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    Clinical Trial Results:
    A Multi Center, Phase IV, Randomized, Controlled, Observer Blind Study to Evaluate the Immunogenicity, Safety, and Tolerability of a Trivalent Subunit Inactivated Influenza Vaccine in Healthy Subjects Aged 50 Years and Above

    Summary
    EudraCT number
    		 2012-003740-74
    Trial protocol
    		 CZ  
    Global end of trial date
    16 Dec 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    29 Jul 2016
    First version publication date
    29 Nov 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
    V71_22
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01867021
    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
    Lucie Černá Hlavatá, Novartis s.r.l., 420 226293041, lucie.cerna_hlavata@novartis.com
    Scientific contact
    Lucie Černá Hlavatá, Novartis s.r.l., 420 226293041, lucie.cerna_hlavata@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
    16 Dec 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of the post-vaccination (Day 22) hemagglutination inhibition (HI) geometric mean titers (GMTs) of AGRIFLU over the corresponding GMTs of the comparator vaccine for all three influenza strains, in healthy adults aged 50 years and above. To demonstrate non-inferiority of the percentages of subjects achieving seroconversion in antibody titers at Day 22 in the AGRIFLU group over the corresponding percentages of subjects in the comparator group for all three strains, in healthy adults aged 50 years and above. Safety Objectives To evaluate the safety and tolerability of of AGRIFLU or comparator vaccines in healthy adults aged 50 years and above.
    Protection of trial subjects
    Novartis Vaccines or the investigator provided the ethics committee (EC) with all appropriate material,including the Informed Consent Form (ICF), according to local regulations. The EC also was asked for a written statement regarding the composition of the committee and to comply with GCP (Good Clinical Practices) and with the applicable regulatory requirement(s). The trial was not initiated until appropriate EC approval of the protocol and the ICF was obtained. In addition, all documents were submitted to other authorities in compliance with local jurisdictions. Prior to enrollment, the sponsor and the investigator exchanged written confirmation that their ethical and legal responsibilities had been observed. The EC and, if applicable, other authorities were informed of protocol amendments in accordance with local legal requirements. Appropriate reports on the progress of the study were made to the EC and the sponsor by the investigator in accordance with applicable governmental regulations and in agreement with policy established by the sponsor
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 May 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 36 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 785
    Country: Number of subjects enrolled
    Philippines: 500
    Country: Number of subjects enrolled
    South Africa: 1207
    Country: Number of subjects enrolled
    Thailand: 410
    Worldwide total number of subjects
    2902
    EEA total number of subjects
    785
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    1441
    From 65 to 84 years
    1436
    85 years and over
    25

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 24 sites with 3 sites in Thailand, 4 sites in Philippines, 15 sites in South Africa and 2 sites in Czech Republic.

    Pre-assignment
    Screening details
    		 All enrolled subjects 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, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Agriflu
    Arm description
    		 Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trivalent Subunit Inactivated Influenza Vaccine
    Investigational medicinal product code
    V71
    Other name
    Pharmaceutical forms
    Emulsion and suspension for emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single 0.5 mL dose of the study vaccine was supplied in prefilled syringes and was administered intramuscular (IM) in the deltoid muscle of (preferably) the nondominant arm.

    Arm title
    		 Fluvirin
    Arm description
    		 Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluvirin
    Investigational medicinal product code
    V71
    Other name
    Pharmaceutical forms
    Emulsion and suspension for emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single 0.5 mL dose of the Fluvirin was administered IM in the deltoid muscle of (preferably) the nondominant arm.

    Number of subjects in period 1
    		Agriflu Fluvirin
    Started
    1452
    1450
    Completed
    1450
    1440
    Not completed
    2
    10
         Consent withdrawn by subject
    1
    6
         Adverse event, non-fatal
    -
    1
         Not eligible
    -
    1
         Death
    1
    -
         Lost to follow-up
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Agriflu
    Reporting group description
    		 Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV

    Reporting group title
    Fluvirin
    Reporting group description
    		 Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf

    Reporting group values
    		 Agriflu Fluvirin Total
    Number of subjects
    		 1452 1450 2902
    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: years
        arithmetic mean (standard deviation)
    		 64.2 ( 8.9 ) 64.2 ( 8.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 943 893 1836
        Male
    		 509 557 1066

    End points

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    End points reporting groups
    Reporting group title
    Agriflu
    Reporting group description
    		 Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV

    Reporting group title
    Fluvirin
    Reporting group description
    		 Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf

    Subject analysis set title
    ≥50 to ≤64 years_Agriflu_PPS1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects ≥50 to ≤64 years of age who received an investigational vaccine TIV

