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    Clinical Trial Results:
    Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years

    Summary
    EudraCT number
    2014-001711-40
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    16 Aug 2010

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

    Trial information

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    Trial identification
    Sponsor protocol code
    CYD24
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00788151
    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
    Director, Clinical Development, Sanofi Pasteur SA, 33 04 37 65 60 60, eric.plennevaux@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 04 37 65 60 60, eric.plennevaux@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
    Final
    Date of interim/final analysis
    28 Jan 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Aug 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Humoral immune response to dengue before and after each vaccination with dengue vaccine in children previously vaccinated with yellow fever (YF) vaccine Safety and reactogenicity Viremia after the first and second vaccinations in a subset
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    26 Sep 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Peru: 300
    Worldwide total number of subjects
    300
    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)
    300
    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 from 26 September 2008 to 16 August 2010 at 1 clinical site in Peru.

    Pre-assignment
    Screening details
    A total of 300 subjects who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized; however, only 298 subjects received at least one vaccination.

    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
    The observer-blind design was implemented. The person who performed vaccinations knew which product was administered while neither the subject nor the Investigator in charge of safety evaluation knew which product was injected. To maintain the blind and minimize any potential bias, the control group used the same route and schedule as the study vaccine.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Dengue vaccine group
    Arm description
    Subjects received 3 injections of the CYD Dengue vaccine, 1 injection each at 0, 6, and 12 months.
    Arm type
    Experimental

    Investigational medicinal product name
    CYD Dengue vaccine
    Investigational medicinal product code
    323
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, 3 injections. One each at 0, 6, and 12 months.

    Arm title
    Control group
    Arm description
    Subjects received a placebo as first and second injections at 0 and 6 months, respectively, and pneumococcal polysaccharide vaccine (Pneumo23) as third injection at 12 months.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo (NaCl containing human serum albumin)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, 1 injection each as first and second vaccinations at 0 and 6 months.

    Investigational medicinal product name
    Pneumo23 (pneumococcal polysaccharide vaccine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, 1 injection as third vaccination at 12 months.

    Number of subjects in period 1 [1]
    Dengue vaccine group Control group
    Started
    199
    99
    Completed
    186
    90
    Not completed
    13
    9
         Protocol deviation
             -
             1
         Adverse event, non-fatal
             -
             2
         Consent withdrawn by subject
             13
             6
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number reported in the baseline period were based on the total number of subjects who received the first vaccine. Two subjects (1 in each group) did not receive any vaccine.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dengue vaccine group
    Reporting group description
    Subjects received 3 injections of the CYD Dengue vaccine, 1 injection each at 0, 6, and 12 months.

    Reporting group title
    Control group
    Reporting group description
    Subjects received a placebo as first and second injections at 0 and 6 months, respectively, and pneumococcal polysaccharide vaccine (Pneumo23) as third injection at 12 months.

    Reporting group values
    Dengue vaccine group Control group Total
    Number of subjects
    199 99 298
    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)
    199 99 298
        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)
    6.4 ± 2.8 6.4 ± 2.9 -
    Gender categorical
    Units: Subjects
        Female
    98 53 151
        Male
    101 46 147
    Study subgroups by age
    Study subjects were also categorized into 2 children subgroups based on their age.
    Units: Subjects
        2 to 5 years
    100 50 150
        6 to 11 years
    99 49 148

    End points

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    End points reporting groups
    Reporting group title
    Dengue vaccine group
    Reporting group description
    Subjects received 3 injections of the CYD Dengue vaccine, 1 injection each at 0, 6, and 12 months.

    Reporting group title
    Control group
    Reporting group description
    Subjects received a placebo as first and second injections at 0 and 6 months, respectively, and pneumococcal polysaccharide vaccine (Pneumo23) as third injection at 12 months.

    Primary: Percentage of All Subjects Reporting Solicited Injection-site and Systemic Reactions Following Each Injection with CYD Dengue Tetravalent Vaccine

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    End point title
    Percentage of All Subjects Reporting Solicited Injection-site and Systemic Reactions Following Each Injection with CYD Dengue Tetravalent Vaccine [1]
    End point description
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Solicited systemic reactions: Fever, >39°C; Headache, Malaise, Myalgia, and Asthenia, Prevents daily activities.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 14 post-each 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
    Dengue vaccine group Control group
    Number of subjects analysed
    199
    99
    Units: Percentage of subjects
    number (not applicable)
        Inj. site Pain; Post-Inj. 1 (All ages)
    20.6
    17.2
        Grade 3 Inj. site Pain; Post-Inj. 1 (All ages)
    0
    0
        Inj. site Erythema; Post-Inj. 1 (All ages)
    7.5
    4
        Grade 3 Inj. site Erythema; Post-Inj. 1 (All ages)
    0
    0
        Inj. site Swelling; Post-Inj. 1 (All ages)
    5.5
    5.1
        Grade 3 Inj. site Swelling; Post-Inj. 1 (All ages)
    0
    0
        Inj. site Pain; Post-Inj. 2 (All ages)
    19.7
    17.4
        Grade 3 Inj. site Pain; Post-Inj. 2 (All ages)
    0
    1.1
        Inj. site Erythema; Post-Inj. 2 (All ages)
    4.3
    1.1
        Grade 3 Inj. site Erythema; Post-Inj. 2 (All ages)
    0
    0
        Inj. site Swelling; Post-Inj. 2 (All ages)
    2.1
    0
        Grade 3 Inj. site Swelling; Post-Inj. 2 (All ages)
    0
    0
        Inj. site Pain; Post-Inj. 3 (All ages)
    17.7
    32.2
        Grade 3 Inj. site Pain; Post-Inj. 3 (All ages)
    0.5
    2.2
        Inj. site Erythema; Post-Inj. 3 (All ages)
    4.3
    11.1
        Grade 3 Inj. site Erythema; Post-Inj. 3 (All ages)
    0
    3.3
        Inj. site Swelling; Post-Inj. 3 (All ages)
    3.2
    8.9
        Grade 3 Inj. site Swelling; Post-Inj. 3 (All ages)
    0
    3.3
        Fever; Post-Inj. 1 (All ages)
    31.3
    10.1
        Grade 3 Fever; Post-Inj. 1 (All ages)
    3.5
    0
        Headache; Post-Inj. 1 (All ages)
    35.7
    16.2
        Grade 3 Headache; Post-Inj. 1 (All ages)
    0.5
    0
        Malaise; Post-Inj. 1 (All ages)
    33.7
    23.2
        Grade 3 Malaise; Post-Inj. 1 (All ages)
    0.5
    0
        Myalgia; Post-Inj. 1 (All ages)
    19.1
    13.1
        Grade 3 Myalgia; Post-Inj. 1 (All ages)
    0
    0
        Asthenia; Post-Inj. 1 (All ages)
    13.6
    13.1
        Grade 3 Asthenia; Post-Inj. 1 (All ages)
    0.5
    0
        Fever; Post-Inj. 2 (All ages)
    19.7
    16.3
        Grade 3 Fever; Post-Inj. 2 (All ages)
    0.5
    0
        Headache; Post-Inj. 2 (All ages)
    22.3
    19.6
        Grade 3 Headache; Post-Inj. 2 (All ages)
    0.5
    1.1
        Malaise; Post-Inj. 2 (All ages)
    18.1
    16.3
        Grade 3 Malaise; Post-Inj. 2 (All ages)
    0.5
    2.2
        Myalgia; Post-Inj. 2 (All ages)
    14.9
    10.9
        Grade 3 Myalgia; Post-Inj. 2 (All ages)
    1.1
    0
        Asthenia; Post-Inj. 2 (All ages)
    11.2
    7.6
        Grade 3 Asthenia; Post-Inj. 2 (All ages)
    0.5
    1.1
        Fever; Post-Inj. 3 (All ages)
    18.4
    22.5
        Grade 3 Fever; Post-Inj. 3 (All ages)
    0
    3.4
        Headache; Post-Inj. 3 (All ages)
    18.8
    27.8
        Grade 3 Headache; Post-Inj. 3 (All ages)
    0
    3.3
        Malaise; Post-Inj. 3 (All ages)
    16.7
    23.3
        Grade 3 Malaise; Post-Inj. 3 (All ages)
    0
    2.2
        Myalgia; Post-Inj. 3 (All ages)
    13.4
    26.7
        Grade 3 Myalgia; Post-Inj. 3 (All ages)
    0
    2.2
        Asthenia; Post-Inj. 3 (All ages)
    10.2
    16.7
        Grade 3 Asthenia; Post-Inj. 3 (All ages)
    0
    1.1
    No statistical analyses for this end point

