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    Clinical Trial Results:
    Randomized, Double-Blind, Active-Controlled Study in Adults to Assess the Safety and Immunogenicity of Abbott’s Candidate Quadrivalent Influenza Vaccine and its Non-Inferiority to Trivalent Influenza Vaccine.

    Summary
    EudraCT number
    		 2014-001042-24
    Trial protocol
    		 DE   LV   HU   LT   BE  
    Global end of trial date
    06 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Dec 2016
    First version publication date
    09 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    INFQ3001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Abbott Biologicals B.V.
    Sponsor organisation address
    C.J. van Houtenlaan 36, Weesp, Netherlands, NL-1381 CP
    Public contact
    Global Clinical Director, Abbott Healthcare Products B.V., serge.vandewitte@abbott.com
    Scientific contact
    Global Clinical Director, Abbott Healthcare Products B.V., serge.vandewitte@abbott.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
    07 Apr 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jan 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate in subjects ≥ 18 years of age the non-inferiority of QIV with respect to post-vaccination geometric mean hemagglutinin inhibition (HI) antibody titers against the shared strains compared with the trivalent influenza vaccines (TIV) with either the B-strain of the Victoria (TIV(Vic)) or the B-strain of the Yamagata lineage (TIV(Yam)).
    Protection of trial subjects
    This study has been conducted in accordance with the ICH Guidelines on Good Clinical Practice.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 May 2015
    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
    Belgium: 216
    Country: Number of subjects enrolled
    Germany: 478
    Country: Number of subjects enrolled
    Hungary: 518
    Country: Number of subjects enrolled
    Latvia: 429
    Country: Number of subjects enrolled
    Lithuania: 339
    Worldwide total number of subjects
    1980
    EEA total number of subjects
    1980
    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)
    1207
    From 65 to 84 years
    749
    85 years and over
    24

    Subject disposition

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    Recruitment
    Recruitment details
    		 Twenty study centres in five countries (Belgium, Germany, Hungary, Latvia, and Lithuania) screened and enrolled subjects. The first subject entered the study on 28 May 2015 and the last subject completed the last visit on 06 Jan 2016.

    Pre-assignment
    Screening details
    		 A total of 2,011 subjects provided informed consent and were screened for eligibility. Of these, 31 subjects failed screening and 1,980 subjects were randomly assigned to receive a study vaccine.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    All of the syringes were identical in appearance and packaged in the proper proportion to ensure that the desired dosages were used and that blinding was maintained.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Quadrivalent influenza vaccine
    Arm description
    		 A single 0.5 mL dose of quadrivalent influenza subunit vaccine containing approximately 15 μg HA antigen per virus strain, given intramuscularly in the deltoid muscle of the upper arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Quadrivalent Influenza Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose of 0.5 mL of quadrivalent influenza vaccine administered by intramuscular injection on Day 1 (Visit 1).

    Arm title
    		 Trivalent influenza vaccine (Vic)
    Arm description
    		 A single 0.5 mL dose of trivalent influenza subunit vaccine (Victoria) containing approximately 15 μg HA antigen per virus strain, given intramuscularly in the deltoid muscle of the upper arm.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Trivalent Influenza Vaccine (Vic)
    Investigational medicinal product code
    Other name
    Influvac
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose of 0.5 mL of trivalent influenza vaccine (Vic) administered by intramuscular injection on Day 1 (Visit 1).

    Arm title
    		 Trivalent influenza vaccine (Yam)
    Arm description
    		 A single 0.5 mL dose of trivalent influenza subunit vaccine (Yamagata) containing approximately 15 μg HA antigen per virus strain, given intramuscularly in the deltoid muscle of the upper arm.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Trivalent Influenza Vaccine (Yam)
    Investigational medicinal product code
    Other name
    Influvac
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose of 0.5 mL of influenza vaccine (Yam) administered by intramuscular injection on Day 1 (Visit 1).

    Number of subjects in period 1
    		Quadrivalent influenza vaccine Trivalent influenza vaccine (Vic) Trivalent influenza vaccine (Yam)
    Started
    1538
    221
    221
    Completed
    1530
    220
    219
    Not completed
    8
    1
    2
         Consent withdrawn by subject
    2
    1
    1
         Administrative
    1
    -
    -
         Adverse event, non-fatal
    3
    -
    -
         Lost to follow-up
    2
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 1980 1980
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 1207 1207
        From 65-84 years
    		 749 749
        85 years and over
    		 24 24
    Gender categorical
    Units: Subjects
        Male
    		 859 859
        Female
    		 1121 1121

    End points

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    End points reporting groups
    Reporting group title
    Quadrivalent influenza vaccine
    Reporting group description
    		 A single 0.5 mL dose of quadrivalent influenza subunit vaccine containing approximately 15 μg HA antigen per virus strain, given intramuscularly in the deltoid muscle of the upper arm.

