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    Clinical Trial Results:
    Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia

    Summary
    EudraCT number
    2014-001708-24
    Trial protocol
    Outside EU/EEA  
    Global end of trial date

    Results information
    Results version number
    v1
    This version publication date
    08 Feb 2016
    First version publication date
    17 Apr 2015
    Other versions
    v2

    Trial information

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    Trial identification
    Sponsor protocol code
    CYD14
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01373281
    WHO universal trial number (UTN)
    U1111-1116-4957
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon Cedex 07, France, F-69367
    Public contact
    Director, Clinical Development, Sanofi Pasteur SA, +65 6431 2359, Anh.Wartel-Tram@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, +65 6431 2359, 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?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    28 May 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    Efficacy of CYD dengue vaccine after 3 vaccinations at 0, 6 and 12 months in preventing symptomatic virologically-confirmed dengue cases, regardless of the severity, due to any of the four serotypes in children aged 2 to 14 years at the time of inclusion.
    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 were 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
    03 Jun 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy
    Long term follow-up duration
    4 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Philippines: 3501
    Country: Number of subjects enrolled
    Malaysia: 1401
    Country: Number of subjects enrolled
    Vietnam: 2333
    Country: Number of subjects enrolled
    Thailand: 1170
    Country: Number of subjects enrolled
    Indonesia: 1870
    Worldwide total number of subjects
    10275
    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)
    7946
    Adolescents (12-17 years)
    2329
    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 03 June 2011 to 01 December 2011 at 9 sites in Indonesia, 5 in Malaysia, 3 in Thailand, 5 in Philippines, and 2 in Vietnam.

    Pre-assignment
    Screening details
    A total of 10275 subjects who met all of the inclusion criteria and none of the exclusion criteria were enrolled; 3 subjects were not vaccinated and were excluded from the Full Analysis Set for Efficacy and the Safety Analysis Set.

    Period 1
    Period 1 title
    Active Phase (primary endpoint) (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Monitor, Assessor, Subject
    Blinding implementation details
    An observer-blind procedure was followed for the 3 CYD dengue vaccine or placebo injections. The 'vaccinator' in charge of preparing and administering the vaccines was not authorized to collect safety data and also ensured that the documents on randomization were stored in a secure place with no unathorized access.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    CYD Dengue Vaccine Group
    Arm description
    Subjects received 3 doses of CYD dengue vaccine; one 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 doses at 0, 6, and 12 months.

    Arm title
    Placebo Group
    Arm description
    Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo (NaCl)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, 3 doses at 0, 6, and 12 months.

    Number of subjects in period 1
    CYD Dengue Vaccine Group Placebo Group
    Started
    6851
    3424
    Completed
    6772
    3379
    Not completed
    79
    45
         Protocol deviation
    13
    4
         Adverse event, non-fatal
    4
    4
         Consent withdrawn by subject
    52
    31
         Serious adverse event
    6
    5
         Lost to follow-up
    4
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CYD Dengue Vaccine Group
    Reporting group description
    Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.

    Reporting group title
    Placebo Group
    Reporting group description
    Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.

    Reporting group values
    CYD Dengue Vaccine Group Placebo Group Total
    Number of subjects
    6851 3424 10275
    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)
    5296 2650 7946
        Adolescents (12-17 years)
    1555 774 2329
        Adults (18-64 years)
    0 0 0
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    8.8 ± 3.45 8.8 ± 3.42 -
    Gender categorical
    Units: Subjects
        Female
    3524 1767 5291
        Male
    3327 1657 4984

    End points

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    End points reporting groups
    Reporting group title
    CYD Dengue Vaccine Group
    Reporting group description
    Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.

    Reporting group title
    Placebo Group
    Reporting group description
    Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.

