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    Clinical Trial Results:
    A Phase II, Observer-Blind, Parallel Groups, Single Center, Extension Study to Evaluate the Immunogenicity and Safety Following a Single Intramuscular Dose of Fluad® or Vaxigrip® Influenza Vaccines in Healthy Children who Received Either One or the Other Vaccine in the Previous V70P2 Study.

    Summary
    EudraCT number
    		 2007-003339-22
    Trial protocol
    		 FI  
    Global end of trial date
    11 Jun 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 Jul 2016
    First version publication date
    07 Dec 2014
    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

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    Trial identification
    Sponsor protocol code
    V70P2E1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00644540
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics S.r.l.
    Sponsor organisation address
    Via Fiorentina 1, Siena, Italy, 53100
    Public contact
    Posting Director, Novartis Vaccines, RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines, RegistryContactVaccinesUS@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000149-PIP01-07
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Oct 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jun 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To evaluate the immunogenicity of a single 0.25mL or 0.5mL IM injection of Fluad or Vaxigrip influenza vaccines in healthy children aged up to 48 months. •To evaluate the safety and tolerability of a single 0.25mL or 0.5mL IM injection of Fluad or Vaxigrip influenza vaccines in healthy children aged up to 48 months.
    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
    14 Nov 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 89
    Worldwide total number of subjects
    89
    EEA total number of subjects
    89
    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)
    13
    Children (2-11 years)
    76
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled in one centre in Finland.

    Pre-assignment
    Screening details
    		 All children 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, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 aTIV <36
    Arm description
    		 Each subject has received half a dose of a TIV.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adjuvunated trivalent influenza virus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose of 0.25mL of vaccine is administered by IM injection into deltoid muscle of non-dominant arm.

    Arm title
    		 TIV <36
    Arm description
    		 Each subject has received a half a dose of TIV.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Trivalent influenza vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose of 0.25mL of vaccine is administered by IM injection into deltoid muscle of non-dominant arm.

    Arm title
    		 aTIV >36
    Arm description
    		 Each subject has received a full dose of aTIV.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adjuvunated trivalent influenza virus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose of 0.5mL of vaccine is administered by IM injection into deltoid muscle of non-dominant arm.

    Arm title
    		 TIV >36
    Arm description
    		 Each subject has received a full dose of TIV.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Trivalent influenza vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose of 0.5mL of vaccine is administered by IM injection into deltoid muscle of non-dominant arm.

    Number of subjects in period 1
    		aTIV <36 TIV <36 aTIV >36 TIV >36
    Started
    25
    23
    18
    23
    Completed
    24
    23
    16
    21
    Not completed
    1
    0
    2
    2
         Withdrew Consent
    -
    -
    -
    1
         Lost to follow-up
    1
    -
    1
    -
         Inappropriate Enrollment
    -
    -
    -
    1
         Protocol deviation
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    aTIV <36
    Reporting group description
    		 Each subject has received half a dose of a TIV.

    Reporting group title
    TIV <36
    Reporting group description
    		 Each subject has received a half a dose of TIV.

    Reporting group title
    aTIV >36
    Reporting group description
    		 Each subject has received a full dose of aTIV.

    Reporting group title
    TIV >36
    Reporting group description
    		 Each subject has received a full dose of TIV.

    Reporting group values
    		 aTIV <36 TIV <36 aTIV >36 TIV >36 Total
    Number of subjects
    		 25 23 18 23 89
    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: days
        arithmetic mean (standard deviation)
    		 27.2 ( 5.4 ) 27.2 ( 5.5 ) 42.3 ( 3 ) 40.7 ( 3.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 12 9 9 40
        Male
    		 15 11 9 14 49

    End points

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    End points reporting groups
    Reporting group title
    aTIV <36
    Reporting group description
    		 Each subject has received half a dose of a TIV.

    Reporting group title
    TIV <36
    Reporting group description
    		 Each subject has received a half a dose of TIV.

    Reporting group title
    aTIV >36
    Reporting group description
    		 Each subject has received a full dose of aTIV.

    Reporting group title
    TIV >36
    Reporting group description
    		 Each subject has received a full dose of TIV.

    Subject analysis set title
    All enrolled population - TIV
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All children who have data in the DEMOG panel.

    Subject analysis set title
    All enrolled population - aTIV
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All children who have data in the DEMOG panel.