    Primary: Percentage of Subjects Aged 2 to 5 Years Reporting Solicited Injection-site and Systemic Reactions Following Each Injection with CYD Dengue Tetravalent Vaccine

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    End point title
    Percentage of Subjects Aged 2 to 5 Years Reporting Solicited Injection-site and Systemic Reactions Following Each Injection with CYD Dengue Tetravalent Vaccine [2]
    End point description
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Solicited systemic reactions: Fever, >39°C; Headache, Malaise, Myalgia, and Asthenia, Prevents daily activities.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 14 post-each vaccination
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    Dengue vaccine group Control group
    Number of subjects analysed
    100
    50
    Units: Percentage of subjects
    number (not applicable)
        Inj. site Pain; Post-Inj. 1 (2-5 years)
    19
    16
        Grade 3 Inj. site Pain; Post-Inj. 1 (2-5 years)
    0
    0
        Inj. site Erythema; Post-Inj. 1 (2-5 years)
    11
    6
        Grade 3 Inj. site Erythema;Post-Inj. 1 (2-5 years)
    0
    0
        Inj. site Swelling; Post-Inj. 1 (2-5 years)
    6
    8
        Grade 3 Inj. site Swelling;Post-Inj. 1 (2-5 years)
    0
    0
        Inj. site Pain; Post-Inj. 2 (2-5 years)
    17.4
    15.6
        Grade 3 Inj. site Pain; Post-Inj. 2 (2-5 years)
    0
    2.2
        Inj. site Erythema; Post-Inj. 2 (2-5 years)
    4.3
    0
        Grade 3 Inj. site Erythema;Post-Inj. 2 (2-5 years)
    0
    0
        Inj. site Swelling; Post-Inj. 2 (2-5 years)
    2.2
    0
        Grade 3 Inj. site Swelling;Post-Inj. 2 (2-5 years)
    0
    0
        Inj. site Pain; Post-Inj. 3 (2-5 years)
    14.4
    23.3
        Grade 3 Inj. site Pain; Post-Inj. 3 (2-5 years)
    0
    4.7
        Inj. site Erythema; Post-Inj. 3 (2-5 years)
    3.3
    9.3
        Grade 3 Inj. site Erythema;Post-Inj. 3 (2-5 years)
    0
    2.3
        Inj. site Swelling; Post-Inj. 3 (2-5 years)
    3.3
    7
        Grade 3 Inj. site Swelling;Post-Inj. 3 (2-5 years)
    0
    2.3
        Fever; Post-Inj. 1 (2-5 years)
    36.4
    16
        Grade 3 Fever; Post-Inj. 1 (2-5 years)
    4
    0
        Headache; Post-Inj. 1 (2-5 years)
    23
    8
        Grade 3 Headache; Post-Inj. 1 (2-5 years)
    1
    0
        Malaise; Post-Inj. 1 (2-5 years)
    33
    26
        Grade 3 Malaise; Post-Inj. 1 (2-5 years)
    1
    0
        Myalgia; Post-Inj. 1 (2-5 years)
    12
    10
        Grade 3 Myalgia; Post-Inj. 1 (2-5 years)
    0
    0
        Asthenia; Post-Inj. 1 (2-5 years)
    13
    12
        Grade 3 Asthenia; Post-Inj. 1 (2-5 years)
    1
    0
        Fever; Post-Inj. 2 (2-5 years)
    23.9
    17.8
        Grade 3 Fever; Post-Inj. 2 (2-5 years)
    0
    0
        Headache; Post-Inj. 2 (2-5 years)
    14.1
    6.7
        Grade 3 Headache; Post-Inj. 2 (2-5 years)
    0
    0
        Malaise; Post-Inj. 2 (2-5 years)
    15.2
    13.3
        Grade 3 Malaise; Post-Inj. 2 (2-5 years)
    1.1
    2.2
        Myalgia; Post-Inj. 2 (2-5 years)
    9.8
    6.7
        Grade 3 Myalgia; Post-Inj. 2 (2-5 years)
    1.1
    0
        Asthenia; Post-Inj. 2 (2-5 years)
    9.8
    8.9
        Grade 3 Asthenia; Post-Inj. 2 (2-5 years)
    1.1
    2.2
        Fever; Post-Inj. 3 (2-5 years)
    16.9
    26.2
        Grade 3 Fever; Post-Inj. 3 (2-5 years)
    0
    7.1
        Headache; Post-Inj. 3 (2-5 years)
    6.7
    18.6
        Grade 3 Headache; Post-Inj. 3 (2-5 years)
    0
    2.3
        Malaise; Post-Inj. 3 (2-5 years)
    6.7
    23.3
        Grade 3 Malaise; Post-Inj. 3 (2-5 years)
    0
    2.3
        Myalgia; Post-Inj. 3 (2-5 years)
    6.7
    20.9
        Grade 3 Myalgia; Post-Inj. 3 (2-5 years)
    0
    2.3
        Asthenia; Post-Inj. 3 (2-5 years)
    4.4
    23.3
        Grade 3 Asthenia; Post-Inj. 3 (2-5 years)
    0
    2.3
    No statistical analyses for this end point

    Primary: Percentage of Subjects Aged 6 to 11 Years Reporting Solicited Injection-site and Systemic Reactions Following Each Injection with CYD Dengue Tetravalent Vaccine

