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    Clinical Trial Results:
    Immunogenicity and Safety of a High-Dose Quadrivalent Influenza Vaccine Administered by the Intramuscular Route in Subjects 60 Years of Age and Older

    Summary
    EudraCT number
    		 2019-000655-14
    Trial protocol
    		 FR   BE   DE   NL   IT  
    Global end of trial date
    05 Jun 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Mar 2021
    First version publication date
    17 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    QHD00011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04024228
    WHO universal trial number (UTN)
    		 U1111-1225-0952
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur
    Sponsor organisation address
    14, Espace Henry Vallée, Lyon, France, 69007
    Public contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.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
    14 May 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jun 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that High-Dose Quadrivalent Influenza Vaccine (QIV-HD) induces an immune response that is superior to the responses induced by Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) for all 4 virus strains 28 days post-vaccination in subjects 60 to 64 years of age and in subjects 65 years of age and older.
    Protection of trial subjects
    Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Oct 2019
    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
    Netherlands: 344
    Country: Number of subjects enrolled
    Poland: 300
    Country: Number of subjects enrolled
    Belgium: 212
    Country: Number of subjects enrolled
    France: 271
    Country: Number of subjects enrolled
    Germany: 327
    Country: Number of subjects enrolled
    Italy: 85
    Worldwide total number of subjects
    1539
    EEA total number of subjects
    1539
    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)
    760
    From 65 to 84 years
    769
    85 years and over
    10

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 17 active centers in 6 countries. A total of 1539 subjects were enrolled and randomised between 28 October 2019 to 15 November 2019.

    Pre-assignment
    Screening details
    		 A total of 1533 subjects were vaccinated in the study.

    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, Assessor
    Blinding implementation details
    Modified double-blind: the subject and the investigators remained unaware of the treatment assignments throughout the study. An unblinded qualified trial staff member administered the appropriate vaccine but were not involved in the immunogenicity and safety evaluations.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: QIV-HD
    Arm description
    		 Subjects received a single injection of 0.7 millilitres (mL) QIV-HD, intramuscularly (IM) at Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    High-Dose Quadrivalent Influenza Vaccine (split virion, inactivated)
    Investigational medicinal product code
    QIV-HD
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.7 mL single injection at Day 0.

    Arm title
    		 Group 2: QIV-SD
    Arm description
    		 Subjects received a single injection of 0.5 mL QIV-SD, IM at Day 0.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Standard-Dose Quadrivalent Influenza Vaccine (Inactivated)
    Investigational medicinal product code
    QIV-SD
    Other name
    Influvac™ Tetra
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL single injection at Day 0.

    Number of subjects in period 1
    		Group 1: QIV-HD Group 2: QIV-SD
    Started
    774
    765
    Vaccinated
    772
    761
    Full Analysis Set (FAS)
    769 [1]
    758 [2]
    Completed
    770
    759
    Not completed
    4
    6
         Adverse Event
    1
    -
         Withdrawal by Subject
    3
    4
         Protocol deviation
    -
    2
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: FAS included all randomised subjects who received the study vaccine and had a post-vaccination blood sample. 377 subjects (60-64 years) and 392 subjects (>=65 years).
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: FAS included all randomised subjects who received the study vaccine and had a post-vaccination blood sample. 377 subjects (60-64 years) and 381 subjects (>=65 years).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: QIV-HD
    Reporting group description
    		 Subjects received a single injection of 0.7 millilitres (mL) QIV-HD, intramuscularly (IM) at Day 0.

    Reporting group title
    Group 2: QIV-SD
    Reporting group description
    		 Subjects received a single injection of 0.5 mL QIV-SD, IM at Day 0.

    Reporting group values
    		 Group 1: QIV-HD Group 2: QIV-SD Total
    Number of subjects
    		 774 765 1539
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.6 ( 5.82 ) 66.6 ( 6.11 ) -
    Gender categorical
    Units: Subjects
        Female
    		 385 390 775
        Male
    		 389 375 764
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 4 3 7
        Native Hawaiian or Other Pacific Islander
    		 4 2 6
        Black or African American
    		 2 2 4
        White
    		 758 756 1514
        More than one race
    		 0 1 1
        Unknown or Not Reported
    		 6 1 7

    End points

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    End points reporting groups
    Reporting group title
    Group 1: QIV-HD
    Reporting group description
    		 Subjects received a single injection of 0.7 millilitres (mL) QIV-HD, intramuscularly (IM) at Day 0.

