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    Clinical Trial Results:
    Safety and Immunogenicity of a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Adult and Elderly Subjects

    Summary
    EudraCT number
    2011-001976-21
    Trial protocol
    DE  
    Global end of trial date
    11 Jun 2012

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Feb 2016
    First version publication date
    29 Jan 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GQM01
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    U1111-1120-1486
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, F-69367 Lyon Cedex 07, France,
    Public contact
    Director, Clinical Development, Sanofi Pasteur, +33 (4) 37 37 58 50, Stephanie.Pepin@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur, +33 (4) 37 37 58 50, Stephanie.Pepin@sanofipasteur.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
    27 Sep 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jun 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate non-inferiority of antibody responses induced by quadrivalent influenza vaccine (QIV) compared with the licensed 2011-2012 trivalent influenza vaccine (TIV; containing the B/Brisbane strain) and the investigational TIV (containing the B/Florida strain) as assessed in all subjects by geometric mean titer (GMT) for each strain
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. 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
    Not applicable
    Evidence for comparator
    The licensed TIV for the 2011-2012 season containing the B/Brisbane strain (TIV1) was used as an active control.
    Actual start date of recruitment
    21 Oct 2011
    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
    France: 1088
    Country: Number of subjects enrolled
    Germany: 480
    Worldwide total number of subjects
    1568
    EEA total number of subjects
    1568
    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)
    1260
    From 65 to 84 years
    303
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    Study subjects were enrolled from 21 October 2011 to 10 November 2011 at 14 clinical sites in France and 4 in Germany.

    Pre-assignment
    Screening details
    A total of 1568 subjects who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.

    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
    Blinding implementation details
    This study was blinded to the Investigator and for all subjects in the QIV and TIV1 groups. After the 1st database lock, the code could be broken by the Investigator in the event of an SAE and if identification of the vaccine received could influence SAE treatment (Responsible Medical Officer was to be notified first) and by the GPV department for reporting to Health authorities in the case of an SAE as described in International Conference on Harmonisation (only for the subject in question).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    QIV 18-60 years
    Arm description
    Adults aged 18-60 years who received one dose of quadrivalent influenza vaccine (QIV).
    Arm type
    Experimental

    Investigational medicinal product name
    Quadrivalent influenza vaccine (split virion, inactivated) (QIV)
    Investigational medicinal product code
    481
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, intramuscular to be injected into the deltoid muscle or deep subcutaneous (SC), one dose on Day 0.

    Arm title
    QIV >60 years
    Arm description
    Elderly subjects aged >60 years who received one dose of quadrivalent influenza vaccine (QIV).
    Arm type
    Experimental

    Investigational medicinal product name
    Quadrivalent influenza vaccine (split virion, inactivated) (QIV)
    Investigational medicinal product code
    481
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, intramuscular to be injected into the deltoid muscle or deep subcutaneous (SC), one dose on Day 0.

    Arm title
    Licensed TIV 18-60 years
    Arm description
    Adults aged 18-60 years who received one dose of licensed trivalent influenza vaccine for the 2011-2012 season that contained either the B strain from the Victoria lineage, the B/Brisbane strain (TIV1).
    Arm type
    Active comparator

    Investigational medicinal product name
    Sanofi Pasteur licensed TIV for the 2011-2012 season (TIV1)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, intramuscular (IM) to be injected into the deltoid muscle or deep subcutaneous (SC), one dose on Day 0.

    Arm title
    Licensed TIV >60 years
    Arm description
    Elderly subjects aged >60 years who received one dose of licensed trivalent influenza vaccine for the 2011-2012 season that contained either the B strain from the Victoria lineage, the B/Brisbane strain (TIV1).
    Arm type
    Active comparator

    Investigational medicinal product name
    Sanofi Pasteur licensed TIV for the 2011-2012 season (TIV1)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, intramuscular (IM) to be injected into the deltoid muscle or deep subcutaneous (SC), one dose on Day 0.