    Subject analysis set title
    ≥50 to ≤64 years_Fluvirin_PPS1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects ≥50 to ≤64 years of age who received a control vaccine TIVf

    Subject analysis set title
    ≥65 years_Agriflu_PPS1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects ≥65 years of age who received an investigational vaccine TIV

    Subject analysis set title
    ≥65 years_Fluvirin_PPS1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects ≥65 years of age who received a control vaccine TIVf

    Subject analysis set title
    ≥50 to ≤64 years_Agriflu_PPS2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects ≥50 to ≤64 years of age who received an investigational vaccine TIV

    Subject analysis set title
    ≥50 to ≤64 years_Fluvirin_PPS2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects ≥50 to ≤64 years of age who received a control vaccine TIVf

    Subject analysis set title
    ≥65 years_Agriflu_PPS2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects ≥65 years of age who received an investigational vaccine TIV

    Subject analysis set title
    ≥65 years_Fluvirin_PPS2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects ≥65 years of age who received a control vaccine TIVf

    Subject analysis set title
    ≥50 years_Agriflu_PPS1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects ≥50 years of age who received an investigational vaccine TIV

    Subject analysis set title
    ≥50 years_Fluvirin_PPS1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects ≥50 years of age who received a control vaccine TIVf

    Primary: 1.Non-inferiority of Postvaccination Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group

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    End point title
    		 1.Non-inferiority of Postvaccination Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group
    End point description
    Immunogenicity was measured as the hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, against each of three vaccine strains, three weeks after one vaccination of TIV (Trivalent Subunit Inactivated Influenza Vaccine) and TIVf vaccine (day 22), evaluated using HI antigen assay. The upper limit of the two-sided 95% confidence interval (CI) on the ratio of GMTs (GMT TIVf/GMT TIV) should not exceed the non-inferiority margin of 1.5.
    End point type
    Primary
    End point timeframe
    Day 22
    End point values
    		 Agriflu Fluvirin
    Number of subjects analysed
    1452
    1450
    Units: Titers
    geometric mean (confidence interval 95%)
        A/H1N1(1401, 1397)
    315 (281 to 352)
    581 (519 to 651)
        A/H3N2(1401, 1397)
    697 (635 to 764)
    1048 (955 to 1149)
        B(1402, 1397)
    36 (33 to 39)
    36 (33 to 39)
    Statistical analysis title
    		 Non-inferiority of HI GMTs of TIV vaccine over HI
    Statistical analysis description
    The HI GMTs of TIV vaccine for strain A/H1N1 considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5
    Comparison groups
    Fluvirin v Agriflu
    Number of subjects included in analysis
    2902
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 ANCOVA
    Parameter type
    		 Ratios of GMTs
    Point estimate
    1.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.66
         upper limit
    		 2.06
    Statistical analysis title
    		 Non-inferiority of HI GMTs of TIV vaccine over HI
    Statistical analysis description
    The HI GMTs of TIV vaccine for strain A/H3N2 considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5
    Comparison groups
    Agriflu v Fluvirin
    Number of subjects included in analysis
    2902
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of GMTs
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.38
         upper limit
    		 1.64
    Statistical analysis title
    		 Non-inferiority of HI GMTs of TIV vaccine over HI
    Statistical analysis description
    The HI GMTs of TIV vaccine for strain B considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5
    Comparison groups
    Agriflu v Fluvirin
    Number of subjects included in analysis
    2902
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of GMTs
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.08

    Primary: 2. Non-inferiority of the Percentages of Subjects Achieving Seroconversion (SC) in Antibody Titers At Day 22 in the TIV Group

