Dengue Vaccine Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [43]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 19.62
    Notes
    [43] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 2; Serotype 4; Any grade
    Statistical analysis description
    Relative risk (RR) analysis of the annual incidence rate at Year 2 Serotype 4 Any grade between the CYD Dengue vaccine group and the Control group. The RR was not calculated for Year 1 and is reported for only those serotypes and grades calculated in Year 2.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [44]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 19.62
    Notes
    [44] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.
    Statistical analysis title
    		 Relative Risk; Year 2; Serotype 4; Grade I
    Statistical analysis description
    Relative risk (RR) analysis of the annual incidence rate at Year 2 Serotype 4 Grade I between the CYD Dengue vaccine group and the Control group. The RR was not calculated for Year 1 and is reported for only those serotypes and grades calculated in Year 2.
    Comparison groups
    CYD Dengue Vaccine Group v Control Group
    Number of subjects included in analysis
    3203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [45]
    Method
    Parameter type
    		 Relative Risk
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 19.62
    Notes
    [45] - The 95% confidence interval of the relative risk is calculated using the Exact method described by Breslow and Day.

    Primary: Number of Cases and Episodes of Hospitalized Virologically-Confirmed Dengue Cases Due to Any and Each Serotype and Meeting WHO 1997 Criteria Collected In Year I and Year 2 Passive Surveillance After Previous Vaccination with CYD Dengue Vaccine or Placebo

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    End point title
    		 Number of Cases and Episodes of Hospitalized Virologically-Confirmed Dengue Cases Due to Any and Each Serotype and Meeting WHO 1997 Criteria Collected In Year I and Year 2 Passive Surveillance After Previous Vaccination with CYD Dengue Vaccine or Placebo [46]
    End point description
    Cases were defined as the number of subjects with at least one hospitalized virologically-confirmed dengue episode meeting WHO criteria. Episodes are defined as the number of hospitalized virologically-confirmed dengue episodes meeting WHO criteria. Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test. Grade II: Spontaneous bleeding in addition to the manifestations of Grade I patients, usually in the form of skin and/or other hemorrhages. Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness. Grade IV: Profound shock with undetectable blood pressure and pulse.
    End point type
    Primary
    End point timeframe
    Year 1 and Year 2 post-vaccination
    Notes
    [46] - 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
    		 CYD Dengue Vaccine Group Control Group
    Number of subjects analysed
    2131
    1072
    Units: Number of cases and episodes
    number (not applicable)
        Year 1 Cases: Any of the 4 Serotypes Any grade
    4
    0
        Year 1 Episodes: Any of the 4 Serotypes Any grade
    4
    0
        Year 1 Cases: Any of the 4 Serotypes Grade I
    1
    0
        Year 1 Episodes: Any of the 4 Serotypes Grade I
    1
    0
        Year 1 Cases: Any of the 4 Serotypes Grade II
    1
    0
        Year 1 Episodes: Any of the 4 Serotypes Grade II
    1
    0
        Year 1 Cases: Any of the 4 Serotypes Grade III
    2
    0
        Year 1 Episodes: Any of the 4 Serotypes Grade III
    2
    0
