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 II, Observer-Blind, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Fluad® and Fluzone® Influenza Vaccines in Healthy Children Aged 6 to <60 Months.

    Summary
    EudraCT number
    		 2014-004543-12
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    15 Oct 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 Jul 2016
    First version publication date
    07 Jan 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Required for the re-QC project because of the EudraCT system glitch and possible updates to results may be required. Moreover, a change in system user for this study is necessary.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V70P6
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00649883
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Sample data: Sample data
    Sponsors
    Sponsor organisation name
    Novartis Vaccines
    Sponsor organisation address
    Via Fiorentina, Siena, Italy, 53100
    Public contact
    Posting Director, Novartis Vaccines and Diagnostics , RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines and Diagnostics , RegistryContactVaccinesUS@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Jun 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Oct 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the immunogenicity of two 0.25 mL IM doses of Fluad or Fluzone influenza vaccines in terms of post-vaccination geometric mean titers (GMTs), seroprotection rates and seroconversion rates, as measured by HI assay. To evaluate the immunogenicity induced by two 0.25 mL IM doses of Fluad or Fluzone influenza vaccines against influenza virus strains different from those included in the study vaccines formulations (Northern Hemisphere 2007/2008), in terms of postvaccination GMTs, seroconversion rates and seroprotection rates, as measured by HI assay
    Protection of trial subjects
    Study vaccines were not administered to individuals with known hypersensitivity to any component of the vaccines. An oral temperature ≥38.0°C (≥100.4°F) or serious active infection was a reason for delaying vaccination. Standard immunization practices were observed and care was taken to administer the injection intramuscularly. As with all injectable vaccines, appropriate medical treatment and supervision was readily available in case of rare anaphylactic reactions following administration of the study vaccine. Epinephrine 1:1000 and diphenhydramine was available in case of any anaphylactic reactions. Care was taken to ensure that the vaccine is not injected into a blood vessel
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jan 2008
    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
    Guatemala: 360
    Worldwide total number of subjects
    360
    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)
    166
    Children (2-11 years)
    194
    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
    		 Participants were enrolled from one country sites in Guatemala

    Pre-assignment
    Screening details
    		 All subjects enrolled were included in the trial.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 aTIV (≥6to ≤36 months)
    Arm description
    		 Children 6 to <36 months of age received two 0.25 mL doses of MF59 adjuvanted trivalent influenza vaccine(aTIV), administered four weeks apart
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adjuvanted trivalent influenza virus vaccine (surface antigen, inactivated, adjuvanted with MF59C.1, egg-derived)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Children 6 to <36 months received two 0.25mL doses of MF59- aTIV. Administered by IM injection (four weeks apart) into the deltoid muscle preferably of the non-dominant arm

    Arm title
    		 TIV (≥6 to ≤36 months)
    Arm description
    		 Children 6 to <36 months of age received two 0.25 mL doses of non-adjuvanted split influenza vaccine (TIV), administered four weeks apart
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trivalent influenza virus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Children 6 to <36 months received two 0.25mL doses of TIV. Administered by IM injection (four weeks apart) into the deltoid muscle preferably of the non-dominant arm

    Arm title
    		 aTIV (≥36 to ≤60 months)
    Arm description
    		 Children 36 to <60 months of age received two 0.5 mL doses of aTIV, administered four weeks apart
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adjuvanted trivalent influenza virus vaccine (surface antigen, inactivated, adjuvanted with MF59C.1, egg-derived)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Children 36 to <60months received two 0.5mL doses of MF59- aTIV administered by IM injection (four weeks apart) into the deltoid muscle preferably of the non-dominant arm

    Arm title
    		 TIV (≥36 to ≤60 months)
    Arm description
    		 Children 36 to <60 months of age received two 0.5 mL doses of either TIV, administered four weeks apart.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trivalent influenza virus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Children 36 to <60months received two 0.5mL doses of TIV administered by IM injection (four weeks apart) into the deltoid muscle preferably of the non-dominant arm

    Number of subjects in period 1
    		aTIV (≥6to ≤36 months) TIV (≥6 to ≤36 months) aTIV (≥36 to ≤60 months) TIV (≥36 to ≤60 months)
    Started
    136
    132
    44
    48
    Completed
    123
    118
    42
    44
    Not completed
    13
    14
    2
    4
         Consent withdrawn by subject
    4
    6
    1
    1
         Adverse Event
    -
    -
    1
    1
         Death
    -
    1
    -
    -
         Lost to follow-up
    9
    7
    -
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    aTIV (≥6to ≤36 months)
    Reporting group description
    		 Children 6 to <36 months of age received two 0.25 mL doses of MF59 adjuvanted trivalent influenza vaccine(aTIV), administered four weeks apart

    Reporting group title
    TIV (≥6 to ≤36 months)
    Reporting group description
    		 Children 6 to <36 months of age received two 0.25 mL doses of non-adjuvanted split influenza vaccine (TIV), administered four weeks apart

    Reporting group title
    aTIV (≥36 to ≤60 months)
    Reporting group description
    		 Children 36 to <60 months of age received two 0.5 mL doses of aTIV, administered four weeks apart

    Reporting group title
    TIV (≥36 to ≤60 months)
    Reporting group description
    		 Children 36 to <60 months of age received two 0.5 mL doses of either TIV, administered four weeks apart.