    Primary: Vaccine Efficacy Against Symptomatic Virologically-confirmed Dengue Cases Due to Any Serotype During the Active Phase Post-dose 3 Injection with CYD Dengue Vaccine

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    End point title
    Vaccine Efficacy Against Symptomatic Virologically-confirmed Dengue Cases Due to Any Serotype During the Active Phase Post-dose 3 Injection with CYD Dengue Vaccine
    End point description
    Symptomatic virologically-confirmed dengue (VCD) cases were defined as acute febrile illness (temperature ≥38°C on at least 2 consecutive days) and confirmed by dengue reverse transcriptase-polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay. Cases defined as number of subjects with at least one symptomatic VCD episode from 28 days post-injection 3 to the end of Active Phase. Density incidence: data are cases per 100 person-years at risk. The person-years at risk was the cumulative time (in years) until the participant was diagnosed with VCD or until the end of the active period, whichever came first. Data presented is the sum of individual units of time for which the participants contributed to the analyses. Incidence density was calculated as the number of VCD cases divided by the cumulative person-years at risk. The vaccine efficacy is considered as significant if the lower bound of its 95% CI (exact method by Breslow & Day) is greater than 25%.
    End point type
    Primary
    End point timeframe
    28 days post-injection 3 and up to the end of the Active Phase (13 months post-injection 3)
    End point values
    CYD Dengue Vaccine Group Placebo Group
    Number of subjects analysed
    6710
    3350
    Units: Cases
    number (not applicable)
        Symptomatic virologicaly-confirmed dengue cases
    117
    133
        Person-years at risk
    6526
    3227
        Density incidence
    1.8
    4.1
    Statistical analysis title
    Vaccine efficacy of the CYD dengue vaccine
    Statistical analysis description
    The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine was considered significant if the lower bound of its 95% CI was greater than 25%.
    Comparison groups
    CYD Dengue Vaccine Group v Placebo Group
    Number of subjects included in analysis
    10060
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Vaccine efficacy (%)
    Point estimate
    56.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    43.8
         upper limit
    66.4

    Secondary: Geometric Mean Titers of Antibodies Against Each Serotype with the Parental Dengue Virus Strain Before and Following Injection with CYD Dengue Tetravalent Vaccine