        Year 1 Cases: Any of the 4 Serotypes Grade IV
    0
    0
        Year 1 Episodes: Any of the 4 Serotypes Grade IV
    0
    0
        Year 1 Cases: Serotype 1 Any grade
    4
    0
        Year 1 Episodes: Serotype 1 Any grade
    4
    0
        Year 1 Cases: Serotype 1 Grade I
    1
    0
        Year 1 Episodes: Serotype 1 Grade I
    1
    0
        Year 1 Cases: Serotype 1 Grade II
    1
    0
        Year 1 Episodes: Serotype 1 Grade II
    1
    0
        Year 1 Cases: Serotype 1 Grade III
    2
    0
        Year 1 Episodes: Serotype 1 Grade III
    2
    0
        Year 1 Cases: Serotype 1 Grade IV
    0
    0
        Year 1 Episodes: Serotype 1 Grade IV
    0
    0
        Year 1 Cases: Serotype 2 Any grade
    1
    0
        Year 1 Episodes: Serotype 2 Any grade
    1
    0
        Year 1 Cases: Serotype 2 Grade I
    1
    0
        Year 1 Episodes: Serotype 2 Grade I
    1
    0
        Year 1 Cases: Serotype 2 Grade II
    0
    0
        Year 1 Episodes: Serotype 2 Grade II
    0
    0
        Year 1 Cases: Serotype 2 Grade III
    0
    0
        Year 1 Episodes: Serotype 2 Grade III
    0
    0
        Year 1 Cases: Serotype 2 Grade IV
    0
    0
        Year 1 Episodes: Serotype 2 Grade IV
    0
    0
        Year 1 Cases: Serotype 3 Any grade
    0
    0
        Year 1 Episodes: Serotype 3 Any grade
    0
    0
        Year 1 Cases: Serotype 3 Grade I
    0
    0
        Year 1 Episodes: Serotype 3 Grade I
    0
    0
        Year 1 Cases: Serotype 3 Grade II
    0
    0
        Year 1 Episodes: Serotype 3 Grade II
    0
    0
        Year 1 Cases: Serotype 3 Grade III
    0
    0
        Year 1 Episodes: Serotype 3 Grade III
    0
    0
        Year 1 Cases: Serotype 3 Grade IV
    0
    0
        Year 1 Episodes: Serotype 3 Grade IV
    0
    0
        Year 1 Cases: Serotype 4 Any grade
    0
    0
        Year 1 Episodes: Serotype 4 Any grade
    0
    0
        Year 1 Cases: Serotype 4 Grade I
    0
    0
        Year 1 Episodes: Serotype 4 Grade I
    0
    0
        Year 1 Cases: Serotype 4 Grade II
    0
    0
        Year 1 Episodes: Serotype 4 Grade II
    0
    0
        Year 1 Cases: Serotype 4 Grade III
    0
    0
        Year 1 Episodes: Serotype 4 Grade III
    0
    0
        Year 1 Cases: Serotype 4 Grade IV
    0
    0
        Year 1 Episodes: Serotype 4 Grade IV
    0
    0
        Year 1 Cases: Unserotyped Any grade
    0
    0
        Year 1 Episodes: Unserotyped Any grade
    0
    0
        Year 1 Cases: Unserotyped Grade I
    0
    0
        Year 1 Episodes: Unserotyped Grade I
    0
    0
        Year 1 Cases: Unserotyped Grade II
    0
    0
        Year 1 Episodes: Unserotyped Grade II
    0
    0
        Year 1 Cases: Unserotyped Grade III
    0
    0
        Year 1 Episodes: Unserotyped Grade III
    0
    0
        Year 1 Cases: Unserotyped Grade IV
    0
    0
        Year 1 Episodes: Unserotyped Grade IV
    0
    0
        Year 2 Cases: Any of the 4 Serotypes Any grade
    1
    2
        Year 2 Episodes: Any of the 4 Serotypes Any grade
    1
    2
        Year 2 Cases: Any of the 4 Serotypes Grade I
    0
    2
        Year 2 Episodes: Any of the 4 Serotypes Grade I
    0
    2
        Year 2 Cases: Any of the 4 Serotypes Grade II
    1
    0
        Year 2 Episodes: Any of the 4 Serotypes Grade II
    1
    0
        Year 2 Cases: Any of the 4 Serotypes Grade III
    0
    0
        Year 2 Episodes: Any of the 4 Serotypes Grade III
    0
    0
        Year 2 Cases: Any of the 4 Serotypes Grade IV
    0
    0
        Year 2 Episodes: Any of the 4 Serotypes Grade IV
    0
    0
        Year 2 Cases: Serotype 1 Any grade
