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    Clinical Trial Results:
    A Phase I/II, randomized, controlled, observer-blind, multi-center study to assess the reactogenicity, safety and immunogenicity of three GlaxoSmithKline (GSK) Biologicals’ investigational supra-seasonal universal influenza vaccines (SUIVs) (unadjuvanted or adjuvanted with AS03 or AS01) administered as a 1 or 2-dose priming schedule followed by a booster dose 12 months post-primary vaccination in 18 to 39 year-old healthy subjects

    Summary
    EudraCT number
    2017-001584-20
    Trial protocol
    BE  
    Global end of trial date
    26 Mar 2020

    Results information
    Results version number
    v2(current)
    This version publication date
    01 May 2021
    First version publication date
    01 Apr 2021
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Results have been amended to account for consistency with other registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    207543
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03275389
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.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
    10 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the reactogenicity and safety of each vaccine dose throughout the entire study period, in all study groups. To describe the anti-H1 stalk humoral immune response 28 days after each priming dose (1 or 2 dose(s)) in all study groups.
    Protection of trial subjects
    The subjects were observed closely for at least 60 minutes (Phase I subjects) or 30 minutes (Phase II subjects) following the administration of the vaccines/products, with appropriate medical treatment readily available in case of anaphylaxis.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    08 Sep 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 101
    Country: Number of subjects enrolled
    United States: 369
    Worldwide total number of subjects
    470
    EEA total number of subjects
    101
    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)
    470
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    470 subjects were enrolled and randomized in the study, however, while 2 subjects were allocated subjects numbers, they did not receive any vaccine dose.

    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, Monitor, Assessor
    Blinding implementation details
    The site staff worked in an observer-blind manner. As the vaccines appearance and preparation were different, two teams of study personnel were set up: • A team of unblinded personnel (responsible for the reception, preparation and administration of the vaccines). • A team of blinded personnel (responsible for the clinical safety evaluation of the subjects).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    D-SUIV Adjuvanted Group 1
    Arm description
    Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
    Arm type
    Experimental

    Investigational medicinal product name
    D-SUIV cH8/1N1+AS03 Placebo D-SUIV cH5/1N1+AS03
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose at Day 1 (D-SUIV cH8/1N1+AS03) 1 dose at Day 57 (Placebo); 1 dose at Month 14 (D-SUIV cH5/1N1+AS03)

    Arm title
    D-SUIV Adjuvanted Group 2
    Arm description
    Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
    Arm type
    Experimental

    Investigational medicinal product name
    D-SUIV cH5/1N1+AS03 Placebo D-SUIV cH8/1N1+AS03
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose at Day 1 (D-SUIV cH5/1N1+AS03); 1 dose at Day 57 (Placebo); 1 dose at Month 14 (D-SUIV cH8/1N1+AS03)

    Arm title
    D-SUIV Adjuvanted Group 3
    Arm description
    Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
    Arm type
    Experimental

    Investigational medicinal product name
    D-SUIV cH8/1N1+AS03 D-SUIV cH5/1N1+AS03 D-SUIV cH11/1N1+AS03
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose at Day 1 (D-SUIV cH8/1N1+AS03); 1 dose at Day 57 (D-SUIV cH5/1N1+AS03); 1 dose at Month 14 (D-SUIV cH11/1N1+AS03)

    Arm title
    D-SUIV Adjuvanted Group 4
    Arm description
    Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
    Arm type
    Experimental

    Investigational medicinal product name
    D-SUIV cH8/1N1+AS01 Placebo D-SUIV cH5/1N1+AS01
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose at Day 1 (D-SUIV cH8/1N1+AS01); 1 dose at Day 57 (Placebo); 1 dose at Month 14 (D-SUIV cH5/1N1+AS01)

    Arm title
    D-SUIV Adjuvanted Group 5
    Arm description
    Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
    Arm type
    Experimental

    Investigational medicinal product name
    D-SUIV cH5/1N1+AS01 Placebo D-SUIV cH8/1N1+AS01
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose at Day 1 (D-SUIV cH5/1N1+AS01); 1 dose at Day 57 (Placebo); 1 dose at Month 14 (D-SUIV cH8/1N1+AS01)

    Arm title
    D-SUIV Adjuvanted Group 6
    Arm description
    Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
    Arm type
    Experimental

    Investigational medicinal product name
    D-SUIV cH8/1N1+AS01 D-SUIV cH5/1N1+AS01 D-SUIV cH11/1N1+AS01
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose at Day 1 (D-SUIV cH8/1N1+AS01); 1 dose at Day 57 (D-SUIV cH5/1N1+AS01); 1 dose at Month 14 (D-SUIV cH11/1N1+AS01)

    Arm title
    D-SUIV Unadjuvanted Group 1
    Arm description
    Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
    Arm type
    Experimental

    Investigational medicinal product name
    D-SUIV cH8/1N1 Placebo D-SUIV cH5/1N1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose at Day 1 (D-SUIV cH8/1N1); 1 dose at Day 57 (Placebo); 1 dose at Month 14 (D-SUIV cH5/1N1)

    Arm title
    D-SUIV Unadjuvanted Group 2
    Arm description
    Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
    Arm type
    Experimental

    Investigational medicinal product name
    D-SUIV cH5/1N1 Placebo D-SUIV cH8/1N1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose at Day 1 (D-SUIV cH5/1N1); 1 dose at Day 57 (Placebo); 1 dose at Month 14 (D-SUIV cH8/1N1)

    Arm title
    D-SUIV Unadjuvanted Group 3
    Arm description
    Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
    Arm type
    Experimental

    Investigational medicinal product name
    D-SUIV cH8/1N1 D-SUIV cH5/1N1 D-SUIV cH11/1N1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose at Day 1 (D-SUIV cH8/1N1); 1 dose at Day 57 (D-SUIV cH5/1N1); 1 dose at Month 14 (D-SUIV cH11/1N1)

    Arm title
    IIV4 Group
    Arm description
    Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
    Arm type
    Active comparator

    Investigational medicinal product name
    Fluarix Quadrivalent (IIV4); Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose at Day 1 (Fluarix Quadrivalent (IIV4)) 1 dose at Day 57 (Placebo) 1 dose at Month 14 (Fluarix Quadrivalent)

    Number of subjects in period 1 [1]
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Started
    45
    46
    47
    47
    48
    47
    47
    48
    46
    47
    Completed
    34
    30
    24
    25
    32
    29
    22
    30
    31
    29
    Not completed
    11
    16
    23
    22
    16
    18
    25
    18
    15
    18
         NOT WILLING TO PARTICIPATE THIS VISIT
    -
    -
    1
    -
    -
    -
    -
    -
    -
    1
         Unknown
    -
    4
    3
    2
    2
    2
    -
    -
    1
    -
         MIGRATED / MOVED FROM THE STUDY AREA
    -
    2
    -
    3
    -
    -
    1
    -
    -
    -
         Lost to follow-up
    10
    10
    19
    12
    11
    12
    21
    15
    12
    14
         SERIOUS ADVERSE EVENT AND/OR PIMD
    -
    -
    -
    -
    -
    1
    -
    -
    -
    1
         CONSENT WITHDRAWAL NOT DUE TO ADV. EVENT
    1
    -
    -
    5
    3
    3
    3
    3
    2
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 470 subjects were enrolled and randomized in the study, however, while 2 subjects were allocated subjects numbers, they did not receive any vaccine dose.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    D-SUIV Adjuvanted Group 1
    Reporting group description
    Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Reporting group title
    D-SUIV Adjuvanted Group 2
    Reporting group description
    Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Reporting group title
    D-SUIV Adjuvanted Group 3
    Reporting group description
    Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Reporting group title
    D-SUIV Adjuvanted Group 4
    Reporting group description
    Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Reporting group title
    D-SUIV Adjuvanted Group 5
    Reporting group description
    Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Reporting group title
    D-SUIV Adjuvanted Group 6
    Reporting group description
    Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Reporting group title
    D-SUIV Unadjuvanted Group 1
    Reporting group description
    Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Reporting group title
    D-SUIV Unadjuvanted Group 2
    Reporting group description
    Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Reporting group title
    D-SUIV Unadjuvanted Group 3
    Reporting group description
    Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Reporting group title
    IIV4 Group
    Reporting group description
    Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Reporting group values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group Total
    Number of subjects
    45 46 47 47 48 47 47 48 46 47 468
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0 0 0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0 0 0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0 0 0 0 0 0 0
        Adults (18-64 years)
    45 46 47 47 48 47 47 48 46 47 468
        From 65-84 years
    0 0 0 0 0 0 0 0 0 0 0
        85 years and over
    0 0 0 0 0 0 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    29.0 ± 6.6 29.3 ± 5.7 28.6 ± 6.0 28.7 ± 6.4 29.1 ± 6.2 28.8 ± 6.1 29.6 ± 5.8 28.5 ± 5.9 28.8 ± 5.9 29.3 ± 5.8 -
    Sex: Female, Male
    Units: Participants
        Female
    26 27 28 28 27 27 27 26 25 27 268
        Male
    19 19 19 19 21 20 20 22 21 20 200
    Race/Ethnicity, Customized
    Units: Subjects
        American indian or alaska native
    0 0 0 0 1 0 0 0 0 0 1
        Asian - central / south asian heritage
    0 0 0 0 0 0 0 0 1 0 1
        Asian - east asian heritage
    0 1 0 0 0 0 0 0 0 0 1
        Asian - south east asian heritage
    0 1 0 1 0 0 0 0 0 0 2
        Black or african american
    11 9 10 8 5 7 10 13 6 9 88
        Native hawaiian or other pacific islander
    0 0 0 0 0 0 1 0 0 0 1
        Other, Not specified
    0 0 0 2 2 1 1 1 2 1 10
        White - arabic / north african heritage
    0 1 0 0 0 1 0 1 0 2 5
        White - caucasian / european heritage
    34 34 37 36 40 38 35 33 37 35 359

    End points

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    End points reporting groups
    Reporting group title
    D-SUIV Adjuvanted Group 1
    Reporting group description
    Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Reporting group title
    D-SUIV Adjuvanted Group 2
    Reporting group description
    Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Reporting group title
    D-SUIV Adjuvanted Group 3
    Reporting group description
    Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Reporting group title
    D-SUIV Adjuvanted Group 4
    Reporting group description
    Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Reporting group title
    D-SUIV Adjuvanted Group 5
    Reporting group description
    Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Reporting group title
    D-SUIV Adjuvanted Group 6
    Reporting group description
    Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Reporting group title
    D-SUIV Unadjuvanted Group 1
    Reporting group description
    Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Reporting group title
    D-SUIV Unadjuvanted Group 2
    Reporting group description
    Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Reporting group title
    D-SUIV Unadjuvanted Group 3
    Reporting group description
    Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Reporting group title
    IIV4 Group
    Reporting group description
    Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Primary: Number of subjects with solicited local adverse events (AEs) after first dose administration

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    End point title
    Number of subjects with solicited local adverse events (AEs) after first dose administration [1]
    End point description
    Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 millimeters (mm) of injection site.
    End point type
    Primary
    End point timeframe
    During the 7-day (Days 1-7) follow-up period after first vaccine dose
    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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    44
    46
    45
    46
    46
    46
    45
    47
    46
    45
    Units: Participants
        Erythema
    1
    3
    2
    2
    1
    3
    1
    0
    1
    0
        Pain
    34
    42
    37
    39
    40
    42
    16
    13
    15
    35
        Swelling
    4
    2
    2
    4
    3
    2
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: Number of subjects with solicited local AEs after second dose administration

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    End point title
    Number of subjects with solicited local AEs after second dose administration [2]
    End point description
    Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 millimeters (mm) of injection site.
    End point type
    Primary
    End point timeframe
    During the 7-day (Days 1-7) follow-up period after second vaccine dose
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    40
    37
    36
    41
    41
    37
    38
    39
    40
    39
    Units: Participants
        Erythema
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        Pain
    5
    2
    29
    2
    8
    32
    4
    5
    12
    10
        Swelling
    0
    0
    4
    0
    0
    2
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with solicited local AEs after booster dose administration

