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    Clinical Trial Results:
    A Study of Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines

    Summary
    EudraCT number
    		 2014-001694-14
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    08 May 2012

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CYD08
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01064141
    WHO universal trial number (UTN)
    		 U1111-1111-5855
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon Cedex 07, France, F-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
    31 Jul 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 May 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Safety of CYD dengue vaccine after each injection; first injection given alone or co-administered with measles, mumps, rubella (MMR) vaccine (Trimovax). Dengue vaccinal viremia
    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
    18 Jan 2010
    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
    Philippines: 210
    Worldwide total number of subjects
    210
    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)
    210
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Study subjects were enrolled from 18 January 2010 to 29 September 2010 at 2 clinical centers in the Philippines.

    Pre-assignment
    Screening details
    		 A total of 210 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
    For all groups, the first injection of CYD dengue vaccine was performed under a modified double-blind process where only the person who administered the injection knew which product had been administered. To maintain the modified double-blind process for the sequential versus co-administration of MMR with the first injection of CYD dengue vaccine, some of the toddlers received one injection of placebo.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 Subjects received a total of 5 injections (Dengue vaccine): First injection - Measles, mumps, rubella (MMR) vaccine (Month-1); Second injection - Dengue vaccine (M0), Third injection - Dengue vaccine (M0+6 months); Fourth injection - Diphtheria, Tetanus, Pertussis, Poliomyelitis, and Hib vaccine (M0+9 months ), and Fifth injection - Dengue vaccine (M0+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, 1 injection at M0, M0+6 months, and M0+12 months.

    Investigational medicinal product name
    MMR Vaccine (TRIMOVAX®)
    Investigational medicinal product code
    065
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous use, 1 injection at Month-1.

    Investigational medicinal product name
    PENTAXIM®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular use, 1 injection at M0+9 months.

    Arm title
    		 Group 2
    Arm description
    		 Subjects received a total of 5 injections (control): First injection - MMR (Month-1); Second injection; control Varicella vaccine (M0); Third injection; control Hepatitis A vaccine (M0 + 6 months); Fourth injection; Diphtheria, Tetanus, Pertussis, Poliomyelitis, and Hib vaccine (M0 + 9 months), and Fifth injection - control Hepatitis A vaccine (M0+12 months).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    MMR Vaccine (TRIMOVAX®)
    Investigational medicinal product code
    065
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous use, 1 injection at Month-1.

    Investigational medicinal product name
    PENTAXIM®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular use, 1 injection at M0+9 months.

    Investigational medicinal product name
    OKAVAX®
    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 use, 1 injection at M0.

    Investigational medicinal product name
    AVAXIM® 80U
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular use, 1 injection at M0+6 months and M0+12 months.

    Arm title
    		 Group 3
    Arm description
    		 Subjects received a total of 6 injections: First injection - control Varicella vaccine (Month-1); Second Dengue vaccine and third MMR injections (M0); Fourth injection; Dengue vaccine (M0+6 months); Fifth injection - Diphtheria, Tetanus, Pertussis, Poliomyelitis, and Hib vaccine (M0+9 months), and Sixth injection; Dengue vaccine (M0+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, 1 injection at M0, M0+6 months, and M0+12 months.

    Investigational medicinal product name
    OKAVAX®
    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 use, 1 injection at Month-1.

    Investigational medicinal product name
    PENTAXIM®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular use, 1 injection at M0+9 months.

    Investigational medicinal product name
    MMR vaccine (TRIMOVAX®)
    Investigational medicinal product code
    065
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous use, 1 injection at M0.

    Arm title
    		 Group 4
    Arm description
    		 Subjects received a total of 6 injections (sequential administration): First injection - MMR (Month-1); Second Dengue vaccine and third placebo injections (M0); Fourth injection - Dengue vaccine (M0+6 months); Fifth injection - Diphtheria, Tetanus, Pertussis, Poliomyelitis, and Hib vaccine (M0+9 months), and Sixth injection - Dengue vaccine (M0+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, 1 injection at M0, M0+6 months, and M0+12 months.

    Investigational medicinal product name
    MMR vaccine (TRIMOVAX®)
    Investigational medicinal product code
    065
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL, subcutaneous use, 1 injection at Month-1.