    Arm title
    Investigational TIV 18-60 years
    Arm description
    Adults aged 18-60 years who received one dose of investigational trivalent influenza vaccine containing the B strain from the Yamagata lineage, the B/Florida strain (TIV2).
    Arm type
    Active comparator

    Investigational medicinal product name
    Investigational TIV (split-virion, inactivated) (TIV2)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, intramuscular (IM) to be injected into the deltoid muscle or deep subcutaneous (SC), one dose on Day 0.

    Arm title
    Investigational TIV >60 years
    Arm description
    Elderly subjects aged >60 years who received one dose of investigational trivalent influenza vaccine containing the B strain from the Yamagata lineage, the B/Florida strain (TIV2).
    Arm type
    Active comparator

    Investigational medicinal product name
    Investigational TIV (split-virion, inactivated) (TIV2)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, intramuscular (IM) to be injected into the deltoid muscle or deep subcutaneous (SC), one dose on Day 0.

    Number of subjects in period 1
    QIV 18-60 years QIV >60 years Licensed TIV 18-60 years Licensed TIV >60 years Investigational TIV 18-60 years Investigational TIV >60 years
    Started
    559
    558
    113
    113
    111
    114
    Completed
    557
    557
    113
    113
    110
    113
    Not completed
    2
    1
    0
    0
    1
    1
         Protocol deviation
             -
             -
             -
             -
             1
             1
         Adverse event, non-fatal
             1
             -
             -
             -
             -
             -
         Consent withdrawn by subject
             1
             1
             -
             -
             -
             -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    QIV 18-60 years
    Reporting group description
    Adults aged 18-60 years who received one dose of quadrivalent influenza vaccine (QIV).

    Reporting group title
    QIV >60 years
    Reporting group description
    Elderly subjects aged >60 years who received one dose of quadrivalent influenza vaccine (QIV).

    Reporting group title
    Licensed TIV 18-60 years
    Reporting group description
    Adults aged 18-60 years who received one dose of licensed trivalent influenza vaccine for the 2011-2012 season that contained either the B strain from the Victoria lineage, the B/Brisbane strain (TIV1).

    Reporting group title
    Licensed TIV >60 years
    Reporting group description
    Elderly subjects aged >60 years who received one dose of licensed trivalent influenza vaccine for the 2011-2012 season that contained either the B strain from the Victoria lineage, the B/Brisbane strain (TIV1).

    Reporting group title
    Investigational TIV 18-60 years
    Reporting group description
    Adults aged 18-60 years who received one dose of investigational trivalent influenza vaccine containing the B strain from the Yamagata lineage, the B/Florida strain (TIV2).

    Reporting group title
    Investigational TIV >60 years
    Reporting group description
    Elderly subjects aged >60 years who received one dose of investigational trivalent influenza vaccine containing the B strain from the Yamagata lineage, the B/Florida strain (TIV2).

    Reporting group values
    QIV 18-60 years QIV >60 years Licensed TIV 18-60 years Licensed TIV >60 years Investigational TIV 18-60 years Investigational TIV >60 years Total
    Number of subjects
    559 558 113 113 111 114 1568
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0 0 0
        Adults (18-64 years)
    559 410 113 33 111 34 1260
        From 65-84 years
    0 148 0 77 0 78 303
        85 years and over
    0 0 0 3 0 2 5
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    41.6 ± 12.7 68.7 ± 5.89 41.3 ± 12.4 68.8 ± 5.95 42.6 ± 12.1 69.1 ± 5.8 -
    Gender categorical
    Units: Subjects
        Female
    355 303 62 56 75 65 916
        Male
    204 255 51 57 36 49 652

    End points

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    End points reporting groups
    Reporting group title
    QIV 18-60 years
    Reporting group description
    Adults aged 18-60 years who received one dose of quadrivalent influenza vaccine (QIV).

    Reporting group title
    QIV >60 years
    Reporting group description
    Elderly subjects aged >60 years who received one dose of quadrivalent influenza vaccine (QIV).