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    End point title
    Number of subjects with solicited local AEs after booster dose administration [3]
    End point description
    Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 mm of injection site.
    End point type
    Primary
    End point timeframe
    During the 7-day (Days 1-7) follow-up period after booster vaccine dose
    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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    33
    32
    27
    30
    31
    30
    24
    32
    33
    31
    Units: Participants
        Erythema
    1
    1
    0
    0
    1
    1
    0
    0
    0
    0
        Pain
    27
    31
    26
    29
    28
    25
    4
    10
    13
    21
        Swelling
    2
    2
    0
    1
    1
    1
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with solicited general AEs after first dose administration

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    End point title
    Number of subjects with solicited general AEs after first dose administration [4]
    End point description
    Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as oral temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade
    End point type
    Primary
    End point timeframe
    During the 7-day (Days 1-7) follow-up period after first vaccine dose
    Notes
    [4] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    44
    46
    45
    46
    46
    46
    45
    47
    46
    46
    Units: Participants
        Arthralgia
    4
    6
    9
    2
    3
    8
    6
    5
    2
    5
        Fatigue
    17
    18
    22
    18
    21
    18
    17
    19
    12
    12
        Gastrointestinal symptoms
    6
    7
    10
    6
    8
    8
    6
    8
    10
    8
        Headache
    18
    18
    19
    23
    16
    26
    16
    19
    15
    14
        Myalgia
    16
    13
    19
    17
    19
    20
    9
    9
    6
    11
        Shivering
    6
    3
    10
    10
    8
    9
    2
    2
    2
    3
        Temperature
    1
    1
    0
    2
    2
    1
    1
    1
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with solicited general AEs after second dose administration

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    End point title
    Number of subjects with solicited general AEs after second dose administration [5]
    End point description
    Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as oral temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade
    End point type
    Primary
    End point timeframe
    During the 7-day (Days 1-7) follow-up period after second vaccine dose
    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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    40
    37
    36
    41
    41
    39
    38
    39
    40
    40
    Units: Participants
        Arthralgia
    3
    4
    4
    0
    4
    4
    0
    0
    2
    2
        Fatigue
    7
    7
    10
    6
    7
    8
    5
    5
    10
    5
        Gastrointestinal symptoms
    3
    4
    4
    3
    3
    6
    1
    4
    2
    2
        Headache
    8
    12
    13
    7
    9
    12
    5
    12
    8
    7
        Myalgia
    5
    6
    12
    1
    4
    16
    3
    2
    6
    3
        Shivering
    2
    4
    4
    0
    3
    5
    1
    0
    2
    1
        Temperature
    1
    2
    0
    0
    1
    2
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with solicited general AEs after booster dose administration

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    End point title
    Number of subjects with solicited general AEs after booster dose administration [6]
    End point description
    Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as oral temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
    End point type
    Primary
    End point timeframe
    During the 7-day (Days 1-7) follow-up period after booster vaccine dose
    Notes
    [6] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    33
    32
    27
    30
    31
    30
    24
    32
    33
    31
    Units: Participants
        Arthralgia
    6
    8
    4
    4
    9
    4
    1
    1
    2
    1
        Fatigue
    15
    19
    17
    16
    20
    9
    2
    6
    6
    3
        Gastrointestinal symptoms
    3
    8
    8
    5
    6
    5
    1
    2
    4
    0
        Headache
    9
    13
    14
    15
    16
    15
    3
    7
    6
    4
        Myalgia
    15
    17
    15
    15
    13
    10
    0
    4
    5
    3
        Shivering
    5
    13
    6
    6
    14
    9
    0
    1
    2
    1
        Temperature
    2
    3
    1
    4
    2
    1
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with any unsolicited AEs post-vaccination period

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    End point title
    Number of subjects with any unsolicited AEs post-vaccination period [7]
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination
    End point type
    Primary
    End point timeframe
    During the 28-day (Days 1-28) follow-up period accross doses
    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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    45
    46
    47
    47
    48
    47
    47
    48
    46
    47
    Units: Participants
    27
    23
    23
    24
    24
    17
    22
    23
    22
    21
    No statistical analyses for this end point

    Primary: Number of subjects with change from baseline in hematological and biochemical laboratory results at Day 8 by toxicity grading

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    End point title
    Number of subjects with change from baseline in hematological and biochemical laboratory results at Day 8 by toxicity grading [8]
    End point description
    Hematological parameters assessed are: Eosinophils increase [EOSi], hemoglobin decrease [HEMd] , lymphocytes decrease [LYMd], Neutrophils decrease [NEUd], platelets decrease [PLTCd], white blood cells decrease [WBCd], WBC increase [WBCi]. Biochemical parameters assessed are: alanine aminotransferase increase [ALTi], aspartate aminotransferase increase [ASTi], blood urea nitrogen [BUN], creatinine [CRE].Toxicity grading is according to the Food and Drug Administration (FDA) guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as follows: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as follows: Parameter- grading at Baseline- grading at Timing: e.g.: "ALTi-G0-G1" (with G=Grade and UNK= Unknown).
    End point type
    Primary
    End point timeframe
    At Day 8
    Notes
    [8] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    44
    46
    45
    46
    46
    46
    44
    47
    45
    46
    Units: Participants
        ALTi, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        ALTi, UNK, G1 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        ALTi,G0,UNK (N=40;46;43;45;45;45;44;44;43;46)
    0
    0
    0
    3
    0
    0
    1
    0
    0
    1
        ALTi, G0, G0 (N=40;46;43;45;45;45;44;44;43;46)
    40
    45
    42
    41
    45
    45
    43
    44
    41
    44
        ALTi, G0, G1 (N=40;46;43;45;45;45;44;44;43;46)
    0
    1
    1
    0
    0
    0
    0
    0
    2
    1
        ALTi, G0, G3 (N=40;46;43;45;45;45;44;44;43;46)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
        ALTi, G1, G0 (N=4;0;2;1;1;1;0;3;2;0)
    3
    0
    1
    1
    1
    0
    0
    2
    2
    0
        ALTi, G1, G1 (N=4;0;2;1;1;1;0;3;2;0)
    1
    0
    1
    0
    0
    1
    0
    1
    0
    0
        ASTi, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
        ASTi, G0, UNK (N=44;46;45;46;46;45;43;46;45;46)
    0
    0
    0
    3
    0
    0
    1
    0
    0
    1
        ASTi, G0, G0 (N=44;46;45;46;46;45;43;46;45;46)
    44
    46
    44
    42
    46
    45
    42
    44
    44
    44
        ASTi, G0, G1 (N=44;46;45;46;46;45;43;46;45;46)
    0
    0
    1
    0
    0
    0
    0
    2
    0
    0
        ASTi, G0, G2 (N=44;46;45;46;46;45;43;46;45;46)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
        ASTi, G0, G4 (N=44;46;45;46;46;45;43;46;45;46)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
        ASTi, G1, G0 (N=0;0;0;0;0;1;1;0;0;0)
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
        ASTi, G2, G0 (N=0;0;0;0;0;0;0;1;0;0)
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
        BUN, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
        BUN, G0, UNK (N=43;46;45;46;46;46;44;47;43;46)
    0
    0
    0
    3
    0
    0
    1
    0
    0
    1
        BUN, G0, G0 (N=43;46;45;46;46;46;44;47;43;46)
    43
    46
    45
    43
    46
    46
    43
    47
    43
    45
        BUN, G1, G0 (N=1;0;0;0;0;0;0;0;1;0)
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
        BUN, G2, G0 (N=0;0;0;0;0;0;0;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        CRE, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
        CRE, G0, UNK (N=44;46;45;46;46;46;44;47;45;46)
    0
    0
    0
    3
    0
    0
    1
    0
    0
    1
        CRE, G0, G0 (N=44;46;45;46;46;46;44;47;45;46)
    44
    46
    45
    43
    46
    46
    43
    47
    45
    45
        EOSi, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)
    1
    1
    3
    1
    1
    1
    1
    2
    5
    2
        EOSi, G0, UNK (N=43;44;41;44;45;45;44;45;40;43)
    2
    0
    2
    1
    0
    0
    2
    2
    1
    2
        EOSi, G0, G0 (N=43;44;41;44;45;45;44;45;40;43)
    41
    43
    38
    43
    45
    44
    40
    43
    38
    41
        EOSi, G0, G1 (N=43;44;41;44;45;45;44;45;40;43)
    0
    1
    1
    0
    0
    1
    2
    0
    1
    0
        EOSi, G1, G0 (N=0;1;1;1;0;0;0;0;1;1)
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
        EOSi, G1, G1 (N=0;1;1;1;0;0;0;0;1;1)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
        HEMd, UNK, G0 (N=0;1;0;0;0;0;1;0;0;1)
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
        HEMd, G0, UNK (N=39;41;42;42;44;43;39;42;43;43)
    1
    0
    1
    1
    0
    0
    1
    1
    1
    2
        HEMd, G0, G0 (N=39;41;42;42;44;43;39;42;43;43)
    37
    37
    40
    39
    43
    40
    37
    40
    40
    40
        HEMd, G0, G1 (N=39;41;42;42;44;43;39;42;43;43)
    1
    4
    1
    1
    1
    3
    1
    1
    2
    1
        HEMd, G0, G2 (N=39;41;42;42;44;43;39;42;43;43)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
        HEMd, G1, UNK (N=3;3;2;4;0;2;4;2;1;2)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        HEMd, G1, G0 (N=3;3;2;4;0;2;4;2;1;2)
    0
    0
    0
    0
    0
    0
    1
    2
    0
    1
        HEMd, G1, G1 (N=3;3;2;4;0;2;4;2;1;2)
    3
    1
    2
    4
    0
    1
    2
    0
    0
    0
        HEMd, G1, G2 (N=3;3;2;4;0;2;4;2;1;2)
    0
    2
    0
    0
    0
    1
    0
    0
    1
    1
        HEMd, G2, G1 (N=2;0;1;0;2;1;1;2;2;0)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        HEMd, G2, G2 (N=2;0;1;0;2;1;1;2;2;0)
    2
    0
    1
    0
    2
    1
    0
    0
    2
    0
        HEMd, G2, G3 (N=2;0;1;0;2;1;1;2;2;0)
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
        HEMd, G3, UNK (N=0;1;0;0;0;0;0;1;0;0)
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
        HEMd, G3, G3 (N=0;1;0;0;0;0;0;1;0;0)
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
        LYMd, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)
    1
    1
    3
    1
    1
    1
    1
    2
    5
    2
        LYMd, G0, UNK (N=43;45;39;45;44;45;44;45;39;44)
    2
    0
    2
    1
    0
    0
    2
    2
    1
    2
        LYMd, G0, G0 (N=43;45;39;45;44;45;44;45;39;44)
    39
    45
    37
    44
    43
    45
    42
    42
    38
    41
        LYMd, G0, G1 (N=43;45;39;45;44;45;44;45;39;44)
    2
    0
    0
    0
    1
    0
    0
    1
    0
    1
        LYMd, G1, G0 (N=0;0;3;0;0;0;0;0;2;0)
    0
    0
    2
    0
    0
    0
    0
    0
    2
    0
        LYMd, G1, G2 (N=0;0;3;0;0;0;0;0;2;0)
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        LYMd, G2, G0 (N=0;0;0;0;1;0;0;0;0;0)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        NEUd, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)
    1
    1
    3
    1
    1
    1
    1
    2
    2
    1
        NEUd, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
        NEUd, UNK, G2 (N=1;1;3;1;1;1;1;2;5;2)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        NEUd, G0, UNK (N=41;41;41;44;41;44;43;41;39;41)
    2
    0
    2
    1
    0
    0
    2
    2
    1
    2
        NEUd, G0, G0 (N=41;41;41;44;41;44;43;41;39;41)
    37
    40
    39
    41
    41
    43
    39
    38
    37
    37
        NEUd, G0, G1 (N=41;41;41;44;41;44;43;41;39;41)
    2
    1
    0
    1
    0
    0
    1
    1
    0
    2
        NEUd, G0, G2 (N=41;41;41;44;41;44;43;41;39;41)
    0
    0
    0
    1
    0
    1
    1
    0
    1
    0
        NEUd, G1, G0 (N=2;4;0;1;2;1;1;2;1;1)
    1
    4
    0
    0
    0
    1
    0
    0
    1
    1
        NEUd, G1, G1 (N=2;4;0;1;2;1;1;2;1;1)
    1
    0
    0
    0
    2
    0
    1
    2
    0
    0
        NEUd, G1, G2 (N=2;4;0;1;2;1;1;2;1;1)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
        NEUd, G2, G0 (N=0;0;1;0;1;0;0;2;1;2)
    0
    0
    1
    0
    1
    0
    0
    2
    1
    2
        NEUd, G3, G0 (N=0;0;0;0;1;0;0;0;0;0)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        PLTCd, UNK, G0 (N=0;1;0;0;0;0;1;0;1;1)
    0
    1
    0
    0
    0
    0
    1
    0
    1
    1
        PLTCd, G0, UNK (N=44;45;45;44;46;46;44;46;44;45)
    1
    0
    2
    1
    0
    0
    2
    2
    1
    2
        PLTCd, G0, G0 (N=44;45;45;44;46;46;44;46;44;45)
    43
    45
    42
    43
    46
    45
    42
    44
    43
    43
        PLTCd, G0, G1 (N=44;45;45;44;46;46;44;46;44;45)
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
        PLTCd, G0, G2 (N=44;45;45;44;46;46;44;46;44;45)
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        PLTCd, G1, G0 (N=0;0;0;2;0;0;0;1;0;0)
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
        PLTCd, G1, G1 (N=0;0;0;2;0;0;0;1;0;0)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
        PLTCd, G2, G1 (N=0;0;0;0;0;0;0;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        WBCd, UNK, G0 (N=0;1;0;0;0;0;1;0;2;1)
    0
    1
    0
    0
    0
    0
    1
    0
    2
    1
        WBCd, G0, UNK (N=43;45;44;46;44;46;44;44;42;45)
    1
    0
    2
    1
    0
    0
    2
    2
    1
    2
        WBCd, G0, G0 (N=43;45;44;46;44;46;44;44;42;45)
    41
    45
    42
    44
    44
    46
    41
    42
    41
    43
        WBCd, G0, G1 (N=43;45;44;46;44;46;44;44;42;45)
    1
    0
    0
    1
    0
    0
    1
    0
    0
    0
        WBCd, G1, G0 (N=1;0;1;0;1;0;0;3;2;0)
    1
    0
    1
    0
    1
    0
    0
    3
    2
    0
        WBCd, G2, G0 (N=0;0;0;0;1;0;0;0;0;0)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        WBCi, UNK, G0 (N=0;1;0;0;0;0;1;0;2;1)
    0
    1
    0
    0
    0
    0
    1
    0
    2
    1
        WBCi, G0, UNK (N=42;43;44;44;45;46;42;44;40;44)
    1
    0
    2
    1
    0
    0
    2
    2
    1
    2
        WBCi, G0, G0 (N=42;43;44;44;45;46;42;44;40;44)
    41
    43
    42
    42
    45
    45
    39
    39
    38
    39
        WBCi, G0, G1 (N=42;43;44;44;45;46;42;44;40;44)
    0
    0
    0
    1
    0
    1
    1
    3
    1
    3
        WBCi, G1, G0 (N=2;2;1;2;1;0;2;3;3;1)
    1
    2
    0
    1
    1
    0
    1
    1
    2
    0
        WBCi, G1, G1 (N=2;2;1;2;1;0;2;3;3;1)
    1
    0
    1
    1
    0
    0
    1
    2
    1
    1
        WBCi, G2, G1 (N=0;0;0;0;0;0;0;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Day 29 versus baseline by toxicity grading

