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    Clinical Trial Results:
    Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine (RIV4) in Children and Adolescents Aged 9 to 17 Years and Adults Aged 18 to 49 Years

    Summary
    EudraCT number
    		 2022-000577-11
    Trial protocol
    		 ES   PL   DK   CZ  
    Global end of trial date
    27 Oct 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 May 2024
    First version publication date
    10 May 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VAP00027
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05513053
    WHO universal trial number (UTN)
    		 U1111-1260-4678
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc.
    Sponsor organisation address
    Discovery Drive, Swiftwater, Pennsylvania, United States, 18370-0187
    Public contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002418-PIP01-18
    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
    13 Dec 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferior hemagglutination inhibition (HAI) immune response of quadrivalent recombinant influenza vaccine (RIV4) for the 4 strains in participants aged 9 to 17 years vs participants aged 18 to 49 years.
    Protection of trial subjects
    Vaccinations were performed by qualified and trained study personnel. Participants with allergy to any of the vaccine components were not vaccinated. After vaccination, participants were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available on site in case of any immediate allergic reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Oct 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czechia: 62
    Country: Number of subjects enrolled
    Poland: 91
    Country: Number of subjects enrolled
    Spain: 81
    Country: Number of subjects enrolled
    United States: 1074
    Worldwide total number of subjects
    1308
    EEA total number of subjects
    234
    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)
    200
    Adolescents (12-17 years)
    448
    Adults (18-64 years)
    660
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 36 investigational sites in 4 countries between 27 Oct 2022 to 27 Oct 2023.

    Pre-assignment
    Screening details
    		 A total of 1308 participants were enrolled in this study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: Participants aged 9 to 17 years
    Arm description
    		 Participants received a single intramuscular (IM) injection of RIV4 0.5 milliliter (mL) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RIV4 season/2022-2023/NH
    Investigational medicinal product code
    Other name
    Supemtek, Flublok Quadrivalent
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    RIV4 0.5 mL was administered as a single IM injection in the deltoid muscle.

    Arm title
    		 Cohort 2: Participants aged 18 to 49 years
    Arm description
    		 Participants received a single IM injection of RIV4 0.5 mL on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RIV4 season/2022-2023/NH
    Investigational medicinal product code
    Other name
    Supemtek, Flublok Quadrivalent
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    RIV4 0.5 mL was administered as a single IM injection in the deltoid muscle.

    Number of subjects in period 1
    		Cohort 1: Participants aged 9 to 17 years Cohort 2: Participants aged 18 to 49 years
    Started
    648
    660
    Completed
    629
    635
    Not completed
    19
    25
         Consent withdrawn by subject
    2
    9
         Adverse event, non-fatal
    -
    2
         Lost to follow-up
    9
    11
         Withdrawal by parent/guardian
    2
    -
         Protocol deviation
    6
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: Participants aged 9 to 17 years
    Reporting group description
    		 Participants received a single intramuscular (IM) injection of RIV4 0.5 milliliter (mL) on Day 1.

    Reporting group title
    Cohort 2: Participants aged 18 to 49 years
    Reporting group description
    		 Participants received a single IM injection of RIV4 0.5 mL on Day 1.

    Reporting group values
    		 Cohort 1: Participants aged 9 to 17 years Cohort 2: Participants aged 18 to 49 years Total
    Number of subjects
    		 648 660 1308
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 13.0 ( 2.49 ) 34.3 ( 9.21 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 312 395 707
        Male
    		 336 265 601
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 5 1 6
        Asian
    		 1 6 7
        Black or African American
    		 157 98 255
        Native Hawaiian or Other Pacific Islander
    		 1 3 4
        White
    		 467 536 1003
        Not Reported
    		 0 2 2
        Unknown
    		 1 1 2
        Multiple
    		 16 13 29

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: Participants aged 9 to 17 years
    Reporting group description
    		 Participants received a single intramuscular (IM) injection of RIV4 0.5 milliliter (mL) on Day 1.

    Reporting group title
    Cohort 2: Participants aged 18 to 49 years
    Reporting group description
    		 Participants received a single IM injection of RIV4 0.5 mL on Day 1.

    Subject analysis set title
    Cohort 1: Participants aged 9 to 17 years (Per Protocol)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received a single IM injection of RIV4 0.5 mL on Day 1.

    Subject analysis set title
    Cohort 2: Participants aged 18 to 49 years (Per Protocol)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received a single IM injection of RIV4 0.5 mL on Day 1.

    Subject analysis set title
    Cohort 1: Participants aged 9 to 17 years (Safety)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received a single IM injection of RIV4 0.5 mL on Day 1.

    Subject analysis set title
    Cohort 2: Participants aged 18 to 49 years (Safety)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received a single IM injection of RIV4 0.5 mL on Day 1.

    Primary: Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29

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    End point title
    		 Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29
    End point description
    GMTs of anti-influenza antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution. Analysis was performed on the Per-protocol analysis set (PPAS)-subset of full analysis set (FAS) which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample.
    End point type
    Primary
    End point timeframe
    Day 29
    End point values
    		 Cohort 1: Participants aged 9 to 17 years (Per Protocol) Cohort 2: Participants aged 18 to 49 years (Per Protocol)
    Number of subjects analysed
    609
    606
    Units: titer
    geometric mean (confidence interval 95%)
        A/H1N1
    1946 (1795 to 2109)
    982 (881 to 1094)
        A/H3N2
    1975 (1771 to 2202)
    604 (531 to 687)
        B/Victoria
    405 (362 to 452)
    258 (233 to 285)
        B/Yamagata
    1941 (1779 to 2118)
    1593 (1477 to 1717)
    Statistical analysis title
    		 Statistical analysis for A/H1N1
    Comparison groups
    Cohort 1: Participants aged 9 to 17 years (Per Protocol) v Cohort 2: Participants aged 18 to 49 years (Per Protocol)
    Number of subjects included in analysis
    1215
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.73
         upper limit
    		 2.27
    Statistical analysis title
    		 Statistical analysis for A/H3N2
    Comparison groups
    Cohort 1: Participants aged 9 to 17 years (Per Protocol) v Cohort 2: Participants aged 18 to 49 years (Per Protocol)
    Number of subjects included in analysis
    1215
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    3.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.76
         upper limit
    		 3.87
    Statistical analysis title
    		 Statistical analysis for B/Victoria
    Comparison groups
    Cohort 1: Participants aged 9 to 17 years (Per Protocol) v Cohort 2: Participants aged 18 to 49 years (Per Protocol)
    Number of subjects included in analysis
    1215
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.35
         upper limit
    		 1.82
    Statistical analysis title
    		 Statistical analysis for B/Yamagata
    Comparison groups
    Cohort 1: Participants aged 9 to 17 years (Per Protocol) v Cohort 2: Participants aged 18 to 49 years (Per Protocol)
    Number of subjects included in analysis
    1215
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.09
         upper limit
    		 1.37

    Primary: Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29

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    End point title
    		 Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29
    End point description
    Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination titer less than (<) 1:10 (1/dilution) at Day 1 and a post-vaccination titer greater than or equal to (>=) 1: 40 (1/dilution) at Day 29 or a pre-vaccination titer >= 1:10 at Day 1 and a >= 4-fold increase in post-vaccination titer. Analysis was performed on the PPAS-subset of FAS which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample. Here ’n’= number of participants with available data for a particular category.
    End point type
    Primary
    End point timeframe
    Day 29
    End point values
    		 Cohort 1: Participants aged 9 to 17 years (Per Protocol) Cohort 2: Participants aged 18 to 49 years (Per Protocol)
    Number of subjects analysed
    609
    606
    Units: percentage of participants
    number (confidence interval 95%)
        A/H1N1 (n = 609, 606)
    78.3 (74.8 to 81.5)
    76.4 (72.8 to 79.7)
        A/H3N2 (n = 609, 606)
    86.5 (83.6 to 89.1)
    87.1 (84.2 to 89.7)
        B/Victoria (n = 609, 605)
    76.8 (73.3 to 80.1)
    73.6 (69.8 to 77.0)
        B/Yamagata (n = 609, 606)
    77.2 (73.6 to 80.5)
    62.9 (58.9 to 66.7)
    Statistical analysis title
    		 Statistical analysis for A/H1N1
    Comparison groups
    Cohort 1: Participants aged 9 to 17 years (Per Protocol) v Cohort 2: Participants aged 18 to 49 years (Per Protocol)
    Number of subjects included in analysis
    1215
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    1.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.78
         upper limit
    		 6.62
    Statistical analysis title
    		 Statistical analysis for B/Victoria
    Comparison groups
    Cohort 1: Participants aged 9 to 17 years (Per Protocol) v Cohort 2: Participants aged 18 to 49 years (Per Protocol)
    Number of subjects included in analysis
    1215
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    3.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.57
         upper limit
    		 8.14
    Statistical analysis title
    		 Statistical analysis for B/Yamagata
    Comparison groups
    Cohort 1: Participants aged 9 to 17 years (Per Protocol) v Cohort 2: Participants aged 18 to 49 years (Per Protocol)
    Number of subjects included in analysis
    1215
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    14.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.17
         upper limit
    		 19.3
    Statistical analysis title
    		 Statistical analysis for A/H3N2
    Comparison groups
    Cohort 1: Participants aged 9 to 17 years (Per Protocol) v Cohort 2: Participants aged 18 to 49 years (Per Protocol)
    Number of subjects included in analysis
    1215
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.41
         upper limit
    		 3.23

    Secondary: GMTs Against Influenza Vaccine Antibodies at Day 1

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    End point title
    		 GMTs Against Influenza Vaccine Antibodies at Day 1
    End point description
    GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution. Analysis was performed on the PPAS-subset of FAS which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample. Here ’n’= number of participants with available data for a particular category.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Day 1
    End point values
    		 Cohort 1: Participants aged 9 to 17 years (Per Protocol) Cohort 2: Participants aged 18 to 49 years (Per Protocol)
    Number of subjects analysed
    609
    606
    Units: titer
    geometric mean (confidence interval 95%)
        A/H1N1 (n = 609, 606)
    154 (137 to 173)
    74.9 (65.8 to 85.1)
        A/H3N2 (n = 609, 606)
    111 (95.4 to 128)
    29.0 (25.7 to 32.8)
        B/Victoria (n = 609, 605)
    48.1 (43.0 to 53.8)
    37.3 (34.0 to 40.9)
        B/Yamagata (n = 609, 606)
    272 (243 to 305)
    300 (269 to 335)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Detectable HAI Titers >=10 and >=40 (1/Dilution) for Influenza Vaccine Antibodies at Days 1 and 29

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    End point title
    		 Percentage of Participants With Detectable HAI Titers >=10 and >=40 (1/Dilution) for Influenza Vaccine Antibodies at Days 1 and 29
    End point description
    Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers >=10 and >=40 against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure. Analysis was performed on the PPAS-subset of FAS which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample. Here ’n’= number of participants with available data for a particular category.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Day 1 and 28 days post-vaccination on Day 29
    End point values
    		 Cohort 1: Participants aged 9 to 17 years (Per Protocol) Cohort 2: Participants aged 18 to 49 years (Per Protocol)
    Number of subjects analysed
    609
    606
    Units: percentage of participants
    number (confidence interval 95%)
        Titer >=10: A/H1N1: Day 1 (n = 609, 606)
    97.0 (95.4 to 98.2)
    89.8 (87.1 to 92.1)
        Titer >=10: A/H1N1: Day 29 (n = 609, 606)
    100 (99.4 to 100)
    99.3 (98.3 to 99.8)
        Titer >=40: A/H1N1: Day 1 (n = 609, 606)
    87.2 (84.3 to 89.7)
    71.8 (68.0 to 75.3)
        Titer >=40: A/H1N1: Day 29 (n = 609, 606)
    99.7 (98.8 to 100)
    97.5 (96.0 to 98.6)
        Titer >=10: A/H3N2: Day 1 (n = 609, 606)
    89.2 (86.4 to 91.5)
    77.7 (74.2 to 81.0)
        Titer >=10: A/H3N2: Day 29 (n = 609, 606)
    100 (99.4 to 100)
    99.7 (98.8 to 100)
        Titer >=40: A/H3N2: Day 1 (n = 609, 606)
    74.7 (71.1 to 78.1)
    45.0 (41.0 to 49.1)
        Titer >=40: A/H3N2: Day 29 (n = 609, 606)
    99.0 (97.9 to 99.6)
    95.0 (93.0 to 96.6)
        Titer >=10: B/Victoria: Day 1 (n = 609, 605)
    92.1 (89.7 to 94.1)
    91.7 (89.2 to 93.8)
        Titer >=10: B/Victoria: Day 29 (n = 609, 606)
    99.5 (98.6 to 99.9)
    99.8 (99.1 to 100)
        Titer >=40: B/Victoria: Day 1 (n = 609, 605)
    61.4 (57.4 to 65.3)
    59.8 (55.8 to 63.8)
        Titer >=40: B/Victoria: Day 29 (n = 609, 606)
    95.6 (93.6 to 97.1)
    97.0 (95.3 to 98.2)
        Titer >=10: B/Yamagata: Day 1 (n = 609, 606)
    97.9 (96.4 to 98.9)
    99.5 (98.6 to 99.9)
        Titer >=10: B/Yamagata: Day 29 (n = 609, 606)
    100 (99.4 to 100)
    100 (99.4 to 100)
        Titer >=40: B/Yamagata: Day 1 (n = 609, 606)
    93.1 (90.8 to 95.0)
    95.2 (93.2 to 96.8)
        Titer >=40: B/Yamagata: Day 29 (n = 609, 606)
    99.5 (98.6 to 99.9)
    100 (99.4 to 100)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies

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    End point title
    		 Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies
    End point description
    GMTR was the ratio of the individual titers post-vaccination over pre-vaccination. The GMTs were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution. Analysis was performed on the PPAS-subset of FAS which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample. Here ’n’= number of participants with available data for a particular category.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Day 1 and 28 days post-vaccination on Day 29
    End point values
    		 Cohort 1: Participants aged 9 to 17 years (Per Protocol) Cohort 2: Participants aged 18 to 49 years (Per Protocol)
    Number of subjects analysed
    609
    606
    Units: ratio
    geometric mean (confidence interval 95%)
        A/H1N1 (n = 609, 606)
    12.7 (11.1 to 14.5)
    13.1 (11.4 to 15.0)
        A/H3N2 (n = 609, 606)
    17.9 (15.7 to 20.3)
    20.8 (18.4 to 23.6)
        B/Victoria (n = 609, 605)
    8.41 (7.55 to 9.37)
    6.91 (6.25 to 7.64)
        B/Yamagata (n = 609, 606)
    7.13 (6.46 to 7.87)
    5.31 (4.79 to 5.88)
    No statistical analyses for this end point

    Secondary: Number of Participants With Immediate Unsolicited Adverse Events (AEs)

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    End point title
    		 Number of Participants With Immediate Unsolicited Adverse Events (AEs)
    End point description
    An AE was any untoward medical occurrence in a clinical investigation participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, prelisted in the case report form (CRF) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs. Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine.
    End point type
    Secondary
    End point timeframe
    Within 30 minutes post-vaccination on Day 1
    End point values
    		 Cohort 1: Participants aged 9 to 17 years (Safety) Cohort 2: Participants aged 18 to 49 years (Safety)
    Number of subjects analysed
    641
    658
    Units: participants
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions

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    End point title
    		 Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
    End point description
    A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted in the protocol and CRF and considered as related to the study intervention administered. An injection site reaction was an AR at and around the injection site and were commonly inflammatory reactions. Solicited systemic reactions were systemic AEs and those occurring during the specified collection period were always considered related to the intervention even if there was evidence of alternative etiology. Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine. Only those participants with data available at a specified timepoint were analyzed. Here ’n’= number of participants with available data for a particular category.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 8 days post-vaccination
    End point values
    		 Cohort 1: Participants aged 9 to 17 years (Safety) Cohort 2: Participants aged 18 to 49 years (Safety)
    Number of subjects analysed
    618
    635
    Units: participants
        Solicited injection site reaction (n=618, 635)
    220
    259
        Solicited systemic reaction (n=615, 635)
    182
    230
    No statistical analyses for this end point

    Secondary: Number of Participants With Unsolicited AEs

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    End point title
    		 Number of Participants With Unsolicited AEs
    End point description
    An AE was any untoward medical occurrence in a clinical investigation participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 28 days post-vaccination (up to Day 29)
    End point values
    		 Cohort 1: Participants aged 9 to 17 years (Safety) Cohort 2: Participants aged 18 to 49 years (Safety)
    Number of subjects analysed
    641
    658
    Units: participants
    93
    119
    No statistical analyses for this end point

    Secondary: Number of Participants With Medically Attended Adverse Events (MAAEs)

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    End point title
    		 Number of Participants With Medically Attended Adverse Events (MAAEs)
    End point description
    An MAAE was a new onset or a worsening of a condition that prompted the participant or participant’s parent/guardian to seek unplanned medical advice at a physician’s office or emergency department. Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 28 days post-vaccination (up to Day 29)
    End point values
    		 Cohort 1: Participants aged 9 to 17 years (Safety) Cohort 2: Participants aged 18 to 49 years (Safety)
    Number of subjects analysed
    641
    658
    Units: participants
    27
    35
    No statistical analyses for this end point

    Secondary: Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)

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    End point title
    		 Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)
    End point description
    An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention, events for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 6 months post-vaccination (up to Day 181)
    End point values
    		 Cohort 1: Participants aged 9 to 17 years (Safety) Cohort 2: Participants aged 18 to 49 years (Safety)
    Number of subjects analysed
    641
    658
    Units: participants
        SAE
    3
    7
        AESI
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 up to 6 months post-vaccination (up to Day 181)
    Adverse event reporting additional description
    Analysis was performed on the Safety analysis set.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Cohort 1: Participants aged 9 to 17 years
    Reporting group description
    		 Participants received a single IM injection of RIV4 0.5 mL on Day 1.

    Reporting group title
    Cohort 2: Participants aged 18 to 49 years
    Reporting group description
    		 Participants received a single IM injection of RIV4 0.5 mL on Day 1.

    Serious adverse events
    		 Cohort 1: Participants aged 9 to 17 years Cohort 2: Participants aged 18 to 49 years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 641 (0.47%)
    7 / 658 (1.06%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastric Cancer Recurrent
         subjects affected / exposed
    0 / 641 (0.00%)
    1 / 658 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Intentional Overdose
         subjects affected / exposed
    0 / 641 (0.00%)
    1 / 658 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 641 (0.00%)
    1 / 658 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Fracture
         subjects affected / exposed
    1 / 641 (0.16%)
    0 / 658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    0 / 641 (0.00%)
    1 / 658 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Obstructive Pancreatitis
         subjects affected / exposed
    0 / 641 (0.00%)
    1 / 658 (0.15%)
         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
    Acute Respiratory Failure
         subjects affected / exposed
    0 / 641 (0.00%)
    1 / 658 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Major Depression
         subjects affected / exposed
    0 / 641 (0.00%)
    1 / 658 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    2 / 641 (0.31%)
    1 / 658 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Kidney Infection
         subjects affected / exposed
    0 / 641 (0.00%)
    1 / 658 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1: Participants aged 9 to 17 years Cohort 2: Participants aged 18 to 49 years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    263 / 641 (41.03%)
    336 / 658 (51.06%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    114 / 641 (17.78%)
    152 / 658 (23.10%)
         occurrences all number
    121
    153
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    100 / 641 (15.60%)
    106 / 658 (16.11%)
         occurrences all number
    100
    106
    Injection Site Pain
         subjects affected / exposed
    212 / 641 (33.07%)
    255 / 658 (38.75%)
         occurrences all number
    212
    256
    Chills
         subjects affected / exposed
    45 / 641 (7.02%)
    40 / 658 (6.08%)
         occurrences all number
    45
    40
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    119 / 641 (18.56%)
    129 / 658 (19.60%)
         occurrences all number
    119
    129

    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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