    Reporting group title
    Licensed TIV 18-60 years
    Reporting group description
    Adults aged 18-60 years who received one dose of licensed trivalent influenza vaccine for the 2011-2012 season that contained either the B strain from the Victoria lineage, the B/Brisbane strain (TIV1).

    Reporting group title
    Licensed TIV >60 years
    Reporting group description
    Elderly subjects aged >60 years who received one dose of licensed trivalent influenza vaccine for the 2011-2012 season that contained either the B strain from the Victoria lineage, the B/Brisbane strain (TIV1).

    Reporting group title
    Investigational TIV 18-60 years
    Reporting group description
    Adults aged 18-60 years who received one dose of investigational trivalent influenza vaccine containing the B strain from the Yamagata lineage, the B/Florida strain (TIV2).

    Reporting group title
    Investigational TIV >60 years
    Reporting group description
    Elderly subjects aged >60 years who received one dose of investigational trivalent influenza vaccine containing the B strain from the Yamagata lineage, the B/Florida strain (TIV2).

    Primary: Geometric Mean Titers (GMTs) of HAI Antibody Response to Quadrivalent Influenza Vaccine (QIV) Strains Before and After Vaccination with a QIV Administered via the Intramuscular Route in Adults and Elderly Subjects

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    End point title
    Geometric Mean Titers (GMTs) of HAI Antibody Response to Quadrivalent Influenza Vaccine (QIV) Strains Before and After Vaccination with a QIV Administered via the Intramuscular Route in Adults and Elderly Subjects [1] [2]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Immunogenicity data were presented based on vaccine and age group specified in the outcome title.
    End point values
    QIV 18-60 years QIV >60 years
    Number of subjects analysed
    556
    554
    Units: Titer (1/dil)
    geometric mean (confidence interval 95%)
        A/California/7/2009 (H1N1); D0
    38.5 (33 to 44.8)
    29.7 (26 to 33.9)
        A/Victoria/210/2009 (H3N2); D0
    28.5 (24.9 to 32.5)
    43.1 (37.4 to 49.6)
        B/Brisbane/60/2008; D0
    53.9 (47.2 to 61.5)
    57.8 (51.1 to 65.4)
        B/Florida/04/2006; D0
    117 (101 to 134)
    93.5 (82.9 to 105)
        A/California/7/2009 (H1N1); D21
    551 (495 to 614)
    229 (204 to 258)
        A/Victoria/210/2009 (H3N2); D21
    417 (374 to 465)
    294 (262 to 331)
        B/Brisbane/60/2008; D21
    657 (599 to 722)
    278 (253 to 305)
        B/Florida/04/2006; D21
    1536 (1397 to 1688)
    673 (615 to 737)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Seroprotection Against Influenza Antigens Before and After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Adults and Elderly Subjects

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    End point title
    Percentage of Subjects With Seroprotection Against Influenza Antigens Before and After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Adults and Elderly Subjects [3] [4]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Seroprotection was defined as subjects having titers ≥ 40 (1/dil) on Day 21.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Immunogenicity data were presented based on vaccine and age group specified in the outcome title.
    End point values
    QIV 18-60 years QIV >60 years
    Number of subjects analysed
    556
    554
    Units: Percentage of subjects
    number (not applicable)
        A/California/7/2009 (H1N1); D0
    49.8
    43.7
        A/Victoria/210/2009 (H3N2); D0
    41.7
    53.7
        B/Brisbane/60/2008; D0
    58.1
    65.1
        B/Florida/04/2006; D0
    73.2
    75.8
        A/California/7/2009 (H1N1); D21
    96.4
    90.1
        A/Victoria/210/2009 (H3N2); D21
    97.1
    93.7
        B/Brisbane/60/2008; D21
    99.5
    97.5
        B/Florida/04/2006; D21
    99.6
    99.8
    No statistical analyses for this end point

    Primary: Percentage of Subjects Achieving Seroconversion or Significant increase Against Influenza Antigens After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Adults and Elderly Subjects