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    End point title
    Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Day 29 versus baseline by toxicity grading [9]
    End point description
    Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALTi-G0-G1" (with G=Grade and UNK=Unknown). The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
    End point type
    Primary
    End point timeframe
    From Day 8 to Day 29
    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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    44
    46
    45
    46
    46
    46
    44
    47
    45
    46
    Units: Participants
        ALTi, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        ALTi, UNK, G1 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        ALTi, G0, UNK (N=40;46;43;45;45;45;44;44;43;46)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        ALTi, G0, G0 (N=40;46;43;45;45;45;44;44;43;46)
    40
    45
    41
    44
    45
    44
    41
    43
    40
    44
        ALTi, G0, G1 (N=40;46;43;45;45;45;44;44;43;46)
    0
    1
    2
    0
    0
    1
    2
    0
    3
    2
        ALTi, G0, G2 (N=40;46;43;45;45;45;44;44;43;46)
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
        ALTi, G0, G3 (N=40;46;43;45;45;45;44;44;43;46)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
        ALTi, G1, G0 (N=4;0;2;1;1;1;0;3;2;0)
    3
    0
    1
    1
    1
    0
    0
    2
    2
    0
        ALTi, G1, G1 (N=4;0;2;1;1;1;0;3;2;0)
    1
    0
    1
    0
    0
    1
    0
    1
    0
    0
        ASTi, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
        ASTi, G0, UNK (N=44;46;45;46;46;45;43;46;45;46)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        ASTi, G0, G0 (N=44;46;45;46;46;45;43;46;45;46)
    44
    46
    44
    45
    46
    44
    42
    43
    42
    45
        ASTi, G0, G1 (N=44;46;45;46;46;45;43;46;45;46)
    0
    0
    1
    0
    0
    1
    0
    3
    2
    0
        ASTi, G0, G2 (N=44;46;45;46;46;45;43;46;45;46)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
        ASTi, G0, G4 (N=44;46;45;46;46;45;43;46;45;46)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
        ASTi, G1, G0 (N=0;0;0;0;0;1;1;0;0;0)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        ASTi, G1, G1 (N=0;0;0;0;0;1;1;0;0;0)
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
        ASTi, G2, G0 (N=0;0;0;0;0;0;0;1;0;0)
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
        BUN, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
        BUN, G0, UNK (N=43;46;45;46;46;46;44;47;43;46)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        BUN, G0, G0 (N=43;46;45;46;46;46;44;47;43;46)
    43
    45
    45
    46
    46
    46
    43
    47
    43
    46
        BUN, G0, G1 (N=43;46;45;46;46;46;44;47;43;46)
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
        BUN, G1, G0 (N=1;0;0;0;0;0;0;0;1;0)
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
        BUN, G2, G0 (N=0;0;0;0;0;0;0;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        CRE, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
        CRE, G0, UNK (N=44;46;45;46;46;46;44;47;45;46)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        CRE, G0, G0 (N=44;46;45;46;46;46;44;47;45;46)
    44
    46
    45
    46
    46
    46
    43
    47
    45
    46
        EOSi, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)
    1
    1
    3
    1
    1
    1
    0
    2
    5
    2
        EOSi, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        EOSi, G0, UNK (N=43;44;41;44;45;45;44;45;40;43)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        EOSi, G0, G0 (N=43;44;41;44;45;45;44;45;40;43)
    43
    43
    40
    44
    45
    44
    40
    45
    39
    43
        EOSi, G0, G1 (N=43;44;41;44;45;45;44;45;40;43)
    0
    1
    1
    0
    0
    1
    3
    0
    1
    0
        EOSi, G1, G0 (N=0;1;1;1;0;0;0;0;1;1)
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
        EOSi, G1, G1 (N=0;1;1;1;0;0;0;0;1;1)
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
        HEMd, UNK, G0 (N=0;1;0;0;0;0;1;0;0;1)
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
        HEMd, G0, G0 (N=39;41;42;42;44;43;39;42;43;43)
    37
    37
    41
    38
    43
    40
    37
    39
    39
    42
        HEMd, G0, G1 (N=39;41;42;42;44;43;39;42;43;43)
    2
    4
    1
    3
    1
    3
    2
    3
    4
    1
        HEMd, G0, G2 (N=39;41;42;42;44;43;39;42;43;43)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
        HEMd, G1, UNK (N=3;3;2;4;0;2;4;2;1;2)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        HEMd, G1, G0 (N=3;3;2;4;0;2;4;2;1;2)
    0
    0
    0
    0
    0
    0
    1
    2
    0
    1
        HEMd, G1, G1 (N=3;3;2;4;0;2;4;2;1;2)
    3
    1
    2
    4
    0
    1
    2
    0
    0
    0
        HEMd, G1, G2 (N=3;3;2;4;0;2;4;2;1;2)
    0
    2
    0
    0
    0
    1
    0
    0
    1
    1
        HEMd, G2, G2 (N=2;0;1;0;2;1;1;2;2;0)
    2
    0
    1
    0
    2
    1
    1
    0
    2
    0
        HEMd, G2, G3 (N=2;0;1;0;2;1;1;2;2;0)
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
        HEMd, G3, G3 (N=0;1;0;0;0;0;0;1;0;0)
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
        LYMd, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)
    0
    1
    3
    1
    1
    1
    1
    2
    5
    2
        LYMd, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        LYMd, G0, UNK (N=43;45;39;45;44;45;44;45;39;44)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        LYMd, G0, G0 (N=43;45;39;45;44;45;44;45;39;44)
    41
    45
    39
    45
    42
    45
    43
    43
    39
    41
        LYMd, G0, G1 (N=43;45;39;45;44;45;44;45;39;44)
    2
    0
    0
    0
    1
    0
    0
    2
    0
    3
        LYMd, G0, G2 (N=43;45;39;45;44;45;44;45;39;44)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        LYMd, G1, G0 (N=0;0;3;0;0;0;0;0;2;0)
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        LYMd, G1, G1 (N=0;0;3;0;0;0;0;0;2;0)
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
        LYMd, G1, G2 (N=0;0;3;0;0;0;0;0;2;0)
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        LYMd, G2, G0 (N=0;0;0;0;1;0;0;0;0;0)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        NEUd, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)
    0
    1
    3
    1
    1
    1
    1
    2
    2
    1
        NEUd, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)
    1
    0
    0
    0
    0
    0
    0
    0
    2
    0
        NEUd, UNK, G2 (N=1;1;3;1;1;1;1;2;5;2)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
        NEUd, G0, UNK (N=41;41;41;44;41;44;43;41;39;41)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        NEUd, G0, G0 (N=41;41;41;44;41;44;43;41;39;41)
    38
    39
    40
    40
    40
    42
    37
    38
    38
    38
        NEUd, G0, G1 (N=41;41;41;44;41;44;43;41;39;41)
    3
    2
    1
    2
    1
    1
    2
    3
    0
    2
        NEUd, G0, G2 (N=41;41;41;44;41;44;43;41;39;41)
    0
    0
    0
    1
    0
    1
    3
    0
    1
    1
        NEUd, G0, G3 (N=41;41;41;44;41;44;43;41;39;41)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
        NEUd, G1, G0 (N=2;4;0;1;2;1;1;2;1;1)
    1
    3
    0
    0
    0
    1
    0
    0
    0
    0
        NEUd, G1, G1 (N=2;4;0;1;2;1;1;2;1;1)
    1
    1
    0
    0
    1
    0
    1
    1
    1
    1
        NEUd, G1, G2 (N=2;4;0;1;2;1;1;2;1;1)
    0
    0
    0
    1
    1
    0
    0
    1
    0
    0
        NEUd, G2, G0 (N=0;0;1;0;1;0;0;2;1;2)
    0
    0
    1
    0
    0
    0
    0
    1
    1
    1
        NEUd, G2, G1 (N=0;0;1;0;1;0;0;2;1;2)
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
        NEUd, G2, G2 (N=0;0;1;0;1;0;0;2;1;2)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
        NEUd, G3, G0 (N=0;0;0;0;1;0;0;0;0;0)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        PLTCd, UNK, G0 (N=0;1;0;0;0;0;1;0;1;1)
    0
    1
    0
    0
    0
    0
    1
    0
    1
    1
        PLTCd, G0, UNK (N=44;45;45;44;46;46;44;46;44;45)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        PLTCd, G0, G0 (N=44;45;45;44;46;46;44;46;44;45)
    43
    45
    44
    44
    46
    45
    43
    46
    44
    45
        PLTCd, G0, G1 (N=44;45;45;44;46;46;44;46;44;45)
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
        PLTCd, G0, G2 (N=44;45;45;44;46;46;44;46;44;45)
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        PLTCd, G1, G0 (N=0;0;0;2;0;0;0;1;0;0)
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
        PLTCd, G1, G2 (N=0;0;0;2;0;0;0;1;0;0)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
        PLTCd, G2, G1 (N=0;0;0;0;0;0;0;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        WBCd, UNK, G0 (N=0;1;0;0;0;0;1;0;2;1)
    0
    1
    0
    0
    0
    0
    1
    0
    1
    0
        WBCd, UNK, G1 (N=0;1;0;0;0;0;1;0;2;1)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
        WBCd, G0, UNK (N=43;45;44;46;44;46;44;44;42;45)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        WBCd, G0, G0 (N=43;45;44;46;44;46;44;44;42;45)
    41
    44
    44
    43
    43
    46
    42
    44
    41
    42
        WBCd, G0, G1 (N=43;45;44;46;44;46;44;44;42;45)
    2
    1
    0
    3
    1
    0
    1
    0
    1
    3
        WBCd, G1, G0 (N=1;0;1;0;1;0;0;3;2;0)
    1
    0
    1
    0
    1
    0
    0
    3
    2
    0
        WBCd, G2, G0 (N=0;0;0;0;1;0;0;0;0;0)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        WBCi, UNK, G0 (N=0;1;0;0;0;0;1;0;2;1)
    0
    1
    0
    0
    0
    0
    1
    0
    2
    1
        WBCi, G0, UNK (N=42;43;44;44;45;46;42;44;40;44)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        WBCi, G0, G0 (N=42;43;44;44;45;46;42;44;40;44)
    42
    40
    43
    42
    45
    45
    38
    39
    39
    41
        WBCi, G0, G1 (N=42;43;44;44;45;46;42;44;40;44)
    0
    3
    1
    2
    0
    1
    3
    5
    1
    3
        WBCi, G1, G0 (N=2;2;1;2;1;0;2;3;3;1)
    0
    0
    0
    1
    1
    0
    1
    1
    2
    0
        WBCi, G1, G1 (N=2;2;1;2;1;0;2;3;3;1)
    1
    2
    1
    1
    0
    0
    1
    2
    1
    1
        WBCi, G1, G2 (N=2;2;1;2;1;0;2;3;3;1)
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        WBCi, G2, G1 (N=0;0;0;0;0;0;0;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Day 85 versus baseline by toxicity grading