    Reporting group title
    Group 2: QIV-SD
    Reporting group description
    		 Subjects received a single injection of 0.5 mL QIV-SD, IM at Day 0.

    Primary: Geometric Mean Titers (GMTs) of Influenza Antibodies in Subjects Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years

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    End point title
    		 Geometric Mean Titers (GMTs) of Influenza Antibodies in Subjects Aged 60-64 Years and Greater Than or Equal to (>=) 65 Years
    End point description
    GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Titers were expressed in terms of 1/dilution. Analysis was performed on FAS population. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Primary
    End point timeframe
    Day 28 post-vaccination
    End point values
    		 Group 1: QIV-HD Group 2: QIV-SD
    Number of subjects analysed
    769
    758
    Units: titers
    geometric mean (confidence interval 95%)
        A/H1N1: Day 28: 60-64 years (n=377,377)
    471 (416 to 533)
    248 (217 to 283)
        A/H3N2: Day 28: 60-64 years (n=376,377)
    303 (262 to 350)
    178 (154 to 206)
        B1: Day 28: 60-64 years (n=377,377)
    497 (450 to 548)
    330 (297 to 367)
        B2: Day 28: 60-64 years (n=377,377)
    766 (690 to 849)
    433 (391 to 480)
        A/H1N1: Day 28: >= 65 years (n=392,381)
    286 (250 to 326)
    162 (139 to 190)
        A/H3N2: Day 28: >=65 years (n=392,381)
    324 (281 to 374)
    151 (129 to 176)
        B1: Day 28: >=65 years (n=392,381)
    405 (366 to 447)
    262 (236 to 291)
        B2: Day 28: >=65 years (n=392,381)
    536 (485 to 592)
    305 (274 to 340)
    Statistical analysis title
    		 A/H1N1: 60-64 years
    Comparison groups
    Group 1: QIV-HD v Group 2: QIV-SD
    Number of subjects included in analysis
    1527
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    Method
    Parameter type
    		 GMT ratio
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.58
         upper limit
    		 2.28
    Notes
    [1] - Superiority of GMTs was concluded if the lower limit of the 2-sided 95% Confidence Interval (CI) for the ratio of GMTs was above 1 between groups for each of the comparisons.
    Statistical analysis title
    		 A/H3N2: 60-64 years
    Comparison groups
    Group 1: QIV-HD v Group 2: QIV-SD
    Number of subjects included in analysis
    1527
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    Method
    Parameter type
    		 GMT ratio
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.38
         upper limit
    		 2.08
    Notes
    [2] - Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.
    Statistical analysis title
    		 B1: 60-64 years
    Comparison groups
    Group 1: QIV-HD v Group 2: QIV-SD
    Number of subjects included in analysis
    1527
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    Method
    Parameter type
    		 GMT ratio
    Point estimate
    1.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 1.74
    Notes
    [3] - Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.
    Statistical analysis title
    		 B2: 60-64 years
    Comparison groups
    Group 1: QIV-HD v Group 2: QIV-SD
    Number of subjects included in analysis
    1527
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    Method
    Parameter type
    		 GMT ratio
    Point estimate
    1.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.53
         upper limit
    		 2.04
    Notes
    [4] - Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.
    Statistical analysis title
    		 A/H1N1: >=65 years
    Comparison groups
    Group 1: QIV-HD v Group 2: QIV-SD
    Number of subjects included in analysis
    1527
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    Method
    Parameter type
    		 GMT ratio
    Point estimate
    1.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.44
         upper limit
    		 2.15
    Notes
    [5] - Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.
    Statistical analysis title
    		 A/H3N2: >=65 years
    Comparison groups
    Group 1: QIV-HD v Group 2: QIV-SD
    Number of subjects included in analysis
    1527
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    Method
    Parameter type
    		 GMT ratio
    Point estimate
    2.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.74
         upper limit
    		 2.65
    Notes
    [6] - Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.
    Statistical analysis title
    		 B1: >=65 years
    Comparison groups
    Group 1: QIV-HD v Group 2: QIV-SD
    Number of subjects included in analysis
    1527
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    Method
    Parameter type
    		 GMT ratio
    Point estimate
    1.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.34
         upper limit
    		 1.79
    Notes
    [7] - Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.
    Statistical analysis title
    		 B1: >=65 years
    Comparison groups
    Group 1: QIV-HD v Group 2: QIV-SD
    Number of subjects included in analysis
    1527
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    Method
    Parameter type
    		 GMT ratio
    Point estimate
    1.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.52
         upper limit
    		 2.03
    Notes
    [8] - Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.

