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    Clinical Trial Results:
    A Phase III, Observer-Blind, Randomized Multicenter Study to Evaluate the Safety of Trivalent Subunit Influenza Vaccines, Produced Either in Mammalian Cell Culture (TIVc) or in Embryonated Eggs (TIV), in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related Complications

    Summary
    EudraCT number
    		 2013-002080-26
    Trial protocol
    		 IT   ES  
    Global end of trial date
    31 Jul 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    29 Jul 2016
    First version publication date
    30 Jan 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Required for the re-QC because of EudraCT system glitch as possible updates to results are required. Moreover, the study is now transferred to another primary user.

    Trial information

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    Trial identification
    Sponsor protocol code
    V58P15
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01998477
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics
    Sponsor organisation address
    Via Fiorentina, 1, 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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000124-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
    23 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of 1 or 2 intramuscular doses (administered 4 weeks apart) of either the cell culture derived influenza vaccine TIVc or the egg derived influenza vaccine TIV in children and adolescents, 3 to < 18 years of age, at risk for influenza related complications.
    Protection of trial subjects
    This trial was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with Good Clinical Practice (GCP), and the applicable regulatory requirement(s) for the country in which the trial was conducted according to International Conference on Harmonisation (ICH) guidelines, and applicable Standard Operating Procedures (SOPs).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Oct 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 327
    Country: Number of subjects enrolled
    Italy: 103
    Worldwide total number of subjects
    430
    EEA total number of subjects
    430
    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)
    0
    Children (2-11 years)
    214
    Adolescents (12-17 years)
    216
    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 recruited from 12 centers in Spain and 4 centers from Italy.

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

    Period 1
    Period 1 title
    Enrolled (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TIVc
    Arm description
    		 Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cell culture derived influenza vaccine
    Investigational medicinal product code
    V58
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A 0.5 mL dose of Madin Darby Canine Kidney (MDCK) cell culture derived subunit influenza vaccine TIVc intramuscular (IM) injection.

    Arm title
    		 TIVe
    Arm description
    		 Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIVe)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Egg derived subunit influenza vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A 0.5 mL dose of a conventional egg derived subunit influenza vaccine (TIV) IM injection

    Number of subjects in period 1
    		TIVc TIVe
    Started
    282
    148
    Completed
    272
    143
    Not completed
    10
    5
         Consent withdrawn by subject
    6
    -
         Lost to follow-up
    4
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    TIVc
    Reporting group description
    		 Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)

    Reporting group title
    TIVe
    Reporting group description
    		 Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIVe)

    Reporting group values
    		 TIVc TIVe Total
    Number of subjects
    		 282 148 430
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 140 74 214
        Adolescents (12-17 years)
    		 142 74 216
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.7 ± 4 9 ± 3.9 -
    Gender categorical
    Units: Subjects
        Female
    		 121 63 184
        Male
    		 161 85 246

    End points

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    End points reporting groups
    Reporting group title
    TIVc
    Reporting group description
    		 Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)

    Reporting group title
    TIVe
    Reporting group description
    		 Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIVe)

    Subject analysis set title
    TIVc _inj 1 (3 to <18 Years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine naïve and non-naive subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)

    Subject analysis set title
    TIVc_inj 2 (3 to <18 Years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine naïve and non-naive subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)

    Subject analysis set title
    TIV_inj 1 (3 to <18 Years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine naïve and non-naive subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)

    Subject analysis set title
    TIV_inj 2 (3 to <18 Years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine naïve and non-naive subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)

    Subject analysis set title
    TIVc_Non naive_inj 1 (3 to <6 years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine non-naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)

    Subject analysis set title
    TIVc_naive_inj 1 (3 to <6 years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)

    Subject analysis set title
    TIVc_naive_inj 2 (3 to <6 years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)

    Subject analysis set title
    TIV_Non naive_inj 1 (3 to <6 years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine nonnaïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)

    Subject analysis set title
    TIV_naive_inj 1 (3 to <6 years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)

    Subject analysis set title
    TIV_naive_inj 2 (3 to <6 years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)

    Subject analysis set title
    TIVc_Non naive_Inj 1 (≥ 6 to < 9 years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine non-naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)

    Subject analysis set title
    TIVc_Naive_inj 1 (≥ 6 to < 9 years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)

    Subject analysis set title
    TIVc_Naive_inj 2 (≥ 6 to < 9 years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)

    Subject analysis set title
    TIV_Non Naive_inj 1 (≥ 6 to < 9 years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine non-naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)

    Subject analysis set title
    TIV_Naive_inj 1 (≥ 6 to < 9 years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)

    Subject analysis set title
    TIV_Naive_inj 2 (≥ 6 to < 9 years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIV)

    Subject analysis set title
    TIVc_Naive (3 to <9 Years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)

    Subject analysis set title
    TIVc_Non naive (3 to <9 Years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine non naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)

    Subject analysis set title
    TIVc_Non naive (9 to <18 Years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine nonnaïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)

    Subject analysis set title
    TIV_Naive (3 to <9 Years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation

    Subject analysis set title
    TIV_Non naive (3 to <9 Years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine non naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)

    Subject analysis set title
    TIV_Non naive (9 to <18 Years)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Vaccine nonnaïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)

    Primary: 1.Number of subjects reporting solicited adverse events (AEs) following vaccination with either TIVc or TIV by overall age group

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    End point title
    		 1.Number of subjects reporting solicited adverse events (AEs) following vaccination with either TIVc or TIV by overall age group [1]
    End point description
    Safety was assessed in terms of number of the subjects (3 to < 18 years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV
    End point type
    Primary
    End point timeframe
    Day 1 through Day 7 post injection 1 and Day 29 through Day 35 post injection 2
    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: Statistical analysis not applicable for the Outcome measure.
    End point values
    		 TIVc _inj 1 (3 to <18 Years) TIVc_inj 2 (3 to <18 Years) TIV_inj 1 (3 to <18 Years) TIV_inj 2 (3 to <18 Years)
    Number of subjects analysed
    277
    83
    145
    40
    Units: Subjects
        Any Local
    149
    41
    89
    18
        Injection Site Tenderness
    25
    20
    17
    6
        Injection Site Pain
    106
    19
    65
    8
        Injection site erythema < 6 years
    8
    3
    4
    4
        Injection site induration < 6 years
    7
    5
    4
    3
        Injection site ecchymosis <6 years
    6
    1
    3
    3
        Injection site erythema >= 6 years
    16
    5
    22
    3
        Injection site induration >= 6 years
    22
    3
    23
    3
        Injection site ecchymosis >= 6 years
    8
    2
    5
    5
        Any Systemic
    117
    29
    55
    8
        Change in eating habits
    12
    6
    7
    2
        Chills
    32
    6
    9
    0
        Diarrhea
    19
    2
    5
    3
        Irritability
    14
    5
    7
    2
        Sleepiness
    10
    5
    3
    2
        Vomiting
    18
    3
    5
    1
        Arthralgia
    24
    0
    9
    0
        Fatigue
    28
    4
    16
    0
        Headache
    35
    8
    24
    1
        Loss of appetite
    30
    5
    16
    2
        Myalgia
    35
    5
    14
    0
        Nausea
    21
    0
    12
    0
        Body Temp. ( >= 38C )
    18
    2
    6
    0
        Treatment of pain and or Fever
    28
    7
    11
    1
        Prevention of pain and or Fever
    19
    2
    9
    3
    No statistical analyses for this end point

    Primary: 2.Number of subjects reporting solicited adverse events (AEs), following vaccination with either TIVc or TIV by age sub-strata

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    End point title
    		 2.Number of subjects reporting solicited adverse events (AEs), following vaccination with either TIVc or TIV by age sub-strata [2]
    End point description
    Safety was assessed in terms of number of the subjects (3 to <6 years ,≥ 6 to < 9 years and 9 to <18 years of age) who reported solicited local,systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV
    End point type
    Primary
    End point timeframe
    Day 1 through Day 7 after any vaccination
    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: Statistical analysis not applicable for the Outcome measure.
    End point values
    		 TIVc_Non naive_inj 1 (3 to <6 years) TIVc_naive_inj 1 (3 to <6 years) TIVc_naive_inj 2 (3 to <6 years) TIV_Non naive_inj 1 (3 to <6 years) TIV_naive_inj 1 (3 to <6 years) TIV_naive_inj 2 (3 to <6 years) TIVc_Non naive_Inj 1 (≥ 6 to < 9 years) TIVc_Naive_inj 1 (≥ 6 to < 9 years) TIVc_Naive_inj 2 (≥ 6 to < 9 years) TIV_Non Naive_inj 1 (≥ 6 to < 9 years) TIV_Naive_inj 1 (≥ 6 to < 9 years) TIV_Naive_inj 2 (≥ 6 to < 9 years) TIVc_Non naive (9 to <18 Years) TIV_Non naive (9 to <18 Years)
    Number of subjects analysed
    28
    50
    50
    19
    15
    15
    26
    35
    33
    16
    23
    24
    138
    72
    Units: Subjects
        Any Local
    14
    19
    22
    12
    7
    7
    16
    19
    19
    8
    13
    11
    73
    47
        Tenderness(N=28,49,49,19,15,15,0,0,0,0,0,0,0,0)
    10
    15
    20
    11
    6
    6
    0
    0
    0
    0
    0
    0
    0
    0
        Pain(N=0,0,0,0,0,0,26,32,31,16,22,22,0,0)
    0
    0
    0
    0
    0
    0
    15
    18
    19
    8
    10
    8
    73
    47
        erythema27,50,50,18,15,15,26,34,32,16,23,23,131,61
    7
    1
    3
    4
    0
    4
    1
    3
    5
    4
    5
    3
    5
    2
        Induration
    2
    5
    5
    2
    2
    3
    1
    4
    3
    3
    2
    3
    6
    7
        Injection site ecchymosis
    2
    4
    1
    2
    1
    3
    2
    3
    2
    0
    3
    5
    0
    0
        Any Systemic
    10
    22
    14
    9
    5
    5
    9
    18
    15
    5
    5
    3
    58
    31
        Change in eating habits
    5
    7
    6
    3
    4
    2
    0
    0
    0
    0
    0
    0
    0
    0
        Chills28,50,48,19,15,14,25,33,31,16,22,23,138,72
    2
    5
    3
    2
    0
    0
    3
    3
    3
    1
    0
    0
    19
    6
        Diarrhea28,50,50,19,14,15,26,33,31,16,22,23,137,71
    3
    1
    1
    1
    0
    2
    1
    3
    1
    0
    0
    1
    11
    4
        Irritability
    6
    8
    5
    5
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
        Sleepiness(N=28,49,48,19,15,15,0,0,0,0,0,0,0,0)
    4
    6
    5
    3
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
        Vomiting28,50,50,19,15,15,26,33,31,16,22,23,138,72
    3
    4
    2
    1
    0
    1
    0
    3
    1
    1
    0
    0
    8
    3
        Arthralgia0,0,0,0,0,0,26,32,30,16,20,21,136,72
    0
    0
    0
    0
    0
    0
    2
    4
    0
    1
    1
    0
    18
    7
        Fatigue0,0,0,0,0,0,26,32,30,16,20,21,137,72
    0
    0
    0
    0
    0
    0
    2
    3
    4
    2
    0
    0
    23
    14
        Headache0,0,0,0,0,0,26,32,30,16,20,21,138,72
    0
    0
    0
    0
    0
    0
    1
    5
    8
    3
    2
    1
    29
    19
        Loss appetite0,0,0,0,0,0,26,32,31,16,22,23,138,72
    0
    0
    0
    0
    0
    0
    2
    8
    5
    2
    2
    2
    20
    12
        Myalgia0,0,0,0,0,0,26,32,30,16,20,21,138,72
    0
    0
    0
    0
    0
    0
    4
    2
    5
    2
    1
    0
    29
    11
        Nausea0,0,0,0,0,0,26,32,30,16,20,21,137,72
    0
    0
    0
    0
    0
    0
    1
    3
    0
    2
    0
    0
    17
    10
        Body Temp. ( >= 38C )
    4
    8
    2
    3
    0
    0
    1
    1
    0
    0
    0
    0
    4
    3
        Treatment of pain and or fever
    6
    9
    3
    3
    0
    1
    0
    4
    4
    0
    2
    0
    9
    6
    No statistical analyses for this end point