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    End point title
    Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Day 85 versus baseline by toxicity grading [10]
    End point description
    Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALTi-G0-G1" (with G=Grade and UNK= Unknown). The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
    End point type
    Primary
    End point timeframe
    From Day 8 to Day 85
    Notes
    [10] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    44
    46
    45
    46
    46
    46
    44
    47
    45
    46
    Units: Participants
        ALTi, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        ALTi, UNK, G1 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        ALTi, G0, UNK (N=40;46;43;45;45;45;44;44;43;46)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        ALTi, G0, G0 (N=40;46;43;45;45;45;44;44;43;46)
    39
    42
    39
    42
    44
    42
    39
    39
    35
    43
        ALTi, G0, G1 (N=40;46;43;45;45;45;44;44;43;46)
    0
    4
    4
    2
    0
    3
    4
    4
    8
    3
        ALTi, G0, G2 (N=40;46;43;45;45;45;44;44;43;46)
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
        ALTi, G0, G3 (N=40;46;43;45;45;45;44;44;43;46)
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
        ALTi, G1, G0 (N=4;0;2;1;1;1;0;3;2;0)
    3
    0
    1
    1
    1
    0
    0
    2
    2
    0
        ALTi, G1, G1 (N=4;0;2;1;1;1;0;3;2;0)
    1
    0
    1
    0
    0
    1
    0
    1
    0
    0
        ASTi, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
        ASTi, G0, UNK (N=44;46;45;46;46;45;43;46;45;46)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        ASTi, G0, G0 (N=44;46;45;46;46;45;43;46;45;46)
    43
    44
    43
    45
    43
    43
    39
    43
    40
    45
        ASTi, G0, G1 (N=44;46;45;46;46;45;43;46;45;46)
    0
    2
    2
    0
    2
    2
    3
    3
    4
    0
        ASTi, G0, G2 (N=44;46;45;46;46;45;43;46;45;46)
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
        ASTi, G0, G4 (N=44;46;45;46;46;45;43;46;45;46)
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
        ASTi, G1, G1 (N=0;0;0;0;0;1;1;0;0;0)
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
        ASTi, G2, G0 (N=0;0;0;0;0;0;0;1;0;0)
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
        BUN, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
        BUN, G0, UNK (N=43;46;45;46;46;46;44;47;43;46)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        BUN, G0, G0 (N=43;46;45;46;46;46;44;47;43;46)
    42
    45
    45
    44
    45
    45
    43
    46
    42
    45
        BUN, G0, G1 (N=43;46;45;46;46;46;44;47;43;46)
    1
    1
    0
    1
    1
    1
    0
    1
    1
    1
        BUN, G0, G2 (N=43;46;45;46;46;46;44;47;43;46)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
        BUN, G1, G0 (N=1;0;0;0;0;0;0;0;1;0)
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
        BUN, G2, G0 (N=0;0;0;0;0;0;0;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        CRE, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
        CRE, G0, UNK (N=44;46;45;46;46;46;44;47;45;46)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        CRE, G0, G0 (N=44;46;45;46;46;46;44;47;45;46)
    44
    46
    45
    46
    46
    46
    43
    47
    45
    46
        EOSi, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)
    1
    1
    3
    1
    1
    1
    0
    2
    5
    2
        EOSi, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        EOSi, G0, UNK (N=43;44;41;44;45;45;44;45;40;43)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        EOSi, G0, G0 (N=43;44;41;44;45;45;44;45;40;43)
    43
    40
    39
    44
    45
    44
    40
    43
    36
    43
        EOSi, G0, G1 (N=43;44;41;44;45;45;44;45;40;43)
    0
    4
    2
    0
    0
    1
    3
    2
    4
    0
        EOSi, G1, G0 (N=0;1;1;1;0;0;0;0;1;1)
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
        EOSi, G1, G1 (N=0;1;1;1;0;0;0;0;1;1)
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
        HEMd, UNK, G0 (N=0;1;0;0;0;0;1;0;0;1)
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
        HEMd, G0, G0 (N=39;41;42;42;44;43;39;42;43;43)
    37
    34
    41
    35
    42
    37
    37
    39
    39
    40
        HEMd, G0, G1 (N=39;41;42;42;44;43;39;42;43;43)
    2
    7
    1
    6
    2
    6
    2
    3
    4
    3
        HEMd, G0, G2 (N=39;41;42;42;44;43;39;42;43;43)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
        HEMd, G1, UNK (N=3;3;2;4;0;2;4;2;1;2)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        HEMd, G1, G0 (N=3;3;2;4;0;2;4;2;1;2)
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
        HEMd, G1, G1 (N=3;3;2;4;0;2;4;2;1;2)
    2
    1
    1
    3
    0
    1
    2
    0
    0
    0
        HEMd, G1, G2 (N=3;3;2;4;0;2;4;2;1;2)
    1
    2
    1
    1
    0
    1
    1
    0
    1
    1
        HEMd, G2, G2 (N=2;0;1;0;2;1;1;2;2;0)
    1
    0
    1
    0
    2
    1
    1
    0
    1
    0
        HEMd, G2, G3 (N=2;0;1;0;2;1;1;2;2;0)
    1
    0
    0
    0
    0
    0
    0
    2
    1
    0
        HEMd, G3, G3 (N=0;1;0;0;0;0;0;1;0;0)
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
        LYMd, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)
    0
    1
    3
    1
    1
    1
    1
    2
    5
    2
        LYMd, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        LYMd, G0, UNK (N=43;45;39;45;44;45;44;45;39;44)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        LYMd, G0, G0 (N=43;45;39;45;44;45;44;45;39;44)
    41
    41
    39
    44
    40
    44
    43
    41
    38
    40
        LYMd, G0, G1 (N=43;45;39;45;44;45;44;45;39;44)
    2
    1
    0
    1
    3
    1
    0
    4
    1
    4
        LYMd, G0, G2 (N=43;45;39;45;44;45;44;45;39;44)
    0
    2
    0
    0
    1
    0
    0
    0
    0
    0
        LYMd, G0, G3 (N=43;45;39;45;44;45;44;45;39;44)
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
        LYMd, G1, G0 (N=0;0;3;0;0;0;0;0;2;0)
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        LYMd, G1, G1 (N=0;0;3;0;0;0;0;0;2;0)
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
        LYMd, G1, G2 (N=0;0;3;0;0;0;0;0;2;0)
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        LYMd, G2, G0 (N=0;0;0;0;1;0;0;0;0;0)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        NEUd, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)
    0
    1
    2
    0
    1
    0
    1
    1
    2
    1
        NEUd, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)
    1
    0
    1
    1
    0
    1
    0
    0
    1
    0
        NEUd, UNK, G2 (N=1;1;3;1;1;1;1;2;5;2)
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
        NEUd, UNK, G3 (N=1;1;3;1;1;1;1;2;5;2)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        NEUd, G0, UNK (N=41;41;41;44;41;44;43;41;39;41)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        NEUd, G0, G0 (N=41;41;41;44;41;44;43;41;39;41)
    37
    35
    40
    36
    37
    39
    37
    35
    36
    37
        NEUd, G0, G1 (N=41;41;41;44;41;44;43;41;39;41)
    4
    4
    1
    4
    2
    4
    2
    4
    2
    3
        NEUd, G0, G2 (N=41;41;41;44;41;44;43;41;39;41)
    0
    1
    0
    2
    1
    1
    3
    1
    1
    1
        NEUd, G0, G3 (N=41;41;41;44;41;44;43;41;39;41)
    0
    1
    0
    2
    1
    0
    0
    1
    0
    0
        NEUd, G1, G0 (N=2;4;0;1;2;1;1;2;1;1)
    1
    2
    0
    0
    0
    1
    0
    0
    0
    0
        NEUd, G1, G1 (N=2;4;0;1;2;1;1;2;1;1)
    1
    2
    0
    0
    1
    0
    0
    1
    1
    1
        NEUd, G1, G2 (N=2;4;0;1;2;1;1;2;1;1)
    0
    0
    0
    1
    1
    0
    1
    1
    0
    0
        NEUd, G2, G0 (N=0;0;1;0;1;0;0;2;1;2)
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
        NEUd, G2, G1 (N=0;0;1;0;1;0;0;2;1;2)
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
        NEUd, G2, G2 (N=0;0;1;0;1;0;0;2;1;2)
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
        NEUd, G3, G1 (N=0;0;0;0;1;0;0;0;0;0)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        PLTCd, UNK, G0 (N=0;1;0;0;0;0;1;0;1;1)
    0
    1
    0
    0
    0
    0
    1
    0
    1
    1
        PLTCd, G0, UNK (N=44;45;45;44;46;46;44;46;44;45)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        PLTCd, G0, G0 (N=44;45;45;44;46;46;44;46;44;45)
    42
    45
    44
    43
    46
    45
    43
    45
    44
    45
        PLTCd, G0, G1 (N=44;45;45;44;46;46;44;46;44;45)
    2
    0
    0
    0
    0
    1
    0
    1
    0
    0
        PLTCd, G0, G2 (N=44;45;45;44;46;46;44;46;44;45)
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
        PLTCd, G1, G0 (N=0;0;0;2;0;0;0;1;0;0)
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
        PLTCd, G1, G3 (N=0;0;0;2;0;0;0;1;0;0)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
        PLTCd, G2, G1 (N=0;0;0;0;0;0;0;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        WBCd, UNK, G0 (N=0;1;0;0;0;0;1;0;2;1)
    0
    1
    0
    0
    0
    0
    1
    0
    1
    0
        WBCd, UNK, G1 (N=0;1;0;0;0;0;1;0;2;1)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
        WBCd, G0, UNK (N=43;45;44;46;44;46;44;44;42;45)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        WBCd, G0, G0 (N=43;45;44;46;44;46;44;44;42;45)
    41
    43
    44
    41
    41
    46
    42
    42
    40
    41
        WBCd, G0, G1 (N=43;45;44;46;44;46;44;44;42;45)
    2
    2
    0
    5
    2
    0
    1
    2
    2
    4
        WBCd, G0, G2 (N=43;45;44;46;44;46;44;44;42;45)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        WBCd, G1, G0 (N=1;0;1;0;1;0;0;3;2;0)
    1
    0
    1
    0
    1
    0
    0
    2
    2
    0
        WBCd, G1, G1 (N=1;0;1;0;1;0;0;3;2;0)
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
        WBCd, G2, G1 (N=0;0;0;0;1;0;0;0;0;0)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        WBCi, UNK, G0 (N=0;1;0;0;0;0;1;0;2;1)
    0
    1
    0
    0
    0
    0
    1
    0
    2
    1
        WBCi, G0, UNK (N=42;43;44;44;45;46;42;44;40;44)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        WBCi, G0, G0 (N=42;43;44;44;45;46;42;44;40;44)
    41
    39
    42
    39
    45
    44
    36
    39
    38
    39
        WBCi, G0, G1 (N=42;43;44;44;45;46;42;44;40;44)
    1
    4
    2
    5
    0
    2
    5
    5
    1
    5
        WBCi, G0, G3 (N=42;43;44;44;45;46;42;44;40;44)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        WBCi, G1, G0 (N=2;2;1;2;1;0;2;3;3;1)
    0
    0
    0
    1
    1
    0
    0
    1
    1
    0
        WBCi, G1, G1 (N=2;2;1;2;1;0;2;3;3;1)
    1
    2
    1
    1
    0
    0
    2
    2
    2
    1
        WBCi, G1, G2 (N=2;2;1;2;1;0;2;3;3;1)
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        WBCi, G2, G1 (N=0;0;0;0;0;0;0;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Month 14+28 days versus baseline by toxicity grading

