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    Clinical Trial Results:
    Immunogenicity and Safety of Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Viet Nam

    Summary
    EudraCT number
    2014-001709-41
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    12 Jul 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    CYD22
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00875524
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon Cedex 07, France, 69367
    Public contact
    Senior Director, Clinical Development, Sanofi Pasteur SA, +65 6431 2358, Anh.Wartel-Tram@sanofipasteur.com
    Scientific contact
    Senior Director, Clinical Development, Sanofi Pasteur SA, +65 6431 2358, Anh.Wartel-Tram@sanofipasteur.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-001201-PIP01-11
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    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
    10 Nov 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jul 2014
    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 CYD dengue vaccine Persistence of antibodies (Abs) against dengue during 5 years after the first vaccination with CYD dengue vaccine Safety and reactogenicity
    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
    14 Mar 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Vietnam: 180
    Worldwide total number of subjects
    180
    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)
    120
    Adolescents (12-17 years)
    30
    Adults (18-64 years)
    30
    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 18 March 2009 to 01 July 2010 at 1 clinical center in Vietnam.

    Pre-assignment
    Screening details
    A total of 180 subjects who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    The first and second vaccinations were administered in a blind-observer manner. The third vaccination was planned to be administered in a single-blind manner; however, due to the cancellation of the statistical analysis after the second vaccination, the third vaccination was also administered in a blind-observer manner. To ensure the blind-observer design of the 3 vaccinations, the product was prepared in a separate room whether neither the Investigator nor subject had access.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Dengue Group
    Arm description
    Subjects who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) vaccinations.
    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 at Day 0, Day 0 + 6 months, and Day 0 + 12 months.

    Arm title
    Control group
    Arm description
    Subjects who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) vaccinations, respectively.
    Arm type
    Active comparator

    Investigational medicinal product name
    Meningococcal Polysaccharide Vaccine A+C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, 1 injection at Day 0.

    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, subcutaneoous, 1 injection at Day 0 + 6 months.

    Investigational medicinal product name
    Typhoid Vi polysaccharide vaccine (Typhim Vi Vaccine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous, 1 injection at Day 0 + 12 months.

    Number of subjects in period 1
    Dengue Group Control group
    Started
    120
    60
    Completed
    112
    54
    Not completed
    8
    6
         Protocol deviation
             4
             -
         Consent withdrawn by subject
             3
             5
         Serious adverse event
             -
             1
         Lost to follow-up
             1
             -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dengue Group
    Reporting group description
    Subjects who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) vaccinations.

    Reporting group title
    Control group
    Reporting group description
    Subjects who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) vaccinations, respectively.

    Reporting group values
    Dengue Group Control group Total
    Number of subjects
    120 60 180
    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)
    80 40 120
        Adolescents (12-17 years)
    20 10 30
        Adults (18-64 years)
    20 10 30
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    10.9 ± 8.6 11.8 ± 9.6 -
    Gender categorical
    Units: Subjects
        Female
    62 25 87
        Male
    58 35 93

    End points

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    End points reporting groups
    Reporting group title
    Dengue Group
    Reporting group description
    Subjects who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) vaccinations.

    Reporting group title
    Control group
    Reporting group description
    Subjects who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) vaccinations, respectively.