    Reporting group values
    		 aTIV (≥6to ≤36 months) TIV (≥6 to ≤36 months) aTIV (≥36 to ≤60 months) TIV (≥36 to ≤60 months) Total
    Number of subjects
    		 136 132 44 48 360
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 1.2 ± 0.7 1.2 ± 0.7 3.4 ± 0.5 3.5 ± 0.5 -
    Gender categorical
    Units: Subjects
        Female
    		 64 63 16 23 166
        Male
    		 72 69 28 25 194

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    aTIV (≥6to ≤36 months)
    Reporting group description
    		 Children 6 to <36 months of age received two 0.25 mL doses of MF59 adjuvanted trivalent influenza vaccine(aTIV), administered four weeks apart

    Reporting group title
    TIV (≥6 to ≤36 months)
    Reporting group description
    		 Children 6 to <36 months of age received two 0.25 mL doses of non-adjuvanted split influenza vaccine (TIV), administered four weeks apart

    Reporting group title
    aTIV (≥36 to ≤60 months)
    Reporting group description
    		 Children 36 to <60 months of age received two 0.5 mL doses of aTIV, administered four weeks apart

    Reporting group title
    TIV (≥36 to ≤60 months)
    Reporting group description
    		 Children 36 to <60 months of age received two 0.5 mL doses of either TIV, administered four weeks apart.

    Subject analysis set title
    aTIV (≥6to ≤60 months)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all subjects in the Full Analysis Set who: 1) received all the relevant doses of vaccine correctly, and 2) provided evaluable serum samples at the relevant time points, and 3) had no major protocol violation as defined prior to unblinding

    Subject analysis set title
    aTIV (≥6to ≤60 months)-Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    all subjects enrolled who: 1) had received study vaccination 2) provided post-baseline safety data

    Subject analysis set title
    TIV (≥6 to ≤60 months)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all subjects in the Full Analysis Set who: 1) received all the relevant doses of vaccine correctly, and 2) provided evaluable serum samples at the relevant time points, and 3) had no major protocol violation as defined prior to unblinding

    Subject analysis set title
    TIV (≥6 to ≤60 months)-Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    all subjects enrolled who: 1) had received study vaccination 2) provided post-baseline safety data

    Subject analysis set title
    Enrolled
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    all subjects who: 1) had been screened and entered the study

    Primary: Comparison of Antibody Responses of aTIV With TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains

    		 Close Top of page
    End point title
    		 Comparison of Antibody Responses of aTIV With TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains [1]
    End point description
    The Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.
    End point type
    Primary
    End point timeframe
    Day 1, Day 29 and Day 50
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistical analysis done.
    End point values
    		 aTIV (≥6to ≤36 months) TIV (≥6 to ≤36 months) aTIV (≥36 to ≤60 months) TIV (≥36 to ≤60 months) aTIV (≥6to ≤60 months) TIV (≥6 to ≤60 months)
    Number of subjects analysed
    97
    102
    23
    20
    120
    122
    Units: Titers
    geometric mean (confidence interval 95%)
        A/H1N1 Day 1
    14 (9.85 to 20)
    14 (10 to 20)
    26 (12 to 57)
    30 (13 to 70)
    15 (11 to 21)
    15 (11 to 21)
        A/H1N1 Day 29
    588 (416 to 833)
    409 (292 to 574)
    969 (458 to 2052)
    687 (302 to 1560)
    624 (450 to 866)
    434 (313 to 601)
        A/H1N1 Day 50
    1612 (1304 to 1992)
    1379 (1122 to 1696)
    1821 (1328 to 2497)
    1539 (1090 to 2173)
    1639 (1361 to 1975)
    1397 (1161 to 1682)
        A/H3N2 Day 1
    34 (22 to 53)
    31 (20 to 47)
    69 (31 to 152)
    110 (46 to 261)
    37 (25 to 55)
    36 (24 to 53)
        A/H3N2 Day 29
    904 (648 to 1261)
    342 (247 to 472)
    1442 (764 to 2723)
    1762 (879 to 3530)
    913 (669 to 1247)
    416 (305 to 567)
        A/H3N2 Day 50
    2370 (1957 to 2869)
    928 (770 to 1118)
    1702 (1091 to 2655)
    2114 (1300 to 3436)
    2134 (1773 to 2568)
    1029 (856 to 1238)
        B Strain Day 1
    5.81 (5.38 to 6.28)
    5.82 (5.4 to 6.27)
    5.85 (4.44 to 7.73)
    6.98 (5.16 to 9.46)
    5.88 (5.39 to 6.4)
    6.01 (5.52 to 6.55)
        B Strain Day 29
    23 (18 to 30)
    12 (8.95 to 15)
    50 (23 to 111)
    30 (13 to 72)
    27 (20 to 36)
    13 (10 to 18)
        B Strain Day 50
    200 (161 to 248)
    57 (46 to 71)
    171 (99 to 295)
    152 (84 to 275)
    198 (159 to 248)
    67 (54 to 84)
    No statistical analyses for this end point

    Primary: Comparison of Antibody Responses of aTIV With TIV in Terms of Geometric Mean Ratio (GMRs) Against Homologous Strains