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    End point title
    Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Month 14+28 days versus baseline by toxicity grading [11]
    End point description
    Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALTi-G0-G1" (with G=Grade and UNK= Unknown). The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
    End point type
    Primary
    End point timeframe
    From Day 8 to Month 14 + 28 days
    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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    44
    46
    45
    46
    46
    46
    44
    47
    45
    46
    Units: Participants
        ALTi, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        ALTi, UNK, G1 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        ALTi, G0, UNK (N=40;46;43;45;45;45;44;44;43;46)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        ALTi, G0, G0 (N=40;46;43;45;45;45;44;44;43;46)
    38
    38
    39
    42
    40
    41
    38
    39
    30
    40
        ALTi, G0, G1 (N=40;46;43;45;45;45;44;44;43;46)
    1
    8
    3
    2
    4
    3
    5
    4
    13
    6
        ALTi, G0, G2 (N=40;46;43;45;45;45;44;44;43;46)
    0
    0
    1
    0
    1
    1
    0
    1
    0
    0
        ALTi, G0, G3 (N=40;46;43;45;45;45;44;44;43;46)
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
        ALTi, G1, G0 (N=4;0;2;1;1;1;0;3;2;0)
    3
    0
    1
    1
    1
    0
    0
    2
    2
    0
        ALTi, G1, G1 (N=4;0;2;1;1;1;0;3;2;0)
    1
    0
    1
    0
    0
    1
    0
    1
    0
    0
        ASTi, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        ASTi, UNK, G1 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        ASTi, G0, UNK (N=44;46;45;46;46;45;43;46;45;46)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        ASTi, G0, G0 (N=44;46;45;46;46;45;43;46;45;46)
    42
    43
    41
    44
    42
    43
    37
    42
    37
    43
        ASTi, G0, G1 (N=44;46;45;46;46;45;43;46;45;46)
    1
    3
    3
    1
    3
    2
    5
    4
    7
    2
        ASTi, G0, G2 (N=44;46;45;46;46;45;43;46;45;46)
    0
    0
    1
    0
    1
    0
    0
    0
    1
    1
        ASTi, G0, G4 (N=44;46;45;46;46;45;43;46;45;46)
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
        ASTi, G1, G1 (N=0;0;0;0;0;1;1;0;0;0)
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
        ASTi, G2, G0 (N=0;0;0;0;0;0;0;1;0;0)
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
        BUN, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
        BUN, G0, UNK (N=43;46;45;46;46;46;44;47;43;46)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        BUN, G0, G0 (N=43;46;45;46;46;46;44;47;43;46)
    41
    45
    45
    44
    45
    45
    42
    46
    41
    45
        BUN, G0, G1 (N=43;46;45;46;46;46;44;47;43;46)
    1
    1
    0
    0
    1
    1
    1
    1
    2
    1
        BUN, G0, G2 (N=43;46;45;46;46;46;44;47;43;46)
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
        BUN, G0, G3 (N=43;46;45;46;46;46;44;47;43;46)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
        BUN, G1, G0 (N=1;0;0;0;0;0;0;0;1;0)
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
        BUN, G2, G0 (N=0;0;0;0;0;0;0;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        CRE, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
        CRE, G0, UNK (N=44;46;45;46;46;46;44;47;45;46)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        CRE, G0, G0 (N=44;46;45;46;46;46;44;47;45;46)
    44
    46
    45
    46
    46
    46
    43
    47
    45
    46
        EOSi, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)
    1
    1
    3
    1
    1
    1
    0
    2
    5
    2
        EOSi, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        EOSi, G0, UNK (N=43;44;41;44;45;45;44;45;40;43)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        EOSi, G0, G0 (N=43;44;41;44;45;45;44;45;40;43)
    42
    40
    39
    43
    45
    44
    39
    42
    34
    43
        EOSi, G0, G1 (N=43;44;41;44;45;45;44;45;40;43)
    1
    4
    2
    1
    0
    1
    4
    3
    6
    0
        EOSi, G1, G0 (N=0;1;1;1;0;0;0;0;1;1)
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
        EOSi, G1, G1 (N=0;1;1;1;0;0;0;0;1;1)
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
        HEMd, UNK, G0 (N=0;1;0;0;0;0;1;0;0;1)
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
        HEMd, G0, G0 (N=39;41;42;42;44;43;39;42;43;43)
    35
    33
    39
    33
    39
    37
    35
    36
    39
    39
        HEMd, G0, G1 (N=39;41;42;42;44;43;39;42;43;43)
    4
    8
    3
    8
    5
    5
    3
    6
    4
    4
        HEMd, G0, G2 (N=39;41;42;42;44;43;39;42;43;43)
    0
    0
    0
    1
    0
    1
    1
    0
    0
    0
        HEMd, G1, UNK (N=3;3;2;4;0;2;4;2;1;2)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        HEMd, G1, G0 (N=3;3;2;4;0;2;4;2;1;2)
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
        HEMd, G1, G1 (N=3;3;2;4;0;2;4;2;1;2)
    2
    1
    1
    3
    0
    1
    2
    0
    0
    0
        HEMd, G1, G2 (N=3;3;2;4;0;2;4;2;1;2)
    0
    2
    1
    1
    0
    1
    1
    0
    1
    1
        HEMd, G1, G3 (N=3;3;2;4;0;2;4;2;1;2)
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        HEMd, G2, G2 (N=2;0;1;0;2;1;1;2;2;0)
    1
    0
    1
    0
    1
    1
    1
    0
    1
    0
        HEMd, G2, G3 (N=2;0;1;0;2;1;1;2;2;0)
    0
    0
    0
    0
    1
    0
    0
    2
    1
    0
        HEMd, G2, G4 (N=2;0;1;0;2;1;1;2;2;0)
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        HEMd, G3, G3 (N=0;1;0;0;0;0;0;1;0;0)
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
        LYMd, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)
    0
    0
    3
    1
    1
    1
    1
    2
    4
    2
        LYMd, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)
    1
    1
    0
    0
    0
    0
    0
    0
    1
    0
        LYMd, G0, UNK (N=43;45;39;45;44;45;44;45;39;44)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        LYMd, G0, G0 (N=43;45;39;45;44;45;44;45;39;44)
    40
    41
    39
    44
    40
    44
    43
    38
    38
    40
        LYMd, G0, G1 (N=43;45;39;45;44;45;44;45;39;44)
    3
    1
    0
    1
    3
    1
    0
    7
    1
    4
        LYMd, G0, G2 (N=43;45;39;45;44;45;44;45;39;44)
    0
    2
    0
    0
    1
    0
    0
    0
    0
    0
        LYMd, G0, G3 (N=43;45;39;45;44;45;44;45;39;44)
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
        LYMd, G1, G0 (N=0;0;3;0;0;0;0;0;2;0)
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        LYMd, G1, G1 (N=0;0;3;0;0;0;0;0;2;0)
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
        LYMd, G1, G2 (N=0;0;3;0;0;0;0;0;2;0)
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        LYMd, G2, G1 (N=0;0;0;0;1;0;0;0;0;0)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        NEUd, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)
    0
    1
    2
    0
    1
    0
    1
    1
    2
    1
        NEUd, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)
    1
    0
    1
    1
    0
    1
    0
    0
    1
    0
        NEUd, UNK, G2 (N=1;1;3;1;1;1;1;2;5;2)
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
        NEUd, UNK, G3 (N=1;1;3;1;1;1;1;2;5;2)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        NEUd, G0, UNK (N=41;41;41;44;41;44;43;41;39;41)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        NEUd, G0, G0 (N=41;41;41;44;41;44;43;41;39;41)
    36
    34
    37
    35
    36
    38
    34
    35
    34
    34
        NEUd, G0, G1 (N=41;41;41;44;41;44;43;41;39;41)
    5
    4
    2
    5
    3
    5
    5
    4
    4
    6
        NEUd, G0, G2 (N=41;41;41;44;41;44;43;41;39;41)
    0
    2
    2
    2
    1
    1
    3
    1
    1
    1
        NEUd, G0, G3 (N=41;41;41;44;41;44;43;41;39;41)
    0
    1
    0
    2
    1
    0
    0
    1
    0
    0
        NEUd, G1, G0 (N=2;4;0;1;2;1;1;2;1;1)
    1
    2
    0
    0
    0
    1
    0
    0
    0
    0
        NEUd, G1, G1 (N=2;4;0;1;2;1;1;2;1;1)
    0
    2
    0
    0
    1
    0
    0
    1
    0
    1
        NEUd, G1, G2 (N=2;4;0;1;2;1;1;2;1;1)
    1
    0
    0
    1
    1
    0
    1
    1
    1
    0
        NEUd, G2, G0 (N=0;0;1;0;1;0;0;2;1;2)
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
        NEUd, G2, G1 (N=0;0;1;0;1;0;0;2;1;2)
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
        NEUd, G2, G2 (N=0;0;1;0;1;0;0;2;1;2)
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
        NEUd, G3, G1 (N=0;0;0;0;1;0;0;0;0;0)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        PLTCd, UNK, G0 (N=0;1;0;0;0;0;1;0;1;1)
    0
    1
    0
    0
    0
    0
    1
    0
    1
    1
        PLTCd, G0, UNK (N=44;45;45;44;46;46;44;46;44;45)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        PLTCd, G0, G0 (N=44;45;45;44;46;46;44;46;44;45)
    42
    45
    44
    43
    46
    45
    43
    45
    44
    45
        PLTCd, G0, G1 (N=44;45;45;44;46;46;44;46;44;45)
    2
    0
    0
    0
    0
    1
    0
    1
    0
    0
        PLTCd, G0, G2 (N=44;45;45;44;46;46;44;46;44;45)
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
        PLTCd, G1, G0 (N=0;0;0;2;0;0;0;1;0;0)
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
        PLTCd, G1, G3 (N=0;0;0;2;0;0;0;1;0;0)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
        PLTCd, G2, G2 (N=0;0;0;0;0;0;0;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        WBCd, UNK, G0 (N=0;1;0;0;0;0;1;0;2;1)
    0
    1
    0
    0
    0
    0
    1
    0
    1
    0
        WBCd, UNK, G1 (N=0;1;0;0;0;0;1;0;2;1)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
        WBCd, G0, UNK (N=43;45;44;46;44;46;44;44;42;45)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        WBCd, G0, G0 (N=43;45;44;46;44;46;44;44;42;45)
    41
    42
    41
    40
    41
    46
    42
    41
    38
    41
        WBCd, G0, G1 (N=43;45;44;46;44;46;44;44;42;45)
    2
    3
    3
    6
    2
    0
    1
    3
    4
    4
        WBCd, G0, G2 (N=43;45;44;46;44;46;44;44;42;45)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        WBCd, G1, G0 (N=1;0;1;0;1;0;0;3;2;0)
    0
    0
    1
    0
    1
    0
    0
    2
    2
    0
        WBCd, G1, G1 (N=1;0;1;0;1;0;0;3;2;0)
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
        WBCd, G2, G1 (N=0;0;0;0;1;0;0;0;0;0)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        WBCi, UNK, G0 (N=0;1;0;0;0;0;1;0;2;1)
    0
    1
    0
    0
    0
    0
    1
    0
    2
    1
        WBCi, G0, UNK (N=42;43;44;44;45;46;42;44;40;44)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        WBCi, G0, G0 (N=42;43;44;44;45;46;42;44;40;44)
    39
    39
    40
    37
    43
    43
    35
    37
    36
    36
        WBCi, G0, G1 (N=42;43;44;44;45;46;42;44;40;44)
    3
    4
    4
    6
    2
    3
    5
    6
    3
    7
        WBCi, G0, G2 (N=42;43;44;44;45;46;42;44;40;44)
    0
    0
    0
    1
    0
    0
    1
    1
    0
    1
        WBCi, G0, G3 (N=42;43;44;44;45;46;42;44;40;44)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        WBCi, G1, G0 (N=2;2;1;2;1;0;2;3;3;1)
    0
    0
    0
    1
    1
    0
    0
    1
    1
    0
        WBCi, G1, G1 (N=2;2;1;2;1;0;2;3;3;1)
    1
    2
    1
    1
    0
    0
    2
    2
    1
    1
        WBCi, G1, G2 (N=2;2;1;2;1;0;2;3;3;1)
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
        WBCi, G2, G1 (N=0;0;0;0;0;0;0;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Month 26 versus baseline by toxicity grading