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

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    End point title
    Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype with the Parental Dengue Virus Strain Before and Following Injection with ChimeriVax™ Dengue Tetravalent Vaccine [1]
    End point description
    Geometric mean titers against each serotype of the Parental Dengue Virus strains were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
    End point type
    Primary
    End point timeframe
    Pre-dose 1, 2, and 3 and 28 days Post-dose 1, 2, and 3
    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 Group Control group
    Number of subjects analysed
    119
    60
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Dengue Parental Serotype 1; Pre-dose 1
    32.7 (21.6 to 49.5)
    19.6 (12 to 31.8)
        Dengue Parental Serotype 1; Post-dose 1
    70.9 (44.3 to 113)
    18.8 (11.4 to 30.8)
        Dengue Parental Serotype 1; Pre-dose 2
    52.2 (33.3 to 81.6)
    19.8 (11.4 to 34.3)
        Dengue Parental Serotype 1; Post-dose 2
    100 (65.1 to 155)
    20.6 (11.8 to 36)
        Dengue Parental Serotype 1; Pre-dose 3
    70.9 (45.5 to 110)
    24.6 (13.7 to 44)
        Dengue Parental Serotype 1; Post-dose 3
    129 (90.5 to 183)
    25.3 (13.7 to 46.8)
        Dengue Parental Serotype 2; Pre-dose 1
    33.1 (22.5 to 48.7)
    27.2 (15.3 to 48.1)
        Dengue Parental Serotype 2; Post-dose 1
    92.3 (58.5 to 145)
    25 (13.8 to 45.4)
        Dengue Parental Serotype 2; Pre-dose 2
    74.8 (47.7 to 117)
    29.5 (16 to 54.4)
        Dengue Parental Serotype 2; Post-dose 2
    195 (139 to 274)
    29.3 (16 to 53.8)
        Dengue Parental Serotype 2; Pre-dose 3
    111 (74.4 to 165)
    32.3 (17.4 to 59.8)
        Dengue Parental Serotype 2; Post-dose 3
    216 (163 to 286)
    30.4 (16.7 to 55.1)
        Dengue Parental Serotype 3; Pre-dose 1
    31.9 (23.3 to 43.8)
    20.5 (13.2 to 31.9)
        Dengue Parental Serotype 3; Post-dose 1
    95.6 (67.2 to 136)
    18.4 (12 to 28.2)
        Dengue Parental Serotype 3; Pre-dose 2
    60.4 (41.9 to 87.2)
    19.1 (12.1 to 30.3)
        Dengue Parental Serotype 3; Post-dose 2
    152 (115 to 203)
    21.9 (14.1 to 34)
        Dengue Parental Serotype 3; Pre-dose 3
    87.2 (62.5 to 122)
    26.8 (17.1 to 42.1)
        Dengue Parental Serotype 3; Post-dose 3
    169 (134 to 214)
    25.2 (16.3 to 39.1)
        Dengue Parental Serotype 4; Pre-dose 1
    17 (12.8 to 22.5)
    13.9 (9.28 to 20.9)
        Dengue Parental Serotype 4; Post-dose 1
    104 (71 to 153)
    15.4 (10.2 to 23.3)
        Dengue Parental Serotype 4; Pre-dose 2
    51.7 (37 to 72.2)
    14.1 (9.29 to 21.4)
        Dengue Parental Serotype 4; Post-dose 2
    120 (89.2 to 160)
    14.3 (9.44 to 21.6)
        Dengue Parental Serotype 4; Pre-dose 3
    70.1 (52.2 to 94.1)
    17.1 (10.9 to 26.9)
        Dengue Parental Serotype 4; Post-dose 3
    146 (115 to 184)
    17.4 (11.2 to 27)
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Antibody titers ≥ 10 (1/dil) Against Each Serotypes with the Parental Dengue Virus Strains Following Injection with ChimeriVax™ Dengue Tetravalent Vaccine

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    End point title
    Percentage of Subjects with Antibody titers ≥ 10 (1/dil) Against Each Serotypes with the Parental Dengue Virus Strains Following Injection with ChimeriVax™ Dengue Tetravalent Vaccine [2]
    End point description
    Neutralizing antibody levels against each serotype of the Parental Dengue Virus strains were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
    End point type
    Primary
    End point timeframe
    Pre-dose 1, 2, and 3 and 28 days Post-dose 1, 2, and 3
    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 Group Control group
    Number of subjects analysed
    119
    60
    Units: Percentage of subjects
    number (not applicable)
        Dengue Parental Serotype 1; Pre-dose 1
    50.4
    43.3
        Dengue Parental Serotype 1; Post-dose 1
    62.2
    41.7
        Dengue Parental Serotype 1; Pre-dose 2
    58.3
    39.7
        Dengue Parental Serotype 1; Post-dose 2
    79.1
    41.4
        Dengue Parental Serotype 1; Pre-dose 3
    68.4
    46.6
        Dengue Parental Serotype 1; Post-dose 3
    93
    41.4
        Dengue Parental Serotype 2; Pre-dose 1
    49.6
    41.7
        Dengue Parental Serotype 2; Post-dose 1
    66.4
    35.6
        Dengue Parental Serotype 2; Pre-dose 2
    63.5
    39.7
        Dengue Parental Serotype 2; Post-dose 2
    93.9
    41.4
        Dengue Parental Serotype 2; Pre-dose 3
    80.7
    43.1
        Dengue Parental Serotype 2; Post-dose 3
    99.1
    43.1
        Dengue Parental Serotype 3; Pre-dose 1
    63
    52.5
        Dengue Parental Serotype 3; Post-dose 1
    84.9
    47.5
        Dengue Parental Serotype 3; Pre-dose 2
    73
    46.6
        Dengue Parental Serotype 3; Post-dose 2
    94.8
    53.4
        Dengue Parental Serotype 3; Pre-dose 3
    85.1
    62.1
        Dengue Parental Serotype 3; Post-dose 3
    99.1
    58.6
        Dengue Parental Serotype 4; Pre-dose 1
    44.5
    37.3
        Dengue Parental Serotype 4; Post-dose 1
    77.3
    41.7
        Dengue Parental Serotype 4; Pre-dose 2
    73
    39.7
        Dengue Parental Serotype 4; Post-dose 2
    89.6
    40.4
        Dengue Parental Serotype 4; Pre-dose 3
    84.2
    43.1
        Dengue Parental Serotype 4; Post-dose 3
    95.6
    43.1
    No statistical analyses for this end point