    		 Close Top of page
    End point title
    		 Comparison of Antibody Responses of aTIV With TIV in Terms of Geometric Mean Ratio (GMRs) Against Homologous Strains [2]
    End point description
    The GMR of post-vaccination versus pre-vaccination HI titers against homologous strains, three weeks (day 29/day 1; day 50/day 1
    End point type
    Primary
    End point timeframe
    Day 29 and Day 50
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistical analysis done.
    End point values
    		 aTIV (≥6to ≤36 months) TIV (≥6 to ≤36 months) aTIV (≥36 to ≤60 months) TIV (≥36 to ≤60 months) aTIV (≥6to ≤60 months) TIV (≥6 to ≤60 months)
    Number of subjects analysed
    97
    102
    23
    20
    120
    122
    Units: Ratio
    geometric mean (confidence interval 95%)
        A/H1N1 Day 29/Day 1
    41 (33 to 52)
    29 (23 to 36)
    37 (23 to 59)
    23 (14 to 39)
    41 (33 to 51)
    28 (23 to 35)
        A/H1N1 Day 50/Day 1
    113 (84 to 153)
    97 (72 to 129)
    69 (33 to 142)
    51 (23 to 113)
    108 (82 to 144)
    91 (69 to 121)
        A/H3N2 Day 29/Day 1
    26 (20 to 35)
    11 (8.43 to 15)
    21 (12 to 37)
    16 (8.52 to 30)
    24 (19 to 32)
    12 (8.97 to 15)
        A/H3N2 Day 50/Day 1
    69 (47 to 100)
    30 (21 to 44)
    25 (13 to 46)
    19 (9.81 to 38)
    57 (41 to 80)
    29 (21 to 41)
        B Strain Day 29/Day 1
    3.97 (3.16 to 4.97)
    2 (1.61 to 2.5)
    8.61 (4.34 to 17)
    4.33 (2.05 to 9.16)
    4.59 (3.62 to 5.82)
    2.23 (1.76 to 2.82)
        B Strain Day 50/Day 1
    34 (28 to 42)
    9.86 (8.07 to 12)
    29 (17 to 51)
    22 (12 to 40)
    34 (27 to 42)
    11 (9.11 to 14)
    No statistical analyses for this end point

    Primary: Comparison of Antibody Responses of aTIV With TIV in Terms of Percentage of Subjects Achieving Seroconversion or 4-fold Increase in HI Titers Against Homologous Strains

    		 Close Top of page
    End point title
    		 Comparison of Antibody Responses of aTIV With TIV in Terms of Percentage of Subjects Achieving Seroconversion or 4-fold Increase in HI Titers Against Homologous Strains [3]
    End point description
    Seroconversion rate is defined as either pre-vaccination HI titer <10 and a post-vaccination HI titer ≥40 or a prevaccination HI titer ≥10 and a minimum four-fold rise in post-vaccination HI antibody titer
    End point type
    Primary
    End point timeframe
    Day 1, Day 29 and Day 50
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistical analysis done.
    End point values
    		 aTIV (≥6to ≤36 months) TIV (≥6 to ≤36 months) aTIV (≥36 to ≤60 months) TIV (≥36 to ≤60 months) aTIV (≥6to ≤60 months) TIV (≥6 to ≤60 months)
    Number of subjects analysed
    97
    102
    23
    20
    120
    122
    Units: Percentages of subjects
    number (confidence interval 95%)
        A/H1N1 Day 29
    97 (91 to 99)
    97 (92 to 99)
    100 (85 to 100)
    95 (75 to 100)
    98 (93 to 99)
    97 (92 to 99)
        A/H1N1 Day 50
    99 (94 to 100)
    98 (93 to 100)
    96 (78 to 100)
    95 (75 to 100)
    98 (94 to 100)
    98 (93 to 99)
        A/H3N2 Day 29
    95 (88 to 98)
    85 (77 to 92)
    91 (72 to 99)
    90 (68 to 99)
    94 (88 to 98)
    86 (79 to 92)
        A/H3N2 Day 50
    98 (93 to 100)
    89 (82 to 94)
    91 (72 to 99)
    95 (75 to 100)
    97 (92 to 99)
    90 (83 to 95)
        B Strain Day 29
    32 (23 to 42)
    9 (4 to 16)
    61 (39 to 80)
    30 (12 to 54)
    38 (29 to 47)
    12 (7 to 19)
        B Strain Day 50
    95 (88 to 98)
    75 (65 to 83)
    96 (78 to 100)
    80 (56 to 94)
    95 (89 to 98)
    75 (67 to 83)
    No statistical analyses for this end point

    Primary: Comparison of Antibody Responses of aTIV With TIV in Terms of Percentage of Subjects Achieving Seroprotection as measured by HI Titers Against Homologous Strains