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    End point title
    Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Month 26 versus baseline by toxicity grading [12]
    End point description
    Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALTi-G0-G1" (with G=Grade and UNK= Unknown). The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
    End point type
    Primary
    End point timeframe
    From Day 8 to Month 26
    Notes
    [12] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    44
    46
    45
    46
    46
    46
    44
    47
    45
    46
    Units: Participants
        ALTi, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        ALTi, UNK, G1 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        ALTi, G0, UNK (N=40;46;43;45;45;45;44;44;43;46)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        ALTi, G0, G0 (N=40;46;43;45;45;45;44;44;43;46)
    38
    38
    39
    42
    40
    39
    37
    38
    29
    40
        ALTi, G0, G1 (N=40;46;43;45;45;45;44;44;43;46)
    1
    8
    3
    2
    4
    5
    6
    5
    14
    6
        ALTi, G0, G2 (N=40;46;43;45;45;45;44;44;43;46)
    0
    0
    1
    0
    1
    1
    0
    1
    0
    0
        ALTi, G0, G3 (N=40;46;43;45;45;45;44;44;43;46)
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
        ALTi, G1, G0 (N=4;0;2;1;1;1;0;3;2;0)
    2
    0
    1
    1
    1
    0
    0
    2
    1
    0
        ALTi, G1, G1 (N=4;0;2;1;1;1;0;3;2;0)
    2
    0
    1
    0
    0
    1
    0
    1
    1
    0
        ASTi, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        ASTi, UNK, G1 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        ASTi, G0, UNK (N=44;46;45;46;46;45;43;46;45;46)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        ASTi, G0, G0 (N=44;46;45;46;46;45;43;46;45;46)
    42
    42
    41
    44
    42
    42
    36
    42
    37
    43
        ASTi, G0, G1 (N=44;46;45;46;46;45;43;46;45;46)
    1
    4
    3
    1
    3
    1
    6
    4
    7
    2
        ASTi, G0, G2 (N=44;46;45;46;46;45;43;46;45;46)
    0
    0
    1
    0
    1
    2
    0
    0
    1
    1
        ASTi, G0, G4 (N=44;46;45;46;46;45;43;46;45;46)
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
        ASTi, G1, G1 (N=0;0;0;0;0;1;1;0;0;0)
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
        ASTi, G2, G0 (N=0;0;0;0;0;0;0;1;0;0)
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
        BUN, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
        BUN, G0, UNK (N=43;46;45;46;46;46;44;47;43;46)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        BUN, G0, G0 (N=43;46;45;46;46;46;44;47;43;46)
    40
    45
    45
    44
    45
    45
    42
    46
    41
    45
        BUN, G0, G1 (N=43;46;45;46;46;46;44;47;43;46)
    2
    1
    0
    0
    1
    1
    1
    1
    2
    1
        BUN, G0, G2 (N=43;46;45;46;46;46;44;47;43;46)
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
        BUN, G0, G3 (N=43;46;45;46;46;46;44;47;43;46)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
        BUN, G1, G0 (N=1; 0;0;0;0;0;0;0;1;0)
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        BUN, G1, G1 (N=1;0;0;0;0;0;0;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        BUN, G2, G0 (N=0;0;0;0;0;0;0;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        CRE, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
        CRE, G0, UNK (N=44;46;45;46;46;46;44;47;45;46)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        CRE, G0, G0 (N=44;46;45;46;46;46;44;47;45;46)
    44
    46
    45
    46
    46
    46
    43
    47
    45
    46
        EOSi, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)
    1
    1
    3
    1
    1
    1
    0
    2
    5
    2
        EOSi, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        EOSi, G0, UNK (N=43;44;41;44;45;45;44;45;40;43)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        EOSi, G0, G0 (N=43;44;41;44;45;45;44;45;40;43)
    42
    40
    39
    43
    45
    44
    38
    41
    34
    42
        EOSi, G0, G1 (N=43;44;41;44;45;45;44;45;40;43)
    1
    4
    2
    1
    0
    1
    5
    4
    6
    1
        EOSi, G1, G0 (N=0;1;1;1;0;0;0;0;1;1)
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
        EOSi, G1, G1 (N=0;1;1;1;0;0;0;0;1;1)
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
        HEMd, UNK, G0 (N=0;1;0;0;0;0;1;0;0;1)
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
        HEMd, G0, G0 (N=39;41;42;42;44;43;39;42;43;43)
    33
    32
    37
    31
    38
    36
    35
    35
    37
    39
        HEMd, G0, G1 (N=39;41;42;42;44;43;39;42;43;43)
    5
    9
    5
    7
    6
    6
    3
    6
    5
    4
        HEMd, G0, G2 (N=39;41;42;42;44;43;39;42;43;43)
    1
    0
    0
    4
    0
    1
    1
    1
    0
    0
        HEMd, G0, G3 (N=39;41;42;42;44;43;39;42;43;43)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        HEMd, G1, UNK (N=3;3;2;4;0;2;4;2;1;2)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        HEMd, G1, G0 (N=3;3;2;4;0;2;4;2;1;2)
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
        HEMd, G1, G1 (N=3;3;2;4;0;2;4;2;1;2)
    2
    1
    1
    3
    0
    1
    2
    0
    0
    0
        HEMd, G1, G2 (N=3;3;2;4;0;2;4;2;1;2)
    0
    2
    1
    1
    0
    1
    1
    0
    1
    1
        HEMd, G1, G3 (N=3;3;2;4;0;2;4;2;1;2)
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        HEMd, G2, G2 (N=2;0;1;0;2;1;1;2;2;0)
    1
    0
    1
    0
    1
    1
    1
    0
    1
    0
        HEMd, G2, G3 (N=2;0;1;0;2;1;1;2;2;0)
    0
    0
    0
    0
    1
    0
    0
    2
    1
    0
        HEMd, G2, G4 (N=2;0;1;0;2;1;1;2;2;0)
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        HEMd, G3, G3 (N=0;1;0;0;0;0;0;1;0;0)
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
        LYMd, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)
    0
    0
    3
    1
    1
    1
    1
    2
    4
    2
        LYMd, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)
    1
    1
    0
    0
    0
    0
    0
    0
    1
    0
        LYMd, G0, UNK (N=43;45;39;45;44;45;44;45;39;44)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        LYMd, G0, G0 (N=43;45;39;45;44;45;44;45;39;44)
    39
    40
    39
    44
    40
    44
    43
    37
    38
    40
        LYMd, G0, G1 (N=43;45;39;45;44;45;44;45;39;44)
    4
    1
    0
    1
    3
    1
    0
    8
    1
    4
        LYMd, G0, G2 (N=43;45;39;45;44;45;44;45;39;44)
    0
    3
    0
    0
    1
    0
    0
    0
    0
    0
        LYMd, G0, G3 (N=43;45;39;45;44;45;44;45;39;44)
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
        LYMd, G1, G0 (N=0;0;3;0;0;0;0;0;2;0)
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        LYMd, G1, G1 (N=0;0;3;0;0;0;0;0;2;0)
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
        LYMd, G1, G2 (N=0;0;3;0;0;0;0;0;2;0)
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        LYMd, G2, G1 (N=0;0;0;0;1;0;0;0;0;0)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        NEUd, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)
    0
    1
    2
    0
    1
    0
    1
    1
    2
    1
        NEUd, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)
    1
    0
    1
    1
    0
    1
    0
    0
    1
    0
        NEUd, UNK, G2 (N=1;1;3;1;1;1;1;2;5;2)
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
        NEUd, UNK, G3 (N=1;1;3;1;1;1;1;2;5;2)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        NEUd, G0, UNK (N=41;41;41;44;41;44;43;41;39;41)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        NEUd, G0, G0 (N=41;41;41;44;41;44;43;41;39;41)
    35
    34
    37
    35
    36
    36
    34
    35
    34
    34
        NEUd, G0, G1 (N=41;41;41;44;41;44;43;41;39;41)
    5
    4
    2
    5
    3
    6
    5
    4
    4
    6
        NEUd, G0, G2 (N=41;41;41;44;41;44;43;41;39;41)
    1
    2
    2
    2
    1
    2
    3
    1
    1
    1
        NEUd, G0, G3 (N=41;41;41;44;41;44;43;41;39;41)
    0
    1
    0
    2
    1
    0
    0
    1
    0
    0
        NEUd, G1, G0 (N=2;4;0;1;2;1;1;2;1;1)
    1
    2
    0
    0
    0
    1
    0
    0
    0
    0
        NEUd, G1, G1 (N=2;4;0;1;2;1;1;2;1;1)
    0
    2
    0
    0
    1
    0
    0
    1
    0
    1
        NEUd, G1, G2 (N=2;4;0;1;2;1;1;2;1;1)
    1
    0
    0
    1
    1
    0
    1
    1
    1
    0
        NEUd, G2, G0 (N=0;0;1;0;1;0;0;2;1;2)
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
        NEUd, G2, G1 (N=0;0;1;0;1;0;0;2;1;2)
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
        NEUd, G2, G2 (N=0;0;1;0;1;0;0;2;1;2)
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
        NEUd, G3, G1 (N=0;0;0;0;1;0;0;0;0;0)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        PLTCd, UNK, G0 (N=0;1;0;0;0;0;1;0;1;1)
    0
    1
    0
    0
    0
    0
    1
    0
    1
    1
        PLTCd, G0, UNK (N=44;45;45;44;46;46;44;46;44;45)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        PLTCd, G0, G0 (N=44;45;45;44;46;46;44;46;44;45)
    42
    45
    44
    43
    46
    44
    43
    45
    44
    45
        PLTCd, G0, G1 (N=44;45;45;44;46;46;44;46;44;45)
    2
    0
    0
    0
    0
    1
    0
    1
    0
    0
        PLTCd, G0, G2 (N=44;45;45;44;46;46;44;46;44;45)
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
        PLTCd, G1, G0 (N=0;0;0;2;0;0;0;1;0;0)
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
        PLTCd, G1, G3 (N=0;0;0;2;0;0;0;1;0;0)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
        PLTCd, G2, G2 (N=0;0;0;0;0;0;0;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        WBCd, UNK, G0 (N=0;1;0;0;0;0;1;0;2;1)
    0
    1
    0
    0
    0
    0
    1
    0
    1
    0
        WBCd, UNK, G1 (N=0;1;0;0;0;0;1;0;2;1)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
        WBCd, G0, UNK (N=43;45;44;46;44;46;44;44;42;45)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        WBCd, G0, G0 (N=43;45;44;46;44;46;44;44;42;45)
    39
    42
    41
    40
    41
    46
    42
    41
    38
    41
        WBCd, G0, G1 (N=43;45;44;46;44;46;44;44;42;45)
    4
    3
    3
    6
    2
    0
    1
    3
    4
    4
        WBCd, G0, G2 (N=43;45;44;46;44;46;44;44;42;45)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        WBCd, G1, G0 (N=1;0;1;0;1;0;0;3;2;0)
    0
    0
    1
    0
    1
    0
    0
    2
    1
    0
        WBCd, G1, G1 (N=1;0;1;0;1;0;0;3;2;0)
    1
    0
    0
    0
    0
    0
    0
    1
    1
    0
        WBCd, G2, G1 (N=0;0;0;0;1;0;0;0;0;0)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        WBCi, UNK, G0 (N=0;1;0;0;0;0;1;0;2;1)
    0
    1
    0
    0
    0
    0
    1
    0
    2
    1
        WBCi, G0, UNK (N=42;43;44;44;45;46;42;44;40;44)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        WBCi, G0, G0 (N=42;43;44;44;45;46;42;44;40;44)
    37
    38
    40
    37
    43
    43
    35
    37
    36
    36
        WBCi, G0, G1 (N=42;43;44;44;45;46;42;44;40;44)
    5
    5
    4
    6
    2
    3
    5
    6
    3
    7
        WBCi, G0, G2 (N=42;43;44;44;45;46;42;44;40;44)
    0
    0
    0
    1
    0
    0
    1
    1
    0
    1
        WBCi, G0, G3 (N=42;43;44;44;45;46;42;44;40;44)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        WBCi, G1, G0 (N=2;2;1;2;1;0;2;3;3;1)
    0
    0
    0
    1
    1
    0
    0
    1
    1
    0
        WBCi, G1, G1 (N=2;2;1;2;1;0;2;3;3;1)
    1
    2
    1
    1
    0
    0
    2
    2
    1
    1
        WBCi, G1, G2 (N=2;2;1;2;1;0;2;3;3;1)
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
        WBCi, G2, G1 (N=0;0;0;0;0;0;0;0;1;0)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: Number of subjects with any medically-attended adverse events (MAEs)