    Secondary: Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Subjects

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    End point title
    		 Geometric Mean Titers of Influenza Antibodies Pre-and Post-Vaccination in All Age Group Subjects
    End point description
    GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Titers were expressed in terms of 1/dilution. Analysis was performed on FAS population. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination), Day 28 (post-vaccination)
    End point values
    		 Group 1: QIV-HD Group 2: QIV-SD
    Number of subjects analysed
    769
    758
    Units: titers
    geometric mean (confidence interval 95%)
        A/H1N1: Day 0 (n=768,758)
    48.6 (43.4 to 54.4)
    46.2 (41.4 to 51.7)
        A/H1N1: Day 28 (n=769,758)
    365 (333 to 400)
    200 (181 to 222)
        A/H3N2: Day 0 (n=767,757)
    13.3 (12.3 to 14.4)
    13.0 (12.0 to 14.1)
        A/H3N2: Day 28 (n=768,758)
    313 (283 to 347)
    164 (148 to 182)
        B1: Day 0 (n=767,757)
    63.9 (57.7 to 70.7)
    74.5 (67.3 to 82.4)
        B1: Day 28 (n=769,758)
    447 (417 to 480)
    294 (272 to 316)
        B2: Day 0 (n=765,755)
    89.7 (80.5 to 99.9)
    96.6 (86.9 to 107)
        B2: Day 28 (n=769,758)
    638 (594 to 686)
    363 (337 to 392)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Subjects Aged 60-64 Years and >=65 Years

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    End point title
    		 Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination in Subjects Aged 60-64 Years and >=65 Years
    End point description
    GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Titers were expressed in terms of 1/dilution. Analysis was performed on FAS population. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination), Day 28 (post-vaccination)
    End point values
    		 Group 1: QIV-HD Group 2: QIV-SD
    Number of subjects analysed
    769
    758
    Units: titers
    geometric mean (confidence interval 95%)
        A/H1N1: Day 0: 60-64 years (n=376,377)
    50.2 (42.7 to 59.0)
    50.0 (42.6 to 58.8)
        A/H1N1: Day 28: 60-64 years (n=377,377)
    471 (416 to 533)
    248 (217 to 283)
        A/H3N2: Day 0: 60-64 years (n=376,377)
    11.5 (10.4 to 12.8)
    12.5 (11.2 to 14.0)
        A/H3N2: Day 28: 60-64 years (n=376,377)
    303 (262 to 350)
    178 (154 to 206)
        B1: Day 0: 60-64 years (n=377,377)
    54.7 (47.4 to 63.2)
    68.7 (59.4 to 79.5)
        B1: Day 28: 60-64 years (n=377,377)
    497 (450 to 548)
    330 (297 to 367)
        B2: Day 0: 60-64 years (n=377,375)
    80.4 (68.6 to 94.3)
    93.2 (79.5 to 109)
        B2: Day 28: 60-64 years (n=377,377)
    766 (690 to 849)
    433 (391 to 480)
        A/H1N1: Day 0: >=65 years (n=392,381)
    47.1 (40.1 to 55.2)
    42.8 (36.6 to 50.0)
        A/H1N1: Day 28: >=65 years (n=392,381)
    286 (250 to 326)
    162 (139 to 190)
        A/H3N2: Day 0: >=65 years (n=391,380)
    15.2 (13.5 to 17.1)
    13.5 (12.1 to 15.0)
        A/H3N2: Day 0: >=65 years (n=392,381)
    324 (281 to 374)
    151 (129 to 176)
        B1: Day 0: >=65 years (n=390,380)
    74.2 (64.3 to 85.6)
    80.7 (70.1 to 92.9)
        B1: Day 28: >=65 years (n=392,381)
    405 (366 to 447)
    262 (236 to 291)
        B2: Day 0: >=65 years (n=388,380)
    99.7 (86.1 to 115)
    100 (86.8 to 115)
        B2: Day 28: >=65 years (n=392,381)
    536 (485 to 592)
    305 (274 to 340)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Subjects