    Subject analysis set title
    Per Protocol Population - TIV
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All enrolled subjects in the Full Analysis Set who received all the doses of vaccine correctly, provided evaluable serum samples at the relevant time points and had no major violations of inclusion/exclusion criteria.

    Subject analysis set title
    Per Protocol Population - aTIV
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All enrolled subjects in the Full Analysis Set who received all the doses of vaccine correctly, provided evaluable serum samples at the relevant time points and had no major violations of inclusion/exclusion criteria.

    Subject analysis set title
    Safety Population - TIV
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the Exposed population who provided post-baseline safety data.

    Subject analysis set title
    Safety Population - aTIV
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the Exposed population who provided post-baseline safety data.

    Primary: GMTs as measured by HI assay in the overall population and in the two age strata

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    End point title
    		 GMTs as measured by HI assay in the overall population and in the two age strata
    End point description
    The immune response after a single IM injection of aTIV or TIV, in terms of post-vaccination GMTs is measured by hemagglutinin inhibition (HI) assay in the overall population and in the two age strata (<36 months and ≥36 months of age).
    End point type
    Primary
    End point timeframe
    Day 1 (baseline) and day 22
    End point values
    		 aTIV <36 TIV <36 aTIV >36 TIV >36 Per Protocol Population - TIV Per Protocol Population - aTIV
    Number of subjects analysed
    23
    20
    18
    20
    40
    41
    Units: GMT
    geometric mean (confidence interval 95%)
        A/H1N1 – Day 1
    8.73 (5.94 to 13)
    6.6 (3.69 to 12)
    16 (6.12 to 40)
    7.98 (4.36 to 15)
    7.26 (4.86 to 11)
    11 (7.18 to 18)
        A/H1N1 – Day 22
    1068 (671 to 1701)
    283 (171 to 471)
    978 (617 to 1549)
    511 (297 to 879)
    381 (264 to 549)
    1027 (749 to 1409)
        A/H3N2 – Day 1
    84 (55 to 127)
    32 (19 to 53)
    60 (35 to 104)
    32 (15 to 68)
    32 (21 to 49)
    72 (52 to 100)
        A/H3N2 – Day 22
    1401 (1020 to 1924)
    251 (186 to 338)
    1076 (765 to 1513)
    608 (398 to 926)
    391 (294 to 519)
    1248 (995 to 1564)
        B Day1
    9.14 (6.84 to 12)
    5 (5 to 5)
    11 (6.92 to 18)
    5.18 (4.81 to 5.57)
    5.09 (4.91 to 5.27)
    9.91 (7.72 to 13)
        B Day 22
    178 (137 to 231)
    21 (14 to 32)
    187 (130 to 269)
    83 (56 to 121)
    41 (29 to 59)
    182 (148 to 223)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Non inferiority a single aTIV vaccination respect to a single TIV vaccination against strain H1N1 is evaluated through the comparison of respective GMTs at day 22 as measured by the between groups ratios
    Comparison groups
    Per Protocol Population - TIV v Per Protocol Population - aTIV
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    		 ANOVA
    Parameter type
    		 Between Groups GMT Ratio
    Point estimate
    2.69
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.81
         upper limit
    		 3.99
    Notes
    [1] - aTIV immune response is to be considered non inferior to TIV immune response if the lower limit of the 95% CI of the between groups ratios of GMTs at day 22 is greater than 0.5
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Non inferiority a single aTIV vaccination respect to a single TIV vaccination against strain H3N2 is evaluated through the comparison of respective GMTs at day 22 as measured by the between groups ratios
    Comparison groups
    Per Protocol Population - aTIV v Per Protocol Population - TIV
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    		 ANOVA
    Parameter type
    		 Between Groups GMT Ratio
    Point estimate
    3.14
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 2.38
         upper limit
    		 4.15
    Notes
    [2] - aTIV immune response is to be considered non inferior to TIV immune response if the lower limit of the 95% CI of the between groups ratios of GMTs at day 22 is greater than 0.5
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Non inferiority a single aTIV vaccination respect to a single TIV vaccination against strain B is evaluated through the comparison of respective GMTs at day 22 as measured by the between groups ratios
    Comparison groups
    Per Protocol Population - aTIV v Per Protocol Population - TIV
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    		 ANOVA
    Parameter type
    		 Between Groups GMT Ratio
    Point estimate
    4.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 3.3
         upper limit
    		 5.86
    Notes
    [3] - aTIV immune response is to be considered non inferior to TIV immune response if the lower limit of the 95% CI of the between groups ratios of GMTs at day 22 is greater than 0.5

    Primary: Number of subjects who reported solicited local and systemic reactions from day 1 to day 7 after vaccination.

