Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A phase III, observer-blind, randomized, multi-country, non-influenza vaccine comparator-controlled study to demonstrate the efficacy of GlaxoSmithKline Biologicals’ quadrivalent seasonal influenza candidate vaccine GSK2321138A (FLU D-QIV), administered intramuscularly in children 6 to 35 months of age.

    Summary
    EudraCT number
    		 2011-000758-41
    Trial protocol
    		 CZ   ES   BE   GB   PL   Outside EU/EEA  
    Global end of trial date
    31 Dec 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    14 Sep 2018
    First version publication date
    07 Jan 2017
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    115345
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01439360
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89,, Rixensart,, Belgium,
    Public contact
    Clinical Trials Call Center,, GlaxoSmithKline Biologicals, 44 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center,, GlaxoSmithKline Biologicals, 44 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000817-PIP02-11
    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
    13 Jul 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To evaluate the efficacy of FLU D-QIV in the prevention of RT-PCR confirmed moderate to severe influenza A and/or B disease due to any seasonal influenza strain, when compared to non-influenza vaccine controls in children aged 6 to 35 months. • To evaluate the efficacy of FLU D-QIV in the prevention of RT-PCR confirmed influenza A and/or B disease due to any seasonal influenza strain, when compared to non-influenza vaccine controls in children aged 6 to 35 months.
    Protection of trial subjects
    All subjects were observed closely for at least 30 minutes following the administration of the vaccine(s)/placebo, with appropriate medical treatment readily available in case of anaphylaxis.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 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
    Bangladesh: 2911
    Country: Number of subjects enrolled
    Belgium: 147
    Country: Number of subjects enrolled
    Czech Republic: 416
    Country: Number of subjects enrolled
    Dominican Republic: 1962
    Country: Number of subjects enrolled
    Honduras: 1314
    Country: Number of subjects enrolled
    India: 465
    Country: Number of subjects enrolled
    Lebanon: 250
    Country: Number of subjects enrolled
    Philippines: 1448
    Country: Number of subjects enrolled
    Poland: 1266
    Country: Number of subjects enrolled
    Spain: 858
    Country: Number of subjects enrolled
    Thailand: 602
    Country: Number of subjects enrolled
    Turkey: 37
    Country: Number of subjects enrolled
    United Kingdom: 370
    Worldwide total number of subjects
    12046
    EEA total number of subjects
    3057
    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)
    6445
    Children (2-11 years)
    5601
    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
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 12046
    Number of subjects completed
    		 12018

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Invalid ICF: 21
    Reason: Number of subjects
    		 Vaccine not administered subject number allocated: 7
    Period 1
    Period 1 title
    Overall Study (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
    Data will be collected in an observer-blind manner. The laboratory in charge of the laboratory testing was blinded to the treatment, and codes were used to link the subject and study (without any link to the treatment attributed to the subject) to each sample.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 D-QIV
    Arm description
    		 Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Influsplit™ Tetra (D-QIV)
    Investigational medicinal product code
    Other name
    Fluarix™ Tetra, GSK2321138A
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 or 2 doses adminstered intramuscurlarly at Day 0 (primed subjects) and Days 0 and 28 (unprimed subjects)

    Arm title
    		 Control
    Arm description
    		 In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevenar 13®
    Investigational medicinal product code
    Other name
    Pfizer’s pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) (PCV-13)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    ­2 doses administered at Days 0 and 28 and 1 booster dose at study completion (Day 180 approximately), according to the prescribing information for subjects < 12 months of age.

    Investigational medicinal product name
    Varivax®
    Investigational medicinal product code
    SUB25312
    Other name
    ProVarivax®
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered (depending on the licensed vaccine in the participating country) at Day 0 in unprimed subjects ≥12 months of age.

    Investigational medicinal product name
    Varilrix®
    Investigational medicinal product code
    SUB20954
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 dose administered subcutaneously (depending on the licensed vaccine in the participating country) at Day 0 in unprimed subjects ≥12 months of age.