    Reporting group title
    Trivalent influenza vaccine (Vic)
    Reporting group description
    		 A single 0.5 mL dose of trivalent influenza subunit vaccine (Victoria) containing approximately 15 μg HA antigen per virus strain, given intramuscularly in the deltoid muscle of the upper arm.

    Reporting group title
    Trivalent influenza vaccine (Yam)
    Reporting group description
    		 A single 0.5 mL dose of trivalent influenza subunit vaccine (Yamagata) containing approximately 15 μg HA antigen per virus strain, given intramuscularly in the deltoid muscle of the upper arm.

    Subject analysis set title
    Primary Efficacy Analysis
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per-protocol (PP) sample was defined through blind data review and consisted of all subjects who were included in the Full Analysis subject sample and did not present any major protocol violations.

    Subject analysis set title
    Secondary Efficacy Analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis (FA) subject sample consisted of all subjects who were in the safety sample and had at least one post-vaccination efficacy observation.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety-subject sample consisted of all subjects who were in the all-subjects-vaccinated sample and had at least one post-vaccination safety observation. The safety data from the subjects vaccinated with a trivalent formulation were pooled.

    Primary: Postvaccination geometric HI antibody titers against A-H1N1 strain

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    End point title
    		 Postvaccination geometric HI antibody titers against A-H1N1 strain
    End point description
    End point type
    Primary
    End point timeframe
    Geometric means of the HI titers were measured on Day 22 (Visit 2) post-vaccination.
    End point values
    		 Quadrivalent influenza vaccine Trivalent influenza vaccine (Vic) Trivalent influenza vaccine (Yam)
    Number of subjects analysed
    1528
    217
    219
    Units: titre
        geometric mean (standard deviation)
    186.1 ( 4.2 )
    234.8 ( 3.9 )
    207.9 ( 4.3 )
    Statistical analysis title
    		 Non-inferiority analysis
    Statistical analysis description
    95% Confidence Interval was obtained from an ANOVA model with vaccine, country and site as a covariate.
    Comparison groups
    Quadrivalent influenza vaccine v Trivalent influenza vaccine (Vic) v Trivalent influenza vaccine (Yam)
    Number of subjects included in analysis
    1964
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Parameter type
    		 Geometric mean ratio
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Primary: Postvaccination geometric HI antibody titers against A-H3N2 strain

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    End point title
    		 Postvaccination geometric HI antibody titers against A-H3N2 strain
    End point description
    End point type
    Primary
    End point timeframe
    Geometric means of the HI titers were measured on Day 22 (Visit 2) post-vaccination.
    End point values
    		 Quadrivalent influenza vaccine Trivalent influenza vaccine (Vic) Trivalent influenza vaccine (Yam)
    Number of subjects analysed
    1528
    217
    219
    Units: titre
        geometric mean (standard deviation)
    339.1 ( 3.5 )
    386.1 ( 3.6 )
    442.6 ( 3.8 )
    Statistical analysis title
    		 Non-inferiority analysis
    Comparison groups
    Quadrivalent influenza vaccine v Trivalent influenza vaccine (Vic) v Trivalent influenza vaccine (Yam)
    Number of subjects included in analysis
    1964
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Parameter type
    		 Geometric mean ratio
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Primary: Postvaccination geometric HI antibody titers against B Victoria strain

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    End point title
    		 Postvaccination geometric HI antibody titers against B Victoria strain
    End point description
    End point type
    Primary
    End point timeframe
    Geometric means of the HI titers were measured on Day 22 (Visit 2) post-vaccination.
    End point values
    		 Quadrivalent influenza vaccine Trivalent influenza vaccine (Vic) Trivalent influenza vaccine (Yam)
    Number of subjects analysed
    1528
    217
    219
    Units: titre
        geometric mean (standard deviation)
    152.9 ( 4.3 )
    142 ( 4.7 )
    64.2 ( 5.4 )
    Statistical analysis title
    		 Non-inferiority analysis
    Statistical analysis description
    95% Confidence Interval was obtained from an ANOVA model with vaccine, country and site as a covariate.
    Comparison groups
    Quadrivalent influenza vaccine v Trivalent influenza vaccine (Vic) v Trivalent influenza vaccine (Yam)
    Number of subjects included in analysis
    1964
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Parameter type
    		 Geometric mean ratio
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Primary: Postvaccination geometric HI antibody titers against B Yamagata strain