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    End point title
    Percentage of Subjects Aged 6 to 11 Years Reporting Solicited Injection-site and Systemic Reactions Following Each Injection with CYD Dengue Tetravalent Vaccine [3]
    End point description
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Solicited systemic reactions: Fever, >39°C; Headache, Malaise, Myalgia, and Asthenia, Prevents daily activities.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 14 post-each vaccination
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    Dengue vaccine group Control group
    Number of subjects analysed
    99
    49
    Units: Percentage of subjects
    number (not applicable)
        Inj. site Pain; Post-Inj. 1 (6-11 years)
    22.2
    18.4
        Gr 3 Inj. site Pain; Post-Inj. 1 (6-11 years)
    0
    0
        Inj. site Erythema; Post-Inj. 1 (6-11 years)
    4
    2
        Gr 3 Inj. site Erythema; Post-Inj. 1 (6-11 years)
    0
    0
        Inj. site Swelling; Post-Inj. 1 (6-11 years)
    5.1
    2
        Gr 3 Inj. site Swelling; Post-Inj. 1 (6-11 years)
    0
    0
        Inj. site Pain; Post-Inj. 2 (6-11 years)
    21.9
    19.1
        Gr 3 Inj. site Pain; Post-Inj. 2 (6-11 years)
    0
    0
        Inj. site Erythema; Post-Inj. 2 (6-11 years)
    4.2
    2.1
        Gr 3 Inj. site Erythema; Post-Inj. 2 (6-11 years)
    0
    0
        Inj. site Swelling; Post-Inj. 2 (6-11 years)
    2.1
    0
        Gr 3 Inj. site Swelling; Post-Inj. 2 (6-11 years)
    0
    0
        Inj. site Pain; Post-Inj. 3 (6-11 years)
    20.8
    40.4
        Gr 3 Inj. site Pain; Post-Inj. 3 (6-11 years)
    1
    0
        Inj. site Erythema; Post-Inj. 3 (6-11 years)
    5.2
    12.8
        Gr 3 Inj. site Erythema; Post-Inj. 3 (6-11 years)
    0
    4.3
        Inj. site Swelling; Post-Inj. 3 (6-11 years)
    3.1
    10.6
        Gr 3 Inj. site Swelling; Post-Inj. 3 (6-11 years)
    0
    4.3
        Fever; Post-Inj. 1 (6-11 years)
    26.3
    4.1
        Gr 3 Fever; Post-Inj. 1 (6-11 years)
    3
    0
        Headache; Post-Inj. 1 (6-11 years)
    48.5
    24.5
        Gr 3 Headache; Post-Inj. 1 (6-11 years)
    0
    0
        Malaise; Post-Inj. 1 (6-11 years)
    34.3
    20.4
        Gr 3 Malaise; Post-Inj. 1 (6-11 years)
    0
    0
        Myalgia; Post-Inj. 1 (6-11 years)
    26.3
    16.3
        Gr 3 Myalgia; Post-Inj. 1 (6-11 years)
    0
    0
        Asthenia; Post-Inj. 1 (6-11 years)
    14.1
    14.3
        Gr 3 Asthenia; Post-Inj. 1 (6-11 years)
    0
    0
        Fever; Post-Inj. 2 (6-11 years)
    15.6
    14.9
        Gr 3 Fever; Post-Inj. 2 (6-11 years)
    1
    0
        Headache; Post-Inj. 2 (6-11 years)
    30.2
    31.9
        Gr 3 Headache; Post-Inj. 2 (6-11 years)
    1
    2.1
        Malaise; Post-Inj. 2 (6-11 years)
    20.8
    19.1
        Gr 3 Malaise; Post-Inj. 2 (6-11 years)
    0
    2.1
        Myalgia; Post-Inj. 2 (6-11 years)
    19.8
    14.9
        Gr 3 Myalgia; Post-Inj. 2 (6-11 years)
    1
    0
        Asthenia; Post-Inj. 2 (6-11 years)
    12.5
    6.4
        Gr 3 Asthenia; Post-Inj. 2 (6-11 years)
    0
    0
        Fever; Post-Inj. 3 (6-11 years)
    19.8
    19.1
        Gr 3 Fever; Post-Inj. 3 (6-11 years)
    0
    0
        Headache; Post-Inj. 3 (6-11 years)
    30.2
    36.2
        Gr 3 Headache; Post-Inj. 3 (6-11 years)
    0
    4.3
        Malaise; Post-Inj. 3 (6-11 years)
    26
    23.4
        Gr 3 Malaise; Post-Inj. 3 (6-11 years)
    0
    2.1
        Myalgia; Post-Inj. 3 (6-11 years)
    19.8
    31.9
        Gr 3 Myalgia; Post-Inj. 3 (6-11 years)
    0
    2.1
        Asthenia; Post-Inj. 3 (6-11 years)
    15.6
    10.6
        Gr 3 Asthenia; Post-Inj. 3 (6-11 years)
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of All Subjects Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine

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    End point title
    Percentage of All Subjects Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
    End point description
    Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer ≥10 1/dil.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1, 2, and 3 and post-dose 1, 2, and 3
    End point values
    Dengue vaccine group Control group
    Number of subjects analysed
    199
    99
    Units: Percentage of subjects
    number (not applicable)
        Dengue parental serotype 1; Pre-dose 1
    29.6
    38.4
        Dengue parental serotype 1; Post-dose 1
    55.4
    37.9
        Dengue parental serotype 1; Pre-dose 2
    42.3
    39.1
        Dengue parental serotype 1; Post-dose 2
    98.4
    39.1
        Dengue parental serotype 1; Pre-dose 3
    74.7
    41.8
        Dengue parental serotype 1; Post-dose 3
    98.4
    46.1
        Dengue parental serotype 2; Pre-dose 1
    17.1
    21.2
        Dengue parental serotype 2; Post-dose 1
    40.4
    21.1
        Dengue parental serotype 2; Pre-dose 2
    32.8
    20.4
        Dengue parental serotype 2; Post-dose 2
    68.1
    16.3
        Dengue parental serotype 2; Pre-dose 3
    35.5
    20.9
        Dengue parental serotype 2; Post-dose 3
    79
    20.2
        Dengue parental serotype 3; Pre-dose 1
    30.7
    38.4
        Dengue parental serotype 3; Post-dose 1
    68.4
    38.9
        Dengue parental serotype 3; Pre-dose 2
    51.9
    39.8
        Dengue parental serotype 3; Post-dose 2
    100
    40.2
        Dengue parental serotype 3; Pre-dose 3
    72.6
    39.6
        Dengue parental serotype 3; Post-dose 3
    98.9
    43.8
        Dengue parental serotype 4; Pre-dose 1
    14.1
    18.2
        Dengue parental serotype 4; Post-dose 1
    74.1
    18.9
        Dengue parental serotype 4; Pre-dose 2
    57.7
    20.4
        Dengue parental serotype 4; Post-dose 2
    97.9
    19.6
        Dengue parental serotype 4; Pre-dose 3
    82.8
    18.7
        Dengue parental serotype 4; Post-dose 3
    98.9
    23.6
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Aged 2 to 5 years Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine

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    End point title
    Percentage of Subjects Aged 2 to 5 years Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
    End point description
    Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer ≥10 1/dil.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1, 2, and 3 and post-dose 1, 2, and 3
    End point values
    Dengue vaccine group Control group
    Number of subjects analysed
    100
    50
    Units: Percentage of subjects
    number (not applicable)
        Dengue parental serotype 1; Pre-dose 1
    30
    32
        Dengue parental serotype 1; Post-dose 1
    54.7
    33.3
        Dengue parental serotype 1; Pre-dose 2
    38.7
    31.1
        Dengue parental serotype 1; Post-dose 2
    97.8
    31.1
        Dengue parental serotype 1; Pre-dose 3
    72.2
    36.4
        Dengue parental serotype 1; Post-dose 3
    98.9
    44.2
        Dengue parental serotype 2; Pre-dose 1
    14
    16
        Dengue parental serotype 2; Post-dose 1
    32.6
    16.7
        Dengue parental serotype 2; Pre-dose 2
    29
    15.2
        Dengue parental serotype 2; Post-dose 2
    64.1
    11.1
        Dengue parental serotype 2; Pre-dose 3
    28.9
    18.2
        Dengue parental serotype 2; Post-dose 3
    77.8
    20.9
        Dengue parental serotype 3; Pre-dose 1
    28
    32
        Dengue parental serotype 3; Post-dose 1
    62.1
    35.4
        Dengue parental serotype 3; Pre-dose 2
    45.2
    32.6
        Dengue parental serotype 3; Post-dose 2
    100
    33.3
        Dengue parental serotype 3; Pre-dose 3
    70
    34.1
        Dengue parental serotype 3; Post-dose 3
    100
    39.5
        Dengue parental serotype 4; Pre-dose 1
    13
    18
        Dengue parental serotype 4; Post-dose 1
    74.7
    22.9
        Dengue parental serotype 4; Pre-dose 2
    60.2
    17.4
        Dengue parental serotype 4; Post-dose 2
    100
    20
        Dengue parental serotype 4; Pre-dose 3
    87.8
    22.7
        Dengue parental serotype 4; Post-dose 3
    100
    27.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Aged 6 to 11 Years Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine

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    End point title
    Percentage of Subjects Aged 6 to 11 Years Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
    End point description
    Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer ≥10 1/dil.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1, 2, and 3 and post-dose 1, 2, and 3
    End point values
    Dengue vaccine group Control group
    Number of subjects analysed
    99
    49
    Units: Percentage of subjects
    number (not applicable)
        Dengue parental serotype 1; Pre-dose 1
    29.3
    44.9
        Dengue parental serotype 1; Post-dose 1
    56.1
    42.6
        Dengue parental serotype 1; Pre-dose 2
    45.8
    46.8
        Dengue parental serotype 1; Post-dose 2
    99
    46.8
        Dengue parental serotype 1; Pre-dose 3
    77.1
    46.8
        Dengue parental serotype 1; Post-dose 3
    97.9
    47.8
        Dengue parental serotype 2; Pre-dose 1
    20.2
    26.5
        Dengue parental serotype 2; Post-dose 1
    48
    25.5
        Dengue parental serotype 2; Pre-dose 2
    36.5
    25.5
        Dengue parental serotype 2; Post-dose 2
    71.9
    21.3
        Dengue parental serotype 2; Pre-dose 3
    41.7
    23.4
        Dengue parental serotype 2; Post-dose 3
    80.2
    19.6
        Dengue parental serotype 3; Pre-dose 1
    33.3
    44.9
        Dengue parental serotype 3; Post-dose 1
    74.5
    42.6
        Dengue parental serotype 3; Pre-dose 2
    58.3
    46.8
        Dengue parental serotype 3; Post-dose 2
    100
    46.8
        Dengue parental serotype 3; Pre-dose 3
    75
    44.7
        Dengue parental serotype 3; Post-dose 3
    97.9
    47.8
        Dengue parental serotype 4; Pre-dose 1
    15.2
    18.4
        Dengue parental serotype 4; Post-dose 1
    73.5
    14.9
        Dengue parental serotype 4; Pre-dose 2
    55.2
    23.4
        Dengue parental serotype 4; Post-dose 2
    95.8
    19.1
        Dengue parental serotype 4; Pre-dose 3
    78.1
    14.9
        Dengue parental serotype 4; Post-dose 3
    97.9
    19.6
    No statistical analyses for this end point

    Secondary: Percentage of All Subjects Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine

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    End point title
    Percentage of All Subjects Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
    End point description
    Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer ≥10 1/dil.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1 and post-dose 2 and 3
    End point values
    Dengue vaccine group Control group
    Number of subjects analysed
    199
    99
    Units: Percentage of subjects
    number (not applicable)
        Dengue parental serotype 1; Pre-dose 1
    30.6
    36.4
        Dengue parental serotype 1; Post-dose 2
    94.7
    39.1
        Dengue parental serotype 1; Post-dose 3
    96.2
    48.3
        Dengue parental serotype 2; Pre-dose 1
    31.5
    41.4
        Dengue parental serotype 2; Post-dose 2
    97.9
    43.5
        Dengue parental serotype 2; Post-dose 3
    98.4
    47.2
        Dengue parental serotype 3; Pre-dose 1
    35
    46.5
        Dengue parental serotype 3; Post-dose 2
    98.9
    51.1
        Dengue parental serotype 3; Post-dose 3
    98.4
    67.4
        Dengue parental serotype 4; Pre-dose 1
    19.3
    22.2
        Dengue parental serotype 4; Post-dose 2
    98.4
    35.9
        Dengue parental serotype 4; Post-dose 3
    98.9
    48.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Aged 2 to 5 years Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine

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    End point title
    Percentage of Subjects Aged 2 to 5 years Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
    End point description
    Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer ≥10 1/dil.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1 and post-dose 2 and 3
    End point values
    Dengue vaccine group Control group
    Number of subjects analysed
    100
    50
    Units: Percentage of subjects
    number (not applicable)
        Dengue parental serotype 1; Pre-dose 1
    30.3
    30
        Dengue parental serotype 1; Post-dose 2
    96.7
    31.1
        Dengue parental serotype 1; Post-dose 3
    97.8
    41.9
        Dengue parental serotype 2; Pre-dose 1
    30.3
    38
        Dengue parental serotype 2; Post-dose 2
    96.7
    37.8
        Dengue parental serotype 2; Post-dose 3
    100
    44.2
        Dengue parental serotype 3; Pre-dose 1
    35.4
    38
        Dengue parental serotype 3; Post-dose 2
    98.9
    53.3
        Dengue parental serotype 3; Post-dose 3
    98.9
    65.1
        Dengue parental serotype 4; Pre-dose 1
    16.2
    22
        Dengue parental serotype 4; Post-dose 2
    97.8
    35.6
        Dengue parental serotype 4; Post-dose 3
    100
    46.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Aged 6 to 11 Years Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine

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    End point title
    Percentage of Subjects Aged 6 to 11 Years Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
    End point description
    Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer ≥10 1/dil.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1 and post-dose 2 and 3
    End point values
    Dengue vaccine group Control group
    Number of subjects analysed
    99
    49
    Units: Percentage of subjects
    number (not applicable)
        Dengue parental serotype 1; Pre-dose 1
    30.9
    42.9
        Dengue parental serotype 1; Post-dose 2
    92.6
    46.8
        Dengue parental serotype 1; Post-dose 3
    94.8
    54.3
        Dengue parental serotype 2; Pre-dose 1
    32.7
    44.9
        Dengue parental serotype 2; Post-dose 2
    98.9
    48.9
        Dengue parental serotype 2; Post-dose 3
    96.9
    50
        Dengue parental serotype 3; Pre-dose 1
    34.7
    55.1
        Dengue parental serotype 3; Post-dose 2
    98.9
    48.9
        Dengue parental serotype 3; Post-dose 3
    97.9
    69.6
        Dengue parental serotype 4; Pre-dose 1
    22.4
    22.4
        Dengue parental serotype 4; Post-dose 2
    98.9
    36.2
        Dengue parental serotype 4; Post-dose 3
    97.9
    50
    No statistical analyses for this end point

    Secondary: Percentage of All Subjects Seropositive for At Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine

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    End point title
    Percentage of All Subjects Seropositive for At Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
    End point description
    Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer ≥10 1/dil.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1, 2, and 3 and post-dose 1, 2, and 3
    End point values
    Dengue vaccine group Control group
    Number of subjects analysed
    199
    99
    Units: Percentage of subjects
    number (not applicable)
        At least 1 positive serotype; Pre-dose 1
    32.2
    40.4
        At least 1 positive serotype; Post-dose 1
    80.8
    40
        At least 1 positive serotype; Pre-dose 2
    69.8
    40.9
        At least 1 positive serotype; Post-dose 2
    100
    42.4
        At least 1 positive serotype; Pre-dose 3
    88.7
    42.9
        At least 1 positive serotype; Post-dose 3
    98.9
    48.3
        At least 2 positive serotypes; Pre-dose 1
    29.1
    38.4
        At least 2 positive serotypes; Post-dose 1
    66.8
    38.9
        At least 2 positive serotypes; Pre-dose 2
    49.2
    39.8
        At least 2 positive serotypes; Post-dose 2
    100
    40.2
        At least 2 positive serotypes; Pre-dose 3
    75.3
    39.6
        At least 2 positive serotypes; Post-dose 3
    98.9
    43.8
        At least 3 positive serotypes; Pre-dose 1
    19.6
    24.2
        At least 3 positive serotypes; Post-dose 1
    52.8
    25.3
        At least 3 positive serotypes; Pre-dose 2
    38.1
    22.6
        At least 3 positive serotypes; Post-dose 2
    98.4
    21.7
        At least 3 positive serotypes; Pre-dose 3
    67.7
    25.3
        At least 3 positive serotypes; Post-dose 3
    98.4
    25.8
        All 4 positive serotypes; Pre-dose 1
    10.6
    13.1
        All 4 positive serotypes; Post-dose 1
    37.8
    12.6
        All 4 positive serotypes; Pre-dose 2
    27.5
    16.1
        All 4 positive serotypes; Post-dose 2
    66
    10.9
        All 4 positive serotypes; Pre-dose 3
    33.9
    13.2
        All 4 positive serotypes; Post-dose 3
    79
    15.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Aged 2 to 5 years Seropositive for At Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine

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    End point title
    Percentage of Subjects Aged 2 to 5 years Seropositive for At Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
    End point description
    Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer ≥10 1/dil.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1, 2, and 3 and post-dose 1, 2, and 3
    End point values
    Dengue vaccine group Control group
    Number of subjects analysed
    100
    50
    Units: Percentage of subjects
    number (not applicable)
        At least 1 positive serotype; Pre-dose 1
    31
    34
        At least 1 positive serotype; Post-dose 1
    78.9
    35.4
        At least 1 positive serotype; Pre-dose 2
    67.7
    32.6
        At least 1 positive serotype; Post-dose 2
    100
    33.3
        At least 1 positive serotype; Pre-dose 3
    90
    36.4
        At least 1 positive serotype; Post-dose 3
    100
    44.2
        At least 2 positive serotypes; Pre-dose 1
    28
    32
        At least 2 positive serotypes; Post-dose 1
    65.3
    35.4
        At least 2 positive serotypes; Pre-dose 2
    46.2
    32.6
        At least 2 positive serotypes; Post-dose 2
    100
    33.3
        At least 2 positive serotypes; Pre-dose 3
    75.6
    34.1
        At least 2 positive serotypes; Post-dose 3
    100
    39.5
        At least 3 positive serotypes; Pre-dose 1
    17
    24
        At least 3 positive serotypes; Post-dose 1
    48.4
    27.1
        At least 3 positive serotypes; Pre-dose 2
    33.3
    19.6
        At least 3 positive serotypes; Post-dose 2
    98.9
    20
        At least 3 positive serotypes; Pre-dose 3
    65.6
    27.3
        At least 3 positive serotypes; Post-dose 3
    98.9
    30.2
        All 4 positive serotypes; Pre-dose 1
    9
    8
        All 4 positive serotypes; Post-dose 1
    31.6
    10.4
        All 4 positive serotypes; Pre-dose 2
    25.8
    10.9
        All 4 positive serotypes; Post-dose 2
    63
    8.9
        All 4 positive serotypes; Pre-dose 3
    27.8
    13.6
        All 4 positive serotypes; Post-dose 3
    77.8
    18.6
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Aged 6 to 11 Years Seropositive for At Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine

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    End point title
    Percentage of Subjects Aged 6 to 11 Years Seropositive for At Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
    End point description
    Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer ≥10 1/dil.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1, 2, and 3 and post-dose 1, 2, and 3
    End point values
    Dengue vaccine group Control group
    Number of subjects analysed
    99
    49
    Units: Percentage of subjects
    number (not applicable)
        At least 1 positive serotype; Pre-dose 1
    33.3
    46.9
        At least 1 positive serotype; Post-dose 1
    82.7
    44.7
        At least 1 positive serotype; Pre-dose 2
    71.9
    48.9
        At least 1 positive serotype; Post-dose 2
    100
    51.1
        At least 1 positive serotype; Pre-dose 3
    87.5
    48.9
        At least 1 positive serotype; Post-dose 3
    97.9
    52.2
        At least 2 positive serotypes; Pre-dose 1
    30.3
    44.9
        At least 2 positive serotypes; Post-dose 1
    68.4
    42.6
        At least 2 positive serotypes; Pre-dose 2
    52.1
    46.8
        At least 2 positive serotypes; Post-dose 2
    100
    46.8
        At least 2 positive serotypes; Pre-dose 3
    75
    44.7
        At least 2 positive serotypes; Post-dose 3
    97.9
    47.8
        At least 3 positive serotypes; Pre-dose 1
    22.2
    24.5
        At least 3 positive serotypes; Post-dose 1
    57.1
    23.4
        At least 3 positive serotypes; Pre-dose 2
    42.7
    25.5
        At least 3 positive serotypes; Post-dose 2
    97.9
    23.4
        At least 3 positive serotypes; Pre-dose 3
    69.8
    23.4
        At least 3 positive serotypes; Post-dose 3
    97.9
    21.7
        All 4 positive serotypes; Pre-dose 1
    12.1
    18.4
        All 4 positive serotypes; Post-dose 1
    43.9
    14.9
        All 4 positive serotypes; Pre-dose 2
    29.2
    21.3
        All 4 positive serotypes; Post-dose 2
    68.8
    12.8
        All 4 positive serotypes; Pre-dose 3
    39.6
    12.8
        All 4 positive serotypes; Post-dose 3
    80.2
    13
    No statistical analyses for this end point

    Secondary: Percentage of All Subjects Seropositive for At Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine

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    End point title
    Percentage of All Subjects Seropositive for At Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
    End point description
    Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer ≥10 1/dil.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1 and post-dose 2 and 3
    End point values
    Dengue vaccine group Control group
    Number of subjects analysed
    199
    99
    Units: Percentage of subjects
    number (not applicable)
        At least 1 positive serotype; Pre-dose 1
    37.6
    48.5
        At least 1 positive serotype; Post-dose 2
    100
    57.6
        At least 1 positive serotype; Post-dose 3
    99.5
    73
        At least 2 positive serotypes; Pre-dose 1
    31.5
    41.4
        At least 2 positive serotypes; Post-dose 2
    99.5
    41.3
        At least 2 positive serotypes; Post-dose 3
    99.5
    52.8
        At least 3 positive serotypes; Pre-dose 1
    29.9
    37.4
        At least 3 positive serotypes; Post-dose 2
    98.4
    41.3
        At least 3 positive serotypes; Post-dose 3
    98.4
    46.1
        All 4 positive serotypes; Pre-dose 1
    17.3
    19.2
        All 4 positive serotypes; Post-dose 2
    90.9
    29.3
        All 4 positive serotypes; Post-dose 3
    94.1
    39.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Aged 2 to 5 years Seropositive for At Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine

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    End point title
    Percentage of Subjects Aged 2 to 5 years Seropositive for At Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
    End point description
    Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer ≥10 1/dil.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1 and post-dose 2 and 3
    End point values
    Dengue vaccine group Control group
    Number of subjects analysed
    100
    50
    Units: Percentage of subjects
    number (not applicable)
        At least 1 positive serotype; Pre-dose 1
    39.4
    42
        At least 1 positive serotype; Post-dose 2
    100
    64.4
        At least 1 positive serotype; Post-dose 3
    100
    74.4
        At least 2 positive serotypes; Pre-dose 1
    30.3
    36
        At least 2 positive serotypes; Post-dose 2
    100
    33.3
        At least 2 positive serotypes; Post-dose 3
    100
    44.2
        At least 3 positive serotypes; Pre-dose 1
    28.3
    34
        At least 3 positive serotypes; Post-dose 2
    97.8
    33.3
        At least 3 positive serotypes; Post-dose 3
    100
    41.9
        All 4 positive serotypes; Pre-dose 1
    14.1
    16
        All 4 positive serotypes; Post-dose 2
    90.2
    26.7
        All 4 positive serotypes; Post-dose 3
    96.7
    37.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Aged 6 to 11 Years Seropositive for At Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine

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    End point title
    Percentage of Subjects Aged 6 to 11 Years Seropositive for At Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
    End point description
    Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer ≥10 1/dil.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1 and post-dose 2 and 3
    End point values
    Dengue vaccine group Control group
    Number of subjects analysed
    99
    49
    Units: Percentage of subjects
    number (not applicable)
        At least 1 positive serotype; Pre-dose 1
    35.7
    55.1
        At least 1 positive serotype; Post-dose 2
    100
    51.1
        At least 1 positive serotype; Post-dose 3
    99
    71.7
        At least 2 positive serotypes; Pre-dose 1
    32.7
    46.9
        At least 2 positive serotypes; Post-dose 2
    98.9
    48.9
        At least 2 positive serotypes; Post-dose 3
    99
    60.9
        At least 3 positive serotypes; Pre-dose 1
    31.6
    40.8
        At least 3 positive serotypes; Post-dose 2
    98.9
    48.9
        At least 3 positive serotypes; Post-dose 3
    96.9
    50
        All 4 positive serotypes; Pre-dose 1
    20.4
    22.4
        All 4 positive serotypes; Post-dose 2
    91.6
    31.9
        All 4 positive serotypes; Post-dose 3
    91.7
    41.3
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype with the Parental Dengue Virus Strain in Dengue-immune Subjects Before and After Injection with CYD Dengue Vaccine

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    End point title
    Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype with the Parental Dengue Virus Strain in Dengue-immune Subjects Before and After Injection with CYD Dengue Vaccine
    End point description
    Geometric mean titers of antibodies against parental dengue virus serotypes were assessed by the plaque reduction neutralization test (PRNT).
    End point type
    Secondary
    End point timeframe
    Pre-dose 1 and post-dose 2 and 3
    End point values
    Dengue vaccine group Control group
    Number of subjects analysed
    199
    99
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Dengue parental serotype 1; Pre-dose 1, All
    17.4 (13 to 23.2)
    22.8 (14.9 to 34.8)
        Dengue parental serotype 1; Post-dose 2, All
    125 (98.5 to 159)
    26.4 (16.7 to 41.8)
        Dengue parental serotype 1; Post-dose 3, All
    179 (143 to 224)
    38.1 (23.4 to 62.1)
        Dengue parental serotype 2; Pre-dose 1, All
    14.4 (11.2 to 18.3)
    18.2 (12.8 to 25.8)
        Dengue parental serotype 2; Post-dose 2, All
    151 (128 to 178)
    17.3 (12.5 to 23.9)
        Dengue parental serotype 2; Post-dose 3, All
    178 (152 to 207)
    21.6 (14.8 to 31.5)
        Dengue parental serotype 3; Pre-dose 1, All
    16.4 (12.7 to 21.2)
    21.8 (15.2 to 31.3)
        Dengue parental serotype 3; Post-dose 2, All
    155 (129 to 186)
    26.6 (18.1 to 39)
        Dengue parental serotype 3; Post-dose 3, All
    190 (162 to 224)
    36.2 (25.1 to 52)
        Dengue parental serotype 4; Pre-dose 1, All
    8.12 (6.91 to 9.54)
    8.94 (6.97 to 11.5)
        Dengue parental serotype 4; Post-dose 2, All
    144 (126 to 166)
    12.8 (9.5 to 17.2)
        Dengue parental serotype 4; Post-dose 3, All
    184 (159 to 212)
    16.7 (12.2 to 22.8)
        Dengue parental serotype 1; Pre-dose 1, 2-5 years
    16.4 (11.1 to 24.3)
    16.2 (9.47 to 27.5)
        Dengue parental serotype 1; Post-dose 2, 2-5 years
    135 (97.2 to 187)
    19 (10.1 to 35.7)
        Dengue parental serotype 1; Post-dose 3, 2-5 years
    205 (149 to 282)
    31.3 (14.9 to 65.9)
        Dengue parental serotype 2; Pre-dose 1, 2-5 years
    11.8 (8.94 to 15.6)
    13.9 (9.31 to 20.6)
        Dengue parental serotype 2; Post-dose 2, 2-5 years
    135 (109 to 168)
    13.2 (8.8 to 19.9)
        Dengue parental serotype 2; Post-dose 3, 2-5 years
    195 (163 to 234)
    21.8 (12.1 to 39.2)
        Dengue parental serotype 3; Pre-dose 1, 2-5 years
    16.2 (11.2 to 23.4)
    16.7 (10.2 to 27.4)
        Dengue parental serotype 3; Post-dose 2, 2-5 years
    171 (131 to 224)
    26.5 (15.4 to 45.7)
        Dengue parental serotype 3; Post-dose 3, 2-5 years
    214 (169 to 270)
    35 (20.3 to 60.6)
        Dengue parental serotype 4; Pre-dose 1, 2-5 years
    7.76 (6.2 to 9.7)
    9.02 (6.27 to 13)
        Dengue parental serotype 4; Post-dose 2, 2-5 years
    165 (134 to 203)
    14.4 (8.83 to 23.6)
        Dengue parental serotype 4; Post-dose 3, 2-5 years
    223 (181 to 276)
    18.7 (11.2 to 31.4)
        Dengue parental serotype 1; Pre-dose 1, 6-11 years
    18.4 (12 to 28.4)
    32.3 (16.6 to 63.1)
        Dengue parental serotype 1;Post-dose 2, 6-11 years
    116 (81.7 to 165)
    36.2 (18.5 to 71)
        Dengue parental serotype 1;Post-dose 3, 6-11 years
    157 (115 to 216)
    45.8 (23.6 to 88.8)
        Dengue parental serotype 2; Pre-dose 1, 6-11 years
    17.5 (11.6 to 26.3)
    24 (13.4 to 43.1)
        Dengue parental serotype 2;Post-dose 2, 6-11 years
    168 (130 to 216)
    22.3 (13.4 to 37)
        Dengue parental serotype 2;Post-dose 3, 6-11 years
    163 (127 to 208)
    21.4 (12.9 to 35.6)
        Dengue parental serotype 3; Pre-dose 1, 6-11 years
    16.6 (11.5 to 24)
    28.6 (16.7 to 48.7)
        Dengue parental serotype 3;Post-dose 2, 6-11 years
    141 (109 to 182)
    26.6 (15.1 to 46.8)
        Dengue parental serotype 3;Post-dose 3, 6-11 years
    171 (137 to 213)
    37.3 (22.5 to 61.6)
        Dengue parental serotype 4; Pre-dose 1, 6-11 years
    8.5 (6.72 to 10.8)
    8.87 (6.21 to 12.6)
        Dengue parental serotype 4;Post-dose 2, 6-11 years
    127 (106 to 153)
    11.4 (7.96 to 16.3)
        Dengue parental serotype 4;Post-dose 3, 6-11 years
    152 (126 to 184)
    15 (10.2 to 22)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Seropositive for Yellow Fever Antibodies Before and Following First Injection with CYD Dengue Vaccine

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    End point title
    Percentage of Subjects Seropositive for Yellow Fever Antibodies Before and Following First Injection with CYD Dengue Vaccine
    End point description
    Seropositivity for yellow fever was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer ≥10 1/dil.
    End point type
    Secondary
    End point timeframe
    Pre- and post-dose 1
    End point values
    Dengue vaccine group Control group
    Number of subjects analysed
    199
    99
    Units: Percentage of subjects
    number (not applicable)
        Pre-dose 1; All subjects
    81.4
    83.8
        Post-dose 1; All subjects
    86.5
    83.2
        Pre-dose 1; 2-5 years
    68
    74
        Post-dose 1; 2-5 years
    76.6
    72.9
        Pre-dose 1; 6-11 years
    94.9
    93.9
        Post-dose 1; 6-11 years
    95.9
    93.6
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Antibodies Against Yellow Fever Virus Before and Following First Injection with CYD Dengue Vaccine