    Investigational medicinal product name
    Havrix®
    Investigational medicinal product code
    SUB25294
    Other name
    Havrix® Junior
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered intramuscularly at Day 0 and booster dose at study completion (Day 180 approximately)

    Number of subjects in period 1 [1]
    		D-QIV Control
    Started
    6006
    6012
    Completed
    5808
    5804
    Not completed
    198
    208
         Consent withdrawn by subject
    140
    129
         Others
    10
    5
         Adverse event, non-fatal
    4
    16
         Lost to follow-up
    43
    58
         Protocol deviation
    1
    -
    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: Out of the 12046 enrolled subjects, 21 subjects were excluded from all statistical analyses due to an invalid informed consent form (ICF), 7 subjects did not receive any study vaccine despite being allocated a subject number.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    D-QIV
    Reporting group description
    		 Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).

    Reporting group title
    Control
    Reporting group description
    		 In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).

    Reporting group values
    		 D-QIV Control Total
    Number of subjects
    		 6006 6012
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 21.9 ( 8.0 ) 21.8 ( 8.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2933 2925 5858
        Male
    		 3073 3087 6160
    Race/Ethnicity, Customized
    Units: Subjects
        African Heritage / African American
    		 24 20 44
        Asian - Central/South Asian Heritage
    		 1062 1053 2115
        Asian - East Asian Heritage
    		 2 0 2
        Asian - Japanese Heritage
    		 2 0 2
        Asian - South East Asian Heritage
    		 1661 1666 3327
        Native Hawaiian or Other Pacific Islander
    		 3 0 3
        Other
    		 1639 1642 3281
        White - Arabic / North African Heritage
    		 142 149 291
        White - Caucasian / European Heritage
    		 1471 1482 2953

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    D-QIV
    Reporting group description
    		 Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).

    Reporting group title
    Control
    Reporting group description
    		 In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).

    Primary: Number of subjects with moderate to severe RT-PCR confirmed influenza.

    		 Close Top of page
    End point title
    		 Number of subjects with moderate to severe RT-PCR confirmed influenza.
    End point description
    Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
    End point type
    Primary
    End point timeframe
    During the surveillance period (approximately 6 to 8 months)
    End point values
    		 D-QIV Control
    Number of subjects analysed
    5707
    5697
    Units: Subjects
    90
    242
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The efficacy of the D-QIV vaccine would be demonstrated if the LL of the two-sided 97.5% CI for vaccine efficacy (VE) is above (>) 25%.
    Comparison groups
    D-QIV v Control
    Number of subjects included in analysis
    11404
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Regression, Cox
    Parameter type
    		 Vaccine efficacy (VE)
    Point estimate
    63.2
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 51.8
         upper limit
    		 72.3

    Primary: Number of subjects with RT-PCR confirmed influenza of any severity.

    		 Close Top of page
    End point title
    		 Number of subjects with RT-PCR confirmed influenza of any severity.
    End point description
    Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
    End point type
    Primary
    End point timeframe
    During the surveillance period (approximately 6 to 8 months)
    End point values
    		 D-QIV Control
    Number of subjects analysed
    5707
    5697
    Units: Subjects
    344
    662
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    The efficacy of the D-QIV vaccine would be demonstrated if the LL of the two-sided 97.5% CI for VE is above 15%.
    Comparison groups
    D-QIV v Control
    Number of subjects included in analysis
    11404
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Regression, Cox
    Parameter type
    		 Vaccine efficacy (VE)
    Point estimate
    49.8
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 41.8
         upper limit
    		 56.8

    Secondary: Number of subjects with first occurrence of lower respiratory illness (LRI) with RT-PCR confirmed influenza.

    		 Close Top of page
    End point title
    		 Number of subjects with first occurrence of lower respiratory illness (LRI) with RT-PCR confirmed influenza.
    End point description
    Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
    End point type
    Secondary
    End point timeframe
    At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)
    End point values
    		 D-QIV Control
    Number of subjects analysed
    5707
    5697
    Units: Subjects
    28
    61
    No statistical analyses for this end point

    Secondary: Number of subjects with first occurrence of culture-confirmed moderate to severe influenza A and/or B disease due to antigenically-matching influenza strains.