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    End point title
    Percentage of Subjects Achieving Seroconversion or Significant increase Against Influenza Antigens After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Adults and Elderly Subjects [5] [6]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Seroconversion was defined as for subjects with a pre-vaccination titer < 10 (1/dil): post-injection titer ≥ 40 (1/dil) on Day 21 or significant increase for subjects with a pre-vaccination titer ≥ 10 (1/dil): ≥ 4-fold increase from pre- to post-injection titer on Day 21.
    End point type
    Primary
    End point timeframe
    Day 21 post-vaccination
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Immunogenicity data were presented based on vaccine and age group specified in the outcome title.
    End point values
    QIV 18-60 years QIV >60 years
    Number of subjects analysed
    556
    554
    Units: Percentage of subjects
    number (not applicable)
        A/California/7/2009 (H1N1)
    72.2
    59.2
        A/Victoria/210/2009 (H3N2)
    74.5
    56.6
        B/Brisbane/60/2008
    69.2
    46.1
        B/Florida/04/2006
    73.9
    61.2
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of HAI antibody response to Trivalent Influenza Vaccine (TIV) strains Before and After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Adults and Elderly Subjects

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    End point title
    Geometric Mean Titers (GMTs) of HAI antibody response to Trivalent Influenza Vaccine (TIV) strains Before and After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Adults and Elderly Subjects [7] [8]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Immunogenicity data were presented based on vaccine and age group specified in the outcome title.
    End point values
    Licensed TIV 18-60 years Licensed TIV >60 years Investigational TIV 18-60 years Investigational TIV >60 years
    Number of subjects analysed
    113
    113
    110
    111
    Units: Titer (1/dil)
    geometric mean (confidence interval 95%)
        Licensed TIV B/Brisbane 60/2008; D0
    69.7 (51.3 to 94.6)
    51.3 (39.5 to 66.6)
    0 (0 to 0)
    0 (0 to 0)
        Investigational TIV B/Florida/04/2006; D0
    0 (0 to 0)
    0 (0 to 0)
    96.6 (69.4 to 135)
    104 (80.2 to 136)
        Licensed TIV B/Brisbane 60/2008; D21
    841 (665 to 1062)
    254 (201 to 321)
    0 (0 to 0)
    0 (0 to 0)
        Investigational TIV B/Florida/04/2006; D21
    0 (0 to 0)
    0 (0 to 0)
    1268 (1017 to 1580)
    725 (591 to 890)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Seroprotection Against Trivalent Influenza Vaccine Antigens Before and After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Adults and Elderly Subjects

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    End point title
    Percentage of Subjects With Seroprotection Against Trivalent Influenza Vaccine Antigens Before and After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Adults and Elderly Subjects [9] [10]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Seroprotection was defined as subjects having titers ≥ 40 (1/dil) on Day 21.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Immunogenicity data were presented based on vaccine and age group specified in the outcome title.
    End point values
    Licensed TIV 18-60 years Licensed TIV >60 years Investigational TIV 18-60 years Investigational TIV >60 years
    Number of subjects analysed
    113
    113
    110
    111
    Units: Percentage of subjects
    number (not applicable)
        Licensed TIV B/Brisbane 60/2008; D0
    62.8
    60.2
    0
    0
        Investigational TIV B/Florida/04/2006; D0
    0
    0
    70
    80.2
        Licensed TIV B/Brisbane 60/2008; D21
    99.1
    96.5
    0
    0
        Investigational TIV B/Florida/04/2006; D21
    0
    0
    99.1
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects Achieving Seroconversion or Significant increase Against Trivalent Influenza Vaccine Antigens After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Adults and Elderly Subjects

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    End point title
    Percentage of Subjects Achieving Seroconversion or Significant increase Against Trivalent Influenza Vaccine Antigens After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Adults and Elderly Subjects [11] [12]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Seroconversion was defined as for subjects with a pre-vaccination titer < 10 (1/dil): post-injection titer ≥ 40 (1/dil) on Day 21 or significant increase for subjects with a pre-vaccination titer ≥ 10 (1/dil): ≥ 4-fold increase from pre- to post-injection titer on Day 21.
    End point type
    Primary
    End point timeframe
    Day 21 post-vaccination
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Immunogenicity data were presented based on vaccine and age group specified in the outcome title.
    End point values
    Licensed TIV 18-60 years Licensed TIV >60 years Investigational TIV 18-60 years Investigational TIV >60 years
    Number of subjects analysed
    113
    113
    110
    111
    Units: Percentage of subjects
    number (not applicable)
        Licensed TIV B/Brisbane 60/2008
    61.1
    42.5
    0
    0
        Investigational TIV B/Florida/04/2006
    0
    0
    75.5
    56.8
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route

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    End point title
    Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route [13]
    End point description
    Solicited injection site: Pain, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 Solicited Injection site reactions: Pain – Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - >100 mm. Grade 3 Solicited systemic reactions: Fever - ≥39˚C; Headache, Malaise, Myalgia, and Shivering – Significant, prevents daily activities.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 7 post-vaccination
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    QIV 18-60 years QIV >60 years Licensed TIV 18-60 years Licensed TIV >60 years Investigational TIV 18-60 years Investigational TIV >60 years
    Number of subjects analysed
    558
    558 [14]
    113
    113 [15]
    110
    113 [16]
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    59.4
    29.9
    48.7
    27.4
    54.5
    23
        Grade 3 Injection site Pain
    0.5
    0.2
    0.9
    0.9
    0
    0
        Injection site Erythema
    9.9
    6.3
    12.4
    7.1
    10
    5.3
        Grade 3 Injection site Erythema
    0
    0
    0
    0
    0.9
    0
        Injection site Swelling
    5.4
    3.8
    3.5
    3.5
    5.5
    1.8
        Grade 3 Injection site Swelling
    0
    0
    0
    0
    0.9
    0
        Injection site Induration
    6.1
    3.6
    3.5
    1.8
    7.3
    1.8
        Grade 3 Injection site Induration
    0
    0
    0
    0
    0
    0
        Injection site Ecchymosis
    0.7
    0.4
    1.8
    0
    0
    0
        Grade 3 Injection site Ecchymosis
    0
    0
    0
    0
    0
    0
        Fever
    2
    0.7
    1.8
    0.9
    0
    1.8
        Grade 3 Fever
    0.4
    0
    1.8
    0
    0
    0
        Headache
    31.8
    16.1
    31.9
    12.4
    30
    14.2
        Grade 3 Headache
    2.3
    0.4
    4.4
    0
    0.9
    0.9
        Malaise
    17.4
    7.5
    16.8
    6.2
    13.6
    8.8
        Grade 3 Malaise
    1.3
    0.2
    1.8
    0.9
    0
    0
        Myalgia
    30.3
    15.4
    29.2
    12.4
    23.6
    8.8
        Grade 3 Myalgia
    1.4
    0.4
    1.8
    0.9
    0
    0
        Shivering
    11.3
    4.1
    6.2
    7.1
    9.1
    5.3
        Grade 3 Shivering
    1.1
    0
    1.8
    0
    0.9
    0
    Notes
    [14] - No vaccine outcome for this group.
    [15] - No vaccine outcome for this group.
    [16] - No vaccine outcome for this group.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    QIV 18-60 years
    Reporting group description
    Adults aged 18-60 years who received one dose of quadrivalent influenza vaccine (QIV).

    Reporting group title
    QIV >60 years
    Reporting group description
    Elderly subjects aged >60 years who received one dose of quadrivalent influenza vaccine (QIV).

    Reporting group title
    Licensed TIV 18-60 years
    Reporting group description
    Adults aged 18-60 years who received one dose of licensed trivalent influenza vaccine for the 2011-2012 season that contained either the B strain from the Victoria lineage, the B/Brisbane strain (TIV1).

    Reporting group title
    Licensed TIV >60 years
    Reporting group description
    Elderly subjects aged >60 years who received one dose of licensed trivalent influenza vaccine for the 2011-2012 season that contained either the B strain from the Victoria lineage, the B/Brisbane strain (TIV1).