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    End point title
    Geometric Mean Titers of Antibodies Against Each Serotype with the Parental Dengue Virus Strain Before and Following Injection with CYD Dengue Tetravalent Vaccine
    End point description
    Geometric mean titers against each serotypes of the Dengue virus strains were assessed using the plaque reduction neutralization test (PRNT) in a predefined subset of 2,000 subjects from each country (1,333 in the CYD Dengue Vaccine Group and 667 in the Control Group).
    End point type
    Secondary
    End point timeframe
    Pre-Injection 1 (Day 0) and Post-Injection 2 (6 months), and 3 (12 months)
    End point values
    CYD Dengue Vaccine Group Placebo Group
    Number of subjects analysed
    1323
    660
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Dengue virus Serotype 1; Pre-Injection 1
    38.3 (33.8 to 43.5)
    42.1 (35 to 50.6)
        Dengue virus Serotype 1; Post-Injection 2
    153 (137 to 170)
    46.1 (38.2 to 55.7)
        Dengue virus Serotype 1; Post-Injection 3
    166 (150 to 183)
    46.6 (38.7 to 56.1)
        Dengue virus Serotype 1; Year 1 post-injection 3
    105 (92.8 to 119)
    57.3 (46.9 to 70)
        Dengue virus Serotype 2; Pre-Injection 1
    55.3 (48.7 to 62.9)
    62.1 (51.7 to 74.7)
        Dengue virus Serotype 2; Post-Injection 2
    360 (329 to 394)
    69.5 (57.7 to 83.6)
        Dengue virus Serotype 2; Post-Injection 3
    355 (327 to 386)
    68.5 (57.1 to 82.2)
        Dengue virus Serotype 2; Year 1 post-injection 3
    194 (175 to 214)
    78.4 (65.1 to 94.4)
        Dengue virus Serotype 3; Pre-Injection 1
    40.1 (35.6 to 45.1)
    40.7 (34.5 to 48)
        Dengue virus Serotype 3; Post-Injection 2
    203 (184 to 223)
    40.8 (34.6 to 48.1)
        Dengue virus Serotype 3; Post-Injection 3
    207 (189 to 226)
    42.5 (36.2 to 49.9)
        Dengue virus Serotype 3; Year 1 post-injection 3
    186 (168 to 206)
    62.4 (51.9 to 74.9)
        Dengue virus Serotype 4; Pre-Injection 1
    25.3 (22.9 to 28)
    26.2 (22.6 to 30.3)
        Dengue virus Serotype 4; Post-Injection 2
    151 (139 to 163)
    24.4 (21.3 to 28.1)
        Dengue virus Serotype 4; Post-Injection 3
    151 (141 to 162)
    26 (22.6 to 29.8)
        Dengue virus Serotype 4; Year 1 post-injection 3
    85.5 (78.5 to 93)
    26.2 (22.5 to 30.5)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Antibody Titer ≥ 10 (1/dil) Against Each Serotype with the Parental Dengue Virus Strains Before and Post-injection with CYD 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 Post-injection with CYD Dengue Tetravalent Vaccine
    End point description
    Antibody titers against each serotype of the Dengue virus strains were assessed using the plaque reduction neutralization test (PRNT).
    End point type
    Secondary
    End point timeframe
    Pre-Injection 1 (Day 0) and Post-Injection 2 (6 months) and 3 (12 months)
    End point values
    CYD Dengue Vaccine Group Placebo Group
    Number of subjects analysed
    1323
    660
    Units: Percentage of subjects
    number (not applicable)
        Dengue virus Serotype 1; Pre-Injection 1
    52
    51.3
        Dengue virus Serotype 1; Post-Injection 2
    88.9
    54.4
        Dengue virus Serotype 1; Post-Injection 3
    94
    55.4
        Dengue virus Serotype 1; 1-Year post-injection 3
    79.8
    55.7
        Dengue virus Serotype 2; Pre-Injection 1
    58
    59.3
        Dengue virus Serotype 2; Post-Injection 2
    97.3
    62.4
        Dengue virus Serotype 2; Post-Injection 3
    98.7
    61.8
        Dengue virus Serotype 2; 1-Year post-injection 3
    92
    65.8
        Dengue virus Serotype 3; Pre-Injection 1
    56.8
    59.4
        Dengue virus Serotype 3; Post-Injection 2
    95.7
    60.2
        Dengue virus Serotype 3; Post-Injection 3
    97
    61
        Dengue virus Serotype 3; 1-Year post-injection 3
    93.6
    62.6
        Dengue virus Serotype 4; Pre-Injection 1
    51.6
    50.7
        Dengue virus Serotype 4; Post-Injection 2
    95.1
    51.8
        Dengue virus Serotype 4; Post-Injection 3
    97
    53.9
        Dengue virus Serotype 4; 1-Year post-injection 3
    89.4
    50.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following Any and Each Injection with CYD Dengue Tetravalent Vaccine