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    End point title
    		 2. Non-inferiority of the Percentages of Subjects Achieving Seroconversion (SC) in Antibody Titers At Day 22 in the TIV Group
    End point description
    Immunogenicity was measured as the percentages of subjects who achieved seroconversion in HI titers, against each of three vaccine strains, at three weeks after one vaccination of TIV and TIVf vaccine (day 22). Seroconversion is defined as a prevaccination titer <10 and postvaccination HI ≥40 or as a prevaccination titer ≥10 and at minimum four-fold rise in postvaccination antibody titer. The upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - SeroconversionTIV) should not exceed 10%.
    End point type
    Primary
    End point timeframe
    Day 22
    End point values
    		 Agriflu Fluvirin
    Number of subjects analysed
    1452
    1450
    Units: Percentage of subjects
    number (confidence interval 95%)
        A/H1N1(1397,1391)
    75 (73 to 78)
    84 (82 to 86)
        A/H3N2(1398,1390)
    72 (70 to 74)
    85 (83 to 87)
        B(1399,1390)
    41 (39 to 44)
    40 (37 to 43)
    Statistical analysis title
    		 Non-inferiority of percentage of subjects with HI
    Statistical analysis description
    Percentage of subjects with HI seroconversion of TIV vaccine for strain A/H1N1 considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.
    Comparison groups
    Agriflu v Fluvirin
    Number of subjects included in analysis
    2902
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in seroconversion rates
    Point estimate
    9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.6
         upper limit
    		 11.5
    Statistical analysis title
    		 Non-inferiority of percentage of subjects with HI
    Statistical analysis description
    Percentage of subjects with HI seroconversion of TIV vaccine for strain A/H1N1 considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.
    Comparison groups
    Agriflu v Fluvirin
    Number of subjects included in analysis
    2902
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in seroconversion rates
    Point estimate
    13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.1
         upper limit
    		 16.1
    Statistical analysis title
    		 Non-inferiority of percentage of subjects with HI
    Statistical analysis description
    Percentage of subjects with HI seroconversion of TIV vaccine for strain A/H1N1 considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.
    Comparison groups
    Agriflu v Fluvirin
    Number of subjects included in analysis
    2902
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in seroconversion rates
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 2.3

    Secondary: 3.Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains

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    End point title
    		 3.Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains
    End point description
    Percentage of subjects achieving HI seroconversion against each of three vaccine strains was measured three weeks after vaccination of TIV and TIVf vaccine (day 22). Percentage of subjects who achieved HI titer ≥1:40 against each of three vaccine strains was measured three weeks after one vaccination of TIV and TIVf vaccine. According to Center for Biologics Evaluation and Research recommendations (CBER 2007), the criterion for seroconversion is considered met if the lower limit of the two-sided 95% CI for the percentage of subjects with HI seroconversion is ≥40% (<65 years) or ≥30% (≥65 years). As per the CBER criteria, the lower limit of the two-sided 95% CI for the percentage of subjects who achieved HI titer ≥ 1:40 should be ≥70% (<65 years) or ≥60% (≥65 years).
    End point type
    Secondary
    End point timeframe
    Day 22
    End point values
    		 ≥50 to ≤64 years_Agriflu_PPS1 ≥50 to ≤64 years_Fluvirin_PPS1 ≥65 years_Agriflu_PPS1 ≥65 years_Fluvirin_PPS1
    Number of subjects analysed
    691
    691
    711
    706
    Units: Percentage of Subjects
    number (confidence interval 95%)
        A/H1N1 –Seroconversion(687,686, 710, 705)
    78 (74 to 81)
    87 (84 to 89)
    73 (70 to 77)
    81 (78 to 84)
        A/H3N2 –Seroconversion(688,686, 710, 704)
    78 (75 to 81)
    88 (85 to 90)
    66 (63 to 70)
    82 (79 to 85)
        B –Seroconversion(688,686, 711, 704)
    44 (40 to 48)
    45 (41 to 49)
    39 (35 to 42)
    35 (32 to 39)
        A/H1N1 – HI≥1:40 (Day 22)[691,691, 710, 706]
    94 (92 to 96)
    96 (94 to 97)
    91 (89 to 93)
    92 (90 to 94)
        A/H3N2 – HI≥1:40 (Day 22)[691,691, 710, 706]
    99 (99 to 100)
    99 (98 to 100)
    99 (98 to 99)
    98 (97 to 99)
        B – HI ≥1:40 (Day22)[691, 691, 711,706]
    58 (55 to 62)
    59 (55 to 63)
    59 (55 to 62)
    56 (52 to 60)
    No statistical analyses for this end point

    Secondary: 4. Geometric Mean Ratio of Subjects Against Each of Three Strains

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    End point title
    		 4. Geometric Mean Ratio of Subjects Against Each of Three Strains
    End point description
    Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs against each of three vaccine strains, three weeks after vaccination of TIV and TIVf vaccine (day 22).
    End point type
    Secondary
    End point timeframe
    Day 22
    End point values
    		 ≥50 to ≤64 years_Agriflu_PPS1 ≥50 to ≤64 years_Fluvirin_PPS1 ≥65 years_Agriflu_PPS1 ≥65 years_Fluvirin_PPS1
    Number of subjects analysed
    688
    686
    711
    705
    Units: Ratios
    geometric mean (confidence interval 95%)
        A/H1N1(687, 686,710, 705)
    18 (15 to 22)
    35 (29 to 42)
    15 (12 to 19)
    27 (21 to 33)
        A/H3N2(688, 686,710, 704)
    13 (11 to 15)
    18 (15 to 20)
    9.65 (7.94 to 12)
    16 (13 to 20)
        B(688, 686, 711,704)
    3.85 (3.43 to 4.31)
    3.91 (3.49 to 4.39)
    3.1 (2.71 to 3.54)
    3 (2.62 to 3.44)
    No statistical analyses for this end point

