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    Clinical Trial Results:
    A phase I, randomized, controlled, double-blind study to assess safety, reactogenicity and immunogenicity of GSK Biologicals’ pneumococcal vaccine 2830930A when administered as a single dose in healthy toddlers aged 12-23 months.

    Summary
    EudraCT number
    		 2011-002225-22
    Trial protocol
    		 DE  
    Global end of trial date
    15 Mar 2012

    Results information
    Results version number
    		 v1
    This version publication date
    01 Mar 2016
    First version publication date
    24 May 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    115373
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01485406
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium,
    Public contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.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
    04 Jul 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Mar 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Mar 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To assess safety and reactogenicity of 1 dose of 2830930A vaccine administered to toddlers aged 12-23 months primed with 3 doses of Synflorix™, in terms of occurrence of grade 3 related solicited and unsolicited adverse events and related serious adverse events.
    Protection of trial subjects
    All subjects were supervised after vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Only eligible subjects that had no contraindications to any components of the vaccines were vaccinated. Subjects were followed-up for 31 days after each/last vaccination
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Dec 2011
    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
    Germany: 61
    Worldwide total number of subjects
    61
    EEA total number of subjects
    61
    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)
    61
    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

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    Recruitment
    Recruitment details
    		 Among the 61 enrolled and vaccinated subjects, 60 subjects completed the study.

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    In a double blind study, the subject, the investigator and sponsor staff who are involved in the treatment or clinical evaluation of the subjects and the review or analysis of data were all unaware of the treatment assignment. The serological data, which would lead to the unblinding of the treatment groups, were not available during the course of the study to any investigator or any person involved in the clinical conduct of the study (including data cleaning).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 12Pn-PD-DiT-CRM group
    Arm description
    		 This group consisted in toddlers aged 12-23 months primed with 3 doses of Synflorix™ who received a single dose of GSK 12-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate (GSK2830930A) vaccine at Study Month 0. Study duration was of about 1 month.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK2189242A
    Investigational medicinal product code
    GSK2189242A
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    one dose administered intramuscularly in the deltoid of the non-dominant arm.

    Arm title
    		 Synflorix™ group
    Arm description
    		 This group consisted in toddlers aged 12-23 months primed with 3 doses of Synflorix™ who received a single dose Synflorix™ at Study Month 0. Study duration was of about 1 month.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    GSK1024850A
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    one dose administered intramuscularly in the deltoid of the non-dominant arm.

    Number of subjects in period 1
    		12Pn-PD-DiT-CRM group Synflorix™ group
    Started
    31
    30
    Completed
    31
    29
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    12Pn-PD-DiT-CRM group
    Reporting group description
    		 This group consisted in toddlers aged 12-23 months primed with 3 doses of Synflorix™ who received a single dose of GSK 12-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate (GSK2830930A) vaccine at Study Month 0. Study duration was of about 1 month.

    Reporting group title
    Synflorix™ group
    Reporting group description
    		 This group consisted in toddlers aged 12-23 months primed with 3 doses of Synflorix™ who received a single dose Synflorix™ at Study Month 0. Study duration was of about 1 month.

    Reporting group values
    		 12Pn-PD-DiT-CRM group Synflorix™ group Total
    Number of subjects
    		 31 30 61
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 15.5 ± 3.1 14.4 ± 2.27 -
    Gender categorical
    Units: Subjects
        Female
    		 16 18 34
        Male
    		 15 12 27

    End points

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    End points reporting groups
    Reporting group title
    12Pn-PD-DiT-CRM group
    Reporting group description
    		 This group consisted in toddlers aged 12-23 months primed with 3 doses of Synflorix™ who received a single dose of GSK 12-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate (GSK2830930A) vaccine at Study Month 0. Study duration was of about 1 month.

    Reporting group title
    Synflorix™ group
    Reporting group description
    		 This group consisted in toddlers aged 12-23 months primed with 3 doses of Synflorix™ who received a single dose Synflorix™ at Study Month 0. Study duration was of about 1 month.

    Primary: Number of subjects reporting each solicited local symptom

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    End point title
    		 Number of subjects reporting each solicited local symptom [1]
    End point description
    Assessed local symptoms were pain, redness and swelling at injection site. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). Primary results correspond to results for occurrences of G3 local symptoms. All solicited local AEs were considered as causally related to the study vaccination.
    End point type
    Primary
    End point timeframe
    during the 7-day (Days 0-6) post-vaccination period
    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: This endpoint contains only descriptive results. No inferential results.
    End point values
    		 12Pn-PD-DiT-CRM group Synflorix™ group
    Number of subjects analysed
    31
    29
    Units: subject
        Any pain
    14
    12
        Grade 3 pain
    0
    0
        Any redness
    20
    19
        Grade 3 redness
    2
    0
        Any swelling
    12
    9
        Grade 3 swelling
    3
    1
    No statistical analyses for this end point