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    End point title
    		 Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies in All Age Group Subjects
    End point description
    GMTRs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0). Analysis was performed on FAS population. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination), Day 28 (post-vaccination)
    End point values
    		 Group 1: QIV-HD Group 2: QIV-SD
    Number of subjects analysed
    769
    758
    Units: ratio
    geometric mean (confidence interval 95%)
        A/H1N1: Day 28/Day 0 (n=768,758)
    7.50 (6.68 to 8.42)
    4.34 (3.88 to 4.84)
        A/H3N2: Day 28/Day 0 (n=767,757)
    23.7 (21.4 to 26.1)
    12.6 (11.3 to 14.0)
        B1: Day 28/Day 0 (n=767,757)
    7.02 (6.34 to 7.77)
    3.95 (3.56 to 4.38)
        B2: Day 28/Day 0 (n=765,755)
    7.13 (6.44 to 7.90)
    3.77 (3.42 to 4.15)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratios of Influenza Antibodies in Subjects Aged 60-64 Years and >=65 Years

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    End point title
    		 Geometric Mean Titer Ratios of Influenza Antibodies in Subjects Aged 60-64 Years and >=65 Years
    End point description
    GMTRs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0). Analysis was performed on FAS population. Here, 'n' = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination), Day 28 (post-vaccination)
    End point values
    		 Group 1: QIV-HD Group 2: QIV-SD
    Number of subjects analysed
    769
    758
    Units: ratio
    geometric mean (confidence interval 95%)
        A/H1N1: Day 28/Day 0: 60-64 years (n=376,377)
    9.36 (7.86 to 11.1)
    4.96 (4.20 to 5.85)
        A/H3N2: Day 28/Day 0: 60-64 years (n=376,377)
    26.2 (22.8 to 30.2)
    14.2 (12.2 to 16.6)
        B1: Day 28/Day 0: 60-64 years (n=377,377)
    9.07 (7.84 to 10.5)
    4.80 (4.11 to 5.60)
        B2: Day 28/Day 0: 60-64 years (n=377,375)
    9.52 (8.19 to 11.1)
    4.66 (4.03 to 5.39)
        A/H1N1: Day 28/Day 0: >=65 years (n=392,381)
    6.07 (5.22 to 7.05)
    3.80 (3.27 to 4.41)
        A/H3N2: Day 28/Day 0: >=65 years (n=391,380)
    21.4 (18.6 to 24.7)
    11.2 (9.66 to 13.0)
        B1: Day 28/Day 0: >=65 years (n=390,380)
    5.48 (4.78 to 6.28)
    3.25 (2.83 to 3.73)
        B2: Day 28/Day 0: >=65 years (n=388,380)
    5.39 (4.72 to 6.15)
    3.06 (2.70 to 3.46)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects (All Age Group Subjects) With Neutralising Antibody Titers >=40 (1/Dilution)

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    End point title
    		 Percentage of Subjects (All Age Group Subjects) With Neutralising Antibody Titers >=40 (1/Dilution)
    End point description
    Neutralising Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Percentage of subjects (all age group subjects) with neutralising antibody titers >=40 (1/dilution) is reported in the end-point. Analysis was performed on FAS population. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 28 post-vaccination
    End point values
    		 Group 1: QIV-HD Group 2: QIV-SD
    Number of subjects analysed
    769
    758
    Units: percentage of subjects
    number (confidence interval 95%)
        A/H1N1: Day 28 (n=769,758)
    96.6 (95.1 to 97.8)
    88.4 (85.9 to 90.6)
        A/H3N2: Day 28 (n=768,758)
    93.8 (91.8 to 95.4)
    86.4 (83.8 to 88.8)
        B1: Day 28 (n=769,758)
    99.5 (98.7 to 99.9)
    99.2 (98.3 to 99.7)
        B2: Day 28 (n=769,758)
    99.5 (98.7 to 99.9)
    98.3 (97.1 to 99.1)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects (Aged 60-64 Years and >=65 Years) With Neutralising Antibody Titers >=40 (1/Dilution)

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    End point title
    		 Percentage of Subjects (Aged 60-64 Years and >=65 Years) With Neutralising Antibody Titers >=40 (1/Dilution)
    End point description
    Neutralising Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Percentage of subjects (aged 60-64 Years and >=65 Years) with neutralising antibody titers >=40 (1/dilution) is reported in the endpoint. Analysis was performed on FAS population. Here, 'n' = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 28 post-vaccination
    End point values
    		 Group 1: QIV-HD Group 2: QIV-SD
    Number of subjects analysed
    769
    758
    Units: percentage of subjects
    number (confidence interval 95%)
        A/H1N1: Day 28: 60-64 years (n=377,377)
    98.1 (96.2 to 99.3)
    92.3 (89.1 to 94.8)
        A/H3N2: Day 28: 60-64 years (n=376,377)
    94.9 (92.2 to 96.9)
    89.1 (85.5 to 92.1)
        B1: Day 28: 60-64 years (n=377,377)
    100 (99.0 to 100)
    99.5 (98.1 to 99.9)
        B2: Day 28: 60-64 years (n=377,377)
    99.7 (98.5 to 100)
    99.5 (98.1 to 99.9)
        A/H1N1: Day 28: >=65 years (n=392,381)
    95.2 (92.5 to 97.1)
    84.5 (80.5 to 88.0)
        A/H3N2: Day 28: >=65 years (n=392,381)
    92.6 (89.5 to 95.0)
    83.7 (79.6 to 87.3)
        B1: Day 28: >=65 years (n=392,381)
    99.0 (97.4 to 99.7)
    99.0 (97.3 to 99.7)
        B2: Day 28: >=65 years (n=392,381)
    99.2 (97.8 to 99.8)
    97.1 (94.9 to 98.6)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects (All Age Group Subjects) Achieving Seroconversion Against Antigens

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    End point title
    		 Percentage of Subjects (All Age Group Subjects) Achieving Seroconversion Against Antigens
    End point description
    Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer less than (<) 1:10 (1/dilution) and a post-vaccination titer >=1:40 (1/dilution) or a pre-vaccination titer >= 1:10 (1/dilution) and a >= four-fold increase in post-vaccination titer at Day 28. Percentage of subjects (all age group subjects) achieving seroconversion is reported in the endpoint. Analysis was performed on FAS population. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 28 post-vaccination
    End point values
    		 Group 1: QIV-HD Group 2: QIV-SD
    Number of subjects analysed
    769
    758
    Units: percentage of subjects
    number (confidence interval 95%)
        A/H1N1: Day 28 (n=768,758)
    62.1 (58.6 to 65.6)
    39.2 (35.7 to 42.8)
        A/H3N2: Day 28 (n=767,757)
    88.1 (85.6 to 90.3)
    74.2 (71.0 to 77.3)
        B1: Day 28 (n=767,757)
    62.5 (58.9 to 65.9)
    41.2 (37.7 to 44.8)
        B2: Day 28 (n=765,755)
    62.7 (59.2 to 66.2)
    41.6 (38.0 to 45.2)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens

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    End point title
    		 Percentage of Subjects (Aged 60-64 Years and >=65 Years) Achieving Seroconversion Against Antigens
    End point description
    Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 (1/dilution) and a post-vaccination titer >= 1:40 (1/dilution) or a pre-vaccination titer >= 1:10 (1/dilution) and a >= four-fold increase in post-vaccination titer at Day 28. Percentage of subjects (aged 60-64 Years and >=65 Years) achieving seroconversion is reported in the endpoint. Analysis was performed on FAS population. Here, 'n' = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 28 post-vaccination
    End point values
    		 Group 1: QIV-HD Group 2: QIV-SD
    Number of subjects analysed
    769
    758
    Units: percentage of subjects
    number (confidence interval 95%)
        A/H1N1: Day 28: 60-64 years (n=376,377)
    66.5 (61.5 to 71.2)
    41.4 (36.4 to 46.5)
        A/H3N2: Day 28: 60-64 years (n=376,377)
    89.4 (85.8 to 92.3)
    76.7 (72.1 to 80.8)
        B1: Day 28: 60-64 years (n=377,377)
    68.2 (63.2 to 72.8)
    47.7 (42.6 to 52.9)
        B2: Day 28: 60-64 years (n=377,375)
    70.6 (65.7 to 75.1)
    48.5 (43.4 to 53.7)
        A/H1N1: Day 28: >=65 years (n=392,381)
    57.9 (52.8 to 62.8)
    37.0 (32.1 to 42.1)
        A/H3N2: Day 28: >=65 years (n=391,380)
    87.0 (83.2 to 90.1)
    71.8 (67.0 to 76.3)
        B1: Day 28: >=65 years (n=390,380)
    56.9 (51.8 to 61.9)
    34.7 (30.0 to 39.8)
        B2: Day 28: >=65 years (n=388,380)
    55.2 (50.1 to 60.2)
    34.7 (30.0 to 39.8)
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Immediate Unsolicited Adverse Events (AEs)

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    End point title
    		 Number of Subjects Reporting Immediate Unsolicited Adverse Events (AEs)
    End point description
    An AE was any untoward medical occurrence in a patient or in a clinical investigation subject administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All subjects were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB. Analysis was performed on safety analysis set (SafAS) which included subjects who had received the study vaccine and had any safety data available.
    End point type
    Secondary
    End point timeframe
    Within 30 minutes post-vaccination
    End point values
    		 Group 1: QIV-HD Group 2: QIV-SD
    Number of subjects analysed
    772
    761
    Units: subjects
        number (not applicable)
    2
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Solicited Injection Site Reactions

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    End point title
    		 Number of Subjects Reporting Solicited Injection Site Reactions
    End point description
    A solicited reaction (SR) was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited injection site reactions included induration, bruising, pain, erythema, and swelling. Analysis was performed on the SafAS population. Here, ‘number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Within 7 days post-vaccination
    End point values
    		 Group 1: QIV-HD Group 2: QIV-SD
    Number of subjects analysed
    770
    759
    Units: subjects
    number (not applicable)
        Bruising
    12
    7
        Erythema
    157
    85
        Induration
    132
    64
        Pain
    350
    159
        Swelling
    140
    62
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Solicited Systemic Reactions

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    End point title
    		 Number of Subjects Reporting Solicited Systemic Reactions
    End point description
    A SR was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering. Analysis was performed on the SafAS population. Here, ‘number of subjects analysed’ = subjects evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Within 7 days post-vaccination
    End point values
    		 Group 1: QIV-HD Group 2: QIV-SD
    Number of subjects analysed
    770
    759
    Units: subjects
    number (not applicable)
        Fever
    18
    4
        Headache
    184
    141
        Malaise
    164
    89
        Myalgia
    202
    93
        Shivering
    128
    54
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Unsolicited Adverse Events (AEs)

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    End point title
    		 Number of Subjects Reporting Unsolicited Adverse Events (AEs)
    End point description
    An AE was any untoward medical occurrence in a patient or in a clinical investigation subject administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on SafAS population.
    End point type
    Secondary
    End point timeframe
    Within 28 days post-vaccination
    End point values
    		 Group 1: QIV-HD Group 2: QIV-SD
    Number of subjects analysed
    772
    761
    Units: subjects
        number (not applicable)
    190
    172
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs)

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    End point title
    		 Number of Subjects Reporting Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs)
    End point description
    A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. A SAE which caused death of the subject was considered as fatal SAE. Adverse events of special interest (AESIs) was defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. Analysis was performed on the SafAS population.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to 6 months post-vaccination
    End point values
    		 Group 1: QIV-HD Group 2: QIV-SD
    Number of subjects analysed
    772
    761
    Units: subjects
    number (not applicable)
        SAE
    17
    21
        AESI
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. SR data were collected up to Day 7 post-vaccination. SAE data were collected throughout the study, i.e. up to 6 months post-vaccination.
    Adverse event reporting additional description
    Safety analysis set. SR was an adverse reaction that was prelisted (i.e., solicited) in CRB and considered to be related to vaccination. Unsolicited AE was an observed AE that did not fulfill the conditions prelisted in CRB in terms of diagnosis and/or onset window post-vaccination. In AE section, SR shivering were reported as chills.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Group 1: QIV-HD
    Reporting group description
    		 Subjects received a single injection of 0.7 mL QIV-HD, IM at Day 0.

