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   43862   clinical trials with a EudraCT protocol, of which   7285   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, Randomized, Observer-blind, Multi-center, Noninferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Trivalent Inactivated Split-Virion Influenza Vaccine in a Pediatric Population Aged Greater Than or Equal to 6 Months to Less Than 18 Years.

    Summary
    EudraCT number
    		 2014-003768-19
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    03 May 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jun 2016
    First version publication date
    30 Jul 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CSLCT-USF-07-36
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00959049
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CSL Limited
    Sponsor organisation address
    45 Poplar Road, Parkville, Australia, VIC 3052
    Public contact
    Clinical Program Director, bioCSL, bioCSL PTY LTD, biocsl.clinicaltrials@biocsl.com.au
    Scientific contact
    Clinical Program Director, bioCSL, bioCSL PTY LTD, biocsl.clinicaltrials@biocsl.com.au
    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
    28 May 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that vaccination with CSL Limited’s Influenza Virus Vaccine (CSL’s IVV) elicits an immune response that is not inferior to that of a US licensed inactivated split-virion influenza vaccine (Fluzone®) in a pediatric population aged 6 months to less than 18 years.
    Protection of trial subjects
    This study was conducted in accordance with standards of Good Clinical Practice, as defined by the International Conference on Harmonisation, the principles outlined in the Declaration of Helsinki and all applicable federal and local regulations.
    Background therapy
    		 None
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Sep 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 1474
    Worldwide total number of subjects
    1474
    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)
    230
    Children (2-11 years)
    945
    Adolescents (12-17 years)
    299
    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
    		 This prospective, randomized, observer-blind, multi-center, non-inferiority study was conducted in 1474 healthy children aged 6 months to less than 18 years at 23 sites in the US, during the Northern Hemisphere’s 2009 autumn.

    Pre-assignment
    Screening details
    		 Healthy children were eligible for enrollment if they were aged 6 months to less than 18 years and were born at or after 36 weeks gestation (this criterion applied only to participants aged younger than 9 years) or returned a negative pregnancy test (this criterion applied only to female participants aged 9 years or older).

    Period 1
    Period 1 title
    On-study period (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
    The following study personnel were unblinded to treatment allocation: • Investigational site staff involved in preparation and administration of the study vaccine; • CRO personnel responsible for study vaccine preparation and management; and • CRO personnel involved in the generation of the randomization code.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Afluria Cohort A
    Arm description
    		 Age 6 months to < 3 years
    Arm type
    		 Experimental

    Investigational medicinal product name
    CSL's Influenza Virus Vaccine (Afluria)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.25 mL (one or two doses) by intramuscular injection as directed by immunization guidelines

    Arm title
    		 Afluria Cohort B
    Arm description
    		 Age 3 to < 9 years
    Arm type
    		 Experimental

    Investigational medicinal product name
    CSL's Influenza Virus Vaccine (Afluria)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines

    Arm title
    		 Afluria Cohort C
    Arm description
    		 Age 9 to < 18 years
    Arm type
    		 Experimental

    Investigational medicinal product name
    CSL's Influenza Virus Vaccine (Afluria)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    one 0.5 mL dose by intramuscular injection

    Arm title
    		 Fluzone Cohort A
    Arm description
    		 Age 6 months to < 3 years
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Comparator US-Licensed Trivalent Influenza Vaccine (Fluzone)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.25 mL (one or two doses) by intramuscular injection as directed by immunization guidelines

    Arm title
    		 Fluzone Cohort B
    Arm description
    		 Age 3 to < 9 years
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Comparator US-Licensed Trivalent Influenza Vaccine (Fluzone)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines

    Arm title
    		 Fluzone Cohort C
    Arm description
    		 Age 9 to < 18 years
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Comparator US-Licensed Trivalent Influenza Vaccine (Fluzone)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL dose by intramuscular injection

    Number of subjects in period 1
    		Afluria Cohort A Afluria Cohort B Afluria Cohort C Fluzone Cohort A Fluzone Cohort B Fluzone Cohort C
    Started
    231
    254
    254
    228
    257
    250
    Completed
    213
    247
    253
    217
    248
    249
    Not completed
    18
    7
    1
    11
    9
    1
         Adverse event, non-fatal
    1
    -
    -
    -
    -
    -
         Lost to follow-up
    17
    5
    1
    10
    9
    1
         Contraindicated medication
    -
    -
    -
    1
    -
    -
         Withdrawal by subject
    -
    2
    -
    -
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Afluria Cohort A
    Reporting group description
    		 Age 6 months to < 3 years

    Reporting group title
    Afluria Cohort B
    Reporting group description
    		 Age 3 to < 9 years