    Primary: Number of subjects reporting each solicited general symptom

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    End point title
    		 Number of subjects reporting each solicited general symptom [2]
    End point description
    Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than or equal to [>=] 38 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 (G3) Drowsiness = Drowsiness that prevented normal activity. G3 Irritability = Crying that could not be comforted/prevented normal activity. G3 Loss of appetite = Subject did not eat at all. G3 Fever = Rectal temperature higher than (>) 40.0°C. Primary results correspond to results for occurrences of G3 &related symptoms assessed by the investigators as related to vaccination.
    End point type
    Primary
    End point timeframe
    during the 7-day (Days 0-6) post-vaccination period
    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: This endpoint contains only descriptive results. No inferential results.
    End point values
    		 12Pn-PD-DiT-CRM group Synflorix™ group
    Number of subjects analysed
    31
    29
    Units: subject
        Any Drowsiness
    9
    6
        Grade 3 Drowsiness
    0
    0
        Related Drowsiness
    8
    5
        G3 & related Drowsiness
    0
    0
        Any Irritability
    15
    14
        Grade 3 Irritability
    0
    1
        Related Irritability
    14
    13
        G3 & related Irritability
    0
    1
        Any Loss of appetite
    6
    9
        Grade 3 Loss of Appetite
    0
    0
        Related Loss of Appetite
    4
    5
        G3 & related Loss of Appetite
    0
    0
        Any Fever
    14
    13
        Grade 3 Fever
    1
    1
        Related Fever
    10
    11
        G3 & related Fever
    0
    1
    No statistical analyses for this end point

    Primary: Number of subjects with any and Grade 3 unsolicited adverse events (AEs) with and without relationship to vaccination

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    End point title
    		 Number of subjects with any and Grade 3 unsolicited adverse events (AEs) with and without relationship to vaccination [3]
    End point description
    An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of AE, regardless of intensity or relationship to vaccination. Grade 3 = Occurrence of AE which prevented normal activities. Related = Occurrence of AE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 unsolicited AE(s) assessed as related to vaccination.
    End point type
    Primary
    End point timeframe
    within 31 days (Day 0-Day 30) after 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: This endpoint contains only descriptive results. No inferential results.
    End point values
    		 12Pn-PD-DiT-CRM group Synflorix™ group
    Number of subjects analysed
    31
    30
    Units: subject
        Any unsolicited AE(s)
    18
    15
        Grade 3 unsolicited AE(s)
    0
    0
        Related unsolicited AE(s)
    1
    1
        Grade 3 and related unsolicited AE(s)
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with any serious adverse events (SAEs) and with SAE(s) with relationship to vaccination

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    End point title
    		 Number of subjects with any serious adverse events (SAEs) and with SAE(s) with relationship to vaccination [4]
    End point description
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. Related = Occurrence of an SAE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of SAE(s) assessed as related to vaccination.
    End point type
    Primary
    End point timeframe
    throughout the entire study (from Month 0 up to Month 1)
    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: This endpoint contains only descriptive results. No inferential results.
    End point values
    		 12Pn-PD-DiT-CRM group Synflorix™ group
    Number of subjects analysed
    31
    30
    Units: Subject
        Any SAE(s)
    0
    0
        SAE(s) related to vaccination
    0
    0
    No statistical analyses for this end point

    Secondary: Antibody concentrations against vaccine serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F

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    End point title
    		 Antibody concentrations against vaccine serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F
    End point description
    Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.
    End point type
    Secondary
    End point timeframe
    1 month post-vaccination
    End point values
    		 12Pn-PD-DiT-CRM group Synflorix™ group
    Number of subjects analysed
    31
    27
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-1 (N=31;27)
    2.34 (1.74 to 3.14)
    2.84 (2.12 to 3.82)
        Anti-4 (N=31;27)
    5.18 (4.05 to 6.63)
    4.52 (3.34 to 6.1)
        Anti-5 (N=31;27)
    3.31 (2.51 to 4.37)
    2.29 (1.52 to 3.46)
        Anti-6A (N=31;26)
    5.97 (3.91 to 9.11)
    0.75 (0.43 to 1.31)
        Anti-6B (N=31;27)
    5.37 (4.03 to 7.14)
    1.92 (1.5 to 2.46)
        Anti-7F (N=31;27)
    3.76 (2.99 to 4.73)
    3.36 (2.48 to 4.55)
        Anti-9V (N=31;27)
    4.38 (3.27 to 5.89)
    3.61 (2.38 to 5.48)
        Anti-14 (N=31;27)
    8.3 (6.27 to 10.98)
    7.15 (5.51 to 9.28)
        Anti-18C (N=31;27)
    11.26 (8.31 to 15.26)
    11.17 (7.99 to 15.62)
        Anti-19A (N=31;27)
    8.22 (5.45 to 12.4)
    1.99 (1.2 to 3.29)
        Anti-19F (N=31;27)
    17.34 (12.09 to 24.87)
    10.89 (8.03 to 14.76)
        Anti-23F (N=31;27)
    3.46 (2.63 to 4.56)
    3.54 (2.65 to 4.72)
    No statistical analyses for this end point

    Secondary: Antibody concentrations against Protein D (PD)