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    End point title
    Geometric Mean Titers (GMTs) of Antibodies Against Yellow Fever Virus Before and Following First Injection with CYD Dengue Vaccine
    End point description
    Geometric mean titers of antibodies against yellow fever virus were assessed by the plaque reduction neutralization test (PRNT).
    End point type
    Secondary
    End point timeframe
    Pre- and post-dose 1
    End point values
    Dengue vaccine group Control group
    Number of subjects analysed
    199
    99
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Pre-dose 1; All subjects
    32.3 (26.5 to 39.4)
    36 (27.1 to 47.7)
        Post-dose 1; All subjects
    43.7 (36.1 to 52.8)
    36 (27.3 to 47.3)
        Pre-dose 1; 2-5 years
    15.9 (12.3 to 20.6)
    20.5 (13.7 to 30.7)
        Post-dose 1; 2-5 years
    22.4 (17.5 to 28.7)
    21.2 (14.4 to 31.1)
        Pre-dose 1; 6-11 years
    66.1 (52.8 to 82.9)
    63.9 (45.8 to 89.2)
        Post-dose 1; 6-11 years
    82.9 (66.2 to 104)
    61.8 (44 to 86.7)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype with the Parental Dengue Virus Strain Before and Following Injection with CYD Dengue 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 CYD Dengue Vaccine
    End point description
    Geometric mean titers of antibodies against parental dengue virus serotypes were assessed by the microneutralization assay.
    End point type
    Secondary
    End point timeframe
    Pre-dose 1, 2, and 3 and post-dose 1, 2, and 3
    End point values
    Dengue vaccine group Control group
    Number of subjects analysed
    199
    99
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Dengue parental serotype 1; Pre-dose 1, All
    18.8 (13.8 to 25.6)
    23.9 (15.5 to 36.9)
        Dengue parental serotype 1; Post-dose 1, All
    43.1 (30 to 61.9)
    22.8 (14.8 to 35.1)
        Dengue parental serotype 1; Pre-dose 2, All
    29.2 (20.5 to 41.7)
    26 (16.2 to 41.5)
        Dengue parental serotype 1; Post-dose 2, All
    214 (171 to 266)
    26.1 (16.3 to 42)
        Dengue parental serotype 1; Pre-dose 3, All
    64.1 (46.1 to 89.2)
    28.9 (17.7 to 47.3)
        Dengue parental serotype 1; Post-dose 3, All
    254 (203 to 318)
    35.3 (21.2 to 58.7)
        Dengue parental serotype 2; Pre-dose 1, All
    7.55 (6.5 to 8.78)
    7.76 (6.31 to 9.53)
        Dengue parental serotype 2; Post-dose 1, All
    15.5 (12.4 to 19.4)
    7.51 (6.19 to 9.12)
        Dengue parental serotype 2; Pre-dose 2, All
    11.6 (9.52 to 14.1)
    7.32 (6.06 to 8.84)
        Dengue parental serotype 2; Post-dose 2, All
    21.4 (17.6 to 25.9)
    6.99 (5.82 to 8.39)
        Dengue parental serotype 2; Pre-dose 3, All
    11.4 (9.39 to 13.8)
    7.26 (6.01 to 8.78)
        Dengue parental serotype 2; Post-dose 3, All
    22.3 (18.9 to 26.4)
    7.73 (6.24 to 9.58)
        Dengue parental serotype 3; Pre-dose 1, All
    13.1 (10.3 to 16.5)
    16.3 (11.6 to 22.8)
        Dengue parental serotype 3; Post-dose 1, All
    41.4 (30.9 to 55.4)
    15.3 (11 to 21.3)
        Dengue parental serotype 3; Pre-dose 2, All
    22.6 (17.3 to 29.5)
    15.4 (11.2 to 21.2)
        Dengue parental serotype 3; Post-dose 2, All
    128 (108 to 150)
    15.5 (11.2 to 21.5)
        Dengue parental serotype 3; Pre-dose 3, All
    31 (24.3 to 39.6)
    14 (10.3 to 19)
        Dengue parental serotype 3; Post-dose 3, All
    99.2 (84.8 to 116)
    16 (11.5 to 22.2)
        Dengue parental serotype 4; Pre-dose 1, All
    7.52 (6.37 to 8.87)
    8.08 (6.39 to 10.2)
        Dengue parental serotype 4; Post-dose 1, All
    87.9 (65.4 to 118)
    7.84 (6.25 to 9.83)
        Dengue parental serotype 4; Pre-dose 2, All
    21.3 (16.9 to 26.8)
    7.73 (6.27 to 9.53)
        Dengue parental serotype 4; Post-dose 2, All
    158 (134 to 186)
    7.81 (6.27 to 9.74)
        Dengue parental serotype 4; Pre-dose 3, All
    39.2 (31.7 to 48.5)
    7.49 (6.06 to 9.26)
        Dengue parental serotype 4; Post-dose 3, All
    147 (126 to 172)
    8.54 (6.71 to 10.9)
        Dengue parental serotype 1; Pre-dose 1, 2-5 years
    20.3 (12.9 to 32)
    18.6 (10.4 to 33.4)
        Dengue parental serotype 1; Post-dose 1, 2-5 years
    44.8 (25.9 to 77.3)
    19.6 (10.6 to 36.1)
        Dengue parental serotype 1; Pre-dose 2, 2-5 years
    31.3 (18.1 to 53.9)
    19.7 (10.1 to 38.2)
        Dengue parental serotype 1; Post-dose 2, 2-5 years
    281 (204 to 386)
    20.9 (10.5 to 41.7)
        Dengue parental serotype 1; Pre-dose 3, 2-5 years
    65.2 (39.6 to 107)
    22.1 (11 to 44.5)
        Dengue parental serotype 1; Post-dose 3, 2-5 years
    315 (228 to 436)
    35.9 (16.4 to 78.6)
        Dengue parental serotype 2; Pre-dose 1, 2-5 years
    6.66 (5.63 to 7.88)
    6.48 (5.3 to 7.92)
        Dengue parental serotype 2; Post-dose 1, 2-5 years
    12.7 (9.35 to 17.3)
    6.73 (5.39 to 8.41)
        Dengue parental serotype 2; Pre-dose 2, 2-5 years
    10.1 (7.85 to 12.9)
    6.28 (5.19 to 7.61)
        Dengue parental serotype 2; Post-dose 2, 2-5 years
    17.1 (13.4 to 21.8)
    6.13 (5.06 to 7.44)
        Dengue parental serotype 2; Pre-dose 3, 2-5 years
    9.03 (7.17 to 11.4)
    6.68 (5.37 to 8.32)
        Dengue parental serotype 2; Post-dose 3, 2-5 years
    19.7 (15.9 to 24.5)
    7.93 (5.76 to 10.9)
        Dengue parental serotype 3; Pre-dose 1, 2-5 years
    11.8 (8.54 to 16.4)
    12.2 (8 to 18.7)
        Dengue parental serotype 3; Post-dose 1, 2-5 years
    37.4 (23.9 to 58.3)
    12.9 (8.39 to 20)
        Dengue parental serotype 3; Pre-dose 2, 2-5 years
    19.8 (13.4 to 29.4)
    12.3 (7.92 to 19)
        Dengue parental serotype 3; Post-dose 2, 2-5 years
    129 (104 to 160)
    12.6 (8.01 to 19.7)
        Dengue parental serotype 3; Pre-dose 3, 2-5 years
    26.7 (18.7 to 38.2)
    12.2 (7.85 to 19.1)
        Dengue parental serotype 3; Post-dose 3, 2-5 years
    108 (86.9 to 135)
    15.3 (9.29 to 25.2)
        Dengue parental serotype 4; Pre-dose 1, 2-5 years
    7.04 (5.67 to 8.74)
    7.74 (5.6 to 10.7)
        Dengue parental serotype 4; Post-dose 1, 2-5 years
    114 (74 to 176)
    8.43 (5.97 to 11.9)
        Dengue parental serotype 4; Pre-dose 2, 2-5 years
    22.3 (16 to 31)
    7.64 (5.53 to 10.6)
        Dengue parental serotype 4; Post-dose 2, 2-5 years
    200 (166 to 240)
    8.22 (5.76 to 11.7)
        Dengue parental serotype 4; Pre-dose 3, 2-5 years
    39.4 (29.5 to 52.8)
    7.97 (5.69 to 11.2)
        Dengue parental serotype 4; Post-dose 3, 2-5 years
    176 (143 to 217)
    9.37 (6.35 to 13.8)
        Dengue parental serotype 1; Pre-dose 1, 6-11 years
    17.4 (11.4 to 26.6)
    31 (16.1 to 59.6)
        Dengue parental serotype 1;Post-dose 1, 6-11 years
    41.5 (25.5 to 67.5)
    26.7 (14.2 to 50)
        Dengue parental serotype 1; Pre-dose 2, 6-11 years
    27.4 (17.2 to 43.6)
    33.9 (17.2 to 66.9)
        Dengue parental serotype 1;Post-dose 2, 6-11 years
    165 (122 to 222)
    32.4 (16.6 to 63.2)
        Dengue parental serotype 1; Pre-dose 3, 6-11 years
    63.2 (40.5 to 98.7)
    37.2 (18.4 to 75.4)
        Dengue parental serotype 1;Post-dose 3, 6-11 years
    207 (152 to 283)
    34.7 (17.4 to 69.1)
        Dengue parental serotype 2; Pre-dose 1, 6-11 years
    8.57 (6.67 to 11)
    9.32 (6.48 to 13.4)
        Dengue parental serotype 2;Post-dose 1, 6-11 years
    18.8 (13.5 to 26.2)
    8.4 (6.07 to 11.6)
        Dengue parental serotype 2; Pre-dose 2, 6-11 years
    13.3 (9.8 to 18)
    8.5 (6.14 to 11.8)
        Dengue parental serotype 2;Post-dose 2, 6-11 years
    26.5 (19.7 to 35.7)
    7.92 (5.82 to 10.8)
        Dengue parental serotype 2; Pre-dose 3, 6-11 years
    14.1 (10.5 to 19)
    7.85 (5.75 to 10.7)
        Dengue parental serotype 2;Post-dose 3, 6-11 years
    25 (19.4 to 32.3)
    7.55 (5.59 to 10.2)
        Dengue parental serotype 3; Pre-dose 1, 6-11 years
    14.4 (10.3 to 20.2)
    21.8 (12.8 to 37.1)
        Dengue parental serotype 3;Post-dose 1, 6-11 years
    45.6 (31 to 67.1)
    18.3 (11 to 30.4)
        Dengue parental serotype 3; Pre-dose 2, 6-11 years
    25.6 (17.8 to 37)
    19.2 (11.9 to 31.1)
        Dengue parental serotype 3;Post-dose 2, 6-11 years
    126 (98.6 to 162)
    19.1 (11.8 to 30.8)
        Dengue parental serotype 3; Pre-dose 3, 6-11 years
    35.6 (25.3 to 50)
    15.8 (10.2 to 24.6)
        Dengue parental serotype 3;Post-dose 3, 6-11 years
    91.3 (73 to 114)
    16.7 (10.7 to 26)
        Dengue parental serotype 4; Pre-dose 1, 6-11 years
    8.03 (6.23 to 10.3)
    8.43 (5.94 to 12)
        Dengue parental serotype 4;Post-dose 1, 6-11 years
    68.2 (45.6 to 102)
    7.28 (5.36 to 9.88)
        Dengue parental serotype 4; Pre-dose 2, 6-11 years
    20.3 (14.6 to 28.1)
    7.82 (5.9 to 10.3)
        Dengue parental serotype 4;Post-dose 2, 6-11 years
    126 (96.3 to 164)
    7.44 (5.63 to 9.83)
        Dengue parental serotype 4; Pre-dose 3, 6-11 years
    39 (28.6 to 53.2)
    7.06 (5.37 to 9.29)
        Dengue parental serotype 4;Post-dose 3, 6-11 years
    125 (98.9 to 157)
    7.82 (5.79 to 10.6)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from Day 0 (post-vaccination) up to 14 days post-vaccination 3.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Dengue vaccine group
    Reporting group description
    Subjects received 3 injections of the CYD Dengue vaccine, 1 injection each at 0, 6, and 12 months.

