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    Clinical Trial Results:
    A Phase 3, Randomized, Multicenter, Observer-blinded, Noninferiority Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Inactivated Influenza Virus Vaccine (Seqirus QIV) with a US-licensed Quadrivalent Inactivated Comparator Influenza Virus Vaccine (Comparator QIV) in a Pediatric Population 6 Months Through 59 Months of Age

    Summary
    EudraCT number
    		 2016-004753-33
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    11 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Oct 2018
    First version publication date
    04 Oct 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CSLCT-QIV-15-03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02914275
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Seqirus
    Sponsor organisation address
    The Point, 29 Market Street, Maidenhead, United Kingdom, SL6 8AA
    Public contact
    Clinical Study Disclosure Manager, Seqirus, Seqirus.ClinicalTrials@Seqirus.com
    Scientific contact
    Clinical Study Disclosure Manager, Seqirus, Seqirus.ClinicalTrials@Seqirus.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001894-PIP01-15
    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
    05 Oct 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that vaccination with Seqirus QIV elicits an immune response that is not inferior to the US-licensed comparator QIV (Comparator QIV) containing the same virus strains as Seqirus QIV among a pediatric population 6 months through 59 months of age
    Protection of trial subjects
    This study was conducted under a Food and Drug Administration (FDA) Investigational New Drug (IND) application, and documented in accordance with the applicable regulatory guidelines and requirements. The procedures set out in this study protocol were designed to ensure that the Sponsor and the Investigators abide by the principles of the current International Conference on Harmonisation Good Clinical Practice (ICH GCP) guideline on the conduct, evaluation and of this study, as described in ICH Topic E6 (Guideline for GCP). The study was carried out according to all applicable international and national regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Sep 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 10 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 2247
    Worldwide total number of subjects
    2247
    EEA total number of subjects
    0
    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)
    505
    Children (2-11 years)
    1742
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled from 27 September 2016 to 11 August 2017 from 39 study sites in the United States of America.

    Pre-assignment
    Screening details
    		 A total of 2339 subjects were screened. Of these, 2247 subjects gave informed consent and were randomized to treatment.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Seqirus Quadrivalent Influenza Vaccine
    Arm description
    		 Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Seqirus Quadrivalent Influenza Vaccine (Seqirus QIV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as either a 0.25mL or 0.5 mL intramuscular dose depending on the age of subjects. The vaccine is presented in a prefilled needleless syringe for the different formulations.

    Arm title
    		 Comparator Quadrivalent Influenza Vaccine
    Arm description
    		 Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Comparator Quadrivalent Influenza Vaccine (Comparator QIV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as either a 0.25mL or 0.5 mL intramuscular dose depending on the age of subjects. The vaccine is presented in a prefilled needleless syringe for the different formulations.

    Number of subjects in period 1
    		Seqirus Quadrivalent Influenza Vaccine Comparator Quadrivalent Influenza Vaccine
    Started
    1684
    563
    Completed
    1566
    521
    Not completed
    118
    42
         Consent withdrawn by subject
    26
    10
         Physician decision
    3
    1
         Other
    4
    1
         Lost to follow-up
    84
    29
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Seqirus Quadrivalent Influenza Vaccine
    Reporting group description
    		 Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.

    Reporting group title
    Comparator Quadrivalent Influenza Vaccine
    Reporting group description
    		 Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.

    Reporting group values
    		 Seqirus Quadrivalent Influenza Vaccine Comparator Quadrivalent Influenza Vaccine Total
    Number of subjects
    		 1684 563 2247
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 36.6 ± 14.70 36.5 ± 14.68 -
    Gender categorical
    Units: Subjects
        Female
    		 820 268 1088
        Male
    		 864 295 1159
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 434 160 594
        Not Hispanic or Latino
    		 1243 400 1643
        Unknown or Not Reported
    		 7 3 10
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 5 2 7
        Asian
    		 15 10 25
        Native Hawaiian or Other Pacific Islander
    		 13 3 16
        Black or African American
    		 361 123 484
        White
    		 1205 391 1596
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 85 34 119
    Vaccination against influenza 2015/2016 season
    Units: Subjects
        Yes
    		 845 294 1139
        No
    		 838 269 1107
        Missing
    		 1 0 1
    Region of Enrollment
    Units: Subjects
        United States
    		 1684 563 2247
    Weight
    Units: kilograms
        arithmetic mean (standard deviation)
    		 15.36 ± 4.224 15.40 ± 4.149 -
    Prevaccination Axillary Temperature
    Units: Temp (°F)
        arithmetic mean (standard deviation)
    		 97.17 ± 0.963 97.25 ± 0.935 -

    End points

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    End points reporting groups
    Reporting group title
    Seqirus Quadrivalent Influenza Vaccine
    Reporting group description
    		 Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.

    Reporting group title
    Comparator Quadrivalent Influenza Vaccine
    Reporting group description
    		 Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.

    Subject analysis set title
    Seqirus QIV Cohort A
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects 6 months through 35 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.

    Subject analysis set title
    Seqirus QIV Cohort B
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects 36 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.

    Subject analysis set title
    Comparator QIV Cohort A
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects 6 months through 35 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.

    Subject analysis set title
    Comparator QIV Cohort B
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects 36 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.

    Primary: Immunogenicity Endpoint: The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.

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    End point title
    		 Immunogenicity Endpoint: The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.
    End point description
    Noninferiority of Seqirus QIV compared to Comparator QIV will be assessed by hemagglutination inhibition (HI) antibody geometric mean titer (GMT) for each viral strain included in the vaccines. The GMT ratio is defined as the geometric mean of the postvaccination HI titer for the Comparator QIV over the geometric mean of the postvaccination HI titer for Seqirus QIV.
    End point type
    Primary
    End point timeframe
    28 days after last vaccination
    End point values
    		 Seqirus Quadrivalent Influenza Vaccine Comparator Quadrivalent Influenza Vaccine
    Number of subjects analysed
    1456 [1]
    484 [2]
    Units: Geometric Mean Titer
    number (not applicable)
        A/H1N1
    353.5
    281.0
        A/H3N2
    393.0
    500.5
        B/Yamagata
    23.7
    26.5
        B/Victoria
    54.6
    52.9
    Notes
    [1] - Strain specific N: A/H1N1, B/Yamagata and B/Victoria=1455; A/H3N2=1454
    [2] - Strain specific N: A/H1N1, A/H3N2 and B/Yamagata=484; B/Victoria=483
    Statistical analysis title
    		 Non-inferiority, A/H1N1, GMT ratio, Day 28
    Statistical analysis description
    Non-inferiority of immune responses to A/H1N1 vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination.
    Comparison groups
    Seqirus Quadrivalent Influenza Vaccine v Comparator Quadrivalent Influenza Vaccine
    Number of subjects included in analysis
    1940
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Geometric Mean Titer Ratio
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 0.88
    Notes
    [3] - The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5
    Statistical analysis title
    		 Non-inferiority, A/H3N2, GMT ratio, Day 28
    Statistical analysis description
    Non-inferiority of immune responses to A/H3N2 vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination.
    Comparison groups
    Seqirus Quadrivalent Influenza Vaccine v Comparator Quadrivalent Influenza Vaccine
    Number of subjects included in analysis
    1940
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Geometric Mean Titer Ratio
    Point estimate
    1.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.15
         upper limit
    		 1.42
    Notes
    [4] - The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5
    Statistical analysis title
    		 Non-inferiority, B/Yamagata, GMT ratio, Day 28
    Statistical analysis description
    Non-inferiority of immune responses to B/Yamagata vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination.
    Comparison groups
    Seqirus Quadrivalent Influenza Vaccine v Comparator Quadrivalent Influenza Vaccine
    Number of subjects included in analysis
    1940
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 Geometric Mean Titer Ratio
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.24
    Notes
    [5] - The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5
    Statistical analysis title
    		 Non-inferiority, B/Victoria, GMT ratio, Day 28
    Statistical analysis description
    Non-inferiority of immune responses to B/Victoria vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination.
    Comparison groups
    Seqirus Quadrivalent Influenza Vaccine v Comparator Quadrivalent Influenza Vaccine
    Number of subjects included in analysis
    1940
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 Geometric Mean Titer Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.09
    Notes
    [6] - The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5

    Primary: Immunogenicity Endpoint: Difference in Seroconversion Rate (SCR) for Each Virus Strain

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    End point title
    		 Immunogenicity Endpoint: Difference in Seroconversion Rate (SCR) for Each Virus Strain
    End point description
    Noninferiority of Seqirus QIV compared to comparator QIV will be assessed by seroconversion rate (SCR) for each viral strain. SCR is defined as the percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI titer. For the SCR comparison, the difference between the SCR for each vaccine (for each strain) will be determined.
    End point type
    Primary
    End point timeframe
    28 days after last vaccination
    End point values
    		 Seqirus Quadrivalent Influenza Vaccine Comparator Quadrivalent Influenza Vaccine
    Number of subjects analysed
    1456 [7]
    484 [8]
    Units: Percentage of Participants
    number (confidence interval 95%)
        A/H1N1
    79.1 (76.9 to 81.1)
    68.8 (64.5 to 72.9)
        A/H3N2
    82.3 (80.2 to 84.2)
    84.9 (81.4 to 88.0)
        B/Yamagata
    38.9 (36.4 to 41.4)
    41.9 (37.5 to 46.5)
        B/Victoria
    60.2 (57.6 to 62.7)
    61.1 (56.6 to 65.4)
    Notes
    [7] - Strain specific N: A/H1N1, B/Yamagata and B/Victoria=1456; A/H3N2=1455
    [8] - Strain specific N: A/H1N1, A/H3N2 and B/Yamagata=484; B/Victoria=483
    Statistical analysis title
    		 Non-inferiority:A/H1N1, SCR difference, Day 28
    Statistical analysis description
    Non-inferiority of immune responses to A/H1N1 vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination
    Comparison groups
    Seqirus Quadrivalent Influenza Vaccine v Comparator Quadrivalent Influenza Vaccine
    Number of subjects included in analysis
    1940
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    Parameter type
    		 Seroconversion Rate Difference
    Point estimate
    -10.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.4
         upper limit
    		 -5.1
    Notes
    [9] - The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.
    Statistical analysis title
    		 Non-inferiority:A/H3N2, SCR difference, Day 28
    Statistical analysis description
    Non-inferiority of immune responses to A/H3N2 vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination
    Comparison groups
    Seqirus Quadrivalent Influenza Vaccine v Comparator Quadrivalent Influenza Vaccine
    Number of subjects included in analysis
    1940
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    Method
    Parameter type
    		 Seroconversion Rate Difference
    Point estimate
    2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.54
         upper limit
    		 7.8
    Notes
    [10] - The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.
    Statistical analysis title
    		 Non-inferiority:B/Yamagata, SCR difference, Day 28
    Statistical analysis description
    Non-inferiority of immune responses to B/Yamagata vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination
    Comparison groups
    Seqirus Quadrivalent Influenza Vaccine v Comparator Quadrivalent Influenza Vaccine
    Number of subjects included in analysis
    1940
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [11]
    Method
    Parameter type
    		 Seroconversion Rate Difference
    Point estimate
    3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 8.2
    Notes
    [11] - The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.
    Statistical analysis title
    		 Non-inferiority:B/Victoria, SCR difference, Day 28
    Statistical analysis description
    Non-inferiority of immune responses to B/Victoria vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination
    Comparison groups
    Seqirus Quadrivalent Influenza Vaccine v Comparator Quadrivalent Influenza Vaccine
    Number of subjects included in analysis
    1940
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [12]
    Method
    Parameter type
    		 Seroconversion Rate Difference
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 6.1
    Notes
    [12] - The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.

    Secondary: Safety Endpoint: Frequency and Severity of Solicited Local Adverse Reactions and Solicited Systemic Adverse Events

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    End point title
    		 Safety Endpoint: Frequency and Severity of Solicited Local Adverse Reactions and Solicited Systemic Adverse Events
    End point description
    End point type
    Secondary
    End point timeframe
    7 days after each vaccination
    End point values
    		 Seqirus Quadrivalent Influenza Vaccine Comparator Quadrivalent Influenza Vaccine
    Number of subjects analysed
    1618 [13]
    545 [14]
    Units: Count of participants
        Solicited AEs, Any
    940
    312
        Solicited AEs, Grade 1
    592
    189
        Solicited AEs, Grade 2
    277
    83
        Solicited AEs, Grade 3
    71
    39
        Solicited AEs, Local
    645
    208
        Solicited AEs, Systemic
    633
    215
    Notes
    [13] - Solicited Safety Population N=1618
    [14] - Solicited Safety Population N=545
    No statistical analyses for this end point

    Secondary: Safety Endpoint: Frequency of Cellulitis-like Reactions

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    End point title
    		 Safety Endpoint: Frequency of Cellulitis-like Reactions
    End point description
    End point type
    Secondary
    End point timeframe
    28 days after each vaccination
    End point values
    		 Seqirus Quadrivalent Influenza Vaccine Comparator Quadrivalent Influenza Vaccine
    Number of subjects analysed
    1618 [15]
    545 [16]
    Units: Count of participants
    0
    1
    Notes
    [15] - Solicited Safety Population N=1618
    [16] - Solicited Safety Population N=545
    No statistical analyses for this end point

    Secondary: Safety Endpoint: Frequency and Severity of Unsolicited AEs

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    End point title
    		 Safety Endpoint: Frequency and Severity of Unsolicited AEs
    End point description
    End point type
    Secondary
    End point timeframe
    28 days after each vaccination dose `
    End point values
    		 Seqirus Quadrivalent Influenza Vaccine Comparator Quadrivalent Influenza Vaccine
    Number of subjects analysed
    1673 [17]
    559 [18]
    Units: Count of participants
        Unsolicited AEs, Any
    536
    171
        Unsolicited AEs, Grade 1
    285
    92
        Unsolicited AEs, Grade 2
    206
    65
        Unsolicited AEs, Grade 3
    45
    14
    Notes
    [17] - Overall Safety Population=1673
    [18] - Overall Safety Population=559
    No statistical analyses for this end point

    Secondary: Safety Endpoint: Frequency of Serious Adverse Events (SAE)

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    End point title
    		 Safety Endpoint: Frequency of Serious Adverse Events (SAE)
    End point description
    End point type
    Secondary
    End point timeframe
    180 days after the last vaccination dose
    End point values
    		 Seqirus Quadrivalent Influenza Vaccine Comparator Quadrivalent Influenza Vaccine
    Number of subjects analysed
    1673 [19]
    559 [20]
    Units: Count of participants
        SAE (Day 1 to Day 28)
    4
    0
        SAE (Day 29 to Day 180)
    7
    3
        Related SAE
    0
    0
        Death
    0
    0
        AESI (Day 1 to Day 28)
    0
    0
        AESI (Day 29 to Day 180)
    2
    0
    Notes
    [19] - Overall Safety Population = 1673
    [20] - Overall Safety Population = 559
    No statistical analyses for this end point

    Secondary: Immunogenicity Endpoint: Geometric Mean Titers, HI Assay Prevaccination and Postvaccination, by Age Subgroup

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    End point title
    		 Immunogenicity Endpoint: Geometric Mean Titers, HI Assay Prevaccination and Postvaccination, by Age Subgroup
    End point description
    The humoral immune response was assessed for Seqirus QIV & Comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate: Geometric mean of HI titers prevaccination & postvaccination.
    End point type
    Secondary
    End point timeframe
    28 days after last vaccination
    End point values
    		 Seqirus QIV Cohort A Seqirus QIV Cohort B Comparator QIV Cohort A Comparator QIV Cohort B
    Number of subjects analysed
    586 [21]
    870
    193
    291 [22]
    Units: Geometric Mean Titer
    number (confidence interval 95%)
        A/H1N1, Prevaccination
    13.8 (12.30 to 15.57)
    60.7 (53.97 to 68.20)
    14.9 (12.25 to 18.22)
    68.7 (55.84 to 84.62)
        A/H1N1, Postvaccination
    184.9 (165.15 to 207.05)
    590.2 (548.62 to 634.93)
    168.3 (137.69 to 205.62)
    469.2 (413.72 to 532.05)
        A/H3N2, Prevaccination
    14.3 (12.48 to 16.39)
    62.4 (55.50 to 70.19)
    16.4 (12.86 to 20.91)
    65.5 (53.76 to 79.88)
        A/H3N2, Postvaccination
    184.9 (164.57 to 207.65)
    778.6 (710.83 to 852.82)
    247.5 (202.14 to 302.95)
    1047 (911.69 to 1202.48)
        B/Yamagata, Prevaccination
    5.9 (5.66 to 6.13)
    7.9 (7.55 to 8.33)
    5.8 (5.47 to 6.22)
    8.3 (7.58 to 9.17)
        B/Yamagata, Postvaccination
    15.6 (14.33 to 17.00)
    35.4 (32.73 to 38.26)
    16.3 (14.03 to 18.95)
    44.1 (38.30 to 50.87)
        B/Victoria, Prevaccination
    7.1 (6.75 to 7.55)
    9.6 (9.04 to 10.19)
    6.9 (6.26 to 7.53)
    10.4 (9.35 to 11.64)
        B/Victoria, Postvaccination
    39.8 (36.02 to 44.04)
    72.1 (65.62 to 79.25)
    31.9 (26.88 to 37.81)
    85.9 (73.16 to 100.96)
    Notes
    [21] - Strain specific N for postvaccination GMT results: A/H1N1, B/Yamagata and B/Victoria=586; A/H3N2=585
    [22] - Strain specific N for prevaccination GMT results: A/H1N1, A/H3N2 and B/Yamagata=291; B/Victoria=290
    No statistical analyses for this end point

    Secondary: Immunogenicity Endpoint: Seroconversion Rates (SCR), HI Assay, by Age Subgroup

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    End point title
    		 Immunogenicity Endpoint: Seroconversion Rates (SCR), HI Assay, by Age Subgroup
    End point description
    The humoral immune response will be assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate SCRs defined as the % of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination titer.
    End point type
    Secondary
    End point timeframe
    28 days after last vaccination
    End point values
    		 Seqirus QIV Cohort A Seqirus QIV Cohort B Comparator QIV Cohort A Comparator QIV Cohort B
    Number of subjects analysed
    586 [23]
    870
    193
    291 [24]
    Units: Percent of Participants
    number (confidence interval 95%)
        A/H1N1
    81.9 (78.6 to 84.9)
    77.1 (74.2 to 79.9)
    80.3 (74.0 to 85.7)
    61.2 (55.3 to 66.8)
        A/H3N2
    82.4 (79.1 to 85.4)
    82.2 (79.5 to 84.7)
    85.0 (79.1 to 89.7)
    84.9 (80.2 to 88.8)
        B/Yamagata
    22.5 (19.2 to 26.1)
    49.9 (46.5 to 53.3)
    26.9 (20.8 to 33.8)
    51.9 (46.0 to 57.8)
        B/Victoria
    52.9 (48.8 to 57.0)
    65.1 (61.8 to 68.2)
    49.7 (42.5 to 57.0)
    68.6 (62.9 to 73.9)
    Notes
    [23] - Strain specific N: A/H1N1, B/Yamagata and B/Victoria=586; A/H3N2=585
    [24] - Strain specific N: A/H1N1, A/H3N2 and B/Yamagata=291; B/Victoria=290
    No statistical analyses for this end point

    Secondary: Immunogenicity Endpoint: Seroprotection Rates, HI Assay by Age Subgroup

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    End point title
    		 Immunogenicity Endpoint: Seroprotection Rates, HI Assay by Age Subgroup
    End point description
    The humoral immune response will be assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate the percentage of subjects with a titer ≥40 (seroprotection rates) at Day 1 and at Study Exit Visit.
    End point type
    Secondary
    End point timeframe
    28 days after last vaccination
    End point values
    		 Seqirus QIV Cohort A Seqirus QIV Cohort B Comparator QIV Cohort A Comparator QIV Cohort B
    Number of subjects analysed
    586 [25]
    870
    193
    291
    Units: Percentage of participants
    number (confidence interval 95%)
        A/H1N1
    90.1 (87.4 to 92.4)
    99.1 (98.2 to 99.6)
    88.6 (83.3 to 92.7)
    98.3 (96.0 to 99.4)
        A/H3N2
    92.5 (90.0 to 94.5)
    98.4 (97.3 to 99.1)
    95.3 (91.3 to 97.8)
    98.6 (96.5 to 99.6)
        B/Yamagata
    24.7 (21.3 to 28.4)
    57.1 (53.8 to 60.4)
    29.0 (22.7 to 36.0)
    61.5 (55.7 to 67.1)
        B/Victoria
    55.6 (51.5 to 59.7)
    71.0 (67.9 to 74.0)
    52.8 (45.6 to 60.1)
    75.3 (69.9 to 80.1)
    Notes
    [25] - Strain specific N: A/H1N1, B/Yamagata and B/Victoria=586; A/H3N2=585
    No statistical analyses for this end point

    Secondary: Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) by Age Subgroup

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    End point title
    		 Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) by Age Subgroup
    End point description
    The humoral immune response will be assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate GMFIs, defined as the geometric mean fold titer rise from Day 1 to Study Exit Visit.
    End point type
    Secondary
    End point timeframe
    28 days after last vaccination
    End point values
    		 Seqirus QIV Cohort A Seqirus QIV Cohort B Comparator QIV Cohort A Comparator QIV Cohort B
    Number of subjects analysed
    586 [26]
    870
    193
    291 [27]
    Units: Geometric Mean Folder Titer Increase
    number (confidence interval 95%)
        A/H1N1
    13.4 (11.98 to 14.90)
    9.7 (8.90 to 10.64)
    11.3 (9.40 to 13.49)
    6.8 (5.83 to 7.99)
        A/H3N2
    13.0 (11.62 to 14.50)
    12.5 (11.42 to 13.62)
    15.1 (12.60 to 18.08)
    16.0 (13.62 to 18.74)
        B/Yamagata
    2.6 (2.45 to 2.86)
    4.5 (4.17 to 4.77)
    2.8 (2.45 to 3.19)
    5.3 (4.67 to 6.00)
        B/Victoria
    5.6 (5.11 to 6.09)
    7.5 (6.93 to 8.15)
    4.6 (3.97 to 5.42)
    8.2 (7.18 to 9.42)
    Notes
    [26] - Strain specific N: A/H1N1, B/Yamagata and B/Victoria=586; A/H3N2=585
    [27] - Strain specific N: A/H1N1, A/H3N2 and B/Yamagata=291; B/Victoria=290
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Seqirus QIV
    Reporting group description
    		 Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine.

    Reporting group title
    Comparator QIV
    Reporting group description
    		 Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine.

    Serious adverse events
    		 Seqirus QIV Comparator QIV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 1673 (0.66%)
    3 / 559 (0.54%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    1 / 1673 (0.06%)
    0 / 559 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body aspiration
         subjects affected / exposed
    1 / 1673 (0.06%)
    0 / 559 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 1673 (0.00%)
    1 / 559 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    2 / 1673 (0.12%)
    0 / 559 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dysphagia
         subjects affected / exposed
    1 / 1673 (0.06%)
    0 / 559 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 1673 (0.00%)
    1 / 559 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    1 / 1673 (0.06%)
    0 / 559 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Croup infectious
         subjects affected / exposed
    2 / 1673 (0.12%)
    0 / 559 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 1673 (0.00%)
    1 / 559 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    1 / 1673 (0.06%)
    0 / 559 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 1673 (0.06%)
    0 / 559 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 1673 (0.06%)
    0 / 559 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 1673 (0.06%)
    0 / 559 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 Seqirus QIV Comparator QIV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    320 / 1673 (19.13%)
    80 / 559 (14.31%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    153 / 1673 (9.15%)
    41 / 559 (7.33%)
         occurrences all number
    167
    52
    Rhinorrhoea
         subjects affected / exposed
    134 / 1673 (8.01%)
    53 / 559 (9.48%)
         occurrences all number
    155
    63
    Infections and infestations
    Pyrexia
         subjects affected / exposed
    91 / 1673 (5.44%)
    25 / 559 (4.47%)
         occurrences all number
    100
    29
    Upper respiratory tract infection
         subjects affected / exposed
    67 / 1673 (4.00%)
    17 / 559 (3.04%)
         occurrences all number
    72
    17

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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