    		 Close Top of page
    End point title
    		 Comparison of Antibody Responses of aTIV With TIV in Terms of Percentage of Subjects Achieving Seroprotection as measured by HI Titers Against Homologous Strains [4]
    End point description
    Immunogenicity was assessed in terms of percentage of subjects achieving seroconversion as measured by HI assay. Seroprotection is defined as an HI titer ≥ 40
    End point type
    Primary
    End point timeframe
    Day 1, Day 29 and Day 50
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistical analysis done.
    End point values
    		 aTIV (≥6to ≤36 months) TIV (≥6 to ≤36 months) aTIV (≥36 to ≤60 months) TIV (≥36 to ≤60 months) aTIV (≥6to ≤60 months) TIV (≥6 to ≤60 months)
    Number of subjects analysed
    97
    102
    23
    20
    120
    122
    Units: Percentages of subjects
    number (confidence interval 95%)
        A/H1N1 Day 1
    29 (20 to 39)
    30 (22 to 40)
    52 (31 to 73)
    60 (36 to 81)
    33 (25 to 43)
    35 (27 to 44)
        A/H1N1 Day 29
    100 (96 to 100)
    99 (95 to 100)
    100 (85 to 100)
    95 (75 to 100)
    100 (97 to 100)
    98 (94 to 100)
        A/H1N1 Day 50
    100 (96 to 100)
    100 (96 to 100)
    100 (83 to 100)
    100 (83 to 100)
    100 (97 to 100)
    100 (97 to 100)
        A/H3N2 Day 1
    41 (31 to 52)
    37 (28 to 47)
    52 (31 to 73)
    70 (46 to 88)
    43 (34 to 53)
    43 (34 to 52)
        A/H3N2 Day 29
    100 (96 to 100)
    99 (95 to 100)
    100 (85 to 100)
    95 (75 to 100)
    100 (97 to 100)
    98 (94 to 100)
        A/H3N2 Day 50
    100 (96 to 100)
    100 (96 to 100)
    100 (85 to 100)
    100 (83 to 100)
    100 (97 to 100)
    100 (97 to 100)
        B Strain Day 1
    1 (0.026 to 6)
    0 (0 to 4)
    4 (0 to 22)
    5 (0 to 25)
    2 (0 to 6)
    1 (0.021 to 4)
        B Strain Day 29
    33 (24 to 43)
    9 (4 to 16)
    61 (39 to 80)
    30 (12 to 54)
    38 (30 to 48)
    12 (7 to 19)
        B Strain Day 50
    95 (88 to 98)
    75 (65 to 83)
    96 (78 to 100)
    80 (56 to 94)
    95 (89 to 98)
    75 (67 to 83)
    No statistical analyses for this end point

    Primary: Comparison of Antibody Responses of aTIV With TIV in Terms of Geometric Mean Ratio (GMRs) Against mismatched Strains (Drifted Strains)

    		 Close Top of page
    End point title
    		 Comparison of Antibody Responses of aTIV With TIV in Terms of Geometric Mean Ratio (GMRs) Against mismatched Strains (Drifted Strains) [5]
    End point description
    The GMR of post-vaccination versus pre-vaccination HI titers against homologous strains, three weeks (day 29/day 1; day 50/day 1)
    End point type
    Primary
    End point timeframe
    Day 29 and Day 50
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistical analysis done.
    End point values
    		 aTIV (≥6to ≤36 months) TIV (≥6 to ≤36 months) aTIV (≥36 to ≤60 months) TIV (≥36 to ≤60 months) aTIV (≥6to ≤60 months) TIV (≥6 to ≤60 months)
    Number of subjects analysed
    97
    102
    23
    20
    120
    122
    Units: Ratios
    geometric mean (confidence interval 95%)
        A/H1N1 Day 29/Day 1
    4.78 (3.5 to 6.52)
    3.49 (2.58 to 4.73)
    11 (5.38 to 22)
    6.27 (2.88 to 14)
    5.29 (3.93 to 7.13)
    3.67 (2.73 to 4.94)
        A/H1N1 Day 50/Day 1
    9.09 (7.06 to 12)
    6.24 (4.88 to 7.97)
    12 (6.7 to 20)
    7.01 (3.83 to 13)
    9.36 (7.4 to 12)
    6.26 (4.96 to 7.91)
        A/H3N2 Day 29/Day 1
    8.85 (6.5 to 12)
    3.49 (2.58 to 4.71)
    9.76 (5.76 to 17)
    13 (7.22 to 23)
    8.73 (6.55 to 12)
    4.2 (3.15 to 5.59)
        A/H3N2 Day 50/Day 1
    25 (19 to 33)
    8.71 (6.64 to 11)
    16 (8.97 to 27)
    16 (8.59 to 29)
    23 (17 to 29)
    9.63 (7.4 to 12)
        B Strain Day 29/Day 1
    1.69 (1.41 to 2.03)
    1.31 (1.1 to 1.57)
    3.58 (2.38 to 5.39)
    1.49 (0.96 to 2.33)
    1.9 (1.6 to 2.27)
    1.31 (1.1 to 1.56)
        B Strain Day 50/Day 1
    3.73 (3.06 to 4.54)
    1.77 (1.46 to 2.15)
    4.58 (2.92 to 7.2)
    2.24 (1.37 to 3.66)
    3.86 (3.2 to 4.64)
    1.82 (1.52 to 2.19)
    No statistical analyses for this end point

    Primary: Comparison of Antibody Responses of aTIV With TIV in Terms of Percentage of Subjects Achieving Seroconversion or 4-fold Increase in HI Titers Against mismatched Strains (Drifted Strains)

