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    Clinical Trial Results:
    An Open Study of the Safety and Efficacy of Saizen®, (Recombinant Human Growth Hormone, r-hGH), in Children Born With Serious Intra-uterine Growth Retardation (IUGR) Treated to Final Height

    Summary
    EudraCT number
    		 2015-001708-69
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    17 Feb 2010

    Results information
    Results version number
    		 v2(current)
    This version publication date
    04 Jun 2016
    First version publication date
    05 Aug 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of full data set

    Trial information

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    Trial identification
    Sponsor protocol code
    20184
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01400698
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck KGaA
    Sponsor organisation address
    Frankfurter Strasse 250, Darmstadt, Germany, 64293
    Public contact
    Communication Centre Merck KGaA, Merck KGaA, +49 6151725200, service@merckgroup.com
    Scientific contact
    Communication Centre Merck KGaA, Merck KGaA, +49 6151725200, service@merckgroup.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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
    17 Feb 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to follow children born with serious IUGR, and treated with 1.4 International units per kilogram per week( IU/kg/week)[0.47 milligram per kilogram per week (mg/kg/week)] of Saizen according to various therapeutic schedules, until they reach final height while assessing both efficacy and safety (studies A, B and C).
    Protection of trial subjects
    Subject protection was ensured by following high medical and ethical standards in accordance with the principles laid down in the Declaration of Helsinki and that are consistent with the Good Clinical Practice and applicable regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Nov 1998
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 91
    Worldwide total number of subjects
    91
    EEA total number of subjects
    91
    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)
    51
    Adolescents (12-17 years)
    40
    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
    		 Subjects who completed 3 or 2 years treatment and at least 1 year post treatment observation in Sponsor Studies GF 4001 (Safety and Efficacy of Saizen in the Treatment of Young Children Born with Severe IUGR or GF 6283 (Effect of Intermittent versus Continuous Saizen Therapy in Young Children Born with Severe IUGR), respectively were enrolled.

    Pre-assignment
    Screening details
    		 Overall, 91 subjects who had participated in and successfully completed either study 4001 or 6283 were enrolled in study 20184.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Saizen® Continuous (A1)
    Arm description
    		 Subjects with bone age less than or equal to (<=) 12 years for girls or 14 years for boys and height <=-2 standard deviation (SD) received continuous treatment with recombinant human Growth Hormone (r-hGH) 0.067 milligram/kilogram/day (mg/kg/day) subcutaneously (sc) until they reached final height for a maximum duration of 10.6 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Saizen
    Investigational medicinal product code
    Other name
    r-hGH, Somatropin
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Continuous treatment with recombinant human Growth Hormone (r-hGH) 0.067 mg/kg/day sc.

    Arm title
    		 Saizen® Intermittent (A2)
    Arm description
    		 Subjects with bone age <=12 years for girls or 14 years for boys and height <=-2 SD received intermittent treatment with r-hGH 0.067 mg/kg/day sc until they reached final height for a maximum duration of 10.6 years. Intermittent treatment was given on an individual basis depending on the height achieved during the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Saizen
    Investigational medicinal product code
    Other name
    r-hGH, Somatropin
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Intermittent treatment with recombinant human Growth Hormone (r-hGH) 0.067 milligram/kilogram/day (mg/kg/day) subcutaneously (sc).

    Arm title
    		 Observed, Not Randomized (B0)
    Arm description
    		 Subjects with bone age <=12 years for girls or 14 years for boys and height greater than (>) -2 SD were observed until first signs of puberty but not randomized.
    Arm type
    		 Observation only

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Observed Then Randomized to Saizen® (B1)
    Arm description
    		 Subjects with bone age <=12 years for girls or 14 years for boys and height >-2 SD were observed until first signs of puberty and if remained at a height >-2 SD, were randomized to receive continuous treatment with r-hGH 0.067 mg/kg/day sc until they reached final height for a maximum duration of 10.6 years. Subjects whose height fell to <=-2 SD before the first sign of puberty, were randomized to either Saizen® Continuous (A1) or Saizen® Intermittent (A2) treatment group.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Saizen
    Investigational medicinal product code
    Other name
    r-hGH, Somatropin
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Continuous treatment with recombinant human Growth Hormone (r-hGH) 0.067 milligram/kilogram/day (mg/kg/day) subcutaneously (sc).

    Investigational medicinal product name
    Saizen
    Investigational medicinal product code
    Other name
    r-hGH, Somatropin
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Intermittent treatment with recombinant human Growth Hormone (r-hGH) 0.067 milligram/kilogram/day (mg/kg/day) subcutaneously (sc).

    Arm title
    		 Observed Then Randomized to Observation (B2)
    Arm description
    		 Subjects with bone age <=12 years for girls or 14 years for boys and height >-2 SD were observed until first signs of puberty and if remained at a height >-2 SD, were randomized to observation group with no treatment until they reached final height for a maximum duration of 10.6 years. Subjects whose height fell to <=-2 SD before the first sign of puberty, were randomized to either Saizen® Continuous (A1) or Saizen® Intermittent (A2) treatment group.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Saizen
    Investigational medicinal product code
    Other name
    r-hGH, Somatropin
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Continuous treatment with recombinant human Growth Hormone (r-hGH) 0.067 milligram/kilogram/day (mg/kg/day) subcutaneously (sc).

    Investigational medicinal product name
    Saizen
    Investigational medicinal product code
    Other name
    r-hGH, Somatropin
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Intermittent treatment with recombinant human Growth Hormone (r-hGH) 0.067 milligram/kilogram/day (mg/kg/day) subcutaneously (sc).

    Arm title
    		 Observation (C)
    Arm description
    		 Subjects with bone age >12 years for girls or 14 years for boys or refused to be treated in any of the above groups were followed without treatment until they reached final height for a maximum duration of 10.6 years.
    Arm type
    		 Observation only

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Saizen® Continuous (A1) Saizen® Intermittent (A2) Observed, Not Randomized (B0) Observed Then Randomized to Saizen® (B1) Observed Then Randomized to Observation (B2) Observation (C)
    Started
    23
    23
    2
    14
    14
    15
    Completed
    8
    12
    0
    6
    7
    9
    Not completed
    15
    11
    2
    8
    7
    6
         Consent withdrawn by subject
    8
    2
    -
    4
    1
    3
         Protocol violation
    -
    1
    -
    -
    1
    -
         Adverse event
    1
    -
    -
    -
    -
    -
         Non-compliance
    -
    1
    -
    1
    -
    -
         Unspecified
    4
    2
    -
    2
    1
    -
         Lost to follow-up
    2
    5
    2
    1
    4
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 -

    Reporting group values
    		 Overall study Total
    Number of subjects
    		 91 91
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 10.3 ( 3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 41 41
        Male
    		 50 50
    Original Study
    Units: Subjects
        GF4001
    		 52 52
        GF6283
    		 39 39
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 2 2
        Black
    		 1 1
        White
    		 88 88
    Birth Height
    Units: Centimeters (cm)
        arithmetic mean (standard deviation)
    		 42.8 ( 3.7 ) -
    Birth Weight
    Units: gram(s)
        arithmetic mean (standard deviation)
    		 2085.3 ( 551.8 ) -
    Length of Gestation
    Units: Weeks
        arithmetic mean (standard deviation)
    		 37.9 ( 2.6 ) -

    End points

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    End points reporting groups
    Reporting group title
    Saizen® Continuous (A1)
    Reporting group description
    		 Subjects with bone age less than or equal to (<=) 12 years for girls or 14 years for boys and height <=-2 standard deviation (SD) received continuous treatment with recombinant human Growth Hormone (r-hGH) 0.067 milligram/kilogram/day (mg/kg/day) subcutaneously (sc) until they reached final height for a maximum duration of 10.6 years.

    Reporting group title
    Saizen® Intermittent (A2)
    Reporting group description
    		 Subjects with bone age <=12 years for girls or 14 years for boys and height <=-2 SD received intermittent treatment with r-hGH 0.067 mg/kg/day sc until they reached final height for a maximum duration of 10.6 years. Intermittent treatment was given on an individual basis depending on the height achieved during the study.

    Reporting group title
    Observed, Not Randomized (B0)
    Reporting group description
    		 Subjects with bone age <=12 years for girls or 14 years for boys and height greater than (>) -2 SD were observed until first signs of puberty but not randomized.

    Reporting group title
    Observed Then Randomized to Saizen® (B1)
    Reporting group description
    		 Subjects with bone age <=12 years for girls or 14 years for boys and height >-2 SD were observed until first signs of puberty and if remained at a height >-2 SD, were randomized to receive continuous treatment with r-hGH 0.067 mg/kg/day sc until they reached final height for a maximum duration of 10.6 years. Subjects whose height fell to <=-2 SD before the first sign of puberty, were randomized to either Saizen® Continuous (A1) or Saizen® Intermittent (A2) treatment group.

    Reporting group title
    Observed Then Randomized to Observation (B2)
    Reporting group description
    		 Subjects with bone age <=12 years for girls or 14 years for boys and height >-2 SD were observed until first signs of puberty and if remained at a height >-2 SD, were randomized to observation group with no treatment until they reached final height for a maximum duration of 10.6 years. Subjects whose height fell to <=-2 SD before the first sign of puberty, were randomized to either Saizen® Continuous (A1) or Saizen® Intermittent (A2) treatment group.

    Reporting group title
    Observation (C)
    Reporting group description
    		 Subjects with bone age >12 years for girls or 14 years for boys or refused to be treated in any of the above groups were followed without treatment until they reached final height for a maximum duration of 10.6 years.

    Subject analysis set title
    Non-Final Height: Not Treated
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Includes all subjects who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.

    Subject analysis set title
    Non-Final Height: Treated
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Includes all subjects who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.

    Subject analysis set title
    Final Height: Not Treated
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Includes all subjects who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.

    Subject analysis set title
    Final Height: Treated
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Includes all subjects who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.

    Primary: Final height

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    End point title
    		 Final height [1]
    End point description
    Final height was defined as the height reached 1 year after height velocity (HV) was less than 2 centimeter/year (cm/year). Height velocity was the change in height since the previous year’s measurement. Height was measured with a wall-mounted stadiometer (or in supine position if the subject’s age was less than 3 years) and the measurement was repeated thrice by the same observer. The mean of the values obtained in the repeated measurements was taken for the analysis. This endpoint was assessed in Intention-to-treat (ITT) population included all subjects enrolled in this study. Safety population was identical in this study.
    End point type
    Primary
    End point timeframe
    One year after final height was attained up to 10.6 years
    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: Only descriptive statistics was planned for this endpoint.
    End point values
    		 Non-Final Height: Not Treated Non-Final Height: Treated Final Height: Not Treated Final Height: Treated
    Number of subjects analysed
    10
    13
    22
    46
    Units: cm
        arithmetic mean (standard deviation)
    145.9 ( 16.08 )
    150.06 ( 12.89 )
    153.27 ( 8.71 )
    155.59 ( 8.38 )
    No statistical analyses for this end point

    Primary: Height standard deviation score (HSDS)

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    End point title
    		 Height standard deviation score (HSDS) [2]
    End point description
    HSDS was calculated as height minus reference mean height divided by SD of the reference mean height, both given by the reference growth table (Sempe) for the corresponding chronological age at the height measurement. Greater HSDS indicate greater height. (Sempe M et al., 1979). This endpoint was assessed in ITT population.
    End point type
    Primary
    End point timeframe
    One year after final height was attained up to 10.6 years
    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: Only descriptive statistics was planned for this endpoint.
    End point values
    		 Non-Final Height: Not Treated Non-Final Height: Treated Final Height: Not Treated Final Height: Treated
    Number of subjects analysed
    10
    13
    22
    46
    Units: standard deviation score
        arithmetic mean (standard deviation)
    -1.45 ( 0.76 )
    -1.9 ( 1.73 )
    -2.33 ( 1.01 )
    -1.99 ( 0.88 )
    No statistical analyses for this end point

    Secondary: Parental Adjusted Height Standard Deviation Score (PAHSDS)

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    End point title
    		 Parental Adjusted Height Standard Deviation Score (PAHSDS)
    End point description
    PAHSDS is the distance between the subject’s current and target heights, expressed in units of SD of the height distribution of the reference population. Target height is a measure of the height which the subject could hypothetically reach based only on his parents’ heights. Target height standard deviation score (THSDS) was calculated as target height minus mean adult height of the reference population divided by SD of the mean adult height of the reference population. This endpoint was assessed in ITT population.
    End point type
    Secondary
    End point timeframe
    One year after final height was attained up to 10.6 years
    End point values
    		 Non-Final Height: Not Treated Non-Final Height: Treated Final Height: Not Treated Final Height: Treated
    Number of subjects analysed
    10
    13
    22
    46
    Units: Standard deviation score
        arithmetic mean (standard deviation)
    -0.82 ( 0.59 )
    -1.52 ( 1.92 )
    -1.64 ( 1.61 )
    -1.24 ( 1.39 )
    No statistical analyses for this end point

    Post-hoc: Duration of treatment

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    End point title
    		 Duration of treatment
    End point description
    ITT population included all subjects enrolled in this study. Safety population was identical in this study. Here, ‘N’ (number of subjects analyzed) signifies those subjects who were treated and hence, were evaluated for this measure.
    End point type
    Post-hoc
    End point timeframe
    Up to 10.6 years
    End point values
    		 Non-Final Height: Treated Final Height: Treated
    Number of subjects analysed
    13
    46
    Units: Years
        arithmetic mean (standard deviation)
    4.09 ( 2.92 )
    4.51 ( 2.2 )
    No statistical analyses for this end point

    Post-hoc: Duration of participation in the study

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    End point title
    		 Duration of participation in the study
    End point description
    ITT population included all subjects enrolled in this study. Safety population was identical in this study. Here, ‘N’ (number of subjects analyzed) signifies those subjects who were evaluated for this measure.
    End point type
    Post-hoc
    End point timeframe
    Up to 10.6 years
    End point values
    		 Non-Final Height: Not Treated Non-Final Height: Treated Final Height: Not Treated Final Height: Treated
    Number of subjects analysed
    9
    13
    22
    46
    Units: Years
        arithmetic mean (standard deviation)
    2.08 ( 2.27 )
    5.29 ( 2.89 )
    4.1 ( 2.87 )
    7.02 ( 2.06 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Day 30 after end of study
    Adverse event reporting additional description
    An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Treated
    Reporting group description
    		 Included all subjects who received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.

    Reporting group title
    Not Treated
    Reporting group description
    		 Included all subjects who did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently

    Serious adverse events
    		 Treated Not Treated
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 59 (22.03%)
    1 / 32 (3.13%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (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
    Congenital jaw malformation
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hereditary haemorrhagic telangiectasia
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Ear tube removal
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillectomy
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (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
    Febrile convulsion
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Keratoconus
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia, obstructive
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Epiphysiolysis
         subjects affected / exposed
    4 / 59 (6.78%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee deformity
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb asymmetry
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (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
    Appendicitis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media chronic
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (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
    		 Treated Not Treated
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 59 (88.14%)
    16 / 32 (50.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 59 (16.95%)
    1 / 32 (3.13%)
         occurrences all number
    14
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    6 / 59 (10.17%)
    1 / 32 (3.13%)
         occurrences all number
    7
    2
    Eczema
         subjects affected / exposed
    4 / 59 (6.78%)
    1 / 32 (3.13%)
         occurrences all number
    4
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 59 (11.86%)
    0 / 32 (0.00%)
         occurrences all number
    8
    0
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    9 / 59 (15.25%)
    5 / 32 (15.63%)
         occurrences all number
    14
    6
    Bronchitis
         subjects affected / exposed
    8 / 59 (13.56%)
    3 / 32 (9.38%)
         occurrences all number
    11
    6
    Gastroenteritis
         subjects affected / exposed
    7 / 59 (11.86%)
    3 / 32 (9.38%)
         occurrences all number
    8
    3
    Nasopharyngitis
         subjects affected / exposed
    6 / 59 (10.17%)
    0 / 32 (0.00%)
         occurrences all number
    11
    0
    Influenza
         subjects affected / exposed
    6 / 59 (10.17%)
    0 / 32 (0.00%)
         occurrences all number
    8
    0
    Ear infection
         subjects affected / exposed
    4 / 59 (6.78%)
    2 / 32 (6.25%)
         occurrences all number
    4
    3
    Rhinitis
         subjects affected / exposed
    4 / 59 (6.78%)
    1 / 32 (3.13%)
         occurrences all number
    4
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/16772718
    http://www.ncbi.nlm.nih.gov/pubmed/9641731
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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