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    End point title
    Number of subjects with any medically-attended adverse events (MAEs) [13]
    End point description
    MAEs are defined as events for which the subject receives medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
    End point type
    Primary
    End point timeframe
    During the entire study period (from Day 1 up to Month 26)
    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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    45
    46
    47
    47
    48
    47
    47
    48
    46
    47
    Units: Participants
    21
    16
    20
    23
    21
    14
    19
    18
    23
    20
    No statistical analyses for this end point

    Primary: Number of subjects reporting any potential immune-mediated diseases (pIMDs)

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    End point title
    Number of subjects reporting any potential immune-mediated diseases (pIMDs) [14]
    End point description
    pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
    End point type
    Primary
    End point timeframe
    During the entire study period (from Day 1 up to Month 26)
    Notes
    [14] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    45
    46
    47
    47
    48
    47
    47
    48
    46
    47
    Units: Participants
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with serious adverse events (SAEs).

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    End point title
    Number of subjects with serious adverse events (SAEs). [15]
    End point description
    SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Primary
    End point timeframe
    During the entire study period (from Day 1 up to Month 26)
    Notes
    [15] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    45
    46
    47
    47
    48
    47
    47
    48
    46
    47
    Units: Participants
    2
    1
    1
    2
    2
    2
    0
    2
    2
    3
    No statistical analyses for this end point

    Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by enzyme-linked immunosorbent assay (ELISA)– Day 1

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    End point title
    Number of seropositive subjects for anti-H1 stalk antibodies measured by enzyme-linked immunosorbent assay (ELISA)– Day 1 [16]
    End point description
    Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 ELISA.Unit per milliliter (EL.U/mL).
    End point type
    Primary
    End point timeframe
    At Day 1
    Notes
    [16] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    45
    46
    47
    47
    48
    47
    47
    46
    44
    45
    Units: Participants
    45
    46
    47
    47
    48
    47
    47
    46
    44
    45
    No statistical analyses for this end point

    Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by ELISA– Day 29

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    End point title
    Number of seropositive subjects for anti-H1 stalk antibodies measured by ELISA– Day 29 [17]
    End point description
    Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.
    End point type
    Primary
    End point timeframe
    At Day 29
    Notes
    [17] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    43
    40
    41
    40
    42
    42
    37
    41
    39
    40
    Units: Participants
    43
    40
    41
    40
    42
    42
    37
    41
    39
    40
    No statistical analyses for this end point

    Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by ELISA– Day 85

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    End point title
    Number of seropositive subjects for anti-H1 stalk antibodies measured by ELISA– Day 85 [18]
    End point description
    Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.
    End point type
    Primary
    End point timeframe
    At Day 85
    Notes
    [18] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    39
    36
    34
    35
    39
    35
    34
    34
    35
    38
    Units: Participants
    39
    36
    34
    35
    39
    35
    34
    34
    35
    38
    No statistical analyses for this end point

    Primary: Concentrations of serum H1 stalk antibodies measured by ELISA– Day 1

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    End point title
    Concentrations of serum H1 stalk antibodies measured by ELISA– Day 1 [19]
    End point description
    Concentrations are presented as Geometric Mean Concentrations (GMCs) and measured by ELISA. ELISA cut-off = 66 EL.U/mL.
    End point type
    Primary
    End point timeframe
    At Day 1
    Notes
    [19] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    45
    46
    47
    47
    48
    47
    47
    46
    44
    45
    Units: EL.U/mL
        geometric mean (confidence interval 95%)
    8887.9 (7004.9 to 11277.1)
    8719.3 (6547.0 to 11612.3)
    9691 (7593.7 to 12367.7)
    9121 (7180.0 to 11586.6)
    9948.6 (8106.2 to 12209.8)
    8555.5 (6980.1 to 10486.4)
    9019.6 (7263.5 to 11200.2)
    9278.2 (7430.7 to 11585.1)
    9039.3 (6930.7 to 11789.5)
    9160 (7225.7 to 11612.2)
    No statistical analyses for this end point

    Primary: Concentrations of serum H1 stalk antibodies measured by ELISA– Day 29

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    End point title
    Concentrations of serum H1 stalk antibodies measured by ELISA– Day 29 [20]
    End point description
    Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.
    End point type
    Primary
    End point timeframe
    At Day 29
    Notes
    [20] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    43
    40
    41
    40
    42
    42
    37
    41
    39
    40
    Units: EL.U/mL
        geometric mean (confidence interval 95%)
    112973.2 (90888.2 to 140424.5)
    45645 (35289.4 to 59039.5)
    116596.8 (93869.6 to 144826.6)
    61634.2 (49810.3 to 76264.7)
    46596.2 (38306.7 to 56679.5)
    67114.6 (54649.7 to 82422.6)
    35580.2 (24654.2 to 51348.2)
    20398.6 (16362.4 to 25430.5)
    36426.2 (29124.8 to 45558.0)
    21938.1 (18037.8 to 26681.8)
    No statistical analyses for this end point

    Primary: Concentrations of serum H1 stalk antibodies measured by ELISA– Day 85

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    End point title
    Concentrations of serum H1 stalk antibodies measured by ELISA– Day 85 [21]
    End point description
    Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.
    End point type
    Primary
    End point timeframe
    At Day 85
    Notes
    [21] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    39
    36
    34
    35
    39
    35
    34
    34
    35
    38
    Units: EL.U/mL
        geometric mean (confidence interval 95%)
    45351.6 (36766.7 to 55941.1)
    28437.5 (21623.4 to 37398.9)
    74639.7 (59986.3 to 92872.6)
    30419.3 (23619.9 to 39176.0)
    25718.6 (20748.8 to 31878.8)
    48775.9 (40697.7 to 58457.7)
    28617.8 (19448.1 to 42110.9)
    15105.9 (12007.7 to 19003.6)
    37911.4 (30149.4 to 47671.7)
    16749.9 (13471.8 to 20825.8)
    No statistical analyses for this end point

    Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by microneutralization (MN) assay – Day 1

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    End point title
    Number of seropositive subjects for anti-H1 stalk antibodies measured by microneutralization (MN) assay – Day 1 [22]
    End point description
    Anti-H1 stalk immune response measured by MN are expressed in 1/DILUTION (DIL). The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.
    End point type
    Primary
    End point timeframe
    At Day 1
    Notes
    [22] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    44
    44
    45
    46
    44
    46
    45
    43
    42
    41
    Units: Participants
    32
    34
    35
    36
    33
    40
    37
    34
    31
    33
    No statistical analyses for this end point

    Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by MN assay – Day 29

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    End point title
    Number of seropositive subjects for anti-H1 stalk antibodies measured by MN assay – Day 29 [23]
    End point description
    Anti-H1 stalk immune response measured by MN are expressed in 1/DIL. The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.
    End point type
    Primary
    End point timeframe
    At Day 29
    Notes
    [23] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    43
    40
    40
    40
    41
    42
    37
    41
    39
    40
    Units: Participants
    43
    40
    40
    40
    41
    41
    36
    41
    37
    40
    No statistical analyses for this end point

    Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by MN assay – Day 85

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    End point title
    Number of seropositive subjects for anti-H1 stalk antibodies measured by MN assay – Day 85 [24]
    End point description
    Anti-H1 stalk immune response measured by MN are expressed in 1/DIL. The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.
    End point type
    Primary
    End point timeframe
    At Day 85
    Notes
    [24] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    38
    36
    34
    33
    39
    35
    34
    34
    35
    38
    Units: Participants
    36
    35
    34
    31
    38
    35
    30
    32
    35
    37
    No statistical analyses for this end point

    Primary: Titers for serum H1 stalk antibodies measured by MN assay – Day 1

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    End point title
    Titers for serum H1 stalk antibodies measured by MN assay – Day 1 [25]
    End point description
    Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.
    End point type
    Primary
    End point timeframe
    At Day 1
    Notes
    [25] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    44
    44
    45
    46
    44
    46
    45
    43
    42
    41
    Units: Titer
        geometric mean (confidence interval 95%)
    40.6 (29.4 to 56.1)
    45.4 (33.4 to 61.6)
    45.9 (34.2 to 61.8)
    45.8 (34.5 to 60.8)
    41.9 (30.7 to 57.3)
    45.1 (35.0 to 58.2)
    44.6 (34.4 to 57.7)
    43.4 (32.4 to 58.0)
    42.7 (31.2 to 58.6)
    38 (28.8 to 50.2)
    No statistical analyses for this end point