    Primary: 3. Number of subjects reporting unsolicited adverse events following vaccination with either TIVc or TIV

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    End point title
    		 3. Number of subjects reporting unsolicited adverse events following vaccination with either TIVc or TIV [3]
    End point description
    Safety was assessed in terms of number of subjects who reported any unsolicited AEs (four weeks after 1st vaccination and up to three weeks after 2nd vaccination), serious adverse events (SAEs), new onset of chronic diseases (NOCD), medically attended AEs and AEs leading to vaccine/study withdrawal after receiving one or two doses of either TIVc or TIV by overall age group (3 to <18 years) and age sub-strata (3 to <9 years and 9 to <18 years)
    End point type
    Primary
    End point timeframe
    Day 1 –Day 181(one dose group) Day 1 –Day 209(two dose group)
    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: Statistical analysis not applicable for the Outcome measure.
    End point values
    		 TIVc TIVe TIVc_Naive (3 to <9 Years) TIVc_Non naive (3 to <9 Years) TIVc_Non naive (9 to <18 Years) TIV_Naive (3 to <9 Years) TIV_Non naive (3 to <9 Years) TIV_Non naive (9 to <18 Years)
    Number of subjects analysed
    278
    148
    85
    54
    139
    39
    35
    74
    Units: Subjects
        Any AEs
    213
    111
    77
    46
    90
    32
    29
    50
        Any possibly related AEs
    17
    12
    7
    3
    7
    5
    3
    4
        SAEs
    12
    4
    4
    2
    6
    0
    2
    2
        Possibly or probably related SAE
    0
    0
    0
    0
    0
    0
    0
    0
        AEs leading to NOCD
    3
    1
    1
    0
    2
    0
    1
    0
        Medically Attended AEs
    187
    94
    71
    38
    78
    28
    24
    42
        AEs leading to vaccine/study Withdrawal
    0
    0
    0
    0
    0
    0
    0
    0
        Deaths
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs Day 1 through end of study
    Adverse event reporting additional description
    Solicited local,systemic AEs collected -day 1 through Day 7 post injection 1 and Day 29 through Day 35 post injection 2, unsolicited AEs -Day 1 through Day 29 post 1st vaccination and Day 29 to Day 57 post 2nd vaccination.Subjects 9 to <18 years of age were determined to be “previously vaccinated (vaccine non-naive)” by default
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    TIVc
    Reporting group description
    		 -

    Reporting group title
    TIVe
    Reporting group description
    		 Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)