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    End point title
    		 Number of subjects who reported solicited local and systemic reactions from day 1 to day 7 after vaccination. [4]
    End point description
    Safety was assessed as the number of subjects who reported local and systemic reactions from day 1 to day 7 after vaccination with TIV and aTIV.
    End point type
    Primary
    End point timeframe
    Days 1 to 7
    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: No inferential statistical analysis was done.
    End point values
    		 aTIV <36 TIV <36 aTIV >36 TIV >36 Safety Population - TIV Safety Population - aTIV
    Number of subjects analysed
    25
    23
    18
    23
    46
    43
    Units: Number of Subjects
        Local (Any)
    15
    10
    15
    11
    21
    30
        Ecchymosis (Local)
    2
    3
    1
    4
    7
    3
        Erythema (Local)
    8
    7
    5
    5
    12
    13
        Induration (Local)
    3
    3
    5
    5
    8
    8
        Swelling (Local)
    3
    4
    3
    0
    4
    6
        Tenderness (Local)
    8
    7
    0
    0
    7
    8
        Pain at Injection Site (Local)
    0
    0
    12
    6
    6
    12
        Systemic (Any)
    11
    9
    7
    8
    17
    18
        Change in eating habits (Systemic)
    3
    5
    0
    0
    5
    3
        Sleepiness (Systemic)
    1
    4
    0
    0
    4
    1
        Unusual crying (Systemic)
    2
    4
    0
    0
    4
    2
        Irritability (Irritability)
    9
    5
    0
    0
    5
    9
        Vomiting (Systemic)
    0
    1
    0
    0
    1
    0
        Diarrhoea (Systemic)
    6
    3
    0
    0
    3
    6
        Shivering (Systemic)
    0
    0
    0
    0
    0
    0
        Other (Analgesic/Antipyretic Medication used) (Sy)
    5
    3
    4
    1
    4
    9
        Chills (Systemic)
    0
    0
    4
    4
    4
    4
        Malaise (Systemic)
    0
    0
    2
    4
    4
    2
        Myalgia (Systemic)
    0
    0
    2
    1
    1
    2
        Arthralgia (Systemic)
    0
    0
    2
    0
    0
    2
        Headache (Systemic)
    0
    0
    3
    2
    2
    3
        Fatigue (Systemic)
    0
    0
    5
    8
    8
    5
    No statistical analyses for this end point

    Primary: Number of subjects reported with unsolicited adverse events post vaccination

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    End point title
    		 Number of subjects reported with unsolicited adverse events post vaccination [5]
    End point description
    Safety was assessed as the number of subjects who reported Unsolicited AE’s during day 1 to day 181 after vaccination with TIV and aTIV.
    End point type
    Primary
    End point timeframe
    Days 1 to day 181 (Study termination).
    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: No inferential statistical analysis was done.
    End point values
    		 aTIV <36 TIV <36 aTIV >36 TIV >36 Safety Population - TIV Safety Population - aTIV
    Number of subjects analysed
    25
    23
    18
    23
    46
    43
    Units: Number of Subjects
        Any Adverse Event
    17
    16
    13
    19
    35
    30
        Serious Adverse Events
    0
    0
    0
    0
    0
    0
        Medically attended AEs
    15
    9
    9
    12
    21
    24
        AEs leading to discontinuation
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentages of Subjects Achieving Seroprotection and Seroconversion or Significant Increase in HI Titres, by Age Group