    		 Close Top of page
    End point title
    		 Number of subjects with first occurrence of culture-confirmed moderate to severe influenza A and/or B disease due to antigenically-matching influenza strains.
    End point description
    Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
    End point type
    Secondary
    End point timeframe
    During the surveillance period (approximately 6 to 8 months)
    End point values
    		 D-QIV Control
    Number of subjects analysed
    5707
    5697
    Units: Subjects
    20
    88
    No statistical analyses for this end point

    Secondary: Number of subjects with first occurrence of culture-confirmed influenza A and/or B disease of any severity due to antigenically-matching influenza strains

    		 Close Top of page
    End point title
    		 Number of subjects with first occurrence of culture-confirmed influenza A and/or B disease of any severity due to antigenically-matching influenza strains
    End point description
    Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
    End point type
    Secondary
    End point timeframe
    During the surveillance period (approximately 6 to 8 months)
    End point values
    		 D-QIV Control
    Number of subjects analysed
    5707
    5697
    Units: Subjects
    88
    216
    No statistical analyses for this end point

    Secondary: Number of subjects with first occurrence of culture-confirmed moderate to severe influenza A and/or B disease due to any seasonal influenza strain.

    		 Close Top of page
    End point title
    		 Number of subjects with first occurrence of culture-confirmed moderate to severe influenza A and/or B disease due to any seasonal influenza strain.
    End point description
    Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
    End point type
    Secondary
    End point timeframe
    During the surveillance period (approximately 6 to 8 months)
    End point values
    		 D-QIV Control
    Number of subjects analysed
    5707
    5697
    Units: Subjects
    79
    216
    No statistical analyses for this end point

    Secondary: Number of subjects with first occurrence of culture-confirmed influenza A and/or B disease of any severity due to any seasonal influenza strain.

    		 Close Top of page
    End point title
    		 Number of subjects with first occurrence of culture-confirmed influenza A and/or B disease of any severity due to any seasonal influenza strain.
    End point description
    Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
    End point type
    Secondary
    End point timeframe
    During the surveillance period (approximately 6 to 8 months)
    End point values
    		 D-QIV Control
    Number of subjects analysed
    5707
    5697
    Units: Subjects
    303
    602
    No statistical analyses for this end point

    Secondary: Number of subjects with first occurrence of acute otitis media (AOM) with RT-PCR confirmed influenza A and/or B infection due to any seasonal influenza strain.

    		 Close Top of page
    End point title
    		 Number of subjects with first occurrence of acute otitis media (AOM) with RT-PCR confirmed influenza A and/or B infection due to any seasonal influenza strain.
    End point description
    Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
    End point type
    Secondary
    End point timeframe
    At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)
    End point values
    		 D-QIV Control
    Number of subjects analysed
    5707
    5697
    Units: Subjects
    12
    28
    No statistical analyses for this end point

    Secondary: Number of subjects with first occurrence of RT-PCR confirmed severe influenza A and/or B due to any seasonal influenza strain.

    		 Close Top of page
    End point title
    		 Number of subjects with first occurrence of RT-PCR confirmed severe influenza A and/or B due to any seasonal influenza strain.
    End point description
    Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
    End point type
    Secondary
    End point timeframe
    During the surveillance period (approximately 6 to 8 months)
    End point values
    		 D-QIV Control
    Number of subjects analysed
    5707
    5697
    Units: Subjects
    2
    3
    No statistical analyses for this end point

    Secondary: Humoral immune response in terms of haemagglutination-inhibition (HI) antibody titres against each of four vaccine strains contained in the D-QIV (in immuno subcohort of subjects only)