    		 Close Top of page
    End point title
    		 Comparison of Antibody Responses of aTIV With TIV in Terms of Percentage of Subjects Achieving Seroconversion or 4-fold Increase in HI Titers Against mismatched Strains (Drifted Strains) [6]
    End point description
    Seroconversion rate is defined as either pre-vaccination HI titer <10 and a post-vaccination HI titer ≥40 or a prevaccination HI titer ≥10 and a minimum four-fold rise in post-vaccination HI antibody titer
    End point type
    Primary
    End point timeframe
    Day 1, Day 29 and Day 50
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistical analysis done.
    End point values
    		 aTIV (≥6to ≤36 months) TIV (≥6 to ≤36 months) aTIV (≥36 to ≤60 months) TIV (≥36 to ≤60 months) aTIV (≥6to ≤60 months) TIV (≥6 to ≤60 months)
    Number of subjects analysed
    97
    102
    23
    20
    120
    122
    Units: Percentages of subjects
    number (confidence interval 95%)
        A/H1N1 Day 29
    47 (37 to 58)
    45 (35 to 55)
    74 (52 to 90)
    70 (46 to 88)
    53 (43 to 62)
    49 (40 to 58)
        A/H1N1 Day 50
    87 (78 to 93)
    73 (63 to 81)
    74 (52 to 90)
    80 (56 to 94)
    84 (76 to 90)
    74 (65 to 81)
        A/H3N2 Day 29
    63 (52 to 72)
    43 (33 to 53)
    83 (61 to 95)
    85 (62 to 97)
    67 (57 to 75)
    50 (41 to 59)
        A/H3N2 Day 50
    96 (90 to 99)
    79 (70 to 87)
    91 (72 to 99)
    90 (68 to 99)
    95 (89 to 98)
    81 (73 to 88)
        B Strain Day 29
    9 (4 to 17)
    6 (2 to 12)
    43 (23 to 66)
    20 (6 to 44)
    16 (10 to 24)
    8 (4 to 15)
        B Strain Day 50
    55 (44 to 65)
    19 (12 to 28)
    70 (47 to 87)
    45 (23 to 68)
    58 (48 to 66)
    23 (12 to 31)
    No statistical analyses for this end point

    Primary: Comparison of Antibody Responses of aTIV With TIV in Terms of Percentage of Subjects Achieving Seroprotection as measured by HI Titers Against mismatched Strains (Drifted Strains)

    		 Close Top of page
    End point title
    		 Comparison of Antibody Responses of aTIV With TIV in Terms of Percentage of Subjects Achieving Seroprotection as measured by HI Titers Against mismatched Strains (Drifted Strains) [7]
    End point description
    Seroprotection is defined as an HI titer ≥40.
    End point type
    Primary
    End point timeframe
    Day 1, Day 29 and Day 50
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistical analysis done.
    End point values
    		 aTIV (≥6to ≤36 months) TIV (≥6 to ≤36 months) aTIV (≥36 to ≤60 months) TIV (≥36 to ≤60 months) aTIV (≥6to ≤60 months) TIV (≥6 to ≤60 months)
    Number of subjects analysed
    97
    102
    23
    20
    120
    122
    Units: Percentages of subjects
    number (confidence interval 95%)
        A/H1N1 Day 1
    80 (71 to 88)
    75 (65 to 83)
    74 (52 to 90)
    95 (75 to 100)
    79 (71 to 86)
    78 (69 to 85)
        A/H1N1 Day 29
    93 (86 to 97)
    92 (85 to 97)
    96 (78 to 100)
    100 (83 to 100)
    93 (87 to 97)
    93 (87 to 97)
        A/H1N1 Day 50
    100 (96 to 100)
    98 (93 to 100)
    96 (78 to 100)
    100 (83 to 100)
    99 (95 to 100)
    98 (94 to 100)
        A/H3N2 Day 1
    36 (27 to 46)
    33 (24 to 43)
    48 (27 to 69)
    65 (41 to 85)
    38 (30 to 48)
    39 (30 to 48)
        A/H3N2 Day 29
    65 (55 to 74)
    48 (38 to 58)
    91 (72 to 99)
    85 (62 to 97)
    70 (61 to 78)
    54 (45 to 63)
        A/H3N2 Day 50
    100 (96 to 199)
    91 (84 to 96)
    100 (85 to 100)
    100 (83 to 100)
    100 (97 to 100)
    93 (86 to 97)
        B Strain Day 1
    16 (10 to 25)
    14 (8 to 22)
    35 (16 to 57)
    35 (15 to 59)
    20 (13 to 28)
    17 (11 to 25)
        B Strain Day 29
    34 (25 to 44)
    21 (13 to 30)
    52 (31 to 73)
    45 (23 to 68)
    38 (29 to 47)
    25 (17 to 33)
        B Strain Day 50
    90 (82 to 95)
    56 (46 to 66)
    78 (56 to 93)
    80 (56 to 94)
    88 (80 to 93)
    60 (51 to 69)
    No statistical analyses for this end point