    Reporting group title
    Afluria Cohort C
    Reporting group description
    		 Age 9 to < 18 years

    Reporting group title
    Fluzone Cohort A
    Reporting group description
    		 Age 6 months to < 3 years

    Reporting group title
    Fluzone Cohort B
    Reporting group description
    		 Age 3 to < 9 years

    Reporting group title
    Fluzone Cohort C
    Reporting group description
    		 Age 9 to < 18 years

    Reporting group values
    		 Afluria Cohort A Afluria Cohort B Afluria Cohort C Fluzone Cohort A Fluzone Cohort B Fluzone Cohort C Total
    Number of subjects
    		 231 254 254 228 257 250 1474
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 118 0 0 112 0 0 230
        Children (2-11 years)
    		 113 254 96 116 257 109 945
        Adolescents (12-17 years)
    		 0 0 158 0 0 141 299
        Adults (18-64 years)
    		 0 0 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 1.94 ± 0.667 5.93 ± 1.725 12.98 ± 2.388 1.96 ± 0.673 5.82 ± 1.748 12.86 ± 2.474 -
    Gender categorical
    Units: Subjects
        Female
    		 119 140 121 101 127 120 728
        Male
    		 112 114 133 127 130 130 746

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Afluria Cohort A
    Reporting group description
    		 Age 6 months to < 3 years

    Reporting group title
    Afluria Cohort B
    Reporting group description
    		 Age 3 to < 9 years

    Reporting group title
    Afluria Cohort C
    Reporting group description
    		 Age 9 to < 18 years

    Reporting group title
    Fluzone Cohort A
    Reporting group description
    		 Age 6 months to < 3 years

    Reporting group title
    Fluzone Cohort B
    Reporting group description
    		 Age 3 to < 9 years

    Reporting group title
    Fluzone Cohort C
    Reporting group description
    		 Age 9 to < 18 years

    Primary: Geometric Mean Titer 30 Days After the Last Study Vaccination

    		 Close Top of page
    End point title
    		 Geometric Mean Titer 30 Days After the Last Study Vaccination
    End point description
    End point type
    Primary
    End point timeframe
    Geometric Mean Titer 30 Days After the Last Study Vaccination
    End point values
    		 Afluria Cohort A Afluria Cohort B Afluria Cohort C Fluzone Cohort A Fluzone Cohort B Fluzone Cohort C
    Number of subjects analysed
    195
    229
    230
    201
    236
    233
    Units: Titers
    geometric mean (confidence interval 95%)
        H1N1 (A/Brisbane/59/2007)
    235.44 (199.6 to 277.61)
    345.5 (295.54 to 403.29)
    652.99 (566.91 to 752.14)
    227.19 (188.39 to 273.98)
    351.88 (303.29 to 408.25)
    652.17 (569.59 to 746.73)
        H3N2 ( A/Uruguay/716/2007)
    309.19 (253.49 to 377.13)
    909.22 (772.67 to 1069.9)
    948.86 (824.88 to 1091.46)
    340.49 (283.98 to 408.25)
    870.34 (751.62 to 1007.8)
    1069.7 (934.77 to 1224.11)
        B (B/Brisbane/60/2008)
    73.46 (59.32 to 90.97)
    122.71 (102.55 to 146.83)
    107.92 (71.77 to 126.91)
    57.92 (46.92 to 71.49)
    104.91 (88.67 to 123.42)
    126.99 (107.53 to 149.97)
    Statistical analysis title
    		 Non-inferiority - H1N1 Strain
    Statistical analysis description
    The non-inferiority of CSL’s IVV compared with Fluzone was assessed by the co-primary endpoint of geometric mean titer (GMT) for each strain contained within the vaccines as follows: • The GMT ratio for the H1N1 strain; • The GMT ratio for the H3N2 strain; • The GMT ratio for the B strain
    Comparison groups
    Afluria Cohort A v Fluzone Cohort A v Afluria Cohort B v Afluria Cohort C v Fluzone Cohort B v Fluzone Cohort C
    Number of subjects included in analysis
    1324
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 ratio of GMTs (H1N1 strain)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.04
    Notes
    [1] - CSL’s IVV was considered to be non-inferior to Fluzone if, for each strain: • The upper bound of the two-sided 95% confidence interval (CI) on the ratio of the GMTs did not exceed 1.5-fold. o The GMT ratio was calculated by using the geometric mean fold increase (GMFI): GMFI Fluzone® / GMFI CSL’s IVV where GMFI = GMT post-vaccination / GMT pre-vaccination
    Statistical analysis title
    		 Non-inferiority - H3N2 Strain
    Statistical analysis description
    The non-inferiority of CSL’s IVV compared with Fluzone was assessed by the co-primary endpoint of geometric mean titer (GMT) for each strain contained within the vaccines as follows: • The GMT ratio for the H1N1 strain; • The GMT ratio for the H3N2 strain; • The GMT ratio for the B strain
    Comparison groups
    Afluria Cohort A v Fluzone Cohort A v Afluria Cohort B v Afluria Cohort C v Fluzone Cohort B v Fluzone Cohort C
    Number of subjects included in analysis
    1324
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 ratio of GMTs
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.23
    Notes
    [2] - CSL’s IVV was considered to be non-inferior to Fluzone if, for each strain: • The upper bound of the two-sided 95% confidence interval (CI) on the ratio of the GMTs did not exceed 1.5-fold. o The GMT ratio was calculated by using the geometric mean fold increase (GMFI): GMFI Fluzone® / GMFI CSL’s IVV where GMFI = GMT post-vaccination / GMT pre-vaccination
    Statistical analysis title
    		 Non-inferiority - B Strain
    Statistical analysis description
    The non-inferiority of CSL’s IVV compared with Fluzone was assessed by the co-primary endpoint of geometric mean titer (GMT) for each strain contained within the vaccines as follows: • The GMT ratio for the H1N1 strain; • The GMT ratio for the H3N2 strain; • The GMT ratio for the B strain
    Comparison groups
    Afluria Cohort A v Fluzone Cohort A v Afluria Cohort B v Afluria Cohort C v Fluzone Cohort B v Fluzone Cohort C
    Number of subjects included in analysis
    1324
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 ratio of GMTs
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.07
    Notes
    [3] - CSL’s IVV was considered to be non-inferior to Fluzone if, for each strain: • The upper bound of the two-sided 95% confidence interval (CI) on the ratio of the GMTs did not exceed 1.5-fold. o The GMT ratio was calculated by using the geometric mean fold increase (GMFI): GMFI Fluzone® / GMFI CSL’s IVV where GMFI = GMT post-vaccination / GMT pre-vaccination