    		 Close Top of page
    End point title
    		 Humoral immune response in terms of haemagglutination-inhibition (HI) antibody titres against each of four vaccine strains contained in the D-QIV (in immuno subcohort of subjects only)
    End point description
    Titers were expressed as geometric mean antibody titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects
    End point type
    Secondary
    End point timeframe
    At Days 0 and 28/56
    End point values
    		 D-QIV Control
    Number of subjects analysed
    753
    579
    Units: Titers
    geometric mean (confidence interval 95%)
        H1N1, PRE [N=744, 567]
    11.9 (10.6 to 13.2)
    11.9 (10.5 to 13.5)
        H1N1, POST [N=752, 578]
    165.3 (148.6 to 183.8)
    12.6 (11.1 to 14.3)
        H3N2, PRE [N=746,568]
    14.8 (13.2 to 16.5)
    13.4 (11.8 to 15.2)
        H3N2, POST [N=753,578]
    132.1 (119.1 to 146.5)
    14.7 (12.9 to 16.7)
        Victoria, PRE [N=745,567]
    10.0 (9.1 to 11.0)
    9.2 (8.3 to 10.1)
        Victoria, POST [N=750,579]
    92.6 (82.3 to 104.1)
    9.2 (8.4 to 10.1)
        Yamagata, PRE [N=745,568]
    7.3 (6.8 to 7.8)
    7.3 (6.8 to 7.9)
        Yamagata, POST [N=753,579]
    121.4 (110.1 to 133.8)
    7.6 (7.0 to 8.3)
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for HI antibodies against each of the 4 influenza strains contained in the D-QIV vaccine (in immuno subcohort of subjects only)

    		 Close Top of page
    End point title
    		 Number of seropositive subjects for HI antibodies against each of the 4 influenza strains contained in the D-QIV vaccine (in immuno subcohort of subjects only)
    End point description
    A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Day 28/56
    End point values
    		 D-QIV Control
    Number of subjects analysed
    753
    579
    Units: Subjects
        H1N1, PRE
    200
    152
        H1N1, POST
    728
    170
        H3N2, PRE
    266
    187
        H3N2, POST
    740
    210
        Victoria, PRE
    205
    138
        Victoria, POST
    701
    147
        Yamagata, PRE
    134
    93
        Yamagata, POST
    719
    108
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for HI antibodies against each of the 4 influenza strains contained in the D-QIV vaccine (in immuno subcohort of subjects only)

    		 Close Top of page
    End point title
    		 Number of seroconverted subjects for HI antibodies against each of the 4 influenza strains contained in the D-QIV vaccine (in immuno subcohort of subjects only)
    End point description
    Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4 fold increase in post vaccination reciprocal titer against the vaccine virus. PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects
    End point type
    Secondary
    End point timeframe
    At Day 28/56 (POST)
    End point values
    		 D-QIV Control
    Number of subjects analysed
    746
    568
    Units: Subjects
        H1N1
    596
    20
        H3N2
    513
    24
        Victoria
    514
    5
        Yamagata
    605
    13
    No statistical analyses for this end point

    Secondary: Mean geometric increase (MGI) for HI antibody titer against each of the 4 vaccine influenza strains contained in the D-QIV vaccine (in immuno subcohort of subjects only).

    		 Close Top of page
    End point title
    		 Mean geometric increase (MGI) for HI antibody titer against each of the 4 vaccine influenza strains contained in the D-QIV vaccine (in immuno subcohort of subjects only).
    End point description
    MGI also known as the seroconversion factor [SCF] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects.
    End point type
    Secondary
    End point timeframe
    At Day 28/56 (POST)
    End point values
    		 D-QIV Control
    Number of subjects analysed
    746
    568
    Units: Fold change
    geometric mean (confidence interval 95%)
        H1N1
    14 (12.8 to 15.3)
    1.1 (1.0 to 1.1)
        H3N2
    9.0 (8.2 to 9.8)
    1.1 (1.0 to 1.2)
        Victoria
    9.3 (8.6 to 10.2)
    1.0 (1.0 to 1.1)
        Yamagata
    16.7 (15.2 to 18.3)
    1.1 (1.0 to 1.1)
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects for HI antibodies against each of the 4 influenza strains contained in the D-QIV vaccine (in immuno subcohort of subjects only)

    		 Close Top of page
    End point title
    		 Number of seroprotected subjects for HI antibodies against each of the 4 influenza strains contained in the D-QIV vaccine (in immuno subcohort of subjects only)
    End point description
    Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects
    End point type
    Secondary
    End point timeframe
    At Day 0 and Day 28/56
    End point values
    		 D-QIV Control
    Number of subjects analysed
    753
    579
    Units: Subjects
        H1N1, PRE
    182
    134
        H1N1, POST
    640
    146
        H3N2, PRE
    238
    159
        H3N2, POST
    612
    175
        Victoria, PRE
    143
    103
        Victoria, POST
    539
    101
        Yamagata, PRE
    73
    59
        Yamagata, POST
    638
    64
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects reporting any and grade 3 solicited local symptoms.
    End point description
    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that resulted crying when limb was moved/ spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. >50mm.
    End point type
    Secondary
    End point timeframe
    During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)
    End point values
    		 D-QIV Control
    Number of subjects analysed
    5907
    5901
    Units: Subjects
        Any Pain, Dose 1 [N=5899, 5896]
    1015
    1047
        Grade 3 Pain, Dose 1 [N=5899, 5896]
    23
    30
        Any Redness, Dose 1 [N=5899, 5896]
    775
    831
        Grade 3 Redness, Pain, Dose 1 [N=5899, 5896]
    1
    0
        Any Swelling, Dose 1 [N=5899, 5896]
    467
    518
        Grade 3 Swelling, Dose 1 [N=5899, 5896]
    0
    0
        Any Pain, Dose 2 [N=5757, 5766]
    808
    820
        Grade 3 Pain, Dose 2 [N=5757, 5766]
    21
    21
        Any Redness, Dose 2 [N=5757, 5766]
    587
    631
        Grade 3 Redness, Dose 2 [N=5757, 5766]
    2
    0
        Any Swelling, Dose 2 [N=5757, 5766]
    375
    409
        Grade 3 Swelling, Dose 2 [N=5757, 5766]
    2
    3
        Any Pain, Across doses [N=5907,5901]
    1350
    1375
        Grade 3 Pain, Across doses [N=5907,5901]
    42
    48
        Any Redness, Across doses [N=5907,5901]
    980
    1091
        Grade 3 Redness, Across doses [N=5907,5901]
    3
    0
        Any Swelling, Across doses [N=5907,5901]
    665
    742
        Grade 3 Swelling, Across doses [N=5907,5901]
    2
    3
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects reporting any, grade 3 and related solicited general symptoms.
    End point description
    Solicited general symptoms assessed were Drowsiness, Irritability/fussiness, Loss of appetite and Temperature (Axillary). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)
    End point values
    		 D-QIV Control
    Number of subjects analysed
    5908
    5901
    Units: Subjects
        Any Drowsiness, Dose 1 [N=5898, 5896]
    739
    829
        Grade 3 Drowsiness, Dose 1 [N=5898, 5896]
    39
    52
        Related Drowsiness, Dose 1 [N=5898, 5896]
    490
    535
        Any Irritability, Dose 1 [N=5898, 5896]
    955
    1029
        Grade 3 Irritability, Dose 1 [N=5898, 5896]
    42
    62
        Related Irritability, Dose 1 [N=5898, 5896]
    617
    669
        Any Loss of appetite, Dose 1 [N=5898, 5896]
    847
    872
        Grade 3 Loss of appetite, Dose 1 [N=5898, 5896]
    68
    60
        Related Loss of appetite, Dose 1 [N=5898, 5896]
    541
    523
        Any Fever, Dose 1 [N=5898, 5896]
    372
    425
        Grade 3 Fever, Dose 1 [N=5898, 5896]
    78
    76
        Related Fever, Dose 1 [N=5898, 5896]
    243
    287
        Any Drowsiness, Dose 2 [N=5755, 5762]
    519
    558
        Grade 3 Drowsiness, Dose 2 [N=5755, 5762]
    25
    24
        Related Drowsiness, Dose 2 [N=5755, 5762]
    324
    361
        Any Irritability, Dose 2 [N=5755, 5762]
    777
    777
        Grade 3 Irritability, Dose 2 [N=5755, 5762]
    36
    52
        Related Irritability, Dose 2 [N=5755, 5762]
    488
    495
        Any Loss of appetite, Dose 2 [N=5755, 5762]
    652
    681
        Grade 3 Loss of appetite, Dose 2 [N=5755, 5762]
    47
    44
        Related Loss of appetite, Dose 2 [N=5755, 5762]
    378
    413
        Any Fever, Dose 2 [N=5755, 5762]
    336
    363
        Grade 3 Fever, Dose 2 [N=5755, 5762]
    65
    70
        Related Fever, Dose 2 [N=5755, 5762]
    195
    215
        Any Drowsiness, Across Doses [N=5908, 5901]
    1024
    1129
        Grade 3 Drowsiness, Across Doses [N=5908, 5901]
    61
    73
        Related Drowsiness, Across Doses [N=5908, 5901]
    673
    738
        Any Irritability, Across Doses [N=5908, 5901]
    1383
    1427
        Grade 3 Irritability, Across Doses [N=5908, 5901]
    77
    107
        Related Irritability, Across Doses [N=5908, 5901]
    905
    940
        Any Loss of appetite, Across Doses [N=5908, 5901]
    1227
    1288
        Grade3 Loss of appetite,Across Doses[N=5908, 5901]
    111
    97
        Related Loss of appetite,AcrossDoses[N=5908, 5901]
    774
    809
        Any Fever, Across Doses [N=5908, 5901]
    659
    732
        Grade 3 Fever, Across Doses [N=5908, 5901]
    137
    141
        Related Fever, Across Doses [N=5908, 5901]
    413
    476
    No statistical analyses for this end point