    Primary: Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination

    		 Close Top of page
    End point title
    		 Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination [8]
    End point description
    Safety was assessed as the number of subjects who reported solicited local and systemic adverse events, 3 weeks after the primary course with aTIV and TIV vaccine
    End point type
    Primary
    End point timeframe
    From day 1 through day 50 after any vaccination
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistical analysis done.
    End point values
    		 aTIV (≥6to ≤36 months) TIV (≥6 to ≤36 months) aTIV (≥36 to ≤60 months) TIV (≥36 to ≤60 months)
    Number of subjects analysed
    130
    130
    44 [9]
    48 [10]
    Units: Number
        Injection Site Ecchymosis
    18
    18
    11
    9
        Injection Site Erythema
    31
    18
    21
    19
        Injection Site Induration
    13
    5
    19
    12
        Injection Site Swelling
    8
    5
    12
    6
        Tenderness
    30
    25
    30
    20
        Changing Eat Habits
    22
    18
    0
    0
        Sleepiness
    9
    8
    0
    0
        Unusual Crying
    32
    28
    0
    0
        Irritability
    23
    20
    0
    0
        Vomiting
    12
    8
    0
    0
        Chills
    0
    0
    7
    5
        Diarrhea
    16
    9
    0
    0
        Shivering
    7
    2
    0
    0
        Malaise
    0
    0
    15
    13
        Myalgia
    0
    0
    7
    5
        Arthralgia
    0
    0
    4
    1
        Headache
    0
    0
    9
    11
        Sweating
    0
    0
    2
    4
        Fatigue
    0
    0
    7
    5
        Fever (≥38°C)
    89
    100
    41
    39
        Temp (≥40°C)
    0
    0
    0
    1
        Stayed Home
    30
    22
    8
    6
        Analg.Antipy. Med. Used
    46
    30
    17
    11
    Notes
    [9] - A total of 6 subjects were erroneously randomized in the 36 to < 60 aTIV months age group
    [10] - A total of 2 subjects were errneously randomized to 36 to < 60 TIV months of age group
    No statistical analyses for this end point

    Primary: Number of Subjects Reporting Unsolicited Adverse Events after any vaccination

    		 Close Top of page
    End point title
    		 Number of Subjects Reporting Unsolicited Adverse Events after any vaccination [11]
    End point description
    All AEs and concomitant medications were collected from visit 1 (day 1) to visit 5 (day 50
    End point type
    Primary
    End point timeframe
    Day 1 through day 50
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistical analysis done.
    End point values
    		 aTIV (≥6to ≤36 months) TIV (≥6 to ≤36 months) aTIV (≥36 to ≤60 months) TIV (≥36 to ≤60 months)
    Number of subjects analysed
    136
    132
    44
    48
    Units: Number of subjects
        Any AE
    57
    47
    16
    23
        At least possibly related AEs
    6
    3
    1
    1
        Any SAE
    0
    0
    0
    0
        At least possibly related SAEs
    0
    0
    0
    0
        AE leading to discontinuation
    0
    0
    1
    1
        Death
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Comparison of Antibody Responses of aTIV With TIV in Terms of Geometric Mean Titers (GMTs) Against mismatched Strains (Drifted Strains)

    		 Close Top of page
    End point title
    		 Comparison of Antibody Responses of aTIV With TIV in Terms of Geometric Mean Titers (GMTs) Against mismatched Strains (Drifted Strains)
    End point description
    The Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.
    End point type
    Secondary
    End point timeframe
    Day 1, Day 29 and Day 50
    End point values
    		 aTIV (≥6to ≤36 months) TIV (≥6 to ≤36 months) aTIV (≥36 to ≤60 months) TIV (≥36 to ≤60 months)
    Number of subjects analysed
    97
    102
    23
    20
    Units: Titers
    geometric mean (confidence interval 95%)
        A/HINI Day 1
    43 (36 to 52)
    45 (37 to 54)
    39 (25 to 62)
    61 (37 to 100)
        A/H1N1 Day 29
    207 (143 to 300)
    157 (109 to 225)
    430 (189 to 977)
    381 (155 to 933)
        A/H1N1 Day 50
    394 (298 to 522)
    279 (213 to 367)
    458 (259 to 809)
    426 (228 to 793)
        A/H3N2 Day 1
    19 (13 to 28)
    16 (11 to 23)
    40 (20 to 81)
    64 (30 to 138)
        A/H3N2 Day 29
    168 (104 to 273)
    56 (35 to 90)
    393 (167 to 925)
    827 (325 to 2107)
        A/H3N2 Day 50
    475 (346 to 651)
    56 (35 to 90)
    629 (363 to 1091)
    1014 (556 to 1850)
        B Strain Day 1
    15 (13 to 17)
    14 (12 to 16)
    16 (12 to 22)
    36 (25 to 51)
        B Strain Day 29
    25 (21 to 30)
    18 (16 to 22)
    57 (35 to 94)
    53 (31 to 92)
        B Strain Day 50
    55 (47 to 65)
    25 (21 to 29)
    73 (45 to 119)
    80 (47 to 136)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to Day 50
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    TIV (≥6 to ≤36 months)
    Reporting group description
    		 Children 6 to <36 months of age received two 0.25 mL doses of non-adjuvanted split influenza vaccine (TIV), administered four weeks apart

    Reporting group title
    aTIV (≥6to ≤36 months)
    Reporting group description
    		 Children 6 to <36 months of age received two 0.25 mL doses of MF59 adjuvanted trivalent influenza vaccine(aTIV), administered four weeks apart

    Reporting group title
    aTIV (≥36 to ≤60 months)
    Reporting group description
    		 Children 36 to <60 months of age received two 0.5 mL doses of aTIV, administered four weeks apart

    Reporting group title
    TIV (≥36 to ≤60 months)
    Reporting group description
    		 Children 36 to <60 months of age received two 0.5 mL doses of either TIV, administered four weeks apart.