    Primary: Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination

    		 Close Top of page
    End point title
    		 Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination
    End point description
    Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.
    End point type
    Primary
    End point timeframe
    30 days after the last study vaccination
    End point values
    		 Afluria Cohort A Afluria Cohort B Afluria Cohort C Fluzone Cohort A Fluzone Cohort B Fluzone Cohort C
    Number of subjects analysed
    195
    229
    230
    201
    236
    233
    Units: percentage of participants
    number (confidence interval 95%)
        H1N1 (A/Brisbane/59/2007)
    84 (78 to 89)
    66 (59 to 72)
    64 (57 to 70)
    74 (67 to 80)
    64 (58 to 70)
    61 (55 to 68)
        H3N2 ( A/Uruguay/716/2007)
    83 (77 to 88)
    71 (65 to 77)
    72 (66 to 78)
    85 (79 to 90)
    74 (68 to 80)
    73 (66 to 78)
        B (B/Brisbane/60/2008)
    67 (60 to 73)
    73 (67 to 79)
    67 (31 to 73)
    61 (54 to 68)
    76 (70 to 82)
    73 (67 to 79)
    Statistical analysis title
    		 Non-inferiority - H1N1 Strain
    Statistical analysis description
    Non-inferiority of CSL’s IVV compared with Fluzone was assessed by the co-primary endpoint of seroconversion rate for each strain contained within the vaccines as follows: • The difference between the seroconversion rates for the H1N1 strain; • The difference between the seroconversion rates for the H3N2 strain; • The difference between the seroconversion rates for the B strain
    Comparison groups
    Fluzone Cohort A v Afluria Cohort B v Afluria Cohort A v Afluria Cohort C v Fluzone Cohort B v Fluzone Cohort C
    Number of subjects included in analysis
    1324
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Difference in seroconversion rates
    Point estimate
    -4.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.1
         upper limit
    		 -0.9
    Notes
    [4] - CSL’s IVV was considered to be non-inferior to Fluzone if, for each strain: The upper bound of the two-sided 95% CI on the difference between the seroconversion rates did not exceed 10 percentage points. The difference in seroconversion rates was calculated by: Seroconversion Fluzone – Seroconversion CSL’s IVV.
    Statistical analysis title
    		 Non-inferiority - H3N2 Strain
    Statistical analysis description
    Non-inferiority of CSL’s IVV compared with Fluzone was assessed by the co-primary endpoint of seroconversion rate for each strain contained within the vaccines as follows: • The difference between the seroconversion rates for the H1N1 strain; • The difference between the seroconversion rates for the H3N2 strain; • The difference between the seroconversion rates for the B strain
    Comparison groups
    Afluria Cohort A v Fluzone Cohort A v Afluria Cohort B v Afluria Cohort C v Fluzone Cohort B v Fluzone Cohort C
    Number of subjects included in analysis
    1324
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 Difference in seroconversion rates
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.7
         upper limit
    		 6.5
    Notes
    [5] - CSL’s IVV was considered to be non-inferior to Fluzone if, for each strain: The upper bound of the two-sided 95% CI on the difference between the seroconversion rates did not exceed 10 percentage points. The difference in seroconversion rates was calculated by: Seroconversion Fluzone – Seroconversion CSL’s IVV.
    Statistical analysis title
    		 Non-inferiority - B Strain
    Statistical analysis description
    Non-inferiority of CSL’s IVV compared with Fluzone was assessed by the co-primary endpoint of seroconversion rate for each strain contained within the vaccines as follows: • The difference between the seroconversion rates for the H1N1 strain; • The difference between the seroconversion rates for the H3N2 strain; • The difference between the seroconversion rates for the B strain
    Comparison groups
    Afluria Cohort A v Fluzone Cohort A v Afluria Cohort B v Afluria Cohort C v Fluzone Cohort B v Fluzone Cohort C
    Number of subjects included in analysis
    1324
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 Difference in seroconversion rates
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 6.3
    Notes
    [6] - CSL’s IVV was considered to be non-inferior to Fluzone if, for each strain: The upper bound of the two-sided 95% CI on the difference between the seroconversion rates did not exceed 10 percentage points. The difference in seroconversion rates was calculated by: Seroconversion Fluzone – Seroconversion CSL’s IVV.