    Secondary: Duration of solicited local symptoms

    		 Close Top of page
    End point title
    		 Duration of solicited local symptoms
    End point description
    Duration was defined as number of days with any grade of local symptoms.
    End point type
    Secondary
    End point timeframe
    During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)
    End point values
    		 D-QIV Control
    Number of subjects analysed
    1015
    1047
    Units: Days
    median (full range (min-max))
        Pain, Dose 1 [N=1015,1047]
    1.0 (1.0 to 2.0)
    1.0 (1.0 to 2.0)
        Pain, Dose 2 [N=808,820]
    1.0 (1.0 to 2.0)
    1.0 (1.0 to 2.0)
        Redness, Dose 1 [N=775,831]
    2.0 (1.0 to 3.0)
    2.0 (1.0 to 3.0)
        Redness, Dose 2 [N=587,631]
    2.0 (1.0 to 3.0)
    2.0 (1.0 to 3.0)
        Swelling, Dose 1 [N=467,518]
    2.0 (1.0 to 3.0)
    2.0 (1.0 to 3.0)
        Swelling, Dose 2 [N=375,409]
    1.0 (1.0 to 2.0)
    2.0 (1.0 to 2.0)
    No statistical analyses for this end point

    Secondary: Duration of solicited general symptoms

    		 Close Top of page
    End point title
    		 Duration of solicited general symptoms
    End point description
    Duration was defined as number of days with any grade of general symptoms.
    End point type
    Secondary
    End point timeframe
    During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)
    End point values
    		 D-QIV Control
    Number of subjects analysed
    955
    1029
    Units: Days
    median (full range (min-max))
        Drowsiness, Dose 1 [N=739,829]
    2.0 (1.0 to 3.0)
    2.0 (1.0 to 3.0)
        Drowsiness, Dose 2 [N=519,558]
    2.0 (1.0 to 3.0)
    2.0 (1.0 to 3.0)
        Irritability, Dose 1 [N=955,1029]
    2.0 (1.0 to 3.0)
    2.0 (1.0 to 3.0)
        Irritability, Dose 2 [N=777,777]
    2.0 (1.0 to 3.0)
    2.0 (1.0 to 3.0)
        Loss of appetite, Dose 1 [N=847,872]
    2.0 (1.0 to 4.0)
    2.0 (1.0 to 4.0)
        Loss of appetite, Dose 2 [N=652,681]
    3.0 (2.0 to 4.0)
    2.0 (1.0 to 4.0)
        Fever, Dose 1 [N=390,438]
    1.0 (1.0 to 2.0)
    1.0 (1.0 to 2.0)
        Fever, Dose 2 [N=347,372]
    2.0 (1.0 to 3.0)
    1.0 (1.0 to 3.0)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related unsolicited adverse events (AEs)