    1
    0
        Year 2 Episodes: Serotype 1 Any grade
    1
    0
        Year 2 Cases: Serotype 1 Grade I
    0
    0
        Year 2 Episodes: Serotype 1 Grade I
    0
    0
        Year 2 Cases: Serotype 1 Grade II
    1
    0
        Year 2 Episodes: Serotype 1 Grade II
    1
    0
        Year 2 Cases: Serotype 1 Grade III
    0
    0
        Year 2 Episodes: Serotype 1 Grade III
    0
    0
        Year 2 Cases: Serotype 1 Grade IV
    0
    0
        Year 2 Episodes: Serotype 1 Grade IV
    0
    0
        Year 2 Cases: Serotype 2 Any grade
    0
    1
        Year 2 Episodes: Serotype 2 Any grade
    0
    1
        Year 2 Cases: Serotype 2 Grade I
    0
    1
        Year 2 Episodes: Serotype 2 Grade I
    0
    1
        Year 2 Cases: Serotype 2 Grade II
    0
    0
        Year 2 Episodes: Serotype 2 Grade II
    0
    0
        Year 2 Cases: Serotype 2 Grade III
    0
    0
        Year 2 Episodes: Serotype 2 Grade III
    0
    0
        Year 2 Cases: Serotype 2 Grade IV
    0
    0
        Year 2 Episodes: Serotype 2 Grade IV
    0
    0
        Year 2 Cases: Serotype 3 Any grade
    0
    0
        Year 2 Episodes: Serotype 3 Any grade
    0
    0
        Year 2 Cases: Serotype 3 Grade I
    0
    0
        Year 2 Episodes: Serotype 3 Grade I
    0
    0
        Year 2 Cases: Serotype 3 Grade II
    0
    0
        Year 2 Episodes: Serotype 3 Grade II
    0
    0
        Year 2 Cases: Serotype 3 Grade III
    0
    0
        Year 2 Episodes: Serotype 3 Grade III
    0
    0
        Year 2 Cases: Serotype 3 Grade IV
    0
    0
        Year 2 Episodes: Serotype 3 Grade IV
    0
    0
        Year 2 Cases: Serotype 4 Any grade
    0
    1
        Year 2 Episodes: Serotype 4 Any grade
    0
    1
        Year 2 Cases: Serotype 4 Grade I
    0
    1
        Year 2 Episodes: Serotype 4 Grade I
    0
    1
        Year 2 Cases: Serotype 4 Grade II
    0
    0
        Year 2 Episodes: Serotype 4 Grade II
    0
    0
        Year 2 Cases: Serotype 4 Grade III
    0
    0
        Year 2 Episodes: Serotype 4 Grade III
    0
    0
        Year 2 Cases: Serotype 4 Grade IV
    0
    0
        Year 2 Episodes: Serotype 4 Grade IV
    0
    0
        Year 2 Cases: Unserotyped Any grade
    0
    0
        Year 2 Episodes: Unserotyped Any grade
    0
    0
        Year 2 Cases: Unserotyped Grade I
    0
    0
        Year 2 Episodes: Unserotyped Grade I
    0
    0
        Year 2 Cases: Unserotyped Grade II
    0
    0
        Year 2 Episodes: Unserotyped Grade II
    0
    0
        Year 2 Cases: Unserotyped Grade III
    0
    0
        Year 2 Episodes: Unserotyped Grade III
    0
    0
        Year 2 Cases: Unserotyped Grade IV
    0
    0
        Year 2 Episodes: Unserotyped Grade IV
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    This study involved a passive surveillance of hospitalized dengue cases in subjects that participated in a previous study. No vaccine were administered in the study and adverse event data were also not collected.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: This was a long-term immunogenicity follow-up study of subjects who participated in the primary study. No vaccines were administered in the follow-up study and adverse event data were also not collected.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jan 2014
    Additional clarifications were added to the study objectives.
    17 Feb 2014
    Study objectives were further updated and statistical analyses were revised.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/22975340
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