    Reporting group title
    Investigational TIV 18-60 years
    Reporting group description
    Adults aged 18-60 years who received one dose of investigational trivalent influenza vaccine containing the B strain from the Yamagata lineage, the B/Florida strain (TIV2).

    Reporting group title
    Investigational TIV >60 years
    Reporting group description
    Elderly subjects aged >60 years who received one dose of investigational trivalent influenza vaccine containing the B strain from the Yamagata lineage, the B/Florida strain (TIV2).

    Serious adverse events
    QIV 18-60 years QIV >60 years Licensed TIV 18-60 years Licensed TIV >60 years Investigational TIV 18-60 years Investigational TIV >60 years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 558 (0.18%)
    2 / 558 (0.36%)
    1 / 113 (0.88%)
    1 / 113 (0.88%)
    1 / 110 (0.91%)
    1 / 113 (0.88%)
         number of deaths (all causes)
    0
    2
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 558 (0.18%)
    0 / 558 (0.00%)
    0 / 113 (0.00%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    0 / 558 (0.00%)
    1 / 558 (0.18%)
    0 / 113 (0.00%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 558 (0.00%)
    0 / 558 (0.00%)
    0 / 113 (0.00%)
    1 / 113 (0.88%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Gastric banding
         subjects affected / exposed
    1 / 558 (0.18%)
    0 / 558 (0.00%)
    0 / 113 (0.00%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mammoplasty
         subjects affected / exposed
    1 / 558 (0.18%)
    0 / 558 (0.00%)
    0 / 113 (0.00%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign neoplasm of the skin
         subjects affected / exposed
    1 / 558 (0.18%)
    0 / 558 (0.00%)
    0 / 113 (0.00%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 558 (0.00%)
    1 / 558 (0.18%)
    0 / 113 (0.00%)
    1 / 113 (0.88%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholesteatoma
         subjects affected / exposed
    0 / 558 (0.00%)
    0 / 558 (0.00%)
    1 / 113 (0.88%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    0 / 558 (0.00%)
    1 / 558 (0.18%)
    0 / 113 (0.00%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 558 (0.18%)
    0 / 558 (0.00%)
    0 / 113 (0.00%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    1 / 558 (0.18%)
    0 / 558 (0.00%)
    0 / 113 (0.00%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 558 (0.00%)
    1 / 558 (0.18%)
    0 / 113 (0.00%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 558 (0.00%)
    0 / 558 (0.00%)
    0 / 113 (0.00%)
    1 / 113 (0.88%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    0 / 558 (0.00%)
    2 / 558 (0.36%)
    0 / 113 (0.00%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 558 (0.00%)
    1 / 558 (0.18%)
    0 / 113 (0.00%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Inner ear disorder
         subjects affected / exposed
    1 / 558 (0.18%)
    0 / 558 (0.00%)
    0 / 113 (0.00%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 558 (0.18%)
    0 / 558 (0.00%)
    0 / 113 (0.00%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic haemorrhage
         subjects affected / exposed
    0 / 558 (0.00%)
    1 / 558 (0.18%)
    0 / 113 (0.00%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    0 / 558 (0.00%)
    0 / 558 (0.00%)
    1 / 113 (0.88%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Foot deformity
         subjects affected / exposed
    0 / 558 (0.00%)
    1 / 558 (0.18%)
    0 / 113 (0.00%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Encephalitis herpes
         subjects affected / exposed
    0 / 558 (0.00%)
    0 / 558 (0.00%)
    1 / 113 (0.88%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 558 (0.00%)
    0 / 558 (0.00%)
    1 / 113 (0.88%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paronychia
         subjects affected / exposed
    0 / 558 (0.00%)
    1 / 558 (0.18%)
    0 / 113 (0.00%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 558 (0.00%)
    0 / 558 (0.00%)
    1 / 113 (0.88%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    0 / 558 (0.00%)
    0 / 558 (0.00%)
    1 / 113 (0.88%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    QIV 18-60 years QIV >60 years Licensed TIV 18-60 years Licensed TIV >60 years Investigational TIV 18-60 years Investigational TIV >60 years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    331 / 558 (59.32%)
    167 / 558 (29.93%)
    55 / 113 (48.67%)
    31 / 113 (27.43%)
    60 / 110 (54.55%)
    26 / 113 (23.01%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    177 / 557 (31.78%)
    90 / 558 (16.13%)
    36 / 113 (31.86%)
    14 / 113 (12.39%)
    33 / 110 (30.00%)
    16 / 113 (14.16%)
         occurrences all number
    177
    90
    36
    14
    33
    16
    General disorders and administration site conditions
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    331 / 557 (59.43%)
    167 / 558 (29.93%)
    55 / 113 (48.67%)
    31 / 113 (27.43%)
    60 / 110 (54.55%)
    26 / 113 (23.01%)
         occurrences all number
    331
    167
    55
    31
    60
    26
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    55 / 557 (9.87%)
    35 / 558 (6.27%)
    14 / 113 (12.39%)
    8 / 113 (7.08%)
    11 / 110 (10.00%)
    6 / 113 (5.31%)
         occurrences all number
    55
    35
    14
    8
    11
    6
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    30 / 557 (5.39%)
    21 / 558 (3.76%)
    4 / 113 (3.54%)
    4 / 113 (3.54%)
    6 / 110 (5.45%)
    2 / 113 (1.77%)
         occurrences all number
    30
    21
    4
    4
    6
    2
    Injection site ecchymosis
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    4 / 557 (0.72%)
    2 / 558 (0.36%)
    2 / 113 (1.77%)
    0 / 113 (0.00%)
    0 / 110 (0.00%)
    0 / 113 (0.00%)
         occurrences all number
    4
    2
    2
    0
    0
    0
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    97 / 557 (17.41%)
    42 / 558 (7.53%)
    19 / 113 (16.81%)
    7 / 113 (6.19%)
    15 / 110 (13.64%)
    10 / 113 (8.85%)
         occurrences all number
    97
    42
    19
    7
    15
    10
    Shivering
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    63 / 557 (11.31%)
    23 / 558 (4.12%)
    7 / 113 (6.19%)
    8 / 113 (7.08%)
    10 / 110 (9.09%)
    6 / 113 (5.31%)
         occurrences all number
    63
    23
    7
    8
    10
    6
    Skin and subcutaneous tissue disorders
    Injection site induration
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    34 / 557 (6.10%)
    20 / 558 (3.58%)
    4 / 113 (3.54%)
    2 / 113 (1.77%)
    8 / 110 (7.27%)
    2 / 113 (1.77%)
         occurrences all number
    34
    20
    4
    2
    8
    2
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    169 / 557 (30.34%)
    86 / 558 (15.41%)
    33 / 113 (29.20%)
    14 / 113 (12.39%)
    26 / 110 (23.64%)
    10 / 113 (8.85%)
         occurrences all number
    169
    86
    33
    14
    26
    10
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects who returned the safety diary card and data were available for the event during the period.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects who returned the safety diary card and data were available for the event during the period.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects who returned the safety diary card and data were available for the event during the period.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects who returned the safety diary card and data were available for the event during the period.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects who returned the safety diary card and data were available for the event during the period.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects who returned the safety diary card and data were available for the event during the period.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects who returned the safety diary card and data were available for the event during the period.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects who returned the safety diary card and data were available for the event during the period.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects who returned the safety diary card and data were available for the event during the period.

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Aug 2011
    A statement was added that defined specific criteria for stopping the trial during the enrollment phase in case of post-vaccination safety concerns.
    22 Mar 2012
    The protocol was amended in regards to a site (Center 003) closing. For subjects included in Center 003, the 6-month safety follow-up would be conducted by Center 004 and subjects would be asked to sign an addendum to the ICF to consent to being contacted by Center 004. It also clarified how subjects from Center 003 would be handled in the clinical database if they refuse to be followed by Center 004 for the 6-month safety follow-up and where source documents of subjects included in Center 003 are archived.

    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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