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    End point title
    		 Postvaccination geometric HI antibody titers against B Yamagata strain
    End point description
    End point type
    Primary
    End point timeframe
    Geometric means of the HI titers were measured on Day 22 (Visit 2) post-vaccination.
    End point values
    		 Quadrivalent influenza vaccine Trivalent influenza vaccine (Vic) Trivalent influenza vaccine (Yam)
    Number of subjects analysed
    1528
    217
    219
    Units: titre
        geometric mean (standard deviation)
    102.1 ( 4.3 )
    47.5 ( 5 )
    86.1 ( 4.2 )
    Statistical analysis title
    		 Non-inferiority analysis
    Statistical analysis description
    95% Confidence Interval was obtained from an ANOVA model with vaccine, country and site as a covariate.
    Comparison groups
    Quadrivalent influenza vaccine v Trivalent influenza vaccine (Vic) v Trivalent influenza vaccine (Yam)
    Number of subjects included in analysis
    1964
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events (AEs) have been reported separately for the period up to the Day 22 visit (all AEs) and between the Day 22 visit and Phone Contact 2 (Day 183) period (only new serious AEs and new chronic illnesses).
    Adverse event reporting additional description
    The safety data from the subjects vaccinated with QIV or TIV were be done by age group. To assess safety and reactogenicity, the following assessments were made: solicited local and systemic reactions (reactogenicity, reported 7 days post vaccination), overall inconvenience, and unsolicited AEs. Data of the subjects vaccinated with TIV were pooled.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Quadrivalent influenza vaccine
    Reporting group description
    		 A single 0.5 mL dose of quadrivalent influenza subunit vaccine containing approximately 15 μg HA antigen per virus strain, given intramuscularly in the deltoid muscle of the upper arm.

    Reporting group title
    Trivalent influenza vaccine
    Reporting group description
    		 A single 0.5 mL dose of trivalent influenza subunit vaccine containing approximately 15 μg HA antigen per virus strain, given intramuscularly in the deltoid muscle of the upper arm.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: None of the non-serious adverse events met the threshold of up to 5% for reporting.
    Serious adverse events
    		 Quadrivalent influenza vaccine Trivalent influenza vaccine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    46 / 1535 (3.00%)
    14 / 441 (3.17%)
         number of deaths (all causes)
    5
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-cell lymphoma
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma stage II
         subjects affected / exposed
    0 / 1535 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    0 / 1535 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism arterial
         subjects affected / exposed
    0 / 1535 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    2 / 1535 (0.13%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Selective abortion
         subjects affected / exposed
    0 / 1535 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion spontaneous incomplete
         subjects affected / exposed
    0 / 1535 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Device malfunction
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical dysplasia
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 1535 (0.07%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Weight decreased
         subjects affected / exposed
    0 / 1535 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Cartilage injury
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 1535 (0.07%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 1535 (0.13%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorder
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 1535 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 1535 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Brain oedema
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    2 / 1535 (0.13%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 1535 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraventricular haemorrhage
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine with aura
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculitis lumbosacral
         subjects affected / exposed
    0 / 1535 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reversible ischaemic neurological deficit
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (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
    Anaemia
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    0 / 1535 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 1535 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 1535 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis chronic
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Skin and subcutaneous tissue disorders
    Hyperkeratosis
         subjects affected / exposed
    0 / 1535 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 1535 (0.07%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (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
    Abdominal wall abscess
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amniotic cavity infection
         subjects affected / exposed
    0 / 1535 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder abscess
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious colitis
         subjects affected / exposed
    0 / 1535 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subacute endocarditis
         subjects affected / exposed
    0 / 1535 (0.00%)
    1 / 441 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 1535 (0.07%)
    0 / 441 (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
    		 Quadrivalent influenza vaccine Trivalent influenza vaccine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1535 (0.00%)
    0 / 441 (0.00%)

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Apr 2015
    Changes in conduct or management of the trial.

    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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