    Reporting group title
    aTIV (≥6to ≤60 months)
    Reporting group description
    		 Children aged 6 to <36 months received two doses of 0.25 mL and those aged 36 to <60 received two doses of 0.5 mL of aTIV, administered four weeks apart.

    Reporting group title
    TIV (≥6 to ≤60 months)
    Reporting group description
    		 Children aged 6 to <36 months received two doses of 0.25 mL and those aged 36 to <60 received two doses of 0.5 mL of TIV, administered four weeks apart

    Serious adverse events
    		 TIV (≥6 to ≤36 months) aTIV (≥6to ≤36 months) aTIV (≥36 to ≤60 months) TIV (≥36 to ≤60 months) aTIV (≥6to ≤60 months) TIV (≥6 to ≤60 months)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 132 (0.76%)
    1 / 136 (0.74%)
    0 / 44 (0.00%)
    0 / 48 (0.00%)
    1 / 180 (0.56%)
    1 / 180 (0.56%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Multiple injuries
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 136 (0.00%)
    0 / 44 (0.00%)
    0 / 48 (0.00%)
    0 / 180 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Pleural cyst
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 136 (0.74%)
    0 / 44 (0.00%)
    0 / 48 (0.00%)
    1 / 180 (0.56%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Lobar pneumonia
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 136 (0.74%)
    0 / 44 (0.00%)
    0 / 48 (0.00%)
    1 / 180 (0.56%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    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
    		 TIV (≥6 to ≤36 months) aTIV (≥6to ≤36 months) aTIV (≥36 to ≤60 months) TIV (≥36 to ≤60 months) aTIV (≥6to ≤60 months) TIV (≥6 to ≤60 months)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    76 / 132 (57.58%)
    101 / 136 (74.26%)
    40 / 44 (90.91%)
    40 / 48 (83.33%)
    141 / 180 (78.33%)
    116 / 180 (64.44%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 132 (1.52%)
    0 / 136 (0.00%)
    9 / 44 (20.45%)
    11 / 48 (22.92%)
    9 / 180 (5.00%)
    13 / 180 (7.22%)
         occurrences all number
    2
    0
    13
    17
    13
    19
    Somnolence
         subjects affected / exposed
    8 / 132 (6.06%)
    9 / 136 (6.62%)
    0 / 44 (0.00%)
    0 / 48 (0.00%)
    9 / 180 (5.00%)
    8 / 180 (4.44%)
         occurrences all number
    9
    11
    0
    0
    11
    9
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    2 / 132 (1.52%)
    8 / 136 (5.88%)
    6 / 44 (13.64%)
    5 / 48 (10.42%)
    14 / 180 (7.78%)
    7 / 180 (3.89%)
         occurrences all number
    2
    8
    6
    6
    14
    8
    Crying
         subjects affected / exposed
    28 / 132 (21.21%)
    32 / 136 (23.53%)
    0 / 44 (0.00%)
    0 / 48 (0.00%)
    32 / 180 (17.78%)
    28 / 180 (15.56%)
         occurrences all number
    40
    43
    0
    0
    43
    40
    Fatigue
         subjects affected / exposed
    0 / 132 (0.00%)
    0 / 136 (0.00%)
    7 / 44 (15.91%)
    5 / 48 (10.42%)
    7 / 180 (3.89%)
    5 / 180 (2.78%)
         occurrences all number
    0
    0
    10
    6
    10
    6
    Injection site haemmorhage
         subjects affected / exposed
    18 / 132 (13.64%)
    18 / 136 (13.24%)
    11 / 44 (25.00%)
    9 / 48 (18.75%)
    29 / 180 (16.11%)
    27 / 180 (15.00%)
         occurrences all number
    22
    22
    13
    11
    35
    33
    Injection site induration
         subjects affected / exposed
    5 / 132 (3.79%)
    14 / 136 (10.29%)
    18 / 44 (40.91%)
    12 / 48 (25.00%)
    32 / 180 (17.78%)
    17 / 180 (9.44%)
         occurrences all number
    5
    18
    25
    16
    43
    21
    Injection site pain
         subjects affected / exposed
    25 / 132 (18.94%)
    31 / 136 (22.79%)
    29 / 44 (65.91%)
    20 / 48 (41.67%)
    60 / 180 (33.33%)
    45 / 180 (25.00%)
         occurrences all number
    32
    38
    43
    27
    81
    59
    Injection site swelling
         subjects affected / exposed
    5 / 132 (3.79%)
    8 / 136 (5.88%)
    12 / 44 (27.27%)
    6 / 48 (12.50%)
    20 / 180 (11.11%)
    11 / 180 (6.11%)
         occurrences all number
    6
    10
    12
    7
    22
    13
    Malaise
         subjects affected / exposed
    0 / 132 (0.00%)
    0 / 136 (0.00%)
    15 / 44 (34.09%)
    13 / 48 (27.08%)
    15 / 180 (8.33%)
    13 / 180 (7.22%)
         occurrences all number
    0
    0
    18
    20
    18
    20
    Pyrexia
         subjects affected / exposed
    34 / 132 (25.76%)
    44 / 136 (32.35%)
    11 / 44 (25.00%)
    13 / 48 (27.08%)
    55 / 180 (30.56%)