    Reporting group title
    Group 2: QIV-SD
    Reporting group description
    		 Subjects received a single injection of 0.5 mL QIV-SD, IM at Day 0.

    Serious adverse events
    		 Group 1: QIV-HD Group 2: QIV-SD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 772 (2.20%)
    21 / 761 (2.76%)
         number of deaths (all causes)
    2
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast Cancer
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial Carcinoma
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial Cancer
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polycythaemia Vera
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid Neoplasm
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Forearm Fracture
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus Fracture
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus Injury
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Thermal Burn
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Intermittent Claudication
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Myocardial Infarction
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Stenosis
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    0 / 772 (0.00%)
    2 / 761 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral Thrombosis
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 761 (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
    0 / 772 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss Of Consciousness
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    1 / 772 (0.13%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vith Nerve Paralysis
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric Perforation
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Haemorrhage
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestinal Obstruction
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Haemorrhage
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Prolapse
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 761 (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
    Pulmonary Embolism
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Incontinence
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rheumatoid Arthritis
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Corona Virus Infection
         subjects affected / exposed
    2 / 772 (0.26%)
    1 / 761 (0.13%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pilonidal Cyst
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumococcal Sepsis
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 761 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 761 (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
    		 Group 1: QIV-HD Group 2: QIV-SD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    507 / 772 (65.67%)
    354 / 761 (46.52%)
    Nervous system disorders
    Headache
    Additional description: Headache events that occurred after 7 days post-vaccination were considered as unsolicited AE.
         subjects affected / exposed
    190 / 772 (24.61%)
    149 / 761 (19.58%)
         occurrences all number
    196
    156
    General disorders and administration site conditions
    Chills
    Additional description: Chills/Shivering events that occurred after 7 days post-vaccination were considered as unsolicited AE.
         subjects affected / exposed
    128 / 772 (16.58%)
    57 / 761 (7.49%)
         occurrences all number
    130
    58
    Injection Site Erythema
         subjects affected / exposed
    157 / 772 (20.34%)
    85 / 761 (11.17%)
         occurrences all number
    158
    85
    Injection Site Induration
         subjects affected / exposed
    132 / 772 (17.10%)
    64 / 761 (8.41%)
         occurrences all number
    133
    64
    Injection Site Pain
    Additional description: Pain events that occurred after 7 days post-vaccination were considered as unsolicited AE.
         subjects affected / exposed
    350 / 772 (45.34%)
    161 / 761 (21.16%)
         occurrences all number
    350
    161
    Injection Site Swelling
         subjects affected / exposed
    140 / 772 (18.13%)
    62 / 761 (8.15%)
         occurrences all number
    140
    62
    Malaise
    Additional description: Malaise events that occurred after 7 days post-vaccination were considered as unsolicited AE.
         subjects affected / exposed
    168 / 772 (21.76%)
    90 / 761 (11.83%)
         occurrences all number
    168
    90
    Musculoskeletal and connective tissue disorders
    Myalgia
    Additional description: Myalgia events that occurred after 7 days post-vaccination were considered as unsolicited AE.
         subjects affected / exposed
    206 / 772 (26.68%)
    94 / 761 (12.35%)
         occurrences all number
    207
    94

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Aug 2019
    Following changes were made: Table of Study procedures footnote was corrected to indicate that the diary card will be collected at Visit 02 to review any solicited reactions that are still ongoing at Visit 02; Accurately reflected the frequency of reactions at the injection site as presented in the current QIV HD Investigator’s Brochure; Eliminated the 3 redundant “≥” symbols in these 3 sentences: "Slovakia recommended vaccination of persons ≥ 59 years of age and older. Malta and Poland recommended vaccination of persons ≥ 55 years of age and older. Three countries (Austria, Belgium, and Ireland) recommended vaccination of those who are ≥ 50 years of age and older"; Provided the correct description of the control vaccine as a subunit vaccine (not a split virion vaccine); Added additional details in the Section 10.5 Reporting SAEs to Health Authorities and IECs/IRBs as per Paul Ehrlich Institute (German Health Authority) request.

    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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