    		 Close Top of page
    End point title
    		 Number of subjects reporting any, grade 3 and related unsolicited adverse events (AEs)
    End point description
    Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 28-day (Days 0-27) post-vaccination period
    End point values
    		 D-QIV Control
    Number of subjects analysed
    6006
    6012
    Units: Subjects
        Any unsolicited AEs
    2640
    2679
        Grade 3 unsolicited AEs
    160
    149
        Related unsolicited AEs
    106
    116
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related AEs with medically attended visits (MAVs)

    		 Close Top of page
    End point title
    		 Number of subjects reporting any, grade 3 and related AEs with medically attended visits (MAVs)
    End point description
    MAVs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was defined as MAVs that prevented normal activities and related was defined as MAVs assessed by the investigator to be causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    During the entire study period (approximately 6- 8 months per subject)
    End point values
    		 D-QIV Control
    Number of subjects analysed
    6006
    6012
    Units: Subjects
        Any MAVs
    3885
    3988
        Grade 3 MAVs
    200
    211
        Related MAVs
    57
    58
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related potential immune-mediated diseases (pIMDs).

    		 Close Top of page
    End point title
    		 Number of subjects reporting any, grade 3 and related potential immune-mediated diseases (pIMDs).
    End point description
    pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = pIMDs that prevented normal activities. Related = symptom assed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    During the entire study period (approximately 6- 8 months per subject)
    End point values
    		 D-QIV Control
    Number of subjects analysed
    6006
    6012
    Units: Subjects
        Any pIMDs
    5
    0
        Grade 3 pIMDs
    3
    0
        Related pIMDs
    3
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and related serious adverse events (SAEs).

    		 Close Top of page
    End point title
    		 Number of subjects reporting any and related serious adverse events (SAEs).
    End point description
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    During the entire study period (approximately 6- 8 months per subject)
    End point values
    		 D-QIV Control
    Number of subjects analysed
    6006
    6012
    Units: Subjects
        Any SAEs
    217
    201
        Related SAEs
    6
    2
        Fatal SAEs
    1
    3
        Related fatal SAEs
    0
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms were assessed during the 7-day post-vaccination period; unsolicited AEs were assessed during the 28-day post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    D-QIV
    Reporting group description
    		 Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).

    Reporting group title
    Control
    Reporting group description
    		 In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).