    Secondary: 5. Number of Subjects Who Reported Solicited Local and Systemic Adverse Events after One Vaccination of TIV and TIVf

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    End point title
    		 5. Number of Subjects Who Reported Solicited Local and Systemic Adverse Events after One Vaccination of TIV and TIVf
    End point description
    Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIV and control.
    End point type
    Secondary
    End point timeframe
    Day 1 to 7 postvaccination
    End point values
    		 Agriflu Fluvirin
    Number of subjects analysed
    1428
    1433
    Units: Participants
        Pain(1412, 1424)
    264
    254
        Ecchymosis Type I(1419, 1425)
    26
    33
        Ecchymosis Type II(1419, 1425)
    7
    11
        Erythema Type I(1410, 1427)
    91
    93
        Erythema Type II(1410, 1427)
    16
    10
        Induration Type I(1423, 1429)
    78
    65
        Induration Type II(1423, 1429)
    25
    19
        Swelling Type I(1419, 1427)
    50
    44
        Swelling Type II(1419, 1427)
    21
    15
        Chills(1403,1407)
    64
    68
        Malaise(1402,1405)
    88
    95
        Nausea(1401,1405)
    48
    44
        Myalgia(1400,1403)
    128
    140
        Arthralgia(1396,1403)
    83
    87
        Headache(1397,1403)
    153
    161
        Sweating(1403,1405)
    99
    102
        Fatigue(1404,1407)
    143
    145
        Loss of Appetite(1404,1403)
    43
    59
        Fever(>=38°C)[1422,1428]
    20
    21
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 22 days
    Adverse event reporting additional description
    Serious adverse events (SAEs) were collected from day 1 through day 22. Safety Set (Overall)-All subjects in the Exposed Set who had either postvaccination AE or solicited AE data
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Agriflu
    Reporting group description
    		 Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV

    Reporting group title
    Fluvirin
    Reporting group description
    		 Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf

    Serious adverse events
    		 Agriflu Fluvirin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 1452 (0.21%)
    5 / 1445 (0.35%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    FEMUR FRACTURE
         subjects affected / exposed
    0 / 1452 (0.00%)
    1 / 1445 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    0 / 1452 (0.00%)
    1 / 1445 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    MYOCARDIAL INFARCTION
         subjects affected / exposed
    1 / 1452 (0.07%)
    1 / 1445 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    BASAL GANGLIA HAEMORRHAGE
         subjects affected / exposed
    0 / 1452 (0.00%)
    1 / 1445 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBROVASCULAR ACCIDENT
         subjects affected / exposed
    0 / 1452 (0.00%)
    1 / 1445 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    DYSPEPSIA
         subjects affected / exposed
    1 / 1452 (0.07%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PEPTIC ULCER
         subjects affected / exposed
    1 / 1452 (0.07%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLELITHIASIS
         subjects affected / exposed
    1 / 1452 (0.07%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    JAUNDICE CHOLESTATIC
         subjects affected / exposed
    0 / 1452 (0.00%)
    1 / 1445 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    URINARY TRACT INFECTION
         subjects affected / exposed
    1 / 1452 (0.07%)
    0 / 1445 (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
    		 Agriflu Fluvirin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    471 / 1452 (32.44%)
    467 / 1445 (32.32%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    144 / 1452 (9.92%)
    146 / 1445 (10.10%)
         occurrences all number
    162
    169
    Injection Site Pain
         subjects affected / exposed
    281 / 1452 (19.35%)
    276 / 1445 (19.10%)
         occurrences all number
    299
    287
    Malaise
         subjects affected / exposed
    89 / 1452 (6.13%)
    95 / 1445 (6.57%)
         occurrences all number
    97
    110
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    99 / 1452 (6.82%)
    103 / 1445 (7.13%)
         occurrences all number
    116
    122
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    85 / 1452 (5.85%)
    88 / 1445 (6.09%)
         occurrences all number
    96
    105
    Headache
         subjects affected / exposed
    159 / 1452 (10.95%)
    164 / 1445 (11.35%)
         occurrences all number
    192
    192
    Myalgia
         subjects affected / exposed
    133 / 1452 (9.16%)
    141 / 1445 (9.76%)
         occurrences all number
    145
    160

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Nov 2011
    Administrative changes updated

    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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