    Secondary: Frequency and Intensity of Local and Systemic Solicited Symptoms after Any Vaccination

    		 Close Top of page
    End point title
    		 Frequency and Intensity of Local and Systemic Solicited Symptoms after Any Vaccination
    End point description
    Note that the systemic solicited symptoms of loss of appetite and irritability were collected for Afluria cohort A and Fluzone Cohort A only, and malaise, headache and myalgia were not collected for these two cohorts. Afluria Cohort C and Fluzone Cohort C received one dose only. Abbreviations: pd1= post-dose 1, pd2=post-dose 2.
    End point type
    Secondary
    End point timeframe
    7 days after each vaccination
    End point values
    		 Afluria Cohort A Afluria Cohort B Afluria Cohort C Fluzone Cohort A Fluzone Cohort B Fluzone Cohort C
    Number of subjects analysed
    229
    252
    254 [7]
    228
    255
    250
    Units: Number of participants
        Any local solicited symptom post-dose 1
    116
    164
    174
    100
    152
    169
        Any pain post-dose 1
    98
    149
    167
    78
    131
    151
        Grade 3 pain post-dose 1
    1
    1
    1
    0
    4
    4
        Any redness (> 0 mm) post-dose 1
    53
    59
    43
    53
    60
    43
        Grade 3 redness (> 30 mm) post-dose 1
    0
    7
    1
    1
    4
    3
        Any swelling (> 0 mm) post-dose 1
    30
    36
    39
    26
    43
    41
        Grade 3 swelling (> 30 mm) post-dose 1
    1
    6
    4
    0
    2
    7
        Any local solicited symptom post-dose 2
    30
    24
    0
    32
    26
    0
        Any pain post-dose 2
    28
    23
    0
    22
    23
    0
        Grade 3 pain post-dose 2
    0
    0
    0
    0
    0
    0
        Any redness (> 0 mm) post-dose 2
    15
    5
    0
    22
    13
    0
        Grade 3 redness (> 30 mm) post-dose 2
    1
    0
    0
    0
    0
    0
        Any swelling (> 0 mm) post-dose 2
    9
    4
    0
    7
    11
    0
        Grade 3 swelling (> 30 mm) post-dose 2
    0
    0
    0
    0
    0
    0
        Any systemic solicited symptom post-dose 1
    171
    140
    144
    121
    113
    126
        Any fever (≥ 99.5°F ax or ≥ 100.4°F oral) post-dos
    85
    55
    16
    31
    24
    10
        Grade 3 fever (> 103.1°F ax or > 104.0°F oral) pos
    6
    3
    2
    0
    1
    0
        Any nausea/vomiting post-dose 1
    27
    33
    23
    17
    20
    24
        Grade 3 nausea/vomiting (prevented activities) pos
    6
    2
    3
    1
    1
    3
        Any diarrhea post-dose 1
    61
    17
    20
    54
    24
    25
        Grade 3 diarrhea (prevented activities) postdose1
    4
    0
    1
    3
    0
    0
        Any loss of appetite post-dose 1
    73
    0
    0
    45
    0
    0
        Grade 3 loss of appetite (prevented activities) p1
    3
    0
    0
    1
    0
    0
        Any irritability post-dose 1
    134
    0
    0
    85
    0
    0
        Grade 3 irritability (prevented activities) pd1
    10
    0
    0
    5
    0
    0
        Any malaise post-dose 1
    0
    72
    55
    0
    34
    51
        Grade 3 malaise (prevented activities) pd1
    0
    9
    10
    0
    1
    3
        Any headache post-dose 1
    0
    54
    69
    0
    41
    66
        Grade 3 headache (prevented activities) pd1
    0
    5
    7
    0
    0
    3
        Any myalgia post-dose 1
    0
    82
    101
    0
    63
    93
        Grade 3 myalgia (prevented activities) pd1
    0
    1
    5
    0
    1
    4
        Any systemic solicited symptom post-dose 2
    48
    17
    0
    44
    18
    0
        Any fever (≥ 99.5°F ax or ≥ 100.4°F oral) pd2
    14
    4
    0
    15
    5
    0
        Grade 3 fever (> 103.1°F ax or > 104.0°F oral) pd2
    1
    1
    0
    0
    0
    0
        Any nausea/vomiting post-dose 2
    4
    2
    0
    8
    4
    0
        Grade 3 nausea/vomiting (prevented activities) pd2
    2
    1
    0
    0
    0
    0
        Any diarrhea post-dose 2
    17
    6
    0
    16
    5
    0
        Grade 3 diarrhea post-dose 2
    1
    0
    0
    0
    0
    0
        Any loss of appetite post-dose 2
    15
    0
    0
    14
    0
    0
        Grade 3 loss of appetite post-dose 2
    1
    0
    0
    0
    0
    0
        Any irritability post-dose 2
    38
    0
    0
    31
    0
    0
        Grade 3 irritability post-dose 2
    1
    0
    0
    0
    0
    0
        Any malaise post-dose 2
    0
    6
    0
    0
    6
    0
        Grade 3 malaise post-dose 2
    0
    0
    0
    0
    0
    0
        Any headache post-dose 2
    0
    6
    0
    0
    8
    0
        Grade 3 headache post-dose 2
    0
    0
    0
    0
    0
    0
        Any myalgia post-dose 2
    0
    7
    0
    0
    12
    0
        Grade 3 myalgia post-dose 2
    0
    0
    0
    0
    0
    0
    Notes
    [7] - Age 9 to < 18 years - one dose only
    No statistical analyses for this end point

    Secondary: Frequency and Intensity of Unsolicited Adverse Events (UAEs)

    		 Close Top of page
    End point title
    		 Frequency and Intensity of Unsolicited Adverse Events (UAEs)
    End point description
    End point type
    Secondary
    End point timeframe
    30 days after each vaccination
    End point values
    		 Afluria Cohort A Afluria Cohort B Afluria Cohort C Fluzone Cohort A Fluzone Cohort B Fluzone Cohort C
    Number of subjects analysed
    229
    252
    254
    228
    255
    250
    Units: Number of participants
        Any UAE
    123
    100
    88
    112
    84
    70
        Grade 3 UAE
    28
    25
    17
    24
    22
    16
        Any related UAE
    37
    24
    20
    16
    18
    14
    No statistical analyses for this end point

    Secondary: New Onset of Chronic Illnesses (NOCIs)

    		 Close Top of page
    End point title
    		 New Onset of Chronic Illnesses (NOCIs)
    End point description
    New onset of chronic illness after any vaccine dose: A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).
    End point type
    Secondary
    End point timeframe
    6 months after last study vaccination
    End point values
    		 Afluria Cohort A Afluria Cohort B Afluria Cohort C Fluzone Cohort A Fluzone Cohort B Fluzone Cohort C
    Number of subjects analysed
    229
    252
    254
    228
    255
    250
    Units: Number of participants
        Total number of participants with NOCI
    2
    0
    2
    2
    1
    0
        Number of participants with related NOCI
    0
    0
    0
    0
    0
    0
        Asthma
    1
    0
    2
    1
    0
    0
        Von Willebrand's Disease
    1
    0
    0
    0
    0
    0
        Eczema
    0
    0
    0
    1
    0
    0
        Attention deficit disorder
    0
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Serious Adverse Events (SAEs)

    		 Close Top of page
    End point title
    		 Serious Adverse Events (SAEs)
    End point description
    End point type
    Secondary
    End point timeframe
    6 months after last study vaccination
    End point values
    		 Afluria Cohort A Afluria Cohort B Afluria Cohort C Fluzone Cohort A Fluzone Cohort B Fluzone Cohort C
    Number of subjects analysed
    229
    252
    254
    228
    255
    250
    Units: Number of participants
        SAEs
    4
    2
    2
    4
    0
    0
        Related SAEs
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Duration of Local and Systemic Solicited Symptoms

    		 Close Top of page
    End point title
    		 Duration of Local and Systemic Solicited Symptoms
    End point description
    Note that the systemic solicited symptoms of loss of appetite and irritability were collected for Afluria cohort A and Fluzone Cohort A only, and malaise, headache and myalgia were not collected for these two cohorts. Afluria Cohort C and Fluzone Cohort C received one dose only.
    End point type
    Secondary
    End point timeframe
    7 days after each vaccination
    End point values
    		 Afluria Cohort A Afluria Cohort B Afluria Cohort C Fluzone Cohort A Fluzone Cohort B Fluzone Cohort C
    Number of subjects analysed
    229
    252
    254
    228
    255
    250
    Units: Days
    arithmetic mean (standard deviation)
        Any pain post-dose 1
    1.57 ± 0.952
    1.89 ± 1.138
    1.96 ± 1.087
    1.43 ± 0.728
    1.89 ± 1.337
    1.99 ± 1.136
        Any redness (> 0 mm) post-dose 1
    2.09 ± 1.405
    2.32 ± 1.621
    2.02 ± 1.669
    2.22 ± 1.939
    2.1 ± 2.014
    2.38 ± 1.992
        Any swelling (> 0 mm) post-dose 1
    3.13 ± 2.93
    2.39 ± 2.021
    1.75 ± 1.171
    2 ± 1.569
    2.09 ± 1.273
    2.38 ± 1.724
        Any fever (≥ 99.5°F ax or ≥ 100.4°F oral) pd1
    1.38 ± 0.869
    1.45 ± 1.032
    1.82 ± 1.59
    1.49 ± 0.989
    1.4 ± 0.707
    3.1 ± 2.644
        Any nausea/vomiting post-dose 1
    1.42 ± 1.119
    1.27 ± 0.719
    1.36 ± 0.569
    1.29 ± 1.042
    1.43 ± 1.165
    2.88 ± 3.791
        Any diarrhea post-dose 1
    2.23 ± 2.157
    2.89 ± 4.988
    1.18 ± 0.395
    2.16 ± 2.189
    1.44 ± 1.044
    1.36 ± 0.911
        Any malaise post-dose 1
    0 ± 0
    1.86 ± 1.324
    2.09 ± 1.487
    0 ± 0
    1.74 ± 1.094
    2.82 ± 3.449
        Any headache post-dose 1
    0 ± 0
    1.5 ± 0.77
    1.77 ± 1.443
    0 ± 0
    1.66 ± 1.328
    2.05 ± 1.945
        Any myalgia post-dose 1
    0 ± 0
    1.72 ± 1.007
    1.76 ± 1.1
    0 ± 0
    1.63 ± 1.009
    2.11 ± 1.491
        Any loss of appetite post-dose 1
    2.61 ± 3.695
    0 ± 0
    0 ± 0
    2.85 ± 4.458
    0 ± 0
    0 ± 0
        Any irritability post-dose 1
    2.26 ± 2.858
    0 ± 0
    0 ± 0
    2.64 ± 3.825
    0 ± 0
    0 ± 0
        Any pain post-dose 2
    1.54 ± 0.793
    1.96 ± 1.637
    0 ± 0
    1.45 ± 0.739
    1.65 ± 0.775
    0 ± 0
        Any redness (> 0 mm) post-dose 2
    1.8 ± 1.014
    2.4 ± 2.191
    0 ± 0
    1.73 ± 0.935
    1.77 ± 1.235
    0 ± 0
        Any swelling (> 0 mm) post-dose 2
    1.67 ± 0.707
    3 ± 2.16
    0 ± 0
    1.57 ± 0.787
    1.69 ± 1.251
    0 ± 0
        Any fever (≥ 99.5°F ax or ≥ 100.4°F oral) pd2
    1.8 ± 1.146
    1.5 ± 0.577
    0 ± 0
    1.81 ± 1.559
    1 ± 0
    0 ± 0
        Any nausea/vomiting post-dose 2
    2.5 ± 1.291
    1 ± 0
    0 ± 0
    1.78 ± 1.093
    1.2 ± 0.447
    0 ± 0
        Any diarrhea post-dose 2
    2.83 ± 2.431
    1.33 ± 0.816
    0 ± 0
    2.44 ± 2.332
    2.2 ± 0.447
    0 ± 0
        Any malaise post-dose 2
    0 ± 0
    1.83 ± 1.602
    0 ± 0
    0 ± 0
    1.71 ± 0.756
    0 ± 0
        Any headache post-dose 2
    0 ± 0
    1 ± 0
    0 ± 0
    0 ± 0
    1.3 ± 0.483
    0 ± 0
        Any myalgia post-dose 2
    0 ± 0
    2 ± 1.528
    0 ± 0
    0 ± 0
    1.54 ± 0.66
    0 ± 0
        Any loss of appetite post-dose 2
    2.47 ± 1.586
    0 ± 0
    0 ± 0
    2.33 ± 1.447
    0 ± 0
    0 ± 0
        Any irritability post-dose 2
    2.31 ± 1.732
    0 ± 0
    0 ± 0
    2.17 ± 1.543
    0 ± 0
    0 ± 0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected for 180 days after the last study vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Afluria Cohort A
    Reporting group description
    		 Age 6 months to < 3 years