    Serious adverse events
    		 D-QIV Control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    217 / 6006 (3.61%)
    201 / 6012 (3.34%)
         number of deaths (all causes)
    1
    3
         number of deaths resulting from adverse events
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Drowning
         subjects affected / exposed
    1 / 6006 (0.02%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Oedema peripheral
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    4 / 6006 (0.07%)
    4 / 6012 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    2 / 6006 (0.03%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular pain
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal hypertrophy
         subjects affected / exposed
    1 / 6006 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Apnoea
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    6 / 6006 (0.10%)
    8 / 6012 (0.13%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthmatic crisis
         subjects affected / exposed
    5 / 6006 (0.08%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    3 / 6006 (0.05%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial obstruction
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    4 / 6006 (0.07%)
    10 / 6012 (0.17%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 6006 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonitis
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wheezing
         subjects affected / exposed
    3 / 6006 (0.05%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood electrolytes abnormal
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental exposure to product
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental poisoning
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    2 / 6006 (0.03%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    1 / 6006 (0.02%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chemical poisoning
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    2 / 6006 (0.03%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body
         subjects affected / exposed
    0 / 6006 (0.00%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body aspiration
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 6006 (0.02%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Near drowning
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    2 / 6006 (0.03%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Phimosis
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Facial paralysis
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    13 / 6006 (0.22%)
    16 / 6012 (0.27%)
         occurrences causally related to treatment / all
    2 / 14
    1 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    3 / 6006 (0.05%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure anoxic
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (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
    Anaemia
         subjects affected / exposed
    2 / 6006 (0.03%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypochromic anaemia
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoplastic anaemia
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune thrombocytopenic purpura
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Aphthous ulcer
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    8 / 6006 (0.13%)
    9 / 6012 (0.15%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    2 / 6006 (0.03%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    3 / 6006 (0.05%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 6006 (0.05%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 6006 (0.00%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Cystitis haemorrhagic
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess
         subjects affected / exposed
    2 / 6006 (0.03%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acarodermatitis
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amoebiasis
         subjects affected / exposed
    3 / 6006 (0.05%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amoebic dysentery
         subjects affected / exposed
    8 / 6006 (0.13%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascariasis
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    1 / 6006 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial pyelonephritis
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    7 / 6006 (0.12%)
    6 / 6012 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bronchitis
         subjects affected / exposed
    11 / 6006 (0.18%)
    9 / 6012 (0.15%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest wall abscess
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chikungunya virus infection
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholera
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctivitis
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    1 / 6006 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    2 / 6006 (0.03%)
    10 / 6012 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysentery
         subjects affected / exposed
    0 / 6006 (0.00%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterovirus infection
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia pyelonephritis
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    27 / 6006 (0.45%)
    19 / 6012 (0.32%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    2 / 6006 (0.03%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    5 / 6006 (0.08%)
    8 / 6012 (0.13%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis shigella
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    4 / 6006 (0.07%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    1 / 6006 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis a
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    2 / 6006 (0.03%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 6006 (0.00%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    4 / 6006 (0.07%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    6 / 6006 (0.10%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mycoplasma infection
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    2 / 6006 (0.03%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    4 / 6006 (0.07%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    1 / 6006 (0.02%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parasitic gastroenteritis
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    3 / 6006 (0.05%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    2 / 6006 (0.03%)
    5 / 6012 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    56 / 6006 (0.93%)
    66 / 6012 (1.10%)
         occurrences causally related to treatment / all
    0 / 60
    0 / 71
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia bacterial
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia measles
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    1 / 6006 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    2 / 6006 (0.03%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 6006 (0.00%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotavirus infection
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    2 / 6006 (0.03%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Typhoid fever
         subjects affected / exposed
    1 / 6006 (0.02%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 6006 (0.07%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    4 / 6006 (0.07%)
    4 / 6012 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 6006 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral rash
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral rhinitis
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral sepsis
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 6006 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    8 / 6006 (0.13%)
    7 / 6012 (0.12%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    2 / 6006 (0.03%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polydipsia
         subjects affected / exposed
    1 / 6006 (0.02%)
    0 / 6012 (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
    		 D-QIV Control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3427 / 6006 (57.06%)
    3501 / 6012 (58.23%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    1025 / 6006 (17.07%)
    1129 / 6012 (18.78%)
         occurrences all number
    1259
    1388
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    1351 / 6006 (22.49%)
    1376 / 6012 (22.89%)
         occurrences all number
    1824
    1868
    Pyrexia
         subjects affected / exposed
    866 / 6006 (14.42%)
    949 / 6012 (15.79%)
         occurrences all number
    954
    1042
    Swelling
         subjects affected / exposed
    665 / 6006 (11.07%)
    743 / 6012 (12.36%)
         occurrences all number
    842
    928
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    983 / 6006 (16.37%)
    1094 / 6012 (18.20%)
         occurrences all number
    1365
    1467
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    1385 / 6006 (23.06%)
    1428 / 6012 (23.75%)
         occurrences all number
    1734
    1808
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    871 / 6006 (14.50%)
    943 / 6012 (15.69%)
         occurrences all number
    1050
    1111
    Upper respiratory tract infection
         subjects affected / exposed
    522 / 6006 (8.69%)
    516 / 6012 (8.58%)
         occurrences all number
    629
    609
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1230 / 6006 (20.48%)
    1293 / 6012 (21.51%)
         occurrences all number
    1504
    1561

    More information

    		 Close Top of page

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu Apr 25 01:08:18 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA