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

    Summary
    EudraCT number
    2014-001534-29
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    11 Sep 2012

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

    Trial information

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    Trial identification
    Sponsor protocol code
    CYD05
    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, 69367
    Public contact
    Senior Director, Clinical Development, Sanofi Pasteur SA, 65 6431 2358, Anh.Wartel-Tram@sanofipasteur.com
    Scientific contact
    Senior Director, Clinical Development, Sanofi Pasteur SA, 65 6431 2358, Anh.Wartel-Tram@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
    29 Apr 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Sep 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Safety and reactogenicity Dengue immune responses and Persistence of antibodies
    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
    The Typhim Vi vaccine was chosen as a control vaccine since typhoid fever is endemic in the Philippines and the vaccine is not administered routinely. Therefore, it represented a benefit for the subjects.
    Actual start date of recruitment
    02 Mar 2006
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy
    Long term follow-up duration
    5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Philippines: 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 09 March 2006 to 01 September 2007 at 1 clinical center in the Philippines.

    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 randomized.

    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 approach was used for the first injection to ensure unbiased safety evaluation. Qualified and trained study personnel prepared the vaccines for each subject and were therefore the only ones to know which vaccine was administered at the first injection. The CYD dengue vaccine was used as open-label for the second and third injections in all subjects.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Group 1
    Arm description
    Subjects received the CYD dengue vaccine for all three injections, one each on Days 0, 105, and 365, respectively.
    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, subcutaneous use, 3 injections on Days 0, 135, and 365.

    Arm title
    Group 2
    Arm description
    Subjects received typhoid vaccine (Typhim Vi) as first injection and CYD dengue vaccine as second and third injections 8 to 9 months apart (Days 105 and 365).
    Arm type
    Active comparator

    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, subcutaneous, 2 injections. One each on Days 105 and 365.

    Investigational medicinal product name
    Typhoid vaccine
    Investigational medicinal product code
    Other name
    Typhim Vi
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, 1 injection on Day 0.

    Number of subjects in period 1
    Group 1 Group 2
    Started
    84
    42
    Completed
    80
    39
    Not completed
    4
    3
         Protocol deviation
             1
             1
         Adverse event, non-fatal
             3
             1
         Consent withdrawn by subject
             -
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1
    Reporting group description
    Subjects received the CYD dengue vaccine for all three injections, one each on Days 0, 105, and 365, respectively.

    Reporting group title
    Group 2
    Reporting group description
    Subjects received typhoid vaccine (Typhim Vi) as first injection and CYD dengue vaccine as second and third injections 8 to 9 months apart (Days 105 and 365).

    Reporting group values
    Group 1 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)
    12.2 ± 8.3 12.2 ± 9.5 -
    Gender categorical
    Units: Subjects
        Female
    41 27 68
        Male
    43 15 58
    Study sub-groups by age
    Study subjects were also categorized into 4 subgroups based on their ages 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
    Group 1
    Reporting group description
    Subjects received the CYD dengue vaccine for all three injections, one each on Days 0, 105, and 365, respectively.

    Reporting group title
    Group 2
    Reporting group description
    Subjects received typhoid vaccine (Typhim Vi) as first injection and CYD dengue vaccine as second and third injections 8 to 9 months apart (Days 105 and 365).

    Primary: Percentage of Subjects with Antibody titer ≥ 10 (1/dil) Against Each Serotype with the Parental Dengue Virus Strains Before and Following each Injection with ChimeriVax™ Dengue Tetravalent Vaccine

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    End point title
    Percentage of Subjects with Antibody titer ≥ 10 (1/dil) Against Each Serotype with the Parental Dengue Virus Strains Before and Following each Injection with ChimeriVax™ Dengue Tetravalent Vaccine [1]
    End point description
    The immune response against the CYD dengue vaccine was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 105 and 365 post-vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    Group 1 Group 2
    Number of subjects analysed
    84
    42
    Units: Percentage of subjects
    number (not applicable)
        All subjects; Serotype 1; Pre-Inj. 1
    54.9
    63.4
        All subjects; Serotype 1; Post-Inj. 2
    80.5
    75.7
        All subjects; Serotype 1; Post-Inj. 3
    93.4
    100
        All subjects; Serotype 2; Pre-Inj. 1
    57.3
    69
        All subjects; Serotype 2; Post-Inj. 2
    96.3
    82.1
        All subjects; Serotype 2; Post-Inj. 3
    98.7
    100
        All subjects; Serotype 3; Pre-Inj. 1
    69.5
    76.2
        All subjects; Serotype 3; Post-Inj. 2
    100
    94.6
        All subjects; Serotype 3; Post-Inj. 3
    100
    100
        All subjects; Serotype 4; Pre-Inj. 1
    63.4
    71.4
        All subjects; Serotype 4; Post-Inj. 2
    97.6
    94.6
        All subjects; Serotype 4; Post-Inj. 3
    97.4
    100
        18-45 years; Serotype 1; Pre-Inj. 1
    100
    83.3
        18-45 years; Serotype 1; Post-Inj. 2
    100
    100
        18-45 years; Serotype 1; Post-Inj. 3
    100
    100
        18-45 years; Serotype 2; Pre-Inj. 1
    100
    100
        18-45 years; Serotype 2; Post-Inj. 2
    100
    100
        18-45 years; Serotype 2; Post-Inj. 3
    100
    100
        18-45 years; Serotype 3; Pre-Inj. 1
    100
    83.3
        18-45 years; Serotype 3; Post-Inj. 2
    100
    100
        18-45 years; Serotype 3; Post-Inj. 3
    100
    100
        18-45 years; Serotype 4; Pre-Inj. 1
    100
    83.3
        18-45 years; Serotype 4; Post-Inj. 2
    100
    100
        18-45 years; Serotype 4; Post-Inj. 3
    100
    100
        12-17 years; Serotype 1; Pre-Inj. 1
    70.8
    83.3
        12-17 years; Serotype 1; Post-Inj. 2
    87.5
    90.9
        12-17 years; Serotype 1; Post-Inj. 3
    81.8
    100
        12-17 years; Serotype 2; Pre-Inj. 1
    66.7
    91.7
        12-17 years; Serotype 2; Post-Inj. 2
    91.7
    90.9
        12-17 years; Serotype 2; Post-Inj. 3
    95.7
    100
        12-17 years; Serotype 3; Pre-Inj. 1
    79.2
    83.3
        12-17 years; Serotype 3; Post-Inj. 2
    100
    90.9
        12-17 years; Serotype 3; Post-Inj. 3
    100
    100
        12-17 years; Serotype 4; Pre-Inj. 1
    70.8
    83.3
        12-17 years; Serotype 4; Post-Inj. 2
    95.8
    90.9
        12-17 years; Serotype 4; Post-Inj. 3
    100
    100
        6-11 years; Serotype 1; Pre-Inj. 1
    39.1
    72.7
        6-11 years; Serotype 1; Post-Inj. 2
    75
    80
        6-11 years; Serotype 1; Post-Inj. 3
    100
    100
        6-11 years; Serotype 2; Pre-Inj. 1
    47.8
    58.3
        6-11 years; Serotype 2; Post-Inj. 2
    95.8
    72.7
        6-11 years; Serotype 2; Post-Inj. 3
    100
    100
        6-11 years; Serotype 3; Pre-Inj. 1
    56.5
    83.3
        6-11 years; Serotype 3; Post-Inj. 2
    100
    100
        6-11 years; Serotype 3; Post-Inj. 3
    100
    100
        6-11 years; Serotype 4; Pre-Inj. 1
    52.2
    75
        6-11 years; Serotype 4; Post-Inj. 2
    95.8
    90.9
        6-11 years; Serotype 4; Post-Inj. 3
    100
    100
        2-5 years; Serotype 1; Pre-Inj. 1
    33.3
    25
        2-5 years; Serotype 1; Post-Inj. 2
    68.2
    45.5
        2-5 years; Serotype 1; Post-Inj. 3
    95.5
    100
        2-5 years; Serotype 2; Pre-Inj. 1
    37.5
    41.7
        2-5 years; Serotype 2; Post-Inj. 2
    100
    72.7
        2-5 years; Serotype 2; Post-Inj. 3
    100
    100
        2-5 years; Serotype 3; Pre-Inj. 1
    58.3
    58.3
        2-5 years; Serotype 3; Post-Inj. 2
    100
    88.9
        2-5 years; Serotype 3; Post-Inj. 3
    100
    100
        2-5 years; Serotype 4; Pre-Inj. 1
    50
    50
        2-5 years; Serotype 4; Post-Inj. 2
    100
    100
        2-5 years; Serotype 4; Post-Inj. 3
    90.9
    100
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Antibody titer ≥ 10 (1/dil) Against at least 1, 2, 3 or 4 Serotypes with the Parental Dengue Virus Strains Following Injection with ChimeriVax™ Dengue Tetravalent Vaccine

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    End point title
    Percentage of Subjects with Antibody titer ≥ 10 (1/dil) Against at least 1, 2, 3 or 4 Serotypes with the Parental Dengue Virus Strains Following Injection with ChimeriVax™ Dengue Tetravalent Vaccine
    End point description
    The immune response against the CYD dengue vaccine was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and Days 105 and 365 post-vaccination
    End point values
    Group 1 Group 2
    Number of subjects analysed
    84
    42
    Units: Percentage of subjects
    number (not applicable)
        All subjects; At least 1 serotype (Pre-Inj. 1)
    73.2
    85.7
        All subjects; At least 1 serotype (Post-Inj. 2)
    100
    97.4
        All subjects; At least 1 serotype (Post-Inj. 3)
    100
    100
        All subjects; At least 2 serotypes (Pre-Inj. 1)
    63.4
    73.8
        All subjects; At least 2 serotypes (Post-Inj. 2)
    98.8
    87.2
        All subjects; At least 2 serotypes (Post-Inj. 3)
    100
    94.9
        All subjects; At least 3 serotypes (Pre-Inj. 1)
    57.3
    64.3
        All subjects; At least 3 serotypes (Post-Inj. 2)
    96.3
    76.9
        All subjects; At least 3 serotypes (Post-Inj. 3)
    98.7
    84.6
        All subjects; All 4 serotypes (Pre-Inj. 1)
    51.2
    54.8
        All subjects; All 4 serotypes (Post-Inj. 2)
    79.3
    71.8
        All subjects; All 4 serotypes (Post-Inj. 3)
    88.5
    64.1
        18-45 years; At least 1 serotype (Pre-Inj. 1)
    100
    100
        18-45 years; At least 1 serotype (Post-Inj. 2)
    100
    100
        18-45 years; At least 1 serotype (Post-Inj. 3)
    100
    100
        18-45 years; At least 2 serotypes (Pre-Inj. 1)
    100
    83.3
        18-45 years; At least 2 serotypes (Post-Inj. 2)
    100
    100
        18-45 years; At least 2 serotypes (Post-Inj. 3)
    100
    100
        18-45 years; At least 3 serotypes (Pre-Inj. 1)
    100
    83.3
        18-45 years; At least 3 serotypes (Post-Inj. 2)
    100
    100
        18-45 years; At least 3 serotypes (Post-Inj. 3)
    100
    100
        18-45 years; All 4 serotypes (Pre-Inj. 1)
    100
    83.3
        18-45 years; All 4 serotypes (Post-Inj. 2)
    100
    83.3
        18-45 years; All 4 serotypes (Post-Inj. 3)
    88.9
    83.3
        12-17 years; At least 1 serotype (Pre-Inj. 1)
    83.3
    91.7
        12-17 years; At least 1 serotype (Post-Inj. 2)
    100
    90.9
        12-17 years; At least 1 serotype (Post-Inj. 3)
    100
    100
        12-17 years; At least 2 serotypes (Pre-Inj. 1)
    75
    91.7
        12-17 years; At least 2 serotypes (Post-Inj. 2)
    100
    90.9
        12-17 years; At least 2 serotypes (Post-Inj. 3)
    100
    100
        12-17 years; At least 3 serotypes (Pre-Inj. 1)
    66.7
    83.3
        12-17 years; At least 3 serotypes (Post-Inj. 2)
    91.7
    90.9
        12-17 years; At least 3 serotypes (Post-Inj. 3)
    95.7
    100
        12-17 years; All 4 serotypes (Pre-Inj. 1)
    62.5
    75
        12-17 years; All 4 serotypes (Post-Inj. 2)
    83.3
    90.9
        12-17 years; All 4 serotypes (Post-Inj. 3)
    78.3
    81.8
        6-11 years; At least 1 serotype (Pre-Inj. 1)
    65.2
    91.7
        6-11 years; At least 1 serotype (Post-Inj. 2)
    100
    100
        6-11 years; At least 1 serotype (Post-Inj. 3)
    100
    100
        6-11 years; At least 2 serotypes (Pre-Inj. 1)
    47.8
    75
        6-11 years; At least 2 serotypes (Post-Inj. 2)
    95.8
    90.9
        6-11 years; At least 2 serotypes (Post-Inj. 3)
    100
    90.9
        6-11 years; At least 3 serotypes (Pre-Inj. 1)
    47.8
    58.3
        6-11 years; At least 3 serotypes (Post-Inj. 2)
    95.8
    72.7
        6-11 years; At least 3 serotypes (Post-Inj. 3)
    100
    63.6
        6-11 years; All 4 serotypes (Pre-Inj. 1)
    34.8
    58.3
        6-11 years; All 4 serotypes (Post-Inj. 2)
    75
    72.7
        6-11 years; All 4 serotypes (Post-Inj. 3)
    100
    54.5
        2-5 years; At least 1 serotype (Pre-Inj. 1)
    58.3
    66.7
        2-5 years; At least 1 serotype (Post-Inj. 2)
    100
    100
        2-5 years; At least 1 serotype (Post-Inj. 3)
    100
    100
        2-5 years; At least 2 serotypes (Pre-Inj. 1)
    50
    50
        2-5 years; At least 2 serotypes (Post-Inj. 2)
    100
    72.7
        2-5 years; At least 2 serotypes (Post-Inj. 3)
    100
    90.9
        2-5 years; At least 3 serotypes (Pre-Inj. 1)
    37.5
    41.7
        2-5 years; At least 3 serotypes (Post-Inj. 2)
    100
    54.5
        2-5 years; At least 3 serotypes (Post-Inj. 3)
    100
    81.8
        2-5 years; All 4 serotypes (Pre-Inj. 1)
    33.3
    16.7
        2-5 years; All 4 serotypes (Post-Inj. 2)
    68.2
    45.5
        2-5 years; All 4 serotypes (Post-Inj. 3)
    86.4
    45.5
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype with the Parental Dengue Virus Strain Before and Following Injection with ChimeriVax™ Dengue Tetravalent Vaccine

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    End point title
    Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype with the Parental Dengue Virus Strain Before and Following Injection with ChimeriVax™ Dengue Tetravalent Vaccine
    End point description
    Geometric mean titers against each serotype of the Parental Dengue Virus strains were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and Days 105 and 365 post-vaccination
    End point values
    Group 1 Group 2
    Number of subjects analysed
    84
    42
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        All subjects; Serotype 1; Pre-Inj. 1
    44 (26.1 to 74.1)
    82.6 (35.7 to 191)
        All subjects; Serotype 1; Post-Inj. 2
    119 (72.4 to 196)
    170 (73.8 to 391)
        All subjects; Serotype 1; Post-Inj. 3
    152 (98.4 to 235)
    279 (145 to 538)
        All subjects; Serotype 2; Pre-Inj. 1
    51.3 (31.1 to 84.7)
    71.7 (36.2 to 142)
        All subjects; Serotype 2; Post-Inj. 2
    272 (189 to 392)
    185 (91.6 to 375)
        All subjects; Serotype 2; Post-Inj. 3
    287 (207 to 398)
    461 (293 to 725)
        All subjects; Serotype 3; Pre-Inj. 1
    54.1 (35.5 to 82.3)
    107 (54.9 to 210)
        All subjects; Serotype 3; Post-Inj. 2
    379 (284 to 507)
    380 (210 to 687)
        All subjects; Serotype 3; Post-Inj. 3
    304 (240 to 385)
    674 (431 to 1052)
        All subjects; Serotype 4; Pre-Inj. 1
    48.9 (31.6 to 75.9)
    56.6 (31.4 to 102)
        All subjects; Serotype 4; Post-Inj. 2
    266 (195 to 362)
    241 (140 to 414)
        All subjects; Serotype 4; Post-Inj. 3
    228 (171 to 303)
    330 (227 to 479)
        18-45 years; Serotype 1; Pre-Inj. 1
    208 (106 to 410)
    756 (47.3 to 12069)
        18-45 years; Serotype 1; Post-Inj. 2
    626 (381 to 1029)
    2623 (663 to 10377)
        18-45 years; Serotype 1; Post-Inj. 3
    315 (183 to 543)
    599 (110 to 3273)
        18-45 years; Serotype 2; Pre-Inj. 1
    422 (183 to 974)
    491 (99.3 to 2428)
        18-45 years; Serotype 2; Post-Inj. 2
    911 (555 to 1495)
    904 (505 to 1618)
        18-45 years; Serotype 2; Post-Inj. 3
    702 (431 to 1145)
    618 (366 to 1042)
        18-45 years; Serotype 3; Pre-Inj. 1
    235 (123 to 450)
    334 (31.5 to 3542)
        18-45 years; Serotype 3; Post-Inj. 2
    880 (337 to 2297)
    695 (362 to 1335)
        18-45 years; Serotype 3; Post-Inj. 3
    593 (347 to 1012)
    482 (253 to 920)
        18-45 years; Serotype 4; Pre-Inj. 1
    218 (101 to 472)
    190 (24.7 to 1469)
        18-45 years; Serotype 4; Post-Inj. 2
    491 (199 to 1214)
    827 (270 to 2528)
        18-45 years; Serotype 4; Post-Inj. 3
    230 (110 to 481)
    533 (205 to 1390)
        12-17 years; Serotype 1; Pre-Inj. 1
    112 (38.8 to 324)
    249 (59.2 to 1045)
        12-17 years; Serotype 1; Post-Inj. 2
    294 (102 to 849)
    330 (96.7 to 1128)
        12-17 years; Serotype 1; Post-Inj. 3
    261 (81.3 to 840)
    504 (166 to 1534)
        12-17 years; Serotype 2; Pre-Inj. 1
    92 (34.4 to 246)
    203 (65.9 to 625)
        12-17 years; Serotype 2; Post-Inj. 2
    383 (172 to 854)
    312 (95.9 to 1013)
        12-17 years; Serotype 2; Post-Inj. 3
    427 (199 to 920)
    528 (220 to 1269)
        12-17 years; Serotype 3; Pre-Inj. 1
    85.3 (39.1 to 186)
    259 (63.1 to 1063)
        12-17 years; Serotype 3; Post-Inj. 2
    509 (289 to 898)
    352 (81.2 to 1525)
        12-17 years; Serotype 3; Post-Inj. 3
    478 (294 to 778)
    827 (367 to 1864)
        12-17 years; Serotype 4; Pre-Inj. 1
    55.2 (26.7 to 114)
    83.7 (23.2 to 303)
        12-17 years; Serotype 4; Post-Inj. 2
    239 (139 to 409)
    173 (56.1 to 533)
        12-17 years; Serotype 4; Post-Inj. 3
    234 (161 to 340)
    241 (139 to 419)
        6-11 years; Serotype 1; Pre-Inj. 1
    19.1 (8.06 to 45.3)
    108 (18.5 to 637)
        6-11 years; Serotype 1; Post-Inj. 2
    52.3 (23.7 to 116)
    196 (29 to 1323)
        6-11 years; Serotype 1; Post-Inj. 3
    101 (53.2 to 194)
    625 (116 to 3374)
        6-11 years; Serotype 2; Pre-Inj. 1
    33.7 (12.2 to 92.5)
    39.9 (11.3 to 141)
        6-11 years; Serotype 2; Post-Inj. 2
    220 (107 to 455)
    81.6 (17.8 to 373)
        6-11 years; Serotype 2; Post-Inj. 3
    242 (127 to 459)
    364 (101 to 1304)
        6-11 years; Serotype 3; Pre-Inj. 1
    35.7 (14.5 to 88)
    92.2 (29.2 to 291)
        6-11 years; Serotype 3; Post-Inj. 2
    337 (193 to 587)
    396 (162 to 967)
        6-11 years; Serotype 3; Post-Inj. 3
    263 (164 to 424)
    390 (112 to 1358)
        6-11 years; Serotype 4; Pre-Inj. 1
    32 (12.9 to 79.4)
    57.2 (19.2 to 170)
        6-11 years; Serotype 4; Post-Inj. 2
    271 (152 to 484)
    285 (102 to 799)
        6-11 years; Serotype 4; Post-Inj. 3
    270 (159 to 459)
    373 (121 to 1148)
        2-5 years; Serotype 1; Pre-Inj. 1
    18.8 (6.79 to 52)
    7.08 (4.64 to 10.8)
        2-5 years; Serotype 1; Post-Inj. 2
    44.2 (17.5 to 111)
    22.1 (6.38 to 76.7)
        2-5 years; Serotype 1; Post-Inj. 3
    106 (52.3 to 213)
    55.5 (22.9 to 134)
        2-5 years; Serotype 2; Pre-Inj. 1
    16.3 (7.95 to 33.6)
    17.4 (4.87 to 62)
        2-5 years; Serotype 2; Post-Inj. 2
    123 (71.8 to 209)
    106 (18.5 to 604)
        2-5 years; Serotype 2; Post-Inj. 3
    158 (107 to 234)
    412 (137 to 1233)
        2-5 years; Serotype 3; Pre-Inj. 1
    26 (12.6 to 53.5)
    29.5 (9.15 to 95)
        2-5 years; Serotype 3; Post-Inj. 2
    198 (136 to 288)
    265 (45.1 to 1563)
        2-5 years; Serotype 3; Post-Inj. 3
    168 (132 to 215)
    1200 (512 to 2811)
        2-5 years; Serotype 4; Pre-Inj. 1
    32.9 (13 to 83.4)
    20.7 (7.6 to 56.4)
        2-5 years; Serotype 4; Post-Inj. 2
    210 (105 to 419)
    128 (34.3 to 482)
        2-5 years; Serotype 4; Post-Inj. 3
    182 (85.1 to 389)
    298 (95.2 to 931)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects with Antibody titer ≥ 10 (1/dil) Against Each Serotype with the Parental Dengue Virus Strains Post-injection 3 with ChimeriVax™ Dengue Tetravalent Vaccine

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    End point title
    Percentage of Subjects with Antibody titer ≥ 10 (1/dil) Against Each Serotype with the Parental Dengue Virus Strains Post-injection 3 with ChimeriVax™ Dengue Tetravalent Vaccine
    End point description
    Antibody titers against each serotype of the CYD dengue vaccine was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
    End point type
    Other pre-specified
    End point timeframe
    Post-Inj. 3 and 1, 2, 3, 4, and 5 years Post-Inj. 3
    End point values
    Group 1 Group 2
    Number of subjects analysed
    81
    39
    Units: Percentage of subjects
    number (not applicable)
        All subjects; Serotype 1; Post-Inj. 3
    93.4
    100
        All subjects; Serotype 1; 1 year Post-Inj. 3
    75.8
    81.8
        All subjects; Serotype 1; 2 years Post-Inj. 3
    84.8
    84.2
        All subjects; Serotype 1; 3 years Post-Inj. 3
    75.9
    67.6
        All subjects; Serotype 1; 4 years Post-Inj. 3
    78.5
    81.6
        All subjects; Serotype 1; 5 years Post-Inj. 3
    76.6
    83.3
        All subjects; Serotype 2; Post-Inj. 3
    98.7
    100
        All subjects; Serotype 2; 1 year Post-Inj. 3
    91
    88.2
        All subjects; Serotype 2; 2 years Post-Inj. 3
    91.1
    86.8
        All subjects; Serotype 2; 3 years Post-Inj. 3
    86.1
    83.8
        All subjects; Serotype 2; 4 years Post-Inj. 3
    86.1
    86.8
        All subjects; Serotype 2; 5 years Post-Inj. 3
    81.8
    88.9
        All subjects; Serotype 3; Post-Inj. 3
    100
    100
        All subjects; Serotype 3; 1 year Post-Inj. 3
    96.7
    96.8
        All subjects; Serotype 3; 2 years Post-Inj. 3
    92.4
    100
        All subjects; Serotype 3; 3 years Post-Inj. 3
    93.7
    91.9
        All subjects; Serotype 3; 4 years Post-Inj. 3
    87.3
    92.1
        All subjects; Serotype 3; 5 years Post-Inj. 3
    85.7
    88.9
        All subjects; Serotype 4; Post-Inj. 3
    97.4
    100
        All subjects; Serotype 4; 1 year Post-Inj. 3
    95.3
    93.3
        All subjects; Serotype 4; 2 years Post-Inj. 3
    91.1
    97.4
        All subjects; Serotype 4; 3 years Post-Inj. 3
    89.9
    89.2
        All subjects; Serotype 4; 4 years Post-Inj. 3
    86.1
    92.1
        All subjects; Serotype 4; 5 years Post-Inj. 3
    87
    94.4
        18-45 years; Serotype 1; Post-Inj. 3
    100
    100
        18-45 years; Serotype 1; 1 year Post-Inj. 3
    100
    100
        18-45 years; Serotype 1; 2 years Post-Inj. 3
    100
    100
        18-45 years; Serotype 1; 3 years Post-Inj. 3
    100
    80
        18-45 years; Serotype 1; 4 years Post-Inj. 3
    100
    100
        18-45 years; Serotype 1; 5 years Post-Inj. 3
    100
    80
        18-45 years; Serotype 2; Post-Inj. 3
    100
    100
        18-45 years; Serotype 2; 1 year Post-Inj. 3
    100
    100
        18-45 years; Serotype 2; 2 years Post-Inj. 3
    100
    100
        18-45 years; Serotype 2; 3 years Post-Inj. 3
    100
    100
        18-45 years; Serotype 2; 4 years Post-Inj. 3
    100
    100
        18-45 years; Serotype 2; 5 years Post-Inj. 3
    100
    100
        18-45 years; Serotype 3; Post-Inj. 3
    100
    100
        18-45 years; Serotype 3; 1 year Post-Inj. 3
    100
    100
        18-45 years; Serotype 3; 2 years Post-Inj. 3
    100
    100
        18-45 years; Serotype 3; 3 years Post-Inj. 3
    100
    100
        18-45 years; Serotype 3; 4 years Post-Inj. 3
    100
    100
        18-45 years; Serotype 3; 5 years Post-Inj. 3
    100
    100
        18-45 years; Serotype 4; Post-Inj. 3
    100
    100
        18-45 years; Serotype 4; 1 year Post-Inj. 3
    100
    100
        18-45 years; Serotype 4; 2 years Post-Inj. 3
    100
    100
        18-45 years; Serotype 4; 3 years Post-Inj. 3
    100
    100
        18-45 years; Serotype 4; 4 years Post-Inj. 3
    100
    100
        18-45 years; Serotype 4; 5 years Post-Inj. 3
    100
    100
        12-17 years; Serotype 1; Post-Inj. 3
    81.8
    100
        12-17 years; Serotype 1; 1 year Post-Inj. 3
    65
    88.9
        12-17 years; Serotype 1; 2 years Post-Inj. 3
    82.6
    100
        12-17 years; Serotype 1; 3 years Post-Inj. 3
    82.6
    80
        12-17 years; Serotype 1; 4 years Post-Inj. 3
    91.3
    100
        12-17 years; Serotype 1; 5 years Post-Inj. 3
    90.9
    100
        12-17 years; Serotype 2; Post-Inj. 3
    95.7
    100
        12-17 years; Serotype 2; 1 year Post-Inj. 3
    90
    100
        12-17 years; Serotype 2; 2 years Post-Inj. 3
    91.3
    90.9
        12-17 years; Serotype 2; 3 years Post-Inj. 3
    91.3
    90
        12-17 years; Serotype 2; 4 years Post-Inj. 3
    91.3
    100
        12-17 years; Serotype 2; 5 years Post-Inj. 3
    90.9
    100
        12-17 years; Serotype 3; Post-Inj. 3
    100
    100
        12-17 years; Serotype 3; 1 year Post-Inj. 3
    93.8
    100
        12-17 years; Serotype 3; 2 years Post-Inj. 3
    95.7
    100
        12-17 years; Serotype 3; 3 years Post-Inj. 3
    100
    100
        12-17 years; Serotype 3; 4 years Post-Inj. 3
    91.3
    100
        12-17 years; Serotype 3; 5 years Post-Inj. 3
    95.5
    100
        12-17 years; Serotype 4; Post-Inj. 3
    100
    100
        12-17 years; Serotype 4; 1 year Post-Inj. 3
    95
    100
        12-17 years; Serotype 4; 2 years Post-Inj. 3
    87
    100
        12-17 years; Serotype 4; 3 years Post-Inj. 3
    100
    100
        12-17 years; Serotype 4; 4 years Post-Inj. 3
    95.7
    100
        12-17 years; Serotype 4; 5 years Post-Inj. 3
    95.5
    100
        6-11 years; Serotype 1; Post-Inj. 3
    100
    100
        6-11 years; Serotype 1; 1 year Post-Inj. 3
    90
    88.9
        6-11 years; Serotype 1; 2 years Post-Inj. 3
    79.2
    81.8
        6-11 years; Serotype 1; 3 years Post-Inj. 3
    66.7
    72.7
        6-11 years; Serotype 1; 4 years Post-Inj. 3
    66.7
    81.8
        6-11 years; Serotype 1; 5 years Post-Inj. 3
    66.7
    81.8
        6-11 years; Serotype 2; Post-Inj. 3
    100
    100
        6-11 years; Serotype 2; 1 year Post-Inj. 3
    95
    70
        6-11 years; Serotype 2; 2 years Post-Inj. 3
    87.5
    72.7
        6-11 years; Serotype 2; 3 years Post-Inj. 3
    83.3
    72.7
        6-11 years; Serotype 2; 4 years Post-Inj. 3
    83.3
    81.8
        6-11 years; Serotype 2; 5 years Post-Inj. 3
    75
    81.8
        6-11 years; Serotype 3; Post-Inj. 3
    100
    100
        6-11 years; Serotype 3; 1 year Post-Inj. 3
    100
    88.9
        6-11 years; Serotype 3; 2 years Post-Inj. 3
    83.3
    100
        6-11 years; Serotype 3; 3 years Post-Inj. 3
    83.3
    81.8
        6-11 years; Serotype 3; 4 years Post-Inj. 3
    75
    81.8
        6-11 years; Serotype 3; 5 years Post-Inj. 3
    83.3
    90.9
        6-11 years; Serotype 4; Post-Inj. 3
    100
    100
        6-11 years; Serotype 4; 1 year Post-Inj. 3
    100
    100
        6-11 years; Serotype 4; 2 years Post-Inj. 3
    91.7
    100
        6-11 years; Serotype 4; 3 years Post-Inj. 3
    87.5
    81.8
        6-11 years; Serotype 4; 4 years Post-Inj. 3
    83.3
    100
        6-11 years; Serotype 4; 5 years Post-Inj. 3
    83.3
    90.9
        2-5 years; Serotype 1; Post-Inj. 3
    95.5
    100
        2-5 years; Serotype 1; 1 year Post-Inj. 3
    61.1
    63.6
        2-5 years; Serotype 1; 2 years Post-Inj. 3
    86.4
    63.6
        2-5 years; Serotype 1; 3 years Post-Inj. 3
    68.2
    45.5
        2-5 years; Serotype 1; 4 years Post-Inj. 3
    68.2
    54.5
        2-5 years; Serotype 1; 5 years Post-Inj. 3
    63.6
    72.7
        2-5 years; Serotype 2; Post-Inj. 3
    100
    100
        2-5 years; Serotype 2; 1 year Post-Inj. 3
    84.2
    87.5
        2-5 years; Serotype 2; 2 years Post-Inj. 3
    90.9
    90.9
        2-5 years; Serotype 2; 3 years Post-Inj. 3
    77.3
    81.8
        2-5 years; Serotype 2; 4 years Post-Inj. 3
    77.3
    72.7
        2-5 years; Serotype 2; 5 years Post-Inj. 3
    72.7
    81.8
        2-5 years; Serotype 3; Post-Inj. 3
    100
    100
        2-5 years; Serotype 3; 1 year Post-Inj. 3
    94.7
    100
        2-5 years; Serotype 3; 2 years Post-Inj. 3
    95.5
    100
        2-5 years; Serotype 3; 3 years Post-Inj. 3
    95.5
    90.9
        2-5 years; Serotype 3; 4 years Post-Inj. 3
    90.9
    90.9
        2-5 years; Serotype 3; 5 years Post-Inj. 3
    72.7
    72.7
        2-5 years; Serotype 4; Post-Inj. 3
    90.9
    100
        2-5 years; Serotype 4; 1 year Post-Inj. 3
    88.9
    75
        2-5 years; Serotype 4; 2 years Post-Inj. 3
    90.9
    90.9
        2-5 years; Serotype 4; 3 years Post-Inj. 3
    77.3
    81.8
        2-5 years; Serotype 4; 4 years Post-Inj. 3
    72.7
    72.7
        2-5 years; Serotype 4; 5 years Post-Inj. 3
    77.3
    90.9
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype with the Parental Dengue Virus Strain Post-injection 3 with ChimeriVax™ Dengue Tetravalent Vaccine

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    End point title
    Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype with the Parental Dengue Virus Strain Post-injection 3 with ChimeriVax™ Dengue Tetravalent Vaccine
    End point description
    Geometric mean titers against each serotype of the Parental Dengue Virus strains were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
    End point type
    Other pre-specified
    End point timeframe
    Post-Inj. 3 and 1, 2, 3, 4, and 5 years Post-Inj. 3
    End point values
    Group 1 Group 2
    Number of subjects analysed
    81
    39
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        All subjects; Serotype 1; Post-Inj. 3
    152 (98.4 to 235)
    279 (145 to 538)
        All subjects; Serotype 1; 1 year Post-Inj. 3
    79.8 (48 to 133)
    118 (54.8 to 256)
        All subjects; Serotype 1; 2 years Post-Inj. 3
    103 (65.8 to 161)
    151 (74.8 to 306)
        All subjects; Serotype 1; 3 years Post-Inj. 3
    75 (47.4 to 119)
    80.7 (36.4 to 179)
        All subjects; Serotype 1; 4 years Post-Inj. 3
    122 (75.4 to 197)
    148 (71.9 to 304)
        All subjects; Serotype 1; 5 years Post-Inj. 3
    93.5 (58.5 to 149)
    120 (56 to 255)
        All subjects; Serotype 2; Post-Inj. 3
    287 (207 to 398)
    461 (293 to 725)
        All subjects; Serotype 2; 1 year Post-Inj. 3
    189 (119 to 298)
    194 (106 to 355)
        All subjects; Serotype 2; 2 years Post-Inj. 3
    171 (115 to 254)
    182 (102 to 324)
        All subjects; Serotype 2; 3 years Post-Inj. 3
    168 (108 to 262)
    203 (104 to 397)
        All subjects; Serotype 2; 4 years Post-Inj. 3
    209 (133 to 330)
    264 (141 to 494)
        All subjects; Serotype 2; 5 years Post-Inj. 3
    150 (96.2 to 234)
    224 (119 to 420)
        All subjects; Serotype 3; Post-Inj. 3
    304 (240 to 385)
    674 (431 to 1052)
        All subjects; Serotype 3; 1 year Post-Inj. 3
    186 (125 to 275)
    241 (139 to 420)
        All subjects; Serotype 3; 2 years Post-Inj. 3
    182 (127 to 260)
    317 (194 to 518)
        All subjects; Serotype 3; 3 years Post-Inj. 3
    164 (113 to 238)
    179 (96.6 to 331)
        All subjects; Serotype 3; 4 years Post-Inj. 3
    133 (89.4 to 198)
    167 (92 to 303)
        All subjects; Serotype 3; 5 years Post-Inj. 3
    130 (85.3 to 197)
    190 (102 to 354)
        All subjects; Serotype 4; Post-Inj. 3
    228 (171 to 303)
    330 (227 to 479)
        All subjects; Serotype 4; 1 year Post-Inj. 3
    158 (113 to 222)
    103 (57 to 187)
        All subjects; Serotype 4; 2 years Post-Inj. 3
    131 (94.3 to 182)
    142 (87.5 to 230)
        All subjects; Serotype 4; 3 years Post-Inj. 3
    161 (106 to 243)
    154 (83.6 to 283)
        All subjects; Serotype 4; 4 years Post-Inj. 3
    139 (92.2 to 210)
    163 (93.4 to 284)
        All subjects; Serotype 4; 5 years Post-Inj. 3
    99.3 (70.3 to 140)
    116 (67.4 to 201)
        18-45 years; Serotype 1; Post-Inj. 3
    315 (183 to 543)
    599 (110 to 3273)
        18-45 years; Serotype 1; 1 year Post-Inj. 3
    328 (183 to 589)
    779 (155 to 3906)
        18-45 years; Serotype 1; 2 years Post-Inj. 3
    246 (165 to 366)
    535 (50.2 to 5690)
        18-45 years; Serotype 1; 3 years Post-Inj. 3
    208 (148 to 292)
    408 (12.6 to 13196)
        18-45 years; Serotype 1; 4 years Post-Inj. 3
    245 (155 to 387)
    484 (51.3 to 4573)
        18-45 years; Serotype 1; 5 years Post-Inj. 3
    216 (125 to 375)
    294 (15.5 to 5588)
        18-45 years; Serotype 2; Post-Inj. 3
    702 (431 to 1145)
    618 (366 to 1042)
        18-45 years; Serotype 2; 1 year Post-Inj. 3
    474 (252 to 891)
    640 (294 to 1394)
        18-45 years; Serotype 2; 2 years Post-Inj. 3
    410 (255 to 661)
    850 (167 to 4335)
        18-45 years; Serotype 2; 3 years Post-Inj. 3
    427 (209 to 871)
    1132 (338 to 3793)
        18-45 years; Serotype 2; 4 years Post-Inj. 3
    449 (221 to 912)
    855 (409 to 1791)
        18-45 years; Serotype 2; 5 years Post-Inj. 3
    408 (225 to 739)
    957 (531 to 1724)
        18-45 years; Serotype 3; Post-Inj. 3
    593 (347 to 1012)
    482 (253 to 920)
        18-45 years; Serotype 3; 1 year Post-Inj. 3
    240 (163 to 352)
    394 (202 to 768)
        18-45 years; Serotype 3; 2 years Post-Inj. 3
    306 (131 to 712)
    535 (215 to 1329)
        18-45 years; Serotype 3; 3 years Post-Inj. 3
    549 (293 to 1029)
    542 (353 to 832)
        18-45 years; Serotype 3; 4 years Post-Inj. 3
    402 (199 to 813)
    391 (214 to 713)
        18-45 years; Serotype 3; 5 years Post-Inj. 3
    535 (233 to 1228)
    546 (361 to 826)
        18-45 years; Serotype 4; Post-Inj. 3
    230 (110 to 481)
    533 (205 to 1390)
        18-45 years; Serotype 4; 1 year Post-Inj. 3
    272 (111 to 666)
    257 (131 to 504)
        18-45 years; Serotype 4; 2 years Post-Inj. 3
    217 (94.6 to 496)
    385 (205 to 726)
        18-45 years; Serotype 4; 3 years Post-Inj. 3
    377 (152 to 940)
    615 (118 to 3213)
        18-45 years; Serotype 4; 4 years Post-Inj. 3
    422 (221 to 806)
    491 (136 to 1772)
        18-45 years; Serotype 4; 5 years Post-Inj. 3
    194 (78.2 to 480)
    198 (59.9 to 652)
        12-17 years; Serotype 1; Post-Inj. 3
    261 (81.3 to 840)
    504 (166 to 1534)
        12-17 years; Serotype 1; 1 year Post-Inj. 3
    84 (26.4 to 267)
    183 (44.7 to 749)
        12-17 years; Serotype 1; 2 years Post-Inj. 3
    168 (56 to 502)
    292 (100 to 853)
        12-17 years; Serotype 1; 3 years Post-Inj. 3
    200 (68.5 to 586)
    109 (28 to 421)
        12-17 years; Serotype 1; 4 years Post-Inj. 3
    428 (174 to 1057)
    453 (133 to 1540)
        12-17 years; Serotype 1; 5 years Post-Inj. 3
    289 (117 to 717)
    182 (46.7 to 713)
        12-17 years; Serotype 2; Post-Inj. 3
    427 (199 to 920)
    528 (220 to 1269)
        12-17 years; Serotype 2; 1 year Post-Inj. 3
    235 (85.5 to 647)
    360 (142 to 912)
        12-17 years; Serotype 2; 2 years Post-Inj. 3
    233 (104 to 525)
    231 (72.9 to 734)
        12-17 years; Serotype 2; 3 years Post-Inj. 3
    297 (135 to 654)
    258 (72 to 927)
        12-17 years; Serotype 2; 4 years Post-Inj. 3
    385 (177 to 839)
    894 (374 to 2134)
        12-17 years; Serotype 2; 5 years Post-Inj. 3
    277 (141 to 546)
    508 (179 to 1438)
        12-17 years; Serotype 3; Post-Inj. 3
    478 (294 to 778)
    827 (367 to 1864)
        12-17 years; Serotype 3; 1 year Post-Inj. 3
    125 (52.8 to 297)
    454 (186 to 1108)
        12-17 years; Serotype 3; 2 years Post-Inj. 3
    192 (104 to 352)
    341 (147 to 791)
        12-17 years; Serotype 3; 3 years Post-Inj. 3
    279 (134 to 581)
    281 (105 to 755)
        12-17 years; Serotype 3; 4 years Post-Inj. 3
    247 (122 to 499)
    526 (157 to 1763)
        12-17 years; Serotype 3; 5 years Post-Inj. 3
    303 (158 to 580)
    395 (142 to 1100)
        12-17 years; Serotype 4; Post-Inj. 3
    234 (161 to 340)
    241 (139 to 419)
        12-17 years; Serotype 4; 1 year Post-Inj. 3
    188 (112 to 318)
    107 (39.2 to 291)
        12-17 years; Serotype 4; 2 years Post-Inj. 3
    116 (62.4 to 214)
    126 (58.5 to 272)
        12-17 years; Serotype 4; 3 years Post-Inj. 3
    401 (196 to 818)
    231 (82.7 to 645)
        12-17 years; Serotype 4; 4 years Post-Inj. 3
    321 (155 to 663)
    509 (217 to 1197)
        12-17 years; Serotype 4; 5 years Post-Inj. 3
    132 (80.6 to 216)
    100 (37.1 to 272)
        6-11 years; Serotype 1; Post-Inj. 3
    101 (53.2 to 194)
    625 (116 to 3374)
        6-11 years; Serotype 1; 1 year Post-Inj. 3
    104 (47.3 to 230)
    264 (37.2 to 1874)
        6-11 years; Serotype 1; 2 years Post-Inj. 3
    67.5 (32.1 to 142)
    186 (35.2 to 977)
        6-11 years; Serotype 1; 3 years Post-Inj. 3
    33.6 (16.9 to 66.6)
    81.6 (17.6 to 379)
        6-11 years; Serotype 1; 4 years Post-Inj. 3
    51.6 (22.6 to 118)
    126 (27.6 to 572)
        6-11 years; Serotype 1; 5 years Post-Inj. 3
    43.7 (19.6 to 97.5)
    129 (18.7 to 894)
        6-11 years; Serotype 2; Post-Inj. 3
    242 (127 to 459)
    364 (101 to 1304)
        6-11 years; Serotype 2; 1 year Post-Inj. 3
    220 (91.7 to 528)
    92.2 (21.2 to 401)
        6-11 years; Serotype 2; 2 years Post-Inj. 3
    154 (65.2 to 365)
    88.5 (24.9 to 315)
        6-11 years; Serotype 2; 3 years Post-Inj. 3
    100 (45.2 to 222)
    101 (25.9 to 396)
        6-11 years; Serotype 2; 4 years Post-Inj. 3
    132 (53.9 to 324)
    152 (44.9 to 512)
        6-11 years; Serotype 2; 5 years Post-Inj. 3
    106 (41 to 276)
    134 (33.1 to 542)
        6-11 years; Serotype 3; Post-Inj. 3
    263 (164 to 424)
    390 (112 to 1358)
        6-11 years; Serotype 3; 1 year Post-Inj. 3
    349 (154 to 794)
    142 (34.4 to 590)
        6-11 years; Serotype 3; 2 years Post-Inj. 3
    168 (70.4 to 401)
    244 (86.3 to 690)
        6-11 years; Serotype 3; 3 years Post-Inj. 3
    95.3 (45.5 to 200)
    95.9 (29.1 to 316)
        6-11 years; Serotype 3; 4 years Post-Inj. 3
    75.4 (33.4 to 171)
    83.2 (28.7 to 241)
        6-11 years; Serotype 3; 5 years Post-Inj. 3
    88.8 (39.7 to 199)
    146 (37.2 to 572)
        6-11 years; Serotype 4; Post-Inj. 3
    270 (159 to 459)
    373 (121 to 1148)
        6-11 years; Serotype 4; 1 year Post-Inj. 3
    197 (105 to 372)
    159 (45.8 to 551)
        6-11 years; Serotype 4; 2 years Post-Inj. 3
    133 (74.8 to 236)
    177 (53.1 to 590)
        6-11 years; Serotype 4; 3 years Post-Inj. 3
    89.8 (47 to 172)
    139 (36.3 to 531)
        6-11 years; Serotype 4; 4 years Post-Inj. 3
    79.3 (41.8 to 151)
    125 (55.1 to 285)
        6-11 years; Serotype 4; 5 years Post-Inj. 3
    74.4 (38.2 to 145)
    115 (29.5 to 452)
        2-5 years; Serotype 1; Post-Inj. 3
    106 (52.3 to 213)
    55.5 (22.9 to 134)
        2-5 years; Serotype 1; 1 year Post-Inj. 3
    29.8 (10.9 to 81.9)
    21.7 (9.27 to 51)
        2-5 years; Serotype 1; 2 years Post-Inj. 3
    66.1 (28.7 to 153)
    36 (10.7 to 121)
        2-5 years; Serotype 1; 3 years Post-Inj. 3
    40.6 (17.9 to 92.4)
    29.1 (5.3 to 160)
        2-5 years; Serotype 1; 4 years Post-Inj. 3
    60.9 (23.1 to 161)
    33.2 (9.39 to 117)
        2-5 years; Serotype 1; 5 years Post-Inj. 3
    49.2 (19.5 to 124)
    52 (15.7 to 172)
        2-5 years; Serotype 2; Post-Inj. 3
    158 (107 to 234)
    412 (137 to 1233)
        2-5 years; Serotype 2; 1 year Post-Inj. 3
    86.4 (37.6 to 198)
    99 (23.5 to 417)
        2-5 years; Serotype 2; 2 years Post-Inj. 3
    92.9 (47.3 to 182)
    145 (51.5 to 408)
        2-5 years; Serotype 2; 3 years Post-Inj. 3
    107 (38.3 to 300)
    149 (33 to 674)
        2-5 years; Serotype 2; 4 years Post-Inj. 3
    129 (46.2 to 361)
    79.2 (20.3 to 309)
        2-5 years; Serotype 2; 5 years Post-Inj. 3
    78.5 (31.3 to 197)
    98.9 (28.1 to 348)
        2-5 years; Serotype 3; Post-Inj. 3
    168 (132 to 215)
    1200 (512 to 2811)
        2-5 years; Serotype 3; 1 year Post-Inj. 3
    128 (61.2 to 266)
    154 (41.1 to 581)
        2-5 years; Serotype 3; 2 years Post-Inj. 3
    148 (80.3 to 273)
    301 (79.9 to 1135)
        2-5 years; Serotype 3; 3 years Post-Inj. 3
    98.8 (53.6 to 182)
    133 (25.7 to 692)
        2-5 years; Serotype 3; 4 years Post-Inj. 3
    78.2 (37.6 to 163)
    72.2 (21.7 to 240)
        2-5 years; Serotype 3; 5 years Post-Inj. 3
    47 (22.1 to 99.9)
    84.2 (20.8 to 342)
        2-5 years; Serotype 4; Post-Inj. 3
    182 (85.1 to 389)
    298 (95.2 to 931)
        2-5 years; Serotype 4; 1 year Post-Inj. 3
    82.4 (36.7 to 185)
    38.7 (7.86 to 191)
        2-5 years; Serotype 4; 2 years Post-Inj. 3
    118 (53.4 to 259)
    81.1 (28.3 to 233)
        2-5 years; Serotype 4; 3 years Post-Inj. 3
    78.9 (31.3 to 199)
    62.7 (18 to 218)
        2-5 years; Serotype 4; 4 years Post-Inj. 3
    64.9 (25.6 to 164)
    40.8 (13.3 to 126)
        2-5 years; Serotype 4; 5 years Post-Inj. 3
    78 (34.1 to 178)
    104 (32 to 338)
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype with the Parental Dengue Virus Strain Before and Following Injection with ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects

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    End point title
    Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype with the Parental Dengue Virus Strain Before and Following Injection with ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects
    End point description
    Geometric mean titers against each serotype of the Parental Dengue Virus strains were assessed using the microneutralization assay.
    End point type
    Other pre-specified
    End point timeframe
    1 and 2 years Post-Inj. 3
    End point values
    Group 1 Group 2
    Number of subjects analysed
    11
    6
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Serotype 1; 1 year Post-Inj. 3
    206 (130 to 326)
    313 (85.8 to 1140)
        Serotype 1; 2 years Post-Inj. 3
    403 (272 to 597)
    562 (65.4 to 4830)
        Serotype 2; 1 year Post-Inj. 3
    176 (84.3 to 369)
    396 (146 to 1077)
        Serotype 2; 2 years Post-Inj. 3
    165 (72.5 to 373)
    450 (118 to 1714)
        Serotype 3; 1 year Post-Inj. 3
    342 (168 to 698)
    324 (188 to 558)
        Serotype 3; 2 years Post-Inj. 3
    502 (228 to 1105)
    581 (219 to 1538)
        Serotype 4; 1 year Post-Inj. 3
    168 (86 to 329)
    217 (98.6 to 480)
        Serotype 4; 2 years Post-Inj. 3
    116 (58.1 to 231)
    149 (47.5 to 467)
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects with Suspected Dengue Cases During the Four-Year Follow-Up Study Period

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    End point title
    Number of Subjects with Suspected Dengue Cases During the Four-Year Follow-Up Study Period
    End point description
    Dengue cases were assessed through the detection of febrile episodes, defined as temperature ≥38°C for ≥48 hours. In the event of a febrile episode, blood was drawn during the acute phase (within 5 days of onset) and during the convalescent phase (within 7-14 days of onset) for laboratory testing to confirm the diagnosis of dengue infection. Virological diagnoses and confirmations were assessed using reverse transcriptase-polymerase chain reaction and serological diagnoses were assessed using an enzyme-linked immunosorbent assay.
    End point type
    Other pre-specified
    End point timeframe
    4 years post-Injection 3
    End point values
    Group 1 Group 2
    Number of subjects analysed
    81
    39
    Units: Number of subjects
    number (not applicable)
        Follow-up Analysis Set
    81
    39
        At least 1 suspected dengue case
    20
    14
        At least 1 suspected dengue case; 18 to 45 years
    2
    1
        At least 1 suspected dengue case; 12 to 17 years
    1
    2
        At least 1 suspected dengue case; 6 to 11 years
    6
    6
        At least 1 suspected dengue case; 2 to 5 years
    11
    5
        At least 1 lab-confirmed dengue case
    3
    3
        At least 1 lab-confirmed dengue case; 18 to 45 yrs
    0
    0
        At least 1 lab-confirmed dengue case; 12 to 17 yrs
    0
    1
        At least 1 lab-confirmed dengue case; 6 to 11 yrs
    1
    1
        At least 1 lab-confirmed dengue case; 2 to 5 yrs
    2
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse event data were collected from Day 0 (post-vaccination) up to 5 years Post-injection 3.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    7.1
    Reporting groups
    Reporting group title
    Group 1
    Reporting group description
    Subjects received the CYD dengue vaccine for all three injections, one each on Days 0, 105, and 365, respectively.

    Reporting group title
    Group 2
    Reporting group description
    Subjects received typhoid vaccine (Typhim Vi) as first injection and CYD dengue vaccine as second and third injections 8 to 9 months apart (Days 105 and 365).

    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: No non-serious adverse events were collected during year 5.
    Serious adverse events
    Group 1 Group 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 84 (2.38%)
    0 / 42 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Musculoskeletal and connective tissue disorders
    Myofascial pain syndrome
         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
    Dengue fever
         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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Group 1 Group 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 84 (0.00%)
    0 / 42 (0.00%)

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Nov 2009
    The timeframe between two consecutive episodes of fever were defined for one and two episodes; Additional statistical analyses for safety, viremia, and immunogenicity were added; and the reporting period for pregnancies was revised.
    11 Mar 2011
    The use PRNT assay for study and all ongoing Dengue studies was confirmed.
    05 Dec 2011
    The follow up period for assessing the persistence of antibodies was extended to 5years.
    08 Feb 2012
    Effected minor changes received from the Institutional Review Board on protocol version 8.0 dated 05 December 2011.

    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/21477675
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