    Serious adverse events
    		 TIVc TIVe
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 278 (4.32%)
    4 / 148 (2.70%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Post procedural complication
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Sickle cell anaemia with crisis
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Complex partial seizures
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic encephalopathy
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 278 (0.36%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthmatic crisis
         subjects affected / exposed
    1 / 278 (0.36%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumopathy
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety disorder
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 278 (0.72%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 148 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 148 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 TIVc TIVe
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    246 / 278 (88.49%)
    126 / 148 (85.14%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    42 / 278 (15.11%)
    26 / 148 (17.57%)
         occurrences all number
    56
    35
    Somnolence
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 278 (5.04%)
    5 / 148 (3.38%)
         occurrences all number
    17
    6
    General disorders and administration site conditions
    Chills
    alternative assessment type: Systematic
         subjects affected / exposed
    36 / 278 (12.95%)
    9 / 148 (6.08%)
         occurrences all number
    42
    9
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    31 / 278 (11.15%)
    16 / 148 (10.81%)
         occurrences all number
    43
    19
    Injection Site Erythema
         subjects affected / exposed
    32 / 278 (11.51%)
    32 / 148 (21.62%)
         occurrences all number
    35
    36
    Injection Site Haemoorage
         subjects affected / exposed
    17 / 278 (6.12%)
    13 / 148 (8.78%)
         occurrences all number
    17
    16
    Injection Site Induration
         subjects affected / exposed
    35 / 278 (12.59%)
    31 / 148 (20.95%)
         occurrences all number
    39
    34
    Injection Site pain
         subjects affected / exposed
    147 / 278 (52.88%)
    86 / 148 (58.11%)
         occurrences all number
    178
    97
    Pyrexia
         subjects affected / exposed
    37 / 278 (13.31%)
    21 / 148 (14.19%)
         occurrences all number
    45
    25
    Gastrointestinal disorders
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    26 / 278 (9.35%)
    8 / 148 (5.41%)
         occurrences all number
    30
    9
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    23 / 278 (8.27%)
    13 / 148 (8.78%)
         occurrences all number
    26
    13
    Vomitting
    alternative assessment type: Systematic
         subjects affected / exposed
    27 / 278 (9.71%)
    16 / 148 (10.81%)
         occurrences all number
    33
    16
    Respiratory, thoracic and mediastinal disorders
    Asthmatic Crisis
    alternative assessment type: Systematic
         subjects affected / exposed
    18 / 278 (6.47%)
    12 / 148 (8.11%)
         occurrences all number
    32
    20
    Bronchospasm
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 278 (4.68%)
    8 / 148 (5.41%)
         occurrences all number
    19
    10
    Cough
    alternative assessment type: Systematic
         subjects affected / exposed
    26 / 278 (9.35%)
    10 / 148 (6.76%)
         occurrences all number
    29
    12
    Psychiatric disorders
    Decraesed Appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    33 / 278 (11.87%)
    17 / 148 (11.49%)
         occurrences all number
    38
    22
    Eating Disorder
         subjects affected / exposed
    17 / 278 (6.12%)
    7 / 148 (4.73%)
         occurrences all number
    19
    9
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    17 / 278 (6.12%)
    8 / 148 (5.41%)
         occurrences all number
    23
    10
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed
    27 / 278 (9.71%)
    11 / 148 (7.43%)
         occurrences all number
    29
    11
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    40 / 278 (14.39%)
    14 / 148 (9.46%)
         occurrences all number
    47
    15
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    21 / 278 (7.55%)
    12 / 148 (8.11%)
         occurrences all number
    24
    16
    Gastroenteritis
    alternative assessment type: Systematic
         subjects affected / exposed
    19 / 278 (6.83%)
    10 / 148 (6.76%)
         occurrences all number
    21
    14
    Nasopharyngitis
         subjects affected / exposed
    35 / 278 (12.59%)
    19 / 148 (12.84%)
         occurrences all number
    45
    23
    Otitis Media Acute
         subjects affected / exposed
    14 / 278 (5.04%)
    3 / 148 (2.03%)
         occurrences all number
    14
    3
    Pharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    22 / 278 (7.91%)
    12 / 148 (8.11%)
         occurrences all number
    23
    14
    Respiratory Tract Infection
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 278 (5.04%)
    5 / 148 (3.38%)
         occurrences all number
    16
    7
    Tonsilitis
         subjects affected / exposed
    16 / 278 (5.76%)
    6 / 148 (4.05%)
         occurrences all number
    20
    6
    Viral infection
         subjects affected / exposed
    16 / 278 (5.76%)
    6 / 148 (4.05%)
         occurrences all number
    22
    9

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

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