    Reporting group title
    Control group
    Reporting group description
    Subjects received a placebo as first and second injections at 0 and 6 months, respectively, and pneumococcal polysaccharide vaccine (Pneumo23) as third injection at 12 months.

    Serious adverse events
    Dengue vaccine group Control group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 199 (1.01%)
    4 / 99 (4.04%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Food poisoning
         subjects affected / exposed
    0 / 199 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 199 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Vascular purpura
         subjects affected / exposed
    1 / 199 (0.50%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Epiphyseal disorder
         subjects affected / exposed
    1 / 199 (0.50%)
    0 / 99 (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
    Gastrointestinal infection
         subjects affected / exposed
    0 / 199 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 199 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Dengue vaccine group Control group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    71 / 199 (35.68%)
    29 / 99 (29.29%)
    General disorders and administration site conditions
    Injection site Pain; Post-injection 1, All subjects
    alternative assessment type: Systematic
         subjects affected / exposed
    41 / 199 (20.60%)
    17 / 99 (17.17%)
         occurrences all number
    41
    17
    Injection site Erythema; Post-injection 1, All subjects
    alternative assessment type: Systematic
         subjects affected / exposed
    15 / 199 (7.54%)
    4 / 99 (4.04%)
         occurrences all number
    15
    4
    Injection site Swelling; Post-injection 1, All subjects
    alternative assessment type: Systematic
         subjects affected / exposed
    11 / 199 (5.53%)
    5 / 99 (5.05%)
         occurrences all number
    11
    5
    Injection site Pain; Post-injection 2, All subjects
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    37 / 188 (19.68%)
    16 / 92 (17.39%)
         occurrences all number
    37
    16
    Injection site Pain; Post-injection 3, All subjects
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    33 / 186 (17.74%)
    29 / 90 (32.22%)
         occurrences all number
    33
    29
    Injection site Erythema; Post-injection 3, All subjects
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    8 / 186 (4.30%)
    10 / 90 (11.11%)
         occurrences all number
    8
    10
    Injection site Swelling; Post-injection 3, All subjects
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    6 / 186 (3.23%)
    8 / 90 (8.89%)
         occurrences all number
    6
    8
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after the second injection; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after the third injection; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after the third injection; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after the third injection; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 May 2008
    Used serum pregnancy tests instead of urinary pregnancy tests; intensity scales were changed from mild, moderate, and severe to Grade 1, Grade 2, and Grade 3; clarified that the Ministry of Health was also to receive any serious adverse events (SAE) reports; exclusion criterion was added to specify that subjects were not to be previously vaccinated with pneumococcal polysaccharide vaccine; clarified that priority was given to assessing safety over the diagnosis of dengue; SAE reporting section was updated and clarified the use of electronic SAE reporting forms; and avoided the use of the trade name in the ChimeriVax™ in the document.
    13 May 2009
    Specified the exact name of the study site and provided the Investigator with assessment guidelines for biological abnormalities; specified that the visit could be conducted in 2 days within the time window specified; clarified that the last contact with the subject/subject's parents could be face-to-face; replaced dengue plaque assay with reverse transcriptase-polymerase chain reaction to detect dengue vaccine viremia and/or wild type dengue infection; clarified the procedures of unused product; testing priority was defined as suspected dengue cases detected within 28 days after vaccination and those detected after more than 28 days after vaccination; clarified that yellow fever serology would be assessed by PRNT; clarified that another adult could complete the subject's diary card when parents/legally acceptable representative were not available; and the Guidelines for Assessing Viscerotropic and Neurotropic Adverse Events were updated and provided as a protocol appendix.
    09 Oct 2009
    Additional phone call/home visit was implemented 8 to 15 days after the third vaccination; clarified that 2 consecutive febrile episodes were considered separate episodes if the symptom-free interval between the end of the first febrile episode and the onset of the new episode was >14 days; and clarified the time frame to set up the planned phone call/home visit at 3 months after the third vaccination.
    08 Jun 2010
    Informed subject and parents/guardians of the vaccine the subject received and about the trial results at the end of the trial; specified that dengue neutralizing antibodies were assessed by both microneutralization assay and complementary testing using PRNT; stated that dengue non-structural protein 1 antigen enzyme-linked immunosorbent assay was to be performed for virological diagnosis of dengue cases; clarified the procedures for checking and collecting memory aid; specified the lower limit of quantitation of the yellow fever serology assay; clarified rules for inclusion/exclusion of subjects by dose from the Per Protocol Analysis Set; and specified that reporting of SAEs and dengue cases data were ongoing and could not be locked before the interim analysis.

    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/22863660
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