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    End point title
    		 Percentages of Subjects Achieving Seroprotection and Seroconversion or Significant Increase in HI Titres, by Age Group
    End point description
    The immune response after a single IM injection of aTIV or TIV is measured in terms of percentages of subjects achieving Seroprotection (SP) and Seroconversion (SC) in HI Titres.
    End point type
    Secondary
    End point timeframe
    Day1(baseline) and day 22
    End point values
    		 aTIV <36 TIV <36 aTIV >36 TIV >36 Per Protocol Population - TIV Per Protocol Population - aTIV
    Number of subjects analysed
    23
    20
    18
    20
    40
    41
    Units: Percentages
    number (confidence interval 95%)
        A/H1N1 – Day 1 SP
    9 (1 to 28)
    5 (0 to 25)
    22 (6 to 48)
    5 (0 to 25)
    5 (1 to 17)
    15 (6 to 29)
        A/H1N1 – Day 22 SP
    100 (85 to 100)
    100 (83 to 100)
    100 (81 to 100)
    100 (83 to 100)
    100 (91 to 100)
    100 (91 to 100)
        A/H1N1 – Day 22 SC
    100 (85 to 100)
    95 (75 to 100)
    89 (65 to 99)
    95 (75 to 100)
    95 (83 to 99)
    95 (83 to 99)
        A/H3N2 – Day 1 SP
    96 (78 to 100)
    50 (27 to 73)
    78 (52 to 94)
    30 (12 to 54)
    40 (25 to 57)
    88 (74 to 96)
        A/H3N2 – Day 22 SP
    100 (85 to 100)
    100 (83 to 100)
    100 (81 to 100)
    100 (83 to 100)
    100 (91 to 100)
    100 (91 to 100)
        A/H3N2 – Day 22 SC
    100 (85 to 100)
    85 (62 to 97)
    94 (73 to 100)
    85 (62 to 97)
    85 (70 to 94)
    98 (87 to 100)
        B Day1 SP
    4 (0 to 22)
    0 (0 to 17)
    17 (4 to 41)
    0 (0 to 17)
    0 (0 to 9)
    10 (3 to 23)
        B Day 22 SP
    100 (85 to 100)
    45 (23 to 68)
    100 (81 to 100)
    90 (68 to 99)
    68 (51 to 81)
    100 (91 to 100)
        B Day 22 SC
    96 (78 to 100)
    45 (23 to 68)
    100 (81 to 100)
    90 (68 to 99)
    68 (51 to 81)
    98 (87 to 100)
    No statistical analyses for this end point

    Secondary: Geometric Mean HI Titers against mismatched strains measured at day 1 and 22

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    End point title
    		 Geometric Mean HI Titers against mismatched strains measured at day 1 and 22
    End point description
    Immunogenicity against mismatched strains was evaluated by measuring the post immunization geometric mean titers (GMTs), as measured by hemagglutinin inhibition (HI).
    End point type
    Secondary
    End point timeframe
    Day1(baseline) and day 22
    End point values
    		 aTIV <36 TIV <36 aTIV >36 TIV >36 Per Protocol Population - TIV Per Protocol Population - aTIV
    Number of subjects analysed
    23
    20
    18
    20
    40
    41
    Units: GMT
    geometric mean (confidence interval 95%)
        A/H1N1 – Day 1
    18 (12 to 27)
    9.66 (6.14 to 15)
    23 (12 to 46)
    10 (5.97 to 17)
    9.83 (7.09 to 14)
    20 (14 to 29)
        A/H1N1 – Day 22
    1037 (676 to 1590)
    211 (127 to 351)
    871 (586 to 1294)
    485 (266 to 885)
    320 (215 to 477)
    960 (722 to 1277)
        A/H3N2 – Day 1
    18 (11 to 31)
    8.71 (4.91 to 15)
    15 (8.31 to 26)
    11 (5.2 to 25)
    10 (6.26 to 16)
    17 (11 to 24)
        A/H3N2 – Day 22
    378 (244 to 585)
    87 (57 to 134)
    308 (185 to 514)
    181 (109 to 300)
    126 (90 to 176)
    345 (251 to 475)
        B Day 1
    5 (5 to 5)
    5 (5 to 5)
    5.2 (4.79 to 5.64)
    5 (5 to 5)
    5 (5 to 5)
    5.09 (4.91 to 5.26)
        B Day 22
    24 (17 to 32)
    6.16 (4.97 to 7.62)
    22 (15 to 31)
    10 (7.25 to 15)
    7.98 (6.44 to 9.9)
    23 (18 to 29)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited adverse events (AEs) were collected from Day 1 through 7; Serious AEs were collected from day 1 to day 181 after vaccination.
    Adverse event reporting additional description
    Solicited adverse events were collected by systematic assessment; Unsolicited adverse events were collected by non-systematic assessment; analysis was performed as per the safety data set.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    aTIV <36
    Reporting group description
    		 Each subject has received half a dose of a TIV.