    Reporting group title
    Afluria Cohort B
    Reporting group description
    		 Age 3 to < 9 years

    Reporting group title
    Afluria Cohort C
    Reporting group description
    		 Age 9 to < 18 years

    Reporting group title
    Fluzone Cohort A
    Reporting group description
    		 Age 6 months to < 3 years

    Reporting group title
    Fluzone Cohort B
    Reporting group description
    		 Age 3 to < 9 years

    Reporting group title
    Fluzone Cohort C
    Reporting group description
    		 Age 9 to < 18 years

    Serious adverse events
    		 Afluria Cohort A Afluria Cohort B Afluria Cohort C Fluzone Cohort A Fluzone Cohort B Fluzone Cohort C
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 229 (1.75%)
    2 / 252 (0.79%)
    2 / 254 (0.79%)
    4 / 228 (1.75%)
    0 / 255 (0.00%)
    0 / 250 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 229 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
    0 / 228 (0.00%)
    0 / 255 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colonic polyp
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 252 (0.40%)
    0 / 254 (0.00%)
    0 / 228 (0.00%)
    0 / 255 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 229 (0.00%)
    1 / 252 (0.40%)
    0 / 254 (0.00%)
    0 / 228 (0.00%)
    0 / 255 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
    0 / 228 (0.00%)
    0 / 255 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 229 (0.44%)
    1 / 252 (0.40%)
    0 / 254 (0.00%)
    0 / 228 (0.00%)
    0 / 255 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
    1 / 228 (0.44%)
    0 / 255 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 229 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
    0 / 228 (0.00%)
    0 / 255 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 229 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
    1 / 228 (0.44%)
    0 / 255 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Furuncle
         subjects affected / exposed
    0 / 229 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
    1 / 228 (0.44%)
    0 / 255 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 229 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
    1 / 228 (0.44%)
    0 / 255 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 229 (0.44%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
    0 / 228 (0.00%)
    0 / 255 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Afluria Cohort A Afluria Cohort B Afluria Cohort C Fluzone Cohort A Fluzone Cohort B Fluzone Cohort C
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    210 / 229 (91.70%)
    216 / 252 (85.71%)
    214 / 254 (84.25%)
    187 / 228 (82.02%)
    202 / 255 (79.22%)
    202 / 250 (80.80%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 229 (2.62%)
    6 / 252 (2.38%)
    17 / 254 (6.69%)
    3 / 228 (1.32%)
    8 / 255 (3.14%)
    12 / 250 (4.80%)
         occurrences all number
    7
    6
    22
    3
    8
    13
    General disorders and administration site conditions
    Pain at the injection site
    alternative assessment type: Systematic
         subjects affected / exposed
    107 / 229 (46.72%)
    157 / 252 (62.30%)
    167 / 254 (65.75%)
    89 / 228 (39.04%)
    134 / 255 (52.55%)
    151 / 250 (60.40%)
         occurrences all number
    126
    174
    170
    101
    154
    156
    Redness at the injection site
    alternative assessment type: Systematic
         subjects affected / exposed
    60 / 229 (26.20%)
    62 / 252 (24.60%)
    43 / 254 (16.93%)
    60 / 228 (26.32%)
    67 / 255 (26.27%)
    43 / 250 (17.20%)
         occurrences all number
    70
    65
    43
    76
    73
    45
    Swelling at the injection site
    alternative assessment type: Systematic
         subjects affected / exposed
    34 / 229 (14.85%)
    38 / 252 (15.08%)
    39 / 254 (15.35%)
    29 / 228 (12.72%)
    50 / 255 (19.61%)
    41 / 250 (16.40%)
         occurrences all number
    40
    42
    40
    34
    57
    42
    Fever
         subjects affected / exposed