    Primary: 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 [3]
    End point description
    Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 solicited injection site reactions: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 solicited systemic reactions: Fever, >39.0°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 Group Control group
    Number of subjects analysed
    120
    60
    Units: Percentage of subjects
    number (not applicable)
        Inj. site Pain; Post-Any Inj.
    28.3
    80
        Grade 3 Inj. site Pain; Post-Any Inj.
    0
    0
        Inj. site Erythema; Post-Any Inj.
    6.7
    21.7
        Grade 3 Inj. site Erythema; Post-Any Inj.
    0
    1.7
        Inj. site Swelling; Post-Any Inj.
    4.2
    15
        Grade 3 Inj. site Swelling; Post-Any Inj.
    0
    1.7
        Inj. site Pain; Post-Inj. 1
    15.8
    73.3
        Grade 3 Inj. site Pain; Post-Inj. 1
    0
    0
        Inj. site Erythema; Post-Inj. 1
    4.2
    16.7
        Grade 3 Inj. site Erythema; Post-Inj. 1
    0
    1.7
        Inj. site Swelling; Post-Inj. 1
    1.7
    6.7
        Grade 3 Inj. site Swelling; Post-Inj. 1
    0
    1.7
        Inj. site Pain; Post-Inj. 2
    15.5
    15.5
        Grade 3 Inj. site Pain; Post-Inj. 2
    0
    0
        Inj. site Erythema; Post-Inj. 2
    4.3
    5.2
        Grade 3 Inj. site Erythema; Post-Inj. 2
    0
    0
        Inj. site Swelling; Post-Inj. 2
    2.6
    3.4
        Grade 3 Inj. site Swelling; Post-Inj. 2
    0
    0
        Inj. site Pain; Post-Inj. 3
    11.4
    41.4
        Grade 3 Inj. site Pain; Post-Inj. 3
    0
    0
        Inj. site Erythema; Post-Inj. 3
    2.6
    5.2
        Grade 3 Inj. site Erythema; Post-Inj. 3
    0
    0
        Inj. site Swelling; Post-Inj. 3
    0
    6.9
        Grade 3 Inj. site Swelling; Post-Inj. 3
    0
    0
        Fever; Post-Any Inj.
    27.5
    26.7
        Grade 3 Fever; Post-Any Inj.
    0.8
    3.3
        Headache; Post-Any Inj.
    35.3
    30
        Grade 3 Headache; Post-Any Inj.
    0.8
    0
        Malaise; Post-Any Inj.
    29.4
    23.3
        Grade 3 Malaise; Post-Any Inj.
    0
    0
        Myalgia; Post-Any Inj.
    20.2
    23.3
        Grade 3 Myalgia; Post-Any Inj.
    0
    0
        Asthenia; Post-Any Inj.
    13.4
    5
        Grade 3 Asthenia; Post-Any Inj.
    1.7
    0
        Fever; Post-Inj. 1
    19.2
    15
        Grade 3 Fever; Post-Inj. 1
    0.8
    3.3
        Headache; Post-Inj. 1
    29.4
    28.3
        Grade 3 Headache; Post-Inj. 1
    0.8
    0
        Malaise; Post-Inj. 1
    21.8
    16.7
        Grade 3 Malaise; Post-Inj. 1
    0
    0
        Myalgia; Post-Inj. 1
    15.1
    20
        Grade 3 Myalgia; Post-Inj. 1
    0
    0
        Asthenia; Post-Inj. 1
    8.4
    0
        Grade 3 Asthenia; Post-Inj. 1
    0.8
    0
        Fever; Post-Inj. 2
    12.1
    6.9
        Grade 3 Fever; Post-Inj. 2
    0
    0
        Headache; Post-Inj. 2
    15.7
    8.6
        Grade 3 Headache; Post-Inj. 2
    0
    0
        Malaise; Post-Inj. 2
    13
    8.6
        Grade 3 Malaise; Post-Inj. 2
    0
    0
        Myalgia; Post-Inj. 2
    9.6
    5.2
        Grade 3 Myalgia; Post-Inj. 2
    0
    0
        Asthenia; Post-Inj. 2
    6.1
    1.7
        Grade 3 Asthenia; Post-Inj. 2
    0.9
    0
        Fever; Post-Inj. 3
    3.5
    8.6
        Grade 3 Fever; Post-Inj. 3
    0
    0
        Headache; Post-Inj. 3
    8.8
    10.3
        Grade 3 Headache; Post-Inj. 3
    0
    0
        Malaise; Post-Inj. 3
    5.3
    8.6
        Grade 3 Malaise; Post-Inj. 3
    0
    0
        Myalgia; Post-Inj. 3
    4.4
    10.3
        Grade 3 Myalgia; Post-Inj. 3
    0
    0
        Asthenia; Post-Inj. 3
    0.9
    3.4
        Grade 3 Asthenia; Post-Inj. 3
    0
    0
    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 6 months after the last vaccination.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11
    Reporting groups
    Reporting group title
    Dengue Group
    Reporting group description
    Subjects who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) vaccinations.

    Reporting group title
    Control group
    Reporting group description
    Subjects who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) vaccinations, respectively.

    Serious adverse events
    Dengue Group Control group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 120 (2.50%)
    3 / 60 (5.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Dengue fever
         subjects affected / exposed
    1 / 120 (0.83%)
    3 / 60 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Dengue Group Control group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 120 (35.00%)
    48 / 60 (80.00%)
    Nervous system disorders
    Headache; Post-Any Injection
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    42 / 119 (35.29%)
    18 / 60 (30.00%)
         occurrences all number
    63
    28
    General disorders and administration site conditions
    Injection site Pain; Post-Any Injection
    alternative assessment type: Systematic
         subjects affected / exposed
    34 / 120 (28.33%)
    48 / 60 (80.00%)
         occurrences all number
    50
    77
    Injection site Erythema; Post-Any Injection
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 120 (6.67%)
    13 / 60 (21.67%)
         occurrences all number
    13
    16
    Injection site Swelling; Post-Any Injection
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    5 / 119 (4.20%)
    9 / 60 (15.00%)
         occurrences all number
    5
    10
    Fever; Post-Any Injection
    alternative assessment type: Systematic
         subjects affected / exposed
    33 / 120 (27.50%)
    16 / 60 (26.67%)
         occurrences all number
    41
    18
    Malaise; Post-Any Injection
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    35 / 119 (29.41%)
    14 / 60 (23.33%)
         occurrences all number
    47
    20
    Asthenia; Post-Any Injection
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    16 / 119 (13.45%)
    3 / 60 (5.00%)
         occurrences all number
    18
    3
    Musculoskeletal and connective tissue disorders
    Myalgia; Post-Any Injection
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    24 / 119 (20.17%)
    14 / 60 (23.33%)
         occurrences all number
    34
    21
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 120 (0.00%)
    3 / 60 (5.00%)
         occurrences all number
    0
    3
    Pharyngitis
         subjects affected / exposed
    9 / 120 (7.50%)
    7 / 60 (11.67%)
         occurrences all number
    9
    7
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 14 days after any vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days after any vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 14 days after any vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 14 days after any vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 14 days after any vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Apr 2008
    Refined methods used for diagnosis of symptomatic dengue cases, implemented third vaccination blind-observer procedures, clarified exclusion criteria, deleted the fingerprint system for identification, modified the category designations of the intensity scales, avoided the use of the trade name ChimeriVax™, and aligned the informed consent form and assent form with the modifications of the protocol.
    23 Jul 2008
    Updated the protocol in response to comments from the Vietnamese Ministry of Health Ethic Committee and added the possibility to perform safety surveillance on the 4-year follow-up in all subjects with at least 1 dose of dengue vaccine, including subjects who discontinued for any reason, except those discontinued due to consent withdrawal.
    04 Nov 2008
    Changed the name of the Coordinating Investigator, identified the trial organization for laboratory analyses, and updated the planned trial calendar.
    15 Jun 2009
    Updated time period for assay analyses, updated information reviewed by the Safety Review Committee, revised and updated the inclusion and exclusion criteria, and modified follow-up phone call procedures.
    10 Jun 2010
    Replaced the Pan reverse transcriptase-polymerase chain reaction (RT-PCR) assay with the dengue screen RT-PCR and the microneutralization assay with the Dengue Plaque Reduction Neutralization Test (PRNT), and cancelled the post-dose 2 analysis of safety and immunogenicity.
    17 Oct 2013
    Changed the name of the Sponsor's responsible medical officer and regional clinical trial manager, added a database lock and interim analysis on follow-up unblinded data, updated the Institutional Review Board section regarding the Joint Research Ethics Committee, updated the pharmacovigilance email address, and exploratory analyses about natural booster infections were added.

    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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