    Reporting group title
    TIV <36
    Reporting group description
    		 Each subject has received a half a dose of TIV.

    Reporting group title
    aTIV >36
    Reporting group description
    		 Each subject has received a full dose of aTIV.

    Reporting group title
    TIV >36
    Reporting group description
    		 Each subject has received a full dose of TIV.

    Reporting group title
    aTIV overall
    Reporting group description
    		 Each subject received either half or full dose of aTIV.

    Reporting group title
    TIV overall
    Reporting group description
    		 Each subject received either half or full dose of TIV.

    Serious adverse events
    		 aTIV <36 TIV <36 aTIV >36 TIV >36 aTIV overall TIV overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 43 (0.00%)
    0 / 46 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 aTIV <36 TIV <36 aTIV >36 TIV >36 aTIV overall TIV overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 25 (84.00%)
    17 / 23 (73.91%)
    17 / 18 (94.44%)
    19 / 23 (82.61%)
    38 / 43 (88.37%)
    36 / 46 (78.26%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    1 / 25 (4.00%)
    4 / 23 (17.39%)
    0 / 18 (0.00%)
    1 / 23 (4.35%)
    1 / 43 (2.33%)
    5 / 46 (10.87%)
         occurrences all number
    1
    5
    0
    1
    1
    6
    Headache
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    3 / 18 (16.67%)
    3 / 23 (13.04%)
    3 / 43 (6.98%)
    3 / 46 (6.52%)
         occurrences all number
    0
    0
    3
    5
    3
    5
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    4 / 18 (22.22%)
    4 / 23 (17.39%)
    4 / 43 (9.30%)
    4 / 46 (8.70%)
         occurrences all number
    0
    0
    4
    4
    4
    4
    Crying
         subjects affected / exposed
    2 / 25 (8.00%)
    5 / 23 (21.74%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    2 / 43 (4.65%)
    5 / 46 (10.87%)
         occurrences all number
    2
    5
    0
    0
    2
    5
    Fatigue
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    5 / 18 (27.78%)
    8 / 23 (34.78%)
    5 / 43 (11.63%)
    8 / 46 (17.39%)
         occurrences all number
    0
    0
    6
    8
    6
    8
    Injection Site Erythema
         subjects affected / exposed
    8 / 25 (32.00%)
    7 / 23 (30.43%)
    5 / 18 (27.78%)
    5 / 23 (21.74%)
    13 / 43 (30.23%)
    12 / 46 (26.09%)
         occurrences all number
    8
    7
    6
    5
    14
    12
    Injection Site Haemorrahage
         subjects affected / exposed
    2 / 25 (8.00%)
    3 / 23 (13.04%)
    1 / 18 (5.56%)
    4 / 23 (17.39%)
    3 / 43 (6.98%)
    7 / 46 (15.22%)
         occurrences all number
    2
    3
    1
    4
    3
    7
    Injection Site Induration
         subjects affected / exposed
    3 / 25 (12.00%)
    3 / 23 (13.04%)
    5 / 18 (27.78%)
    5 / 23 (21.74%)
    8 / 43 (18.60%)
    8 / 46 (17.39%)
         occurrences all number
    3
    3
    5
    5
    8
    8
    Injection Site Pain
         subjects affected / exposed
    8 / 25 (32.00%)
    7 / 23 (30.43%)
    12 / 18 (66.67%)
    6 / 23 (26.09%)
    20 / 43 (46.51%)
    13 / 46 (28.26%)
         occurrences all number
    9
    7
    13
    6
    22
    13
    Injection Site Swelling
         subjects affected / exposed
    3 / 25 (12.00%)
    4 / 23 (17.39%)
    3 / 18 (16.67%)
    0 / 23 (0.00%)
    6 / 43 (13.95%)
    4 / 46 (8.70%)
         occurrences all number
    3
    4
    3
    0
    6
    4
    Malaise
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    2 / 18 (11.11%)
    4 / 23 (17.39%)
    2 / 43 (4.65%)
    4 / 46 (8.70%)
         occurrences all number
    0
    0
    2
    4
    2
    4
    Pyrexia
         subjects affected / exposed
    7 / 25 (28.00%)
    4 / 23 (17.39%)
    3 / 18 (16.67%)
    5 / 23 (21.74%)
    10 / 43 (23.26%)
    9 / 46 (19.57%)
         occurrences all number
    7
    4
    3
    6
    10
    10
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    7 / 25 (28.00%)
    4 / 23 (17.39%)
    0 / 18 (0.00%)
    1 / 23 (4.35%)
    7 / 43 (16.28%)
    5 / 46 (10.87%)
         occurrences all number
    7
    7
    0
    1
    7
    8
    Lip dry
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 23 (0.00%)
    1 / 43 (2.33%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Vomitting
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 23 (4.35%)
    2 / 18 (11.11%)
    1 / 23 (4.35%)
    2 / 43 (4.65%)
    2 / 46 (4.35%)
         occurrences all number
    0
    1
    2
    1
    2
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 25 (20.00%)
    4 / 23 (17.39%)
    4 / 18 (22.22%)
    4 / 23 (17.39%)
    9 / 43 (20.93%)
    8 / 46 (17.39%)
         occurrences all number
    8
    4
    4
    8
    12
    12
    Asthma
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 23 (0.00%)
    1 / 43 (2.33%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 23 (0.00%)
    1 / 43 (2.33%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Wheezing
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 23 (0.00%)
    1 / 43 (2.33%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Psychiatric disorders
    Eating Disorder
         subjects affected / exposed
    3 / 25 (12.00%)
    5 / 23 (21.74%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    3 / 43 (6.98%)
    5 / 46 (10.87%)
         occurrences all number
    3
    5
    0
    0
    3
    5
    Irritability
         subjects affected / exposed
    9 / 25 (36.00%)
    7 / 23 (30.43%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    9 / 43 (20.93%)
    7 / 46 (15.22%)
         occurrences all number
    10
    8
    0
    0
    10
    8
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    2 / 18 (11.11%)
    0 / 23 (0.00%)
    2 / 43 (4.65%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    2
    0
    2
    0
    Myalgia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    2 / 18 (11.11%)
    1 / 23 (4.35%)
    2 / 43 (4.65%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    3
    1
    3
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 25 (8.00%)
    2 / 23 (8.70%)
    2 / 18 (11.11%)
    0 / 23 (0.00%)
    4 / 43 (9.30%)
    2 / 46 (4.35%)
         occurrences all number
    2
    2
    2
    0
    4
    2
    Conjunctivitis
         subjects affected / exposed
    0 / 25 (0.00%)
    4 / 23 (17.39%)
    2 / 18 (11.11%)
    1 / 23 (4.35%)
    2 / 43 (4.65%)
    5 / 46 (10.87%)
         occurrences all number
    0
    4
    2
    1
    2
    5
    Ear Infection
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 23 (8.70%)
    0 / 18 (0.00%)
    1 / 23 (4.35%)
    1 / 43 (2.33%)
    3 / 46 (6.52%)
         occurrences all number
    1
    2
    0
    1
    1
    3
    Otitis media
         subjects affected / exposed
    8 / 25 (32.00%)
    7 / 23 (30.43%)
    5 / 18 (27.78%)
    7 / 23 (30.43%)
    13 / 43 (30.23%)
    14 / 46 (30.43%)
         occurrences all number
    10
    11
    9
    10
    19
    21
    Nasopharyngitis
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 23 (4.35%)
    1 / 18 (5.56%)
    1 / 23 (4.35%)
    3 / 43 (6.98%)
    2 / 46 (4.35%)
         occurrences all number
    2
    1
    1
    1
    3
    2
    Rhinitis
         subjects affected / exposed
    4 / 25 (16.00%)
    4 / 23 (17.39%)
    2 / 18 (11.11%)
    3 / 23 (13.04%)
    6 / 43 (13.95%)
    7 / 46 (15.22%)
         occurrences all number
    5
    5
    2
    3
    7
    8
    Sinusitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 23 (0.00%)
    1 / 43 (2.33%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 25 (24.00%)
    3 / 23 (13.04%)
    2 / 18 (11.11%)
    5 / 23 (21.74%)
    8 / 43 (18.60%)
    8 / 46 (17.39%)
         occurrences all number
    7
    3
    2
    5
    9
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Oct 2007
    • exclusion criteria have been amended • "Adherence to Treatment Allocation List" has been updated. • Flowchart for Serious Adverse Events reporting. • Outer label for both study vaccines was added and a typing error was amended.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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.

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