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    End point title
    Percentage of Subjects with Solicited Injection-site and Systemic Reactions Following Any and Each Injection with CYD Dengue Tetravalent Vaccine
    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 (2-11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm. Grade 3 Solicited injection site reactions (12-14 years): Pain, Significant, prevents daily activity; Erythema and Swelling, >100 mm. Grade 3 Solicited injection site reactions: Fever, ≥39°C; Headache, Malaise, Myalgia, and Asthenia, Significant, prevents daily activity.
    End point type
    Secondary
    End point timeframe
    Day 0 (post-vaccination) up to 14 days post-any vaccination
    End point values
    CYD Dengue Vaccine Group Placebo Group
    Number of subjects analysed
    1334
    663
    Units: Percentage of subjects
    number (not applicable)
        Inj. site Pain; Post-Any Inj.
    46.1
    41.5
        Grade 3 Inj. site Pain; Post-Any Inj.
    0.1
    0
        Inj. site Erythema; Post-Any Inj.
    8
    7.8
        Grade 3 Inj. site Erythema; Post-Any Inj.
    0
    0.2
        Inj. site Swelling; Post-Any Inj.
    5.1
    5
        Grade 3 Inj. site Swelling; Post-Any Inj.
    0
    0
        Inj. site Pain; Post-Inj. 1
    30.5
    29.6
        Grade 3 Inj. site Pain; Post-Inj. 1
    0.1
    0
        Inj. site Erythema; Post-Inj. 1
    4.7
    5.3
        Grade 3 Inj. site Erythema; Post-Inj. 1
    0
    0
        Inj. site Swelling; Post-Inj. 1
    3
    2.9
        Grade 3 Inj. site Swelling; Post-Inj. 1
    0
    0
        Inj. site Pain; Post-Inj. 2
    23
    20.5
        Grade 3 Inj. site Pain; Post-Inj. 2
    0
    0
        Inj. site Erythema; Post-Inj. 2
    3.3
    3
        Grade 3 Inj. site Erythema; Post-Inj. 2
    0
    0
        Inj. site Swelling; Post-Inj. 2
    1.9
    1.1
        Grade 3 Inj. site Swelling; Post-Inj. 2
    0
    0
        Inj. site Pain; Post-Inj. 3
    21.6
    18
        Grade 3 Inj. site Pain; Post-Inj. 3
    0
    0
        Inj. site Erythema; Post-Inj. 3
    2.7
    2.4
        Grade 3 Inj. site Erythema; Post-Inj. 3
    0
    0.2
        Inj. site Swelling; Post-Inj. 3
    1.4
    1.5
        Grade 3 Inj. site Swelling; Post-Inj. 3
    0
    0
        Fever; Post-Any Inj.
    18.6
    17.8
        Grade 3 Fever; Post-Any Inj.
    3.8
    2.7
        Headache; Post-Any Inj.
    42.2
    39.1
        Grade 3 Headache; Post-Any Inj.
    1.7
    1.4
        Malaise; Post-Any Inj.
    35.7
    36
        Grade 3 Malaise; Post-Any Inj.
    1.4
    1.4
        Myalgia; Post-Any Inj.
    31.1
    29.7
        Grade 3 Myalgia; Post-Any Inj.
    0.6
    0.3
        Asthenia; Post-Any Inj.
    28.4
    25.2
        Grade 3 Asthenia; Post-Any Inj.
    1.1
    2
        Fever; Post-Inj. 1
    7.7
    6.8
        Grade 3 Fever; Post-Inj. 1
    1.4
    1.1
        Headache; Post-Inj. 1
    29.1
    25.3
        Grade 3 Headache; Post-Inj. 1
    0.5
    0.9
        Malaise; Post-Inj. 1
    23.4
    22.3
        Grade 3 Malaise; Post-Inj. 1
    0.5
    0.6
        Myalgia; Post-Inj. 1
    19.1
    18.7
        Grade 3 Myalgia; Post-Inj. 1
    0.2
    0.3
        Asthenia; Post-Inj. 1
    17.2
    14.6
        Grade 3 Asthenia; Post-Inj. 1
    0.4
    0.8
        Fever; Post-Inj. 2
    6.8
    6.7
        Grade 3 Fever; Post-Inj. 2
    1.4
    1.4
        Headache; Post-Inj. 2
    18.7
    17.9
        Grade 3 Headache; Post-Inj. 2
    0.9
    0.5
        Malaise; Post-Inj. 2
    14.6
    15.2
        Grade 3 Malaise; Post-Inj. 2
    0.5
    0.6
        Myalgia; Post-Inj. 2
    13.2
    14
        Grade 3 Myalgia; Post-Inj. 2
    0.2
    0
        Asthenia; Post-Inj. 2
    12
    11.2
        Grade 3 Asthenia; Post-Inj. 2
    0.4
    0.9
        Fever; Post-Inj. 3
    5.8
    6
        Grade 3 Fever; Post-Inj. 3
    1.2
    0.3
        Headache; Post-Inj. 3
    16.7
    17.3
        Grade 3 Headache; Post-Inj. 3
    0.5
    0.2
        Malaise; Post-Inj. 3
    13.9
    15.9
        Grade 3 Malaise; Post-Inj. 3
    0.5
    0.2
        Myalgia; Post-Inj. 3
    11.9
    11.6
        Grade 3 Myalgia; Post-Inj. 3
    0.2
    0
        Asthenia; Post-Inj. 3
    10.8
    11.2
        Grade 3 Asthenia; Post-Inj. 3
    0.3
    0.3
    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 13 months post-third vaccination.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14
    Reporting groups
    Reporting group title
    CYD Dengue Vaccine Group
    Reporting group description
    Subjects who received 3 doses of CYD dengue vaccine at 0, 6, and 12 months.