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    End point title
    		 Antibody concentrations against Protein D (PD)
    End point description
    Anti-PD antibody concentrations were measured by Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in Elisa Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    1 month post-vaccination
    End point values
    		 12Pn-PD-DiT-CRM group Synflorix™ group
    Number of subjects analysed
    31
    26
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PD
    1893.8 (1216.7 to 2947.6)
    1493 (962.4 to 2316.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms: during the 7 days after vaccination. Unsolicited AEs during 31 days after vaccination. SAEs: during the entire study period (Months 0-1).
    Adverse event reporting additional description
    Solicited symptoms results are presented only for subjects for whom results were available. Note: the occurences (all) numbers were not calculated during the analysis: data entered are equal to the subject affected numbers.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    12Pn-PD-DiT-CRM group
    Reporting group description
    		 This group consisted in toddlers aged 12-23 months primed with 3 doses of Synflorix™ who received a single dose of GSK 12-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate (GSK2830930A) vaccine at Study Month 0. Study duration was of about 1 month.

    Reporting group title
    Synflorix™ group
    Reporting group description
    		 This group consisted in toddlers aged 12-23 months primed with 3 doses of Synflorix™ who received a single dose Synflorix™ at Study Month 0. Study duration was of about 1 month.

    Serious adverse events
    		 12Pn-PD-DiT-CRM group Synflorix™ group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 12Pn-PD-DiT-CRM group Synflorix™ group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 31 (64.52%)
    19 / 30 (63.33%)
    General disorders and administration site conditions
    Pain
    Additional description: Symptom reported during the 7-day post-vaccination period
         subjects affected / exposed [1]
    14 / 31 (45.16%)
    12 / 29 (41.38%)
         occurrences all number
    14
    12
    Redness
    Additional description: Symptom reported during the 7-day post-vaccination period
         subjects affected / exposed [2]
    20 / 31 (64.52%)
    19 / 29 (65.52%)
         occurrences all number
    20
    19
    Swelling
    Additional description: Symptom reported during the 7-day post-vaccination period
         subjects affected / exposed [3]
    12 / 31 (38.71%)
    9 / 29 (31.03%)
         occurrences all number
    12
    9
    Drowsiness
    Additional description: Symptom reported during the 7-day post-vaccination period
         subjects affected / exposed [4]
    9 / 31 (29.03%)
    6 / 29 (20.69%)
         occurrences all number
    9
    6
    Irritability
    Additional description: Symptom reported during the 7-day post-vaccination period
         subjects affected / exposed [5]
    15 / 31 (48.39%)
    14 / 29 (48.28%)
         occurrences all number
    15
    14
    Loss of appetite
    Additional description: Symptom reported during the 7-day post-vaccination period
         subjects affected / exposed [6]
    6 / 31 (19.35%)
    9 / 29 (31.03%)
         occurrences all number
    6
    9
    Fever
    Additional description: Symptom reported during the 7-day post-vaccination period. Fever (rectal) >38°C
         subjects affected / exposed [7]
    14 / 31 (45.16%)
    13 / 29 (44.83%)
         occurrences all number
    14
    13
    Influenza like illness
    Additional description: Unsolicited AE reported during the 31-day post-vaccination period.
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 30 (3.33%)
         occurrences all number
    2
    1
    Pyrexia
    Additional description: Unsolicited AE reported during the 31-day post-vaccination period.
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Eye disorders
    Conjunctivitis
    Additional description: Unsolicited AE reported during the 31-day post-vaccination period.
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 30 (3.33%)
         occurrences all number
    2
    1
    Gastrointestinal disorders
    Diarrhoea
    Additional description: Unsolicited AE reported during the 31-day post-vaccination period.
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Infections and infestations
    Rhinitis
    Additional description: Unsolicited AE reported during the 31-day post-vaccination period.
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 31 (12.90%)
    2 / 30 (6.67%)
         occurrences all number
    4
    2
    Viral infection
    Additional description: Unsolicited AE reported during the 31-day post-vaccination period.
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 31 (9.68%)
    2 / 30 (6.67%)
         occurrences all number
    3
    2
    Bronchitis
    Additional description: Unsolicited AE reported during the 31-day post-vaccination period.
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 30 (6.67%)
         occurrences all number
    2
    2
    Gastroenteritis
    Additional description: Unsolicited AE reported during the 31-day post-vaccination period.
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 30 (3.33%)
         occurrences all number
    2
    1
    Otitis media
    Additional description: Unsolicited AE reported during the 31-day post-vaccination period.
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 30 (3.33%)
         occurrences all number
    2
    1
    Otitis externa
    Additional description: Unsolicited AE reported during the 31-day post-vaccination period.
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    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: Solicited symptoms results are presented only for subjects for whom results were available.
    [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: Solicited symptoms results are presented only for subjects for whom results were available.
    [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: Solicited symptoms results are presented only for subjects for whom results were available.
    [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: Solicited symptoms results are presented only for subjects for whom results were available.
    [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: Solicited symptoms results are presented only for subjects for whom results were available.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited symptoms results are presented only for subjects for whom results were available.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited symptoms results are presented only for subjects for whom results were available.

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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
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