    91 / 229 (39.74%)
    58 / 252 (23.02%)
    16 / 254 (6.30%)
    42 / 228 (18.42%)
    29 / 255 (11.37%)
    10 / 250 (4.00%)
         occurrences all number
    109
    64
    17
    53
    32
    10
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    79 / 229 (34.50%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
    54 / 228 (23.68%)
    0 / 255 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    100
    0
    0
    63
    0
    0
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    142 / 229 (62.01%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
    99 / 228 (43.42%)
    0 / 255 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    198
    0
    0
    132
    0
    0
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 229 (0.00%)
    74 / 252 (29.37%)
    55 / 254 (21.65%)
    0 / 228 (0.00%)
    37 / 255 (14.51%)
    51 / 250 (20.40%)
         occurrences all number
    0
    82
    65
    0
    42
    55
    Headache (solicited)
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 229 (0.00%)
    58 / 252 (23.02%)
    69 / 254 (27.17%)
    0 / 228 (0.00%)
    45 / 255 (17.65%)
    66 / 250 (26.40%)
         occurrences all number
    0
    66
    81
    0
    54
    76
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 229 (0.00%)
    87 / 252 (34.52%)
    101 / 254 (39.76%)
    0 / 228 (0.00%)
    66 / 255 (25.88%)
    93 / 250 (37.20%)
         occurrences all number
    0
    92
    106
    0
    78
    98
    Pyrexia
         subjects affected / exposed
    32 / 229 (13.97%)
    24 / 252 (9.52%)
    12 / 254 (4.72%)
    22 / 228 (9.65%)
    17 / 255 (6.67%)
    7 / 250 (2.80%)
         occurrences all number
    34
    29
    18
    23
    18
    9
    Gastrointestinal disorders
    Nausea and vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    31 / 229 (13.54%)
    35 / 252 (13.89%)
    23 / 254 (9.06%)
    23 / 228 (10.09%)
    24 / 255 (9.41%)
    24 / 250 (9.60%)
         occurrences all number
    35
    36
    25
    33
    26
    24
    Diarrhea (solicited)
    alternative assessment type: Systematic
         subjects affected / exposed
    69 / 229 (30.13%)
    22 / 252 (8.73%)
    20 / 254 (7.87%)
    63 / 228 (27.63%)
    27 / 255 (10.59%)
    25 / 250 (10.00%)
         occurrences all number
    87
    25
    22
    80
    30
    28
    Diarrhea
         subjects affected / exposed
    10 / 229 (4.37%)
    3 / 252 (1.19%)
    4 / 254 (1.57%)
    13 / 228 (5.70%)
    3 / 255 (1.18%)
    1 / 250 (0.40%)
         occurrences all number
    11
    3
    4
    14
    3
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    39 / 229 (17.03%)
    40 / 252 (15.87%)
    19 / 254 (7.48%)
    31 / 228 (13.60%)
    33 / 255 (12.94%)
    17 / 250 (6.80%)
         occurrences all number
    44
    40
    22
    39
    36
    19
    Rhinorrhoea
         subjects affected / exposed
    25 / 229 (10.92%)
    14 / 252 (5.56%)
    5 / 254 (1.97%)
    24 / 228 (10.53%)
    10 / 255 (3.92%)
    5 / 250 (2.00%)
         occurrences all number
    28
    14
    6
    29
    10
    5
    Nasal congestion
         subjects affected / exposed
    14 / 229 (6.11%)
    8 / 252 (3.17%)
    16 / 254 (6.30%)
    11 / 228 (4.82%)
    4 / 255 (1.57%)
    6 / 250 (2.40%)
         occurrences all number
    16
    8
    17
    12
    4
    7
    Oropharyngeal pain
         subjects affected / exposed
    4 / 229 (1.75%)
    7 / 252 (2.78%)
    19 / 254 (7.48%)
    2 / 228 (0.88%)
    6 / 255 (2.35%)
    13 / 250 (5.20%)
         occurrences all number
    4
    7
    23
    2
    6
    15
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 229 (3.93%)
    6 / 252 (2.38%)
    4 / 254 (1.57%)
    14 / 228 (6.14%)
    5 / 255 (1.96%)
    4 / 250 (1.60%)
         occurrences all number
    9
    6
    4
    16
    5
    4

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25454878
    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-Fri Apr 26 11:40:59 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA