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    Clinical Trial Results:
    A phase III open-label study to assess the safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine when co-administered with GSK Biologicals’ Infanrix hexa (DTPa-HBV-IPV/Hib) vaccine as a 3-dose primary immunization course at 2, 3 and 4 months of age in infants in Vietnam.

    Summary
    EudraCT number
    		 2012-000162-38
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    26 Jul 2011

    Results information
    Results version number
    		 v2(current)
    This version publication date
    05 Mar 2023
    First version publication date
    05 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of full data set and alignment between registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    113151
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01153841
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut, 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 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
    10 Oct 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jul 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jul 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (Synflorix - 10Pn) vaccine when co-administered with Infanrix hexa (DTPa-HBV-IPV/Hib) vaccine as a 3-dose primary vaccination course at 2, 3 and 4 months of age, in terms of grade 3 solicited and unsolicited adverse events (AEs).
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Feb 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
    Vietnam: 300
    Worldwide total number of subjects
    300
    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)
    300
    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
    		 -

    Pre-assignment
    Screening details
    		 300 subjects were enrolled in this study. 2 subjects among the 101 subjects in the Infanrix Hexa Group were not vaccinated due to consent withdrawal.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Synflorix+Infanrix hexa Group
    Arm description
    		 Healthy male or female subjects who received the Synflorix vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Synflorix
    Investigational medicinal product code
    Other name
    GSK1024850A, 10Pn
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered, according to a 3 dose schedule at 2, 3 and 4 months of age, in the right thigh.

    Investigational medicinal product name
    Infanrix hexa™
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered by intramuscular injection in the left thigh, according to a 3 dose schedule at 2, 3 and 4 months of age.

    Arm title
    		 Infanrix Hexa Group
    Arm description
    		 Healthy male or female subjects who received the Infanrix hexa vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered by intramuscular injection in the left thigh, according to a 3 dose schedule at 2, 3 and 4 months of age.

    Number of subjects in period 1 [1]
    		Synflorix+Infanrix hexa Group Infanrix Hexa Group
    Started
    199
    99
    Completed
    193
    99
    Not completed
    6
    0
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    1
    -
         Protocol deviation
    2
    -
         Lost to follow-up
    2
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 300 subjects were enrolled in this study. 2 subjects among the 101 subjects in the Infanrix Hexa Group were not vaccinated due to consent withdrawal.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Synflorix+Infanrix hexa Group
    Reporting group description
    		 Healthy male or female subjects who received the Synflorix vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.

    Reporting group title
    Infanrix Hexa Group
    Reporting group description
    		 Healthy male or female subjects who received the Infanrix hexa vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.

    Reporting group values
    		 Synflorix+Infanrix hexa Group Infanrix Hexa Group Total
    Number of subjects
    		 199 99 298
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 199 99 298
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 8.8 ( 1.24 ) 8.7 ( 1.11 ) -
    Gender categorical
    Units: Subjects
        Female
    		 93 37 130
        Male
    		 106 62 168

    End points

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    End points reporting groups
    Reporting group title
    Synflorix+Infanrix hexa Group
    Reporting group description
    		 Healthy male or female subjects who received the Synflorix vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.

    Reporting group title
    Infanrix Hexa Group
    Reporting group description
    		 Healthy male or female subjects who received the Infanrix hexa vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.

    Primary: Number of subjects with Grade 3 symptoms (solicited and unsolicited)

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    End point title
    		 Number of subjects with Grade 3 symptoms (solicited and unsolicited) [1]
    End point description
    The incidence and nature of Grade 3 symptoms (solicited and unsolicited) reported during the 31-day post-vaccination period following each dose and across doses are presented. The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with the symptom sheet filled in.
    End point type
    Primary
    End point timeframe
    Within the 31-day (Days 0-30) after each dose and across doses
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Synflorix+Infanrix hexa Group Infanrix Hexa Group
    Number of subjects analysed
    197
    99
    Units: Subjects
        Any symptom Dose 1 [N=197,99]
    24
    3
        Any symptom Dose 2 [N=193,99]
    18
    3
        Any symptom Dose 3 [N=193,99]
    6
    3
        Any symptom Across doses [N=197,99]
    32
    9
        General symptoms Dose 1 [N=197,99]
    5
    1
        General symptoms Dose 2 [N=193,99]
    7
    1
        General symptoms Dose 3 [N=193,99]
    1
    1
        General symptoms Across doses [N=197,99]
    10
    3
        Local symptoms Dose 1 [N=197,99]
    23
    2
        Local symptoms Dose 2 [N=193,99]
    15
    2
        Local symptoms Dose 3 [N=193,99]
    5
    2
        Local symptoms Dose Across doses [N=197,99]
    28
    6
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and grade 3 solicited local symptoms

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    End point title
    		 Number of subjects reporting any and grade 3 solicited local symptoms
    End point description
    Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness greater than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity. The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with the symptom sheet filled in.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each dose
    End point values
    		 Synflorix+Infanrix hexa Group Infanrix Hexa Group
    Number of subjects analysed
    197
    99
    Units: Subjects
        Any Pain Dose 1 [N=197;99]
    116
    34
        Grade 3 Pain Dose 1 [N=197;99]
    22
    1
        Any Redness Dose 1 [N=197;99]
    48
    13
        Grade 3 Redness Dose 1 [N=197;99]
    3
    0
        Any Swelling Dose 1 [N=197;99]
    47
    10
        Grade 3 Swelling Dose 1 [N=197;99]
    3
    1
        Any Pain Dose 2 [N=193;99]
    101
    31
        Grade 3 Pain Dose 2 [N=193;99]
    12
    2
        Any Redness Dose 2 [N=193;99]
    49
    19
        Grade 3 Redness Dose 2 [N=193;99]
    1
    0
        Any Swelling Dose 2 [N=193;99]
    44
    12
        Grade 3 Swelling Dose 2 [N=193;99]
    2
    0
        Any Pain Dose 3 [N=193;99]
    68
    27
        Grade 3 Pain Dose 3 [N=193;99]
    4
    0
        Any Redness Dose 3 [N=193;99]
    38
    12
        Grade 3 Redness Dose 3 [N=193;99]
    1
    1
        Any Swelling Dose 3 [N=193;99]
    29
    12
        Grade 3 Swelling Dose 3 [N=193;99]
    2
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related solicited general symptoms

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    End point title
    		 Number of subjects reporting any, grade 3 and related solicited general symptoms
    End point description
    Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature greater than or equal to [≥] 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) greater than (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with the symptom sheet filled in.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each dose
    End point values
    		 Synflorix+Infanrix hexa Group Infanrix Hexa Group
    Number of subjects analysed
    197
    99
    Units: Subjects
        Any Drowsiness Dose 1 [N=197;99]
    75
    19
        Grade 3 Drowsiness Dose 1 [N=197;99]
    3
    0
        Related Drowsiness Dose 1 [N=197;99]
    60
    15
        Any Fever Dose 1 [N=197;99]
    147
    36
        Grade 3 Fever Dose 1 [N=197;99]
    0
    0
        Related Fever Dose 1 [N=197;99]
    142
    34
        Any Irritability Dose 1 [N=197;99]
    155
    53
        Grade 3 Irritability Dose 1 [N=197;99]
    4
    1
        Related Irritability Dose 1 [N=197;99]
    146
    51
        Any Loss of appetite Dose 1 [N=197;99]
    109
    40
        Grade 3 Loss of appetite Dose 1 [N=197;99]
    0
    0
        Related Loss of appetite Dose 1 [N=197;99]
    86
    31
        Any Drowsiness Dose 2 [N=193;99]
    53
    10
        Grade 3 Drowsiness Dose 2 [N=193;99]
    0
    0
        Related Drowsiness Dose 2 [N=193;99]
    52
    8
        Any Fever Dose 2 [N=193;99]
    108
    16
        Grade 3 Fever Dose 2 [N=193;99]
    0
    0
        Related Fever Dose 2 [N=193;99]
    105
    15
        Any Irritability Dose 2 [N=193;99]
    112
    36
        Grade 3 Irritability Dose 2 [N=193;99]
    6
    0
        Related Irritability Dose 2 [N=193;99]
    110
    32
        Any Loss of appetite Dose 2 [N=193;99]
    94
    25
        Grade 3 Loss of appetite Dose 2 [N=193;99]
    0
    0
        Related Loss of appetite Dose 2 [N=193;99]
    90
    23
        Any Drowsiness Dose 3 [N=193;99]
    25
    5
        Grade 3 Drowsiness Dose 3 [N=193;99]
    0
    0
        Related Drowsiness Dose 3 [N=193;99]
    21
    4
        Any Fever Dose 3 [N=193;99]
    63
    12
        Grade 3 Fever Dose 3 [N=193;99]
    0
    1
        Related Fever Dose 3 [N=193;99]
    60
    12
        Any Irritability Dose 3 [N=193;99]
    71
    31
        Grade 3 Irritability Dose 3 [N=193;99]
    1
    0
        Related Irritability Dose 3 [N=193;99]
    69
    29
        Any Loss of appetite Dose 3 [N=193;99]
    67
    21
        Grade 3 Loss of appetite Dose 3 [N=193;99]
    0
    0
        Related Loss of appetite Dose 3[N=193;99]
    60
    19
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited adverse events (AEs)

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs)
    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. “Any” is defined as incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) follow-up period after each dose
    End point values
    		 Synflorix+Infanrix hexa Group Infanrix Hexa Group
    Number of subjects analysed
    199
    99
    Units: Subjects
        Any AE(s)
    57
    37
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs)

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    End point title
    		 Number of subjects with serious adverse events (SAEs)
    End point description
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
    End point type
    Secondary
    End point timeframe
    After the first vaccination up to study end (From Month 0 to Month 3)
    End point values
    		 Synflorix+Infanrix hexa Group Infanrix Hexa Group
    Number of subjects analysed
    199
    99
    Units: Subjects
        Any SAE(s)
    9
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and general symptoms: during the 4-day (Day 0 - Day 3) post-vaccination period; Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period; SAEs: after the first vaccination up to study end (from Month 0 to Month 3).
    Adverse event reporting additional description
    The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Synflorix+Infanrix hexa Group
    Reporting group description
    		 -

    Reporting group title
    Infanrix hexa Group
    Reporting group description
    		 -

    Serious adverse events
    		 Synflorix+Infanrix hexa Group Infanrix hexa Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 199 (4.52%)
    6 / 99 (6.06%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Kawasaki’s disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 199 (0.50%)
    0 / 99 (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
    Convulsion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 199 (0.50%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile convulsion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 199 (0.50%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 199 (0.50%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Autoimmune thrombocytopenia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 199 (0.50%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulopathy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 199 (0.50%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 199 (0.50%)
    2 / 99 (2.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 199 (0.50%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 199 (1.01%)
    3 / 99 (3.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superinfection fungal
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 199 (0.50%)
    2 / 99 (2.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 199 (0.50%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral candidiasis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 199 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 199 (0.50%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 199 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 199 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Synflorix+Infanrix hexa Group Infanrix hexa Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    195 / 199 (97.99%)
    91 / 99 (91.92%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed [1]
    137 / 197 (69.54%)
    45 / 99 (45.45%)
         occurrences all number
    137
    45
    Redness
         subjects affected / exposed [2]
    90 / 197 (45.69%)
    29 / 99 (29.29%)
         occurrences all number
    90
    29
    Swelling
         subjects affected / exposed [3]
    80 / 197 (40.61%)
    21 / 99 (21.21%)
         occurrences all number
    80
    21
    Drowsiness
         subjects affected / exposed [4]
    95 / 197 (48.22%)
    26 / 99 (26.26%)
         occurrences all number
    95
    26
    Fever (Axillary)
         subjects affected / exposed [5]
    172 / 197 (87.31%)
    50 / 99 (50.51%)
         occurrences all number
    172
    50
    Irritability
         subjects affected / exposed
    169 / 199 (84.92%)
    63 / 99 (63.64%)
         occurrences all number
    169
    63
    Loss of appetite
         subjects affected / exposed [6]
    141 / 197 (71.57%)
    50 / 99 (50.51%)
         occurrences all number
    141
    50
    Respiratory, thoracic and mediastinal disorders
    Wheezing
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 199 (0.50%)
    5 / 99 (5.05%)
         occurrences all number
    1
    5
    Infections and infestations
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    20 / 199 (10.05%)
    8 / 99 (8.08%)
         occurrences all number
    20
    8
    Bronchiolitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    9 / 199 (4.52%)
    9 / 99 (9.09%)
         occurrences all number
    9
    9
    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: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.
    [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: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.
    [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: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.
    [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: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.
    [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: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.
    [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: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.

    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
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