    Investigational medicinal product name
    PENTAXIM®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular use, 1 injection at M0+9 months.

    Number of subjects in period 1
    		Group 1 Group 2 Group 3 Group 4
    Started
    60
    30
    60
    60
    Completed
    58
    30
    57
    60
    Not completed
    2
    0
    3
    0
         Consent withdrawn by subject
    1
    -
    2
    -
         Serious event
    1
    -
    -
    -
         Serious adverse event
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Subjects received a total of 5 injections (Dengue vaccine): First injection - Measles, mumps, rubella (MMR) vaccine (Month-1); Second injection - Dengue vaccine (M0), Third injection - Dengue vaccine (M0+6 months); Fourth injection - Diphtheria, Tetanus, Pertussis, Poliomyelitis, and Hib vaccine (M0+9 months ), and Fifth injection - Dengue vaccine (M0+12 months).

    Reporting group title
    Group 2
    Reporting group description
    		 Subjects received a total of 5 injections (control): First injection - MMR (Month-1); Second injection; control Varicella vaccine (M0); Third injection; control Hepatitis A vaccine (M0 + 6 months); Fourth injection; Diphtheria, Tetanus, Pertussis, Poliomyelitis, and Hib vaccine (M0 + 9 months), and Fifth injection - control Hepatitis A vaccine (M0+12 months).

    Reporting group title
    Group 3
    Reporting group description
    		 Subjects received a total of 6 injections: First injection - control Varicella vaccine (Month-1); Second Dengue vaccine and third MMR injections (M0); Fourth injection; Dengue vaccine (M0+6 months); Fifth injection - Diphtheria, Tetanus, Pertussis, Poliomyelitis, and Hib vaccine (M0+9 months), and Sixth injection; Dengue vaccine (M0+12 months).

    Reporting group title
    Group 4
    Reporting group description
    		 Subjects received a total of 6 injections (sequential administration): First injection - MMR (Month-1); Second Dengue vaccine and third placebo injections (M0); Fourth injection - Dengue vaccine (M0+6 months); Fifth injection - Diphtheria, Tetanus, Pertussis, Poliomyelitis, and Hib vaccine (M0+9 months), and Sixth injection - Dengue vaccine (M0+12 months)

    Reporting group values
    		 Group 1 Group 2 Group 3 Group 4 Total
    Number of subjects
    		 60 30 60 60 210
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 60 30 60 60 210
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 13.4 ± 1.05 13.3 ± 0.969 12.7 ± 0.864 12.8 ± 0.971 -
    Gender categorical
    Units: Subjects
        Female
    		 22 12 26 28 88
        Male
    		 38 18 34 32 122

    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Subjects received a total of 5 injections (Dengue vaccine): First injection - Measles, mumps, rubella (MMR) vaccine (Month-1); Second injection - Dengue vaccine (M0), Third injection - Dengue vaccine (M0+6 months); Fourth injection - Diphtheria, Tetanus, Pertussis, Poliomyelitis, and Hib vaccine (M0+9 months ), and Fifth injection - Dengue vaccine (M0+12 months).

    Reporting group title
    Group 2
    Reporting group description
    		 Subjects received a total of 5 injections (control): First injection - MMR (Month-1); Second injection; control Varicella vaccine (M0); Third injection; control Hepatitis A vaccine (M0 + 6 months); Fourth injection; Diphtheria, Tetanus, Pertussis, Poliomyelitis, and Hib vaccine (M0 + 9 months), and Fifth injection - control Hepatitis A vaccine (M0+12 months).

    Reporting group title
    Group 3
    Reporting group description
    		 Subjects received a total of 6 injections: First injection - control Varicella vaccine (Month-1); Second Dengue vaccine and third MMR injections (M0); Fourth injection; Dengue vaccine (M0+6 months); Fifth injection - Diphtheria, Tetanus, Pertussis, Poliomyelitis, and Hib vaccine (M0+9 months), and Sixth injection; Dengue vaccine (M0+12 months).

    Reporting group title
    Group 4
    Reporting group description
    		 Subjects received a total of 6 injections (sequential administration): First injection - MMR (Month-1); Second Dengue vaccine and third placebo injections (M0); Fourth injection - Dengue vaccine (M0+6 months); Fifth injection - Diphtheria, Tetanus, Pertussis, Poliomyelitis, and Hib vaccine (M0+9 months), and Sixth injection - Dengue vaccine (M0+12 months)

    Primary: Percentage of Subjects Reporting a Solicited Injection-site or Systemic Reactions Following Any Vaccination with Sanofi Pasteur's CYD Dengue Vaccine

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    End point title
    		 Percentage of Subjects Reporting a Solicited Injection-site or Systemic Reactions Following Any Vaccination with Sanofi Pasteur's CYD Dengue Vaccine [1]
    End point description
    Solicited injection site reactions: Pain, Erythema, Swelling. Grade 3 solicited injection site reactions: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 solicited systemic reactions: Fever, >39.5°C or >103.1°F; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite lost, Refused ≥3 feeds/meals or refused most feeds/meals; Irritability, Inconsolable.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) up to Day 7 post-any vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    60
    30
    59
    60
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    20
    20
    10.2
    6.7
        Grade 3 Injection site Pain
    0
    0
    0
    0
        Injection site Erythema
    5
    16.7
    11.9
    3.3
        Grade 3 Injection site Erythema
    0
    0
    0
    0
        Injection site Swelling
    3.3
    10
    1.7
    1.7
        Grade 3 Injection site Swelling
    0
    0
    0
    0
        Fever
    26.7
    36.7
    42.4
    25
        Grade 3 Fever
    0
    0
    0
    0
        Vomiting
    13.3
    36.7
    5.1
    5
        Grade 3 Vomiting
    0
    0
    0
    0
        Crying abnormal
    23.3
    26.7
    13.6
    11.7
        Grade 3 Crying abnormal
    0
    0
    0
    0
        Drowsiness
    8.3
    10
    3.4
    5
        Grade 3 Drowsiness
    0
    0
    0
    0
        Appetite lost
    18.3
    20
    11.9
    10
        Grade 3 Appetite lost
    0
    0
    0
    0
        Irritability
    31.7
    36.7
    11.9
    20
        Grade 3 Irritability
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting a Solicited Injection-site or Systemic Reactions Following First Vaccination with Sanofi Pasteur's CYD Dengue Vaccine

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    End point title
    		 Percentage of Subjects Reporting a Solicited Injection-site or Systemic Reactions Following First Vaccination with Sanofi Pasteur's CYD Dengue Vaccine [2]
    End point description
    Solicited injection site reactions: Pain, Erythema, Swelling. Grade 3 solicited injection site reactions: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 solicited systemic reactions: Fever, >39.5°C or >103.1°F; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite lost, Refused ≥3 feeds/meals or refused most feeds/meals; Irritability, Inconsolable.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) up to Day 7 post-first vaccination
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    60
    30
    59
    60
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    13.3
    20
    6.8
    5
        Grade 3 Injection site Pain
    0
    0
    0
    0
        Injection site Erythema
    5
    16.7
    10.2
    3.3
        Grade 3 Injection site Erythema
    0
    0
    0
    0
        Injection site Swelling
    3.3
    10
    1.7
    1.7
        Grade 3 Injection site Swelling
    0
    0
    0
    0
        Fever
    20
    20
    28.8
    11.7
        Grade 3 Fever
    0
    0
    0
    0
        Vomiting
    11.7
    30
    1.7
    1.7
        Grade 3 Vomiting
    0
    0
    0
    0
        Crying abnormal
    20
    23.3
    13.6
    10
        Grade 3 Crying abnormal
    0
    0
    0
    0
        Drowsiness
    6.7
    10
    3.4
    5
        Grade 3 Drowsiness
    0
    0
    0
    0
        Appetite lost
    16.7
    16.7
    11.9
    5
        Grade 3 Appetite lost
    0
    0
    0
    0
        Irritability
    26.7
    33.3
    11.9
    18.3
        Grade 3 Irritability
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting a Solicited Injection-site or Systemic Reactions Following Second Vaccination with Sanofi Pasteur's CYD Dengue Vaccine

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    End point title
    		 Percentage of Subjects Reporting a Solicited Injection-site or Systemic Reactions Following Second Vaccination with Sanofi Pasteur's CYD Dengue Vaccine [3]
    End point description
    Solicited injection site reactions: Pain, Erythema, Swelling. Grade 3 solicited injection site reactions: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 solicited systemic reactions: Fever, >39.5°C or >103.1°F; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite lost, Refused ≥3 feeds/meals or refused most feeds/meals; Irritability, Inconsolable.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) up to Day 7 post-second 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
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    60
    30
    58
    60
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    5
    3.3
    1.7
    1.7
        Grade 3 Injection site Pain
    0
    0
    0
    0
        Injection site Erythema
    0
    3.3
    1.7
    0
        Grade 3 Injection site Erythema
    0
    0
    0
    0
        Injection site Swelling
    0
    3.3
    0
    0
        Grade 3 Injection site Swelling
    0
    0
    0
    0
        Fever
    3.3
    10
    8.6
    6.7
        Grade 3 Fever
    0
    0
    0
    0
        Vomiting
    0
    3.3
    3.4
    1.7
        Grade 3 Vomiting
    0
    0
    0
    0
        Crying abnormal
    0
    6.7
    0
    0
        Grade 3 Crying abnormal
    0
    0
    0
    0
        Drowsiness
    0
    0
    0
    0
        Grade 3 Drowsiness
    0
    0
    0
    0
        Appetite lost
    1.7
    6.7
    0
    3.3
        Grade 3 Appetite lost
    0
    0
    0
    0
        Irritability
    3.3
    10
    0
    1.7
        Grade 3 Irritability
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting a Solicited Injection-site or Systemic Reactions Following Third Vaccination with Sanofi Pasteur's CYD Dengue Vaccine

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    End point title
    		 Percentage of Subjects Reporting a Solicited Injection-site or Systemic Reactions Following Third Vaccination with Sanofi Pasteur's CYD Dengue Vaccine [4]
    End point description
    Solicited injection site reactions: Pain, Erythema, Swelling. Grade 3 solicited injection site reactions: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 solicited systemic reactions: Fever, >39.5°C or >103.1°F; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite lost, Refused ≥3 feeds/meals or refused most feeds/meals; Irritability, Inconsolable.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) up to Day 7 post-third vaccination
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    58
    30
    57
    60
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    3.4
    0
    1.8
    0
        Grade 3 Injection site Pain
    0
    0
    0
    0
        Injection site Erythema
    0
    3.3
    0
    0
        Grade 3 Injection site Erythema
    0
    0
    0
    0
        Injection site Swelling
    0
    0
    0
    0
        Grade 3 Injection site Swelling
    0
    0
    0
    0
        Fever
    10.3
    6.7
    8.8
    8.3
        Grade 3 Fever
    0
    0
    0
    0
        Vomiting
    1.7
    3.3
    0
    1.7
        Grade 3 Vomiting
    0
    0
    0
    0
        Crying abnormal
    3.4
    0
    0
    1.7
        Grade 3 Crying abnormal
    0
    0
    0
    0
        Drowsiness
    1.7
    0
    0
    0
        Grade 3 Drowsiness
    0
    0
    0
    0
        Appetite lost
    1.7
    0
    0
    3.3
        Grade 3 Appetite lost
    0
    0
    0
    0
        Irritability
    3.4
    3.3
    0
    3.3
        Grade 3 Irritability
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Non-serotype Specific CYD Viremia after the First Vaccination with Sanofi Pasteur's CYD Dengue Vaccine

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    End point title
    		 Percentage of Subjects with Non-serotype Specific CYD Viremia after the First Vaccination with Sanofi Pasteur's CYD Dengue Vaccine [5]
    End point description
    Non-specific specific CYD viremia was assessed using yellow fever (YF) real time polymerase chain reaction (RT-PCR).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) up to Day 8 (post-first vaccination)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    60
    30
    57
    60
    Units: Percentage of subjects
    number (not applicable)
        Viremia detectable
    48.3
    0
    17.5
    28.3
        Viremia quantified
    1.7
    0
    1.8
    1.7
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Seropositivity for Parental Dengue Virus Serotypes Following Each Vaccination with Sanofi Pasteur's CYD Dengue Vaccine

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    End point title
    		 Percentage of Subjects with Seropositivity for Parental Dengue Virus Serotypes Following Each Vaccination with Sanofi Pasteur's CYD Dengue Vaccine [6]
    End point description
    Neutralizing antibody levels against each of the 4 parental dengue virus serotype strains were measured using the dengue neutralization assay. Seropositivity was defined as subjects with antibody titers ≥10 1/dil against the 4 dengue serotypes.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 28 post-second and third injections for Groups 1 and 2 and post-first, second, and third injections for Groups 3 and 4.
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    60
    30
    58
    60
    Units: Percentage of subjects
    number (not applicable)
        Dengue Parental Serotype 1; Pre-inj. 1 (Screening)
    10
    3.3
    6.9
    10
        Dengue Parental Serotype 1; Post-inj. 1 (V04)
    0
    0
    19
    30
        Dengue Parental Serotype 1; Post-inj. 2 (V07)
    91.5
    23.3
    87.9
    93.3
        Dengue Parental Serotype 1; Post-inj. 1 (V10)
    94.8
    20
    94.7
    96.7
        Dengue Parental Serotype 2; Pre-inj. 1 (Screening)
    18.3
    16.7
    13.8
    10
        Dengue Parental Serotype 2; Post-inj. 1 (V04)
    0
    0
    29.3
    33.3
        Dengue Parental Serotype 2; Post-inj. 2 (V07)
    94.9
    26.7
    94.8
    98.3
        Dengue Parental Serotype 2; Post-inj. 3 (V10)
    96.6
    33.3
    96.5
    100
        Dengue Parental Serotype 3; Pre-inj. 1 (Screening)
    26.7
    23.3
    37.9
    40.7
        Dengue Parental Serotype 3; Post-inj. 1 (V04)
    0
    0
    70.7
    86.7
        Dengue Parental Serotype 3; Post-inj. 2 (V07)
    100
    40
    100
    98.3
        Dengue Parental Serotype 3; Post-inj. 3 (V10)
    100
    36.7
    100
    100
        Dengue Parental Serotype 4; Pre-inj. 1 (Screening)
    25
    21.4
    5.2
    16.7
        Dengue Parental Serotype 4; Post-inj. 1 (V04)
    0
    0
    53.4
    83.3
        Dengue Parental Serotype 4; Post-inj. 2 (V07)
    100
    40
    96.6
    98.3
        Dengue Parental Serotype 4; Post-inj. 3 (V10)
    98.3
    23.3
    96.5
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Seropositivity for at Least 1, 2, 3 or 4 Parental Dengue Virus Serotypes Before and After Each Vaccination with Sanofi Pasteur's CYD Dengue Vaccine

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    End point title
    		 Percentage of Subjects with Seropositivity for at Least 1, 2, 3 or 4 Parental Dengue Virus Serotypes Before and After Each Vaccination with Sanofi Pasteur's CYD Dengue Vaccine [7]
    End point description
    Neutralizing antibody levels of at least 1 , 2, 3 or the 4 parental dengue virus serotype strains were measured using the dengue neutralization assay. Seropositivity was defined as subjects with antibody titers ≥10 1/dil against the 4 dengue serotypes.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 28 post-second and third injections for Groups 1 and 2 and post-first, second, and third injections for Groups 3 and 4.
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    60
    30
    58
    60
    Units: Percentage of subjects
    number (not applicable)
        At least 1 serotype; Pre-inj. 1 (Screening)
    38.3
    43.3
    46.6
    46.7
        At least 1 serotype; Post-inj. 1 (V04)
    0
    0
    82.8
    91.7
        At least 1 serotype; Post-inj. 2 (V07)
    100
    50
    100
    100
        At least 1 serotype; Post-inj. 3 (V10)
    100
    43.3
    100
    100
        At least 2 serotypes; Pre-inj. 1 (Screening)
    21.7
    13.3
    12.1
    15
        At least 2 serotypes; Post-inj. 1 (V04)
    0
    0
    53.4
    81.7
        At least 2 serotypes; Post-inj. 2 (V07)
    100
    36.7
    98.3
    100
        At least 2 serotypes; Post-inj. 3 (V10)
    100
    30
    100
    100
        At least 3 serotypes; Pre-inj. 1 (Screening)
    11.7
    3.3
    3.4
    8.3
        At least 3 serotypes; Post-inj. 1 (V04)
    0
    0
    24.1
    38.3
        At least 3 serotypes; Post-inj. 2 (V07)
    94.9
    23.3
    93.1
    98.3
        At least 3 serotypes; Post-inj. 3 (V10)
    96.6
    26.7
    96.5
    100
        4 serotypes; Pre-inj. 1 (Screening)
    8.3
    3.3
    1.7
    6.7
        4 serotypes; Post-inj. 1 (V04)
    0
    0
    12.1
    21.7
        4 serotypes; Post-inj. 2 (V07)
    91.5
    20
    87.9
    90
        4 serotypes; Post-inj. 3 (V10)
    93.1
    13.3
    91.2
    96.7
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Before and Following Each Vaccination with Sanofi Pasteur's CYD Dengue Vaccine

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    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Before and Following Each Vaccination with Sanofi Pasteur's CYD Dengue Vaccine [8]
    End point description
    Geometric mean titers of antibodies against parental dengue virus serotypes were measured using the dengue neutralization assay.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 28 post-second and third injections for Groups 1 and 2 and post-first, second, and third injections for Groups 3 and 4.
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    60
    30
    58
    60
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Dengue Parental Serotype 1; Pre-inj. 1 (Screening)
    6.39 (5.21 to 7.85)
    5.31 (4.69 to 6.02)
    5.59 (4.94 to 6.33)
    6.18 (5.16 to 7.41)
        Dengue Parental Serotype 1; Post-inj. 1 (V04)
    0 (0 to 0)
    0 (0 to 0)
    7.36 (5.9 to 9.18)
    10.4 (7.33 to 14.8)
        Dengue Parental Serotype 1; Post-inj. 2 (V07)
    69.8 (45.4 to 108)
    9.04 (5.59 to 14.6)
    62.5 (43.8 to 89.1)
    73 (51.4 to 104)
        Dengue Parental Serotype 1; Post-inj. 3 (V10)
    105 (73.8 to 148)
    11.5 (5.77 to 22.8)
    108 (80.7 to 144)
    124 (90.9 to 169)
        Dengue Parental Serotype 2; Pre-inj. 1 (Screening)
    10 (6.54 to 15.4)
    9.73 (5.18 to 18.3)
    7.2 (5.3 to 9.77)
    7.46 (5.25 to 10.6)
        Dengue Parental Serotype 2; Post-inj. 1 (V04)
    0 (0 to 0)
    0 (0 to 0)
    10.6 (7.29 to 15.6)
    14.8 (9.26 to 23.7)
        Dengue Parental Serotype 2; Post-inj. 2 (V07)
    159 (93.1 to 272)
    14.5 (6.81 to 30.8)
    141 (88.7 to 224)
    114 (76.5 to 168)
        Dengue Parental Serotype 2; Post-inj. 3 (V10)
    147 (99.2 to 219)
    15.7 (7.7 to 32)
    213 (146 to 311)
    176 (121 to 254)
        Dengue Parental Serotype 3; Pre-inj. 1 (Screening)
    10.1 (6.99 to 14.5)
    9.05 (5.8 to 14.1)
    13.8 (9.49 to 20)
    14.8 (9.5 to 23.1)
        Dengue Parental Serotype 3; Post-inj. 1 (V04)
    0 (0 to 0)
    0 (0 to 0)
    30.8 (21 to 45.1)
    96 (61.9 to 149)
        Dengue Parental Serotype 3; Post-inj. 2 (V07)
    249 (170 to 366)
    13.9 (8.1 to 23.8)
    254 (196 to 329)
    288 (197 to 420)
        Dengue Parental Serotype 3; Post-inj. 3 (V10)
    311 (222 to 436)
    13.4 (7.63 to 23.5)
    358 (277 to 464)
    387 (284 to 527)
        Dengue Parental Serotype 4; Pre-inj. 1 (Screening)
    8.25 (6.4 to 10.7)
    6.98 (5.41 to 9.01)
    5.6 (4.9 to 6.4)
    6.99 (5.66 to 8.63)
        Dengue Parental Serotype 4; Post-inj. 1 (V04)
    0 (0 to 0)
    0 (0 to 0)
    20.5 (13.7 to 30.5)
    89.1 (56.8 to 140)
        Dengue Parental Serotype 4; Post-inj. 2 (V07)
    131 (104 to 166)
    10.1 (7.14 to 14.2)
    121 (90.7 to 161)
    133 (100 to 176)
        Dengue Parental Serotype 4; Post-inj. 3 (V10)
    143 (107 to 192)
    8.16 (5.66 to 11.8)
    127 (96 to 169)
    160 (131 to 195)
    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 Day 28 post-each vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Toddlers who received at total of 5 injections (Dengue vaccine): Month-1 (first injection; MMR), M0 (second injection; Dengue vaccine), M0+6 months (third injection; Dengue vaccine), M0+9 months (fourth injection; Diphtheria, Tetanus, Pertussis, Poliomyelitis, and Hib vaccine), and M0+12 months (fifth injection; Dengue vaccine).

    Reporting group title
    Group 2
    Reporting group description
    		 Toddlers who received at total of 5 injections (control): Month-1 (first injection; MMR), M0 (second injection; control Varicella vaccine), M0+6 months (third injection; control Hepatitis A vaccine), M0+9 months (fourth injection; Diphtheria, Tetanus, Pertussis, Poliomyelitis, and Hib vaccine), and M0+12 months (fifth injection; control Hepatitis A vaccine).

    Reporting group title
    Group 3
    Reporting group description
    		 Toddlers who received a total of 6 injections: Month-1 (first injection; control Varicella vaccine), M0 (second [Dengue vaccine] and third [MMR] injections), M0+6 months (fourth injection; Dengue vaccine), M0+9 months (fifth injection; Diphtheria, Tetanus, Pertussis, Poliomyelitis, and Hib vaccine), and M0+12 months (sixth injection; Dengue vaccine).

    Reporting group title
    Group 4
    Reporting group description
    		 Toddlers who received a total of 6 injections (sequential administration): Month-1 (first injection; MMR), M0 (second [Dengue vaccine] and third [placebo] injections), M0+6 months (fourth injection; Dengue vaccine), M0+9 months (fifth injection; Diphtheria, Tetanus, Pertussis, Poliomyelitis, and Hib vaccine), and M0+12 months (sixth injection; Dengue vaccine).

    Serious adverse events
    		 Group 1 Group 2 Group 3 Group 4
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 30 (3.33%)
    7 / 59 (11.86%)
    1 / 60 (1.67%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 30 (0.00%)
    0 / 59 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 30 (0.00%)
    3 / 59 (5.08%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrotic syndrome
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 30 (0.00%)
    0 / 59 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Dengue fever
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 30 (0.00%)
    1 / 59 (1.69%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 30 (0.00%)
    3 / 59 (5.08%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 30 (3.33%)
    2 / 59 (3.39%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1 Group 2 Group 3 Group 4
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 60 (40.00%)
    15 / 30 (50.00%)
    25 / 59 (42.37%)
    17 / 60 (28.33%)
    Nervous system disorders
    Drowsiness (Post-any injection)
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 60 (8.33%)
    3 / 30 (10.00%)
    2 / 59 (3.39%)
    3 / 60 (5.00%)
         occurrences all number
    5
    3
    2
    3
    General disorders and administration site conditions
    Injection site Pain (Post-any injection)
    alternative assessment type: Systematic
         subjects affected / exposed
    12 / 60 (20.00%)
    6 / 30 (20.00%)
    6 / 59 (10.17%)
    4 / 60 (6.67%)
         occurrences all number
    13
    7
    10
    7
    Injection site Erythema (Post-any injection)
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 60 (5.00%)
    5 / 30 (16.67%)
    7 / 59 (11.86%)
    2 / 60 (3.33%)
         occurrences all number
    3
    7
    10
    3
    Injection site Swelling (Post-any injection)
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 60 (3.33%)
    3 / 30 (10.00%)
    1 / 59 (1.69%)
    1 / 60 (1.67%)
         occurrences all number
    2
    4
    1
    1
    Fever (Post-any injection)
    alternative assessment type: Systematic
         subjects affected / exposed
    16 / 60 (26.67%)
    11 / 30 (36.67%)
    25 / 59 (42.37%)
    15 / 60 (25.00%)
         occurrences all number
    20
    11
    27
    16
    Gastrointestinal disorders
    Vomiting (Post-any injection)
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 60 (13.33%)
    11 / 30 (36.67%)
    3 / 59 (5.08%)
    3 / 60 (5.00%)
         occurrences all number
    8
    11
    3
    3
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 30 (0.00%)
    0 / 59 (0.00%)
    3 / 60 (5.00%)
         occurrences all number
    1
    0
    0
    4
    Psychiatric disorders
    Crying abnormal (Post-any injection)
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 60 (23.33%)
    8 / 30 (26.67%)
    8 / 59 (13.56%)
    7 / 60 (11.67%)
         occurrences all number
    14
    9
    8
    7
    Irritability (Post-any injection)
    alternative assessment type: Systematic
         subjects affected / exposed
    19 / 60 (31.67%)
    11 / 30 (36.67%)
    7 / 59 (11.86%)
    12 / 60 (20.00%)
         occurrences all number
    20
    14
    7
    14
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    3 / 60 (5.00%)
    2 / 30 (6.67%)
    3 / 59 (5.08%)
    0 / 60 (0.00%)
         occurrences all number
    3
    2
    3
    0
    Rhinitis
         subjects affected / exposed
    0 / 60 (0.00%)
    3 / 30 (10.00%)
    6 / 59 (10.17%)
    1 / 60 (1.67%)
         occurrences all number
    0
    3
    6
    1
    Subcutaneous abscess
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 30 (6.67%)
    1 / 59 (1.69%)
    1 / 60 (1.67%)
         occurrences all number
    0
    2
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    24 / 60 (40.00%)
    15 / 30 (50.00%)
    19 / 59 (32.20%)
    17 / 60 (28.33%)
         occurrences all number
    30
    20
    20
    18
    Viral infection
         subjects affected / exposed
    9 / 60 (15.00%)
    1 / 30 (3.33%)
    11 / 59 (18.64%)
    6 / 60 (10.00%)
         occurrences all number
    10
    1
    13
    6
    Viral rhinitis
         subjects affected / exposed
    3 / 60 (5.00%)
    5 / 30 (16.67%)
    0 / 59 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    5
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    4 / 60 (6.67%)
    4 / 30 (13.33%)
    0 / 59 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    4
    4
    0
    0
    Metabolism and nutrition disorders
    Appetite lost (Post-any injection)
    alternative assessment type: Systematic
         subjects affected / exposed
    11 / 60 (18.33%)
    6 / 30 (20.00%)
    7 / 59 (11.86%)
    6 / 60 (10.00%)
         occurrences all number
    12
    7
    7
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Feb 2010
    Administrative edits to revise and update - “Observational” Objectives or Endpoints; definition of a febrile episode; detection of symptomatic dengue cases for homogeneity in the protocol; the time window for the M15 phone call/home visit; and the addition that a “convalescent sample” of 2 mL would be taken in case of suspected symptomatic dengue cases to investigate the relationship between dengue and injection. Other revisions include - statement of applicable exclusion criteria; assessment of febrile convulsions according to the Guideline for definition and collection of cases of febrile convulsions; clarification that toddlers with abnormal biological parameters would be followed up until parameters returned to normal ranges; Specification that wild-type (WT) dengue RT-PCR was tested in acute samples collected from suspected dengue cases, regardless of time of event after injection; and modified the "Interpretation of Results” section.
    09 Apr 2010
    Revised study design from a monocenter to multi-center in view of measles outbreak in the Philippines; Acceleration of recruitment rate for Cohort 3 for protection against measles at the earliest possible time; Revision of "Visit Procedures" to notify general practitioners that patients were going to receive MMR injection during the dengue vaccine trial and for Groups 3 and 4. Revision of dengue microneutralization assay to dengue neutralization assay; Pan flavivirus reverse transcriptase polymerase chain reaction (RT-PCR) was changed to dengue screen RT-PCR and the description of the method was adapted in accordance to the changes.
    03 Feb 2011
    The lower limit of the normal range for Hemoglobin (Hb) was changed from 10.9 g/dL to 9.9 g/dL and the analysis of secondary objectives on measles, mumps, rubella (MMR) vaccine was revised.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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