    Reporting group title
    Placebo Group
    Reporting group description
    Subjects who received 3 doses of placebo at 0, 6, and 12 months.

    Serious adverse events
    CYD Dengue Vaccine Group Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    355 / 6848 (5.18%)
    220 / 3424 (6.43%)
         number of deaths (all causes)
    4
    0
         number of deaths resulting from adverse events
    0
    0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute lymphocytic leukaemia
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip neoplasm benign
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin papilloma
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergy to arthropod sting
         subjects affected / exposed
    2 / 6848 (0.03%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food allergy
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Child abuse
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Physical assault
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Victim of sexual abuse
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Postpartum haemorrhage
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Hernia obstructive
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychosomatic disease
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian haemorrhage
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine haemorrhage
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    1 / 6848 (0.01%)
    2 / 3424 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropod bite
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    7 / 6848 (0.10%)
    2 / 3424 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear injury
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye injury
         subjects affected / exposed
    1 / 6848 (0.01%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    6 / 6848 (0.09%)
    3 / 3424 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body
         subjects affected / exposed
    2 / 6848 (0.03%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body in eye
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital injury
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    2 / 6848 (0.03%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    2 / 6848 (0.03%)
    3 / 3424 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Humerus fracture
         subjects affected / exposed
    5 / 6848 (0.07%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    1 / 6848 (0.01%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Near drowning
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Open wound
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    3 / 6848 (0.04%)
    2 / 3424 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    19 / 6848 (0.28%)
    3 / 3424 (0.09%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Scrotal haematoma
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Snake bite
         subjects affected / exposed
    3 / 6848 (0.04%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue injury
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    2 / 6848 (0.03%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 6848 (0.01%)
    2 / 3424 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheal injury
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    2 / 6848 (0.03%)
    2 / 3424 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatic heart disease
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Phimosis
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    8 / 6848 (0.12%)
    5 / 3424 (0.15%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Acute disseminated encephalomyelitis
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complex partial seizures
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    2 / 6848 (0.03%)
    2 / 3424 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    3 / 6848 (0.04%)
    3 / 3424 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    11 / 6848 (0.16%)
    5 / 3424 (0.15%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 6848 (0.01%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIIth nerve paralysis
         subjects affected / exposed
    2 / 6848 (0.03%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Choroidal dystrophy
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corneal oedema
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    5 / 6848 (0.07%)
    2 / 3424 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    3 / 6848 (0.04%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    4 / 6848 (0.06%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    2 / 6848 (0.03%)
    2 / 3424 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    12 / 6848 (0.18%)
    2 / 3424 (0.06%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    3 / 6848 (0.04%)
    2 / 3424 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland mucocoele
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Glomerulonephritis acute
         subjects affected / exposed
    2 / 6848 (0.03%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post streptococcal glomerulonephritis
         subjects affected / exposed
    4 / 6848 (0.06%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 6848 (0.01%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Henoch-Schonlein purpura
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 6848 (0.01%)
    2 / 3424 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Exostosis
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fasciitis
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture malunion
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myositis
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    2 / 6848 (0.03%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    2 / 6848 (0.03%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess of external auditory meatus
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute tonsillitis
         subjects affected / exposed
    2 / 6848 (0.03%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenoiditis
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amoebiasis
         subjects affected / exposed
    3 / 6848 (0.04%)
    3 / 3424 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amoebic dysentery
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    9 / 6848 (0.13%)
    7 / 3424 (0.20%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    2 / 6848 (0.03%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 6848 (0.01%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    8 / 6848 (0.12%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    4 / 6848 (0.06%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brucellosis
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    2 / 6848 (0.03%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctivitis infective
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    50 / 6848 (0.73%)
    64 / 3424 (1.87%)
         occurrences causally related to treatment / all
    0 / 50
    0 / 64
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 6848 (0.01%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis viral
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Furuncle
         subjects affected / exposed
    2 / 6848 (0.03%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    26 / 6848 (0.38%)
    22 / 3424 (0.64%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis bacterial
         subjects affected / exposed
    1 / 6848 (0.01%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 6848 (0.01%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    2 / 6848 (0.03%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    2 / 6848 (0.03%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    1 / 6848 (0.01%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed
    1 / 6848 (0.01%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hordeolum
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    3 / 6848 (0.04%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenitis bacterial
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Measles
         subjects affected / exposed
    2 / 6848 (0.03%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis bacterial
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotitis
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    10 / 6848 (0.15%)
    6 / 3424 (0.18%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    10 / 6848 (0.15%)
    2 / 3424 (0.06%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasmodium falciparum infection
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    10 / 6848 (0.15%)
    5 / 3424 (0.15%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia primary atypical
         subjects affected / exposed
    2 / 6848 (0.03%)
    2 / 3424 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    3 / 6848 (0.04%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    2 / 6848 (0.03%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    3 / 6848 (0.04%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal infection
         subjects affected / exposed
    1 / 6848 (0.01%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    3 / 6848 (0.04%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis bacterial
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Typhoid fever
         subjects affected / exposed
    5 / 6848 (0.07%)
    5 / 3424 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 6848 (0.06%)
    3 / 3424 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    12 / 6848 (0.18%)
    7 / 3424 (0.20%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    11 / 6848 (0.16%)
    9 / 3424 (0.26%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral pharyngitis
         subjects affected / exposed
    0 / 6848 (0.00%)
    1 / 3424 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral rash
         subjects affected / exposed
    0 / 6848 (0.00%)
    2 / 3424 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 6848 (0.03%)
    0 / 3424 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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
    CYD Dengue Vaccine Group Placebo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    614 / 6848 (8.97%)
    275 / 3424 (8.03%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed [1]
    63 / 1334 (4.72%)
    48 / 663 (7.24%)
         occurrences all number
    69
    61
    Rhinorrhoea
         subjects affected / exposed [2]
    46 / 1334 (3.45%)
    36 / 663 (5.43%)
         occurrences all number
    48
    43
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    562 / 1332 (42.19%)
    259 / 663 (39.06%)
         occurrences all number
    853
    399
    General disorders and administration site conditions
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    614 / 1332 (46.10%)
    275 / 663 (41.48%)
         occurrences all number
    992
    449
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    107 / 1332 (8.03%)
    52 / 663 (7.84%)
         occurrences all number
    142
    71
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    68 / 1332 (5.11%)
    33 / 663 (4.98%)
         occurrences all number
    84
    36
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    248 / 1332 (18.62%)
    118 / 663 (17.80%)
         occurrences all number
    269
    128
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    476 / 1332 (35.74%)
    239 / 663 (36.05%)
         occurrences all number
    687
    352
    Asthenia
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    378 / 1332 (28.38%)
    167 / 663 (25.19%)
         occurrences all number
    529
    244
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    414 / 1332 (31.08%)
    197 / 663 (29.71%)
         occurrences all number
    585
    292
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed [11]
    85 / 1334 (6.37%)
    45 / 663 (6.79%)
         occurrences all number
    113
    61
    Upper respiratory tract infection
         subjects affected / exposed [12]
    95 / 1334 (7.12%)
    54 / 663 (8.14%)
         occurrences all number
    104
    62
    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: As predefined in the protocol, reactogenicity and immunogenicity were evaluated in a subset of 2,000 subjects from each country (1,333 in the CYD Dengue Vaccine Group and 667 in the Control Group).
    [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: As predefined in the protocol, reactogenicity and immunogenicity were evaluated in a subset of 2,000 subjects from each country (1,333 in the CYD Dengue Vaccine Group and 667 in the Control Group).
    [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: As predefined in the protocol, reactogenicity and immunogenicity were evaluated in a subset of 2,000 subjects from each country (1,333 in the CYD Dengue Vaccine Group and 667 in the Control Group).
    [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: As predefined in the protocol, reactogenicity and immunogenicity were evaluated in a subset of 2,000 subjects from each country (1,333 in the CYD Dengue Vaccine Group and 667 in the Control Group).
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: As predefined in the protocol, reactogenicity and immunogenicity were evaluated in a subset of 2,000 subjects from each country (1,333 in the CYD Dengue Vaccine Group and 667 in the Control Group).
    [6] - 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: As predefined in the protocol, reactogenicity and immunogenicity were evaluated in a subset of 2,000 subjects from each country (1,333 in the CYD Dengue Vaccine Group and 667 in the Control Group).
    [7] - 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: As predefined in the protocol, reactogenicity and immunogenicity were evaluated in a subset of 2,000 subjects from each country (1,333 in the CYD Dengue Vaccine Group and 667 in the Control Group).
    [8] - 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: As predefined in the protocol, reactogenicity and immunogenicity were evaluated in a subset of 2,000 subjects from each country (1,333 in the CYD Dengue Vaccine Group and 667 in the Control Group).
    [9] - 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: As predefined in the protocol, reactogenicity and immunogenicity were evaluated in a subset of 2,000 subjects from each country (1,333 in the CYD Dengue Vaccine Group and 667 in the Control Group).
    [10] - 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: As predefined in the protocol, reactogenicity and immunogenicity were evaluated in a subset of 2,000 subjects from each country (1,333 in the CYD Dengue Vaccine Group and 667 in the Control Group).
    [11] - 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: As predefined in the protocol, reactogenicity and immunogenicity were evaluated in a subset of 2,000 subjects from each country (1,333 in the CYD Dengue Vaccine Group and 667 in the Control Group).
    [12] - 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: As predefined in the protocol, reactogenicity and immunogenicity were evaluated in a subset of 2,000 subjects from each country (1,333 in the CYD Dengue Vaccine Group and 667 in the Control Group).

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jan 2011
    The ‘Other Objectives’ section was revised to improve specificity of confirmation of dengue in line with the non-primary endpoint suggested in the WHO guidelines (version 2.0); It was also specified that the safety surveillance will be conducted by the Principal Investigators.
    03 Aug 2011
    Clarified the issue of sample collection times and the reporting period; Extended the collection of all SAEs to the entire study period; Noted that laboratory staff is blinded to treatment allocation and also the stratification by age as (2 to 5 years, 6 to 11 years, and 12 to 14 years); and updated the time window for assessment of serious viscerotropic disease in-line with the update of the Guidelines for Assessing Viscerotropic and Neurotropic Adverse Events, and introduced the use of the WHO Verbal Autopsy Questionnaire.
    29 May 2013
    Modified the testing algorithm for the virological-confirmation by adding the dengue screen reverse transcriptase polymerase chain reaction (RT-PCR) and the Simplexa RT-PCR, assessment of the CYD dengue vaccine in preventing symptomatic virologically-confirmed dengue cases; The study objectives was revised along with the addition of ‘Other Objectives’; The Hospital Phase was extended by 2 years to allow a 5-year follow-up period after the last vaccination; and the addition of use of neutralization antibody assays and analyses in addition to PRNT to characterize the immune response.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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