    Primary: Titers for serum H1 stalk antibodies measured by MN assay – Day 29

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    End point title
    Titers for serum H1 stalk antibodies measured by MN assay – Day 29 [26]
    End point description
    Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.
    End point type
    Primary
    End point timeframe
    At Day 29
    Notes
    [26] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    43
    40
    40
    40
    41
    42
    37
    41
    39
    40
    Units: Titer
        geometric mean (confidence interval 95%)
    100.3 (88.1 to 114.1)
    109.3 (94.0 to 127.0)
    113.1 (96.5 to 132.6)
    105.6 (91.0 to 122.5)
    96.4 (83.2 to 111.6)
    89.8 (73.0 to 110.5)
    86.2 (69.9 to 106.3)
    80 (66.6 to 96.1)
    74.5 (59.6 to 93.2)
    87.2 (75.6 to 100.7)
    No statistical analyses for this end point

    Primary: Titers for serum H1 stalk antibodies measured by MN assay – Day 85

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    End point title
    Titers for serum H1 stalk antibodies measured by MN assay – Day 85 [27]
    End point description
    Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.
    End point type
    Primary
    End point timeframe
    At Day 85
    Notes
    [27] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    38
    36
    34
    33
    39
    35
    34
    34
    35
    38
    Units: Titer
        geometric mean (confidence interval 95%)
    73 (58.3 to 91.5)
    98.9 (81.5 to 119.9)
    122.7 (108.9 to 138.3)
    59.6 (45.9 to 77.4)
    87.4 (71.1 to 107.6)
    109.8 (93.0 to 129.8)
    55.4 (41.3 to 74.3)
    75.3 (56.4 to 100.4)
    88.3 (74.2 to 105.2)
    86.1 (70.2 to 105.5)
    No statistical analyses for this end point

    Primary: Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 29

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    End point title
    Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 29 [28]
    End point description
    Percentage of subjects with an equal or greater than (≥) 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
    End point type
    Primary
    End point timeframe
    At Day 29, compared to pre-vaccination at Day 1
    Notes
    [28] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    43
    40
    41
    40
    42
    42
    37
    41
    39
    40
    Units: Percentage of subjects
        number (confidence interval 95%)
    88.4 (74.9 to 96.1)
    60 (43.3 to 75.1)
    87.8 (73.8 to 95.9)
    70 (53.5 to 83.4)
    52.4 (36.4 to 68.0)
    83.3 (68.6 to 93.0)
    35.1 (20.2 to 52.5)
    24.4 (12.4 to 40.3)
    38.5 (23.4 to 55.4)
    15 (5.7 to 29.8)
    No statistical analyses for this end point

    Primary: Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 85

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    End point title
    Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 85 [29]
    End point description
    Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
    End point type
    Primary
    End point timeframe
    At Day 85, compared to pre-vaccination at Day 1
    Notes
    [29] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    39
    36
    34
    35
    39
    35
    34
    34
    35
    38
    Units: Percentage of subjects
        number (confidence interval 95%)
    51.3 (34.8 to 67.6)
    44.4 (27.9 to 61.9)
    79.4 (62.1 to 91.3)
    37.1 (21.5 to 55.1)
    20.5 (9.3 to 36.5)
    80 (63.1 to 91.6)
    29.4 (15.1 to 47.5)
    8.8 (1.9 to 23.7)
    37.1 (21.5 to 55.1)
    7.9 (1.7 to 21.4)
    No statistical analyses for this end point

    Primary: Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk titer measured by MN assay – Day 29

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    End point title
    Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk titer measured by MN assay – Day 29 [30]
    End point description
    Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.
    End point type
    Primary
    End point timeframe
    At Day 29, compared to pre-vaccination at Day 1
    Notes
    [30] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    42
    38
    38
    39
    38
    41
    35
    38
    37
    36
    Units: Percentage of subjects
        number (confidence interval 95%)
    40.5 (25.6 to 56.7)
    39.5 (24.0 to 56.6)
    31.6 (17.5 to 48.7)
    41 (25.6 to 57.9)
    36.8 (21.8 to 54.0)
    31.7 (18.1 to 48.1)
    34.3 (19.1 to 52.2)
    26.3 (13.4 to 43.1)
    29.7 (15.9 to 47.0)
    36.1 (20.8 to 53.8)
    No statistical analyses for this end point

    Primary: Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk titer measured by MN assay – Day 85

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    End point title
    Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk titer measured by MN assay – Day 85 [31]
    End point description
    Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.
    End point type
    Primary
    End point timeframe
    At Day 85, compared to pre-vaccination at Day 1
    Notes
    [31] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    37
    34
    32
    33
    35
    34
    33
    32
    33
    34
    Units: Percentage of subjects
        number (confidence interval 95%)
    29.7 (15.9 to 47.0)
    38.2 (22.2 to 56.4)
    34.4 (18.6 to 53.2)
    15.2 (5.1 to 31.9)
    31.4 (16.9 to 49.3)
    41.2 (24.6 to 59.3)
    21.2 (9.0 to 38.9)
    18.8 (7.2 to 36.4)
    33.3 (18.0 to 51.8)
    41.2 (24.6 to 59.3)
    No statistical analyses for this end point

    Primary: Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 29

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    End point title
    Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 29 [32]
    End point description
    Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
    End point type
    Primary
    End point timeframe
    At Day 29, compared to pre-vaccination at Day 1
    Notes
    [32] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    43
    40
    41
    40
    42
    42
    37
    41
    39
    40
    Units: Percentage of subjects
        number (confidence interval 95%)
    58.1 (42.1 to 73.0)
    35 (20.6 to 51.7)
    61 (44.5 to 75.8)
    30 (16.6 to 46.5)
    21.4 (10.3 to 36.8)
    42.9 (27.7 to 59.0)
    13.5 (4.5 to 28.8)
    2.4 (0.1 to 12.9)
    15.4 (5.9 to 30.5)
    2.5 (0.1 to 13.2)
    No statistical analyses for this end point

    Primary: Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 85

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    End point title
    Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 85 [33]
    End point description
    Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.
    End point type
    Primary
    End point timeframe
    At Day 85, compared to pre-vaccination at Day 1
    Notes
    [33] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    39
    36
    34
    35
    39
    35
    34
    34
    35
    38
    Units: Percentage of subjects
        number (confidence interval 95%)
    12.8 (4.3 to 27.4)
    5.6 (0.7 to 18.7)
    47.1 (29.8 to 64.9)
    17.1 (6.6 to 33.6)
    5.1 (0.6 to 17.3)
    25.7 (12.5 to 43.3)
    17.6 (6.8 to 34.5)
    2.9 (0.1 to 15.3)
    14.3 (4.8 to 30.3)
    5.3 (0.6 to 17.7)
    No statistical analyses for this end point

    Primary: Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk titer measured by MN assay – Day 29

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    End point title
    Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk titer measured by MN assay – Day 29 [34]
    End point description
    Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.
    End point type
    Primary
    End point timeframe
    At Day 29, compared to pre-vaccination at Day 1
    Notes
    [34] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    42
    38
    38
    39
    38
    41
    35
    38
    37
    36
    Units: Percentage of subjects
        number (confidence interval 95%)
    7.1 (1.5 to 19.5)
    7.9 (1.7 to 21.4)
    10.5 (2.9 to 24.8)
    5.1 (0.6 to 17.3)
    7.9 (1.7 to 21.4)
    4.9 (0.6 to 16.5)
    8.6 (1.8 to 23.1)
    2.6 (0.1 to 13.8)
    2.7 (0.1 to 14.2)
    2.8 (0.1 to 14.5)
    No statistical analyses for this end point

    Primary: Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk titer measured by MN assay – Day 85

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    End point title
    Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk titer measured by MN assay – Day 85 [35]
    End point description
    Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.
    End point type
    Primary
    End point timeframe
    At Day 85, compared to pre-vaccination at Day 1
    Notes
    [35] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    37
    34
    32
    33
    35
    34
    33
    32
    33
    34
    Units: Percentage of subjects
        number (confidence interval 95%)
    2.7 (0.1 to 14.2)
    8.8 (1.9 to 23.7)
    15.6 (5.3 to 32.8)
    3 (0.1 to 15.8)
    8.6 (1.8 to 23.1)
    8.8 (1.9 to 23.7)
    0 (0.0 to 10.6)
    6.3 (0.8 to 20.8)
    3 (0.1 to 15.8)
    2.9 (0.1 to 15.3)
    No statistical analyses for this end point

    Primary: Mean Geometric Increase (MGI) for anti-H1 stalk antibody concentration measured by ELISA – Day 29

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    End point title
    Mean Geometric Increase (MGI) for anti-H1 stalk antibody concentration measured by ELISA – Day 29 [36]
    End point description
    MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1
    End point type
    Primary
    End point timeframe
    At Day 29, compared to pre-vaccination at Day 1
    Notes
    [36] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    43
    40
    41
    40
    42
    42
    37
    41
    39
    40
    Units: Ratio
        geometric mean (confidence interval 95%)
    12.4 (9.2 to 16.7)
    5.9 (4.4 to 8.0)
    12.6 (9.2 to 17.1)
    6.8 (4.9 to 9.5)
    4.7 (3.6 to 6.2)
    8.1 (6.2 to 10.5)
    4.2 (2.9 to 6.2)
    2.3 (1.8 to 3.0)
    3.9 (2.8 to 5.4)
    2.4 (1.9 to 2.9)
    No statistical analyses for this end point

    Primary: MGI for anti-H1 stalk antibody concentration measured by ELISA – Day 85

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    End point title
    MGI for anti-H1 stalk antibody concentration measured by ELISA – Day 85 [37]
    End point description
    MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1
    End point type
    Primary
    End point timeframe
    At Day 85, compared to pre-vaccination at Day 1
    Notes
    [37] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    39
    36
    34
    35
    39
    35
    34
    34
    35
    38
    Units: Ratio
        geometric mean (confidence interval 95%)
    5 (3.9 to 6.5)
    3.4 (2.6 to 4.5)
    8.1 (6.1 to 10.8)
    3.4 (2.4 to 4.9)
    2.6 (2.1 to 3.2)
    6.3 (5.0 to 7.9)
    3.4 (2.3 to 5.0)
    1.7 (1.4 to 2.1)
    3.8 (2.7 to 5.5)
    1.8 (1.5 to 2.3)
    No statistical analyses for this end point

    Primary: MGI for anti-H1 stalk antibody titer measured by MN assay – Day 29

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    End point title
    MGI for anti-H1 stalk antibody titer measured by MN assay – Day 29 [38]
    End point description
    MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1
    End point type
    Primary
    End point timeframe
    At Day 29, compared to pre-vaccination at Day 1
    Notes
    [38] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    42
    38
    38
    39
    38
    41
    35
    38
    37
    36
    Units: Ratio
        geometric mean (confidence interval 95%)
    2.4 (1.7 to 3.3)
    2.6 (1.9 to 3.6)
    2.4 (1.8 to 3.3)
    2.3 (1.7 to 3.2)
    2.3 (1.7 to 3.2)
    2 (1.5 to 2.7)
    2.3 (1.7 to 3.2)
    1.9 (1.4 to 2.5)
    1.7 (1.2 to 2.4)
    2.2 (1.6 to 3.1)
    No statistical analyses for this end point

    Primary: MGI for anti-H1 stalk antibody titer measured by MN assay – Day 85

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    End point title
    MGI for anti-H1 stalk antibody titer measured by MN assay – Day 85 [39]
    End point description
    MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1
    End point type
    Primary
    End point timeframe
    At Day 85, compared to pre-vaccination at Day 1
    Notes
    [39] - 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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
    Number of subjects analysed
    37
    34
    32
    33
    35
    34
    33
    32
    33
    34
    Units: Ratio
        geometric mean (confidence interval 95%)
    1.6 (1.2 to 2.2)
    2.2 (1.5 to 3.2)
    2.5 (1.7 to 3.7)
    1.1 (0.8 to 1.6)
    2 (1.5 to 2.8)
    2.5 (1.7 to 3.5)
    1.2 (0.9 to 1.7)
    1.6 (1.1 to 2.2)
    2 (1.4 to 2.8)
    2.4 (1.7 to 3.3)
    No statistical analyses for this end point

    Secondary: Adjusted GMCs for anti-H1 HA stalk antibody measured by ELISA

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    End point title
    Adjusted GMCs for anti-H1 HA stalk antibody measured by ELISA
    End point description
    The adjusted GMCs are presented to evaluate the adjuvant effect post-do