    47 / 180 (26.11%)
         occurrences all number
    44
    56
    12
    15
    68
    59
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    12 / 132 (9.09%)
    20 / 136 (14.71%)
    0 / 44 (0.00%)
    2 / 48 (4.17%)
    20 / 180 (11.11%)
    14 / 180 (7.78%)
         occurrences all number
    14
    25
    0
    0
    25
    16
    Vomiting
         subjects affected / exposed
    8 / 132 (6.06%)
    12 / 136 (8.82%)
    2 / 44 (4.55%)
    0 / 48 (0.00%)
    14 / 180 (7.78%)
    8 / 180 (4.44%)
         occurrences all number
    8
    14
    2
    0
    16
    8
    Injection site erythema
         subjects affected / exposed
    18 / 132 (13.64%)
    32 / 136 (23.53%)
    20 / 44 (45.45%)
    19 / 48 (39.58%)
    52 / 180 (28.89%)
    37 / 180 (20.56%)
         occurrences all number
    23
    41
    28
    24
    69
    47
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity
         subjects affected / exposed
    5 / 132 (3.79%)
    8 / 136 (5.88%)
    1 / 44 (2.27%)
    1 / 48 (2.08%)
    9 / 180 (5.00%)
    6 / 180 (3.33%)
         occurrences all number
    5
    9
    1
    2
    10
    7
    Cough
         subjects affected / exposed
    5 / 132 (3.79%)
    6 / 136 (4.41%)
    5 / 44 (11.36%)
    8 / 48 (16.67%)
    11 / 180 (6.11%)
    13 / 180 (7.22%)
         occurrences all number
    5
    6
    6
    10
    12
    15
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 132 (0.00%)
    0 / 136 (0.00%)
    2 / 44 (4.55%)
    4 / 48 (8.33%)
    2 / 180 (1.11%)
    4 / 180 (2.22%)
         occurrences all number
    0
    0
    3
    4
    3
    4
    Psychiatric disorders
    Eating disorder
         subjects affected / exposed
    18 / 132 (13.64%)
    22 / 136 (16.18%)
    0 / 44 (0.00%)
    0 / 48 (0.00%)
    22 / 180 (12.22%)
    18 / 180 (10.00%)
         occurrences all number
    24
    29
    0
    0
    29
    24
    Irritability
         subjects affected / exposed
    20 / 132 (15.15%)
    23 / 136 (16.91%)
    0 / 44 (0.00%)
    0 / 48 (0.00%)
    23 / 180 (12.78%)
    20 / 180 (11.11%)
         occurrences all number
    21
    37
    0
    0
    31
    27
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 132 (0.00%)
    0 / 136 (0.00%)
    4 / 44 (9.09%)
    1 / 48 (2.08%)
    4 / 180 (2.22%)
    1 / 180 (0.56%)
         occurrences all number
    0
    0
    5
    1
    5
    1
    Myalgia
         subjects affected / exposed
    0 / 132 (0.00%)
    0 / 136 (0.00%)
    7 / 44 (15.91%)
    5 / 48 (10.42%)
    7 / 180 (3.89%)
    5 / 180 (2.78%)
         occurrences all number
    0
    0
    10
    6
    10
    6
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 132 (2.27%)
    7 / 136 (5.15%)
    5 / 44 (11.36%)
    2 / 48 (4.17%)
    12 / 180 (6.67%)
    5 / 180 (2.78%)
         occurrences all number
    3
    7
    5
    2
    12
    5
    Nasopharyngitis
         subjects affected / exposed
    7 / 132 (5.30%)
    16 / 136 (11.76%)
    1 / 44 (2.27%)
    2 / 48 (4.17%)
    17 / 180 (9.44%)
    9 / 180 (5.00%)
         occurrences all number
    9
    16
    2
    2
    18
    11
    Otitis Media
         subjects affected / exposed
    6 / 132 (4.55%)
    8 / 136 (5.88%)
    3 / 44 (6.82%)
    3 / 48 (6.25%)
    11 / 180 (6.11%)
    9 / 180 (5.00%)
         occurrences all number
    6
    10
    3
    3
    13
    9
    Pharyngitis streptococcal
         subjects affected / exposed
    5 / 132 (3.79%)
    5 / 136 (3.68%)
    0 / 44 (0.00%)
    5 / 48 (10.42%)
    5 / 180 (2.78%)
    10 / 180 (5.56%)
         occurrences all number
    6
    5
    0
    5
    5
    11
    Tonsillitis
         subjects affected / exposed
    2 / 132 (1.52%)
    7 / 136 (5.15%)
    0 / 44 (0.00%)
    4 / 48 (8.33%)
    7 / 180 (3.89%)
    6 / 180 (3.33%)
         occurrences all number
    2
    7
    0
    4
    7
    6
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 132 (6.82%)
    11 / 136 (8.09%)
    1 / 44 (2.27%)
    3 / 48 (6.25%)
    12 / 180 (6.67%)
    12 / 180 (6.67%)
         occurrences all number
    9
    13
    1
    4
    14
    13
    Varicella
         subjects affected / exposed
    4 / 132 (3.03%)
    9 / 136 (6.62%)
    2 / 44 (4.55%)
    2 / 48 (4.17%)
    11 / 180 (6.11%)
    6 / 180 (3.33%)
         occurrences all number
    4
    9
    2
    2
    11
    6

    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/20813217
    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-Wed Apr 24 03:11:23 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA