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    Clinical Trial Results:
    A Phase III, randomized, multi-country study to evaluate the lot-to-lot consistency of GSK’s investigational RSV maternal vaccine and the immune response, safety and reactogenicity of RSV maternal vaccine when co-administered with GSK’s quadrivalent influenza D-QIV vaccine in healthy non-pregnant women 18-49 years of age.

    Summary
    EudraCT number
    		 2021-000357-26
    Trial protocol
    		 ES   FI  
    Global end of trial date
    06 Jun 2022

    Results information
    Results version number
    		 v1
    This version publication date
    18 Jun 2023
    First version publication date
    18 Jun 2023
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    214709
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    GSK Response Center, GlaxoSmithKline, 44 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 44 8664357343, 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
    11 Nov 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jun 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV vaccine up to study end. • To demonstrate the lot-to-lot consistency of 3 lots of the investigational RSV MAT vaccine based on Geometric mean concentration (GMC) of RSV MAT IgG ELISA at Day 31. • To demonstrate non-inferiority of Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone based on Geometric mean titer (GMT) of Flu D-QIV antibody titers against 3 influenza strains at Day 31 post administration.
    Protection of trial subjects
    Study participants were observed closely for at least 30 minutes after the administration of the study intervention(s). Appropriate medical treatment was readily available during the observation period.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Sep 2021
    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
    Canada: 451
    Country: Number of subjects enrolled
    Finland: 113
    Country: Number of subjects enrolled
    Korea, Republic of: 117
    Country: Number of subjects enrolled
    Spain: 584
    Country: Number of subjects enrolled
    United States: 321
    Worldwide total number of subjects
    1586
    EEA total number of subjects
    697
    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)
    1586
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Out of 1586 participants enrolled,47 participants did not receive vaccination as they did not meet the eligibility criteria or they were lost to follow up, therefore only 1539 participants were included in the Exposed Set and started the study.

    Pre-assignment
    Screening details
    		 Analysis of this study results were reported for the RSV Pooled group, RSV+Flu Pooled group and Flu+ Placebo group. The individual lots (RSV lot1 Group, RSV lot2 Group and RSV lot3 Group) were used to present only lot-to-lot analysis.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Investigator [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 RSV pooled Group
    Arm description
    		 The RSV pooled Group consisted of participants pooled from RSV lot1, RSV lot2 and RSV lot3 groups. This pooled group was considered for the immunogenicity analysis of the RSV MAT vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVPreF3(120 μg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single dose of RSVPreF3(120 μg) combined with Sodium Chloride (NaCl) was administrated intramuscular (IM). There were used 3 different lots of RSVPreF3(120 μg), one for each individual group (RSV lot1 Group, RSV lot2 Group and RSV lot3 Group) considered under RSV pooled Group.

    Arm title
    		 RSV+Flu pooled Group
    Arm description
    		 The RSV+Flu pooled Group consisted of participants pooled from RSV lot1+Flu, RSV lot2+Flu and RSV lot3+Flu groups. This pooled group was considered for the immunogenicity analysis of the RSV MAT vaccine and the Flu D-QIV vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Flu Quadrivalent influenza vaccine (15 μg HA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single dose of Flu Quadrivalent influenza (15 μg HA) vaccine was administrated intramuscular (IM).

    Investigational medicinal product name
    RSVPreF3(120 μg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single dose of RSVPreF3(120 μg) combined with Sodium Chloride (NaCl) was administrated intramuscular (IM). There were used 3 different lots of RSVPreF3(120 μg), one for each individual group (RSV lot1 Group, RSV lot2 Group and RSV lot3 Group) considered under RSV pooled Group.

    Arm title
    		 Flu+Placebo Group
    Arm description
    		 Participants randomized to the Flu+Placebo Group received one dose of Flu D-QIV vaccine co-administered with one dose of Placebo, intramuscularly, at Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Flu Quadrivalent influenza vaccine (15 μg HA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single dose of Flu Quadrivalent influenza (15 μg HA) combined with NaCl solution (placebo) vaccine was administrated intramuscular (IM).

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: This study had the purpuse to evaluate the lot-to-lot consistency of RSVPreF3 vaccine and the immune response, reactogenicity and safety of the RSVPreF3 vaccine when coadministered with Flu D-QIV vaccine, thus the study s a single blinded trial.
    Number of subjects in period 1 [2]
    		RSV pooled Group RSV+Flu pooled Group Flu+Placebo Group
    Started
    661
    438
    440
    Completed
    651
    433
    427
    Not completed
    10
    5
    13
         Consent withdrawn by subject
    1
    -
    -
         MIGRATED / MOVED FROM THE STUDY AREA
    1
    -
    -
         Lost to follow-up
    8
    5
    13
    Notes
    [2] - 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: In this study, only the eligible participants from the worldwide total received the study intervention and started the study, hence the difference between the worldwide number enrolled in the trial and the baseline period number of participants.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RSV pooled Group
    Reporting group description
    		 The RSV pooled Group consisted of participants pooled from RSV lot1, RSV lot2 and RSV lot3 groups. This pooled group was considered for the immunogenicity analysis of the RSV MAT vaccine.

    Reporting group title
    RSV+Flu pooled Group
    Reporting group description
    		 The RSV+Flu pooled Group consisted of participants pooled from RSV lot1+Flu, RSV lot2+Flu and RSV lot3+Flu groups. This pooled group was considered for the immunogenicity analysis of the RSV MAT vaccine and the Flu D-QIV vaccine.

    Reporting group title
    Flu+Placebo Group
    Reporting group description
    		 Participants randomized to the Flu+Placebo Group received one dose of Flu D-QIV vaccine co-administered with one dose of Placebo, intramuscularly, at Day 1.

    Reporting group values
    		 RSV pooled Group RSV+Flu pooled Group Flu+Placebo Group Total
    Number of subjects
    		 661 438 440 1539
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 661 438 440 1539
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        median (standard deviation)
    		 30.0 ( 9.4 ) 30.0 ( 8.9 ) 31.0 ( 8.9 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 661 438 440 1539
        Male
    		 0 0 0 0
    Race/Ethnicity, Customized
    Units: Subjects
        AMERICAN INDIAN OR ALASKA NATIVE
    		 9 10 7 26
        ASIAN
    		 68 38 43 149
        BLACK OR AFRICAN AMERICAN
    		 21 17 17 55
        NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
    		 0 1 0 1
        OTHER
    		 8 3 7 18
        WHITE
    		 555 369 366 1290

    End points

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    End points reporting groups
    Reporting group title
    RSV pooled Group
    Reporting group description
    		 The RSV pooled Group consisted of participants pooled from RSV lot1, RSV lot2 and RSV lot3 groups. This pooled group was considered for the immunogenicity analysis of the RSV MAT vaccine.

    Reporting group title
    RSV+Flu pooled Group
    Reporting group description
    		 The RSV+Flu pooled Group consisted of participants pooled from RSV lot1+Flu, RSV lot2+Flu and RSV lot3+Flu groups. This pooled group was considered for the immunogenicity analysis of the RSV MAT vaccine and the Flu D-QIV vaccine.

    Reporting group title
    Flu+Placebo Group
    Reporting group description
    		 Participants randomized to the Flu+Placebo Group received one dose of Flu D-QIV vaccine co-administered with one dose of Placebo, intramuscularly, at Day 1.

    Subject analysis set title
    RSV lot1 Group
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants randomized to the RSV lot1 Group received one dose of RSV MAT Lot 1 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.

    Subject analysis set title
    RSV lot2 Group
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants randomized to the RSV lot2 Group received one dose of RSV MAT Lot 2 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.

    Subject analysis set title
    RSV lot3 Group
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants randomized to the RSV lot3 Group received one dose of RSV MAT Lot 3 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.

    Primary: Percentage of participants reporting solicited administration site events in RSV pooled Group, RSV+Flu pooled Group and Flu+Placebo Group

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    End point title
    		 Percentage of participants reporting solicited administration site events in RSV pooled Group, RSV+Flu pooled Group and Flu+Placebo Group [1]
    End point description
    Assessed solicited administration site events include pain, erythema and swelling. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV . Analysis was performed on the Solicited Safety Set (SSS), which includes all participants who received at least 1 dose of the study intervention (Exposed Set [ES]) and who have solicited safety data.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 (including Day 7)
    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 endpoint was descriptive, hence no statistical analysis was presented.
    End point values
    		 RSV pooled Group RSV+Flu pooled Group Flu+Placebo Group
    Number of subjects analysed
    660
    438
    439
    Units: Percentage of participants
    number (confidence interval 95%)
        Pain
    53.6 (49.7 to 57.5)
    51.1 (46.4 to 55.9)
    34.4 (30 to 39)
        Erythema
    4.4 (3 to 6.2)
    3.7 (2.1 to 5.9)
    0.5 (0.1 to 1.6)
        Swelling
    4.5 (3.1 to 6.4)
    4.6 (2.8 to 7)
    0.9 (0.2 to 2.3)
    No statistical analyses for this end point

    Primary: Percentage of participants reporting solicited systemic events in RSV pooled Group, RSV+Flu pooled Group and Flu+Placebo Group

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    End point title
    		 Percentage of participants reporting solicited systemic events in RSV pooled Group, RSV+Flu pooled Group and Flu+Placebo Group [2]
    End point description
    Assessed solicited systemic events include fatigue, headache, gastrointestinal (GI) symptoms (nausea, vomiting, diarrhea, abdominal pain) and fever. The preferred location for measuring temperature was the oral cavity. Fever was defined as temperature equal to or above (≥) 38.0 °C/ 100.4°F. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. Analysis was performed on the Solicited Safety Set (SSS), which includes all participants who received at least 1 dose of the study intervention (Exposed Set [ES]) and who have solicited safety data.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 (including Day 7)
    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 endpoint was descriptive, hence no statistical analysis was presented.
    End point values
    		 RSV pooled Group RSV+Flu pooled Group Flu+Placebo Group
    Number of subjects analysed
    660
    438
    439
    Units: Percentage of participants
    number (confidence interval 95%)
        Fatigue
    52 (48.1 to 55.8)
    59.8 (55.1 to 64.4)
    51.9 (47.1 to 56.7)
        Headache
    47.6 (43.7 to 51.5)
    51.4 (46.6 to 56.1)
    43.1 (38.4 to 47.8)
        Nausea
    14.5 (11.9 to 17.5)
    15.3 (12.1 to 19)
    12.3 (9.4 to 15.7)
        Vomiting
    2.3 (1.3 to 3.7)
    1.8 (0.8 to 3.6)
    2.3 (1.1 to 4.1)
        Diarrhea
    12.1 (9.7 to 14.9)
    13 (10 to 16.5)
    17.1 (13.7 to 20.9)
        Abdominal pain
    12 (9.6 to 14.7)
    13.5 (10.4 to 17)
    14.1 (11 to 17.7)
        Temperature
    2.4 (1.4 to 3.9)
    3 (1.6 to 5)
    0.7 (0.1 to 2)
    No statistical analyses for this end point

    Primary: Percentage of participants reporting unsolicited adverse events (AEs) in RSV pooled Group, RSV+Flu pooled Group and Flu+Placebo Group

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    End point title
    		 Percentage of participants reporting unsolicited adverse events (AEs) in RSV pooled Group, RSV+Flu pooled Group and Flu+Placebo Group [3]
    End point description
    An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV . Analysis was performed on the ES (Exposed Set), which includes all participants who received at least 1 dose of the study treatment.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 30 (including Day 30)
    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 endpoint was descriptive, hence no statistical analysis was presented.
    End point values
    		 RSV pooled Group RSV+Flu pooled Group Flu+Placebo Group
    Number of subjects analysed
    661
    438
    440
    Units: Percentage of participants
        number (confidence interval 95%)
    26.6 (23.3 to 30.2)
    30.1 (25.9 to 34.7)
    25.7 (21.7 to 30)
    No statistical analyses for this end point

    Primary: Percentage of participants reporting serious adverse events (SAEs) in RSV pooled Group, RSV+Flu pooled Group and Flu+Placebo Group

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    End point title
    		 Percentage of participants reporting serious adverse events (SAEs) in RSV pooled Group, RSV+Flu pooled Group and Flu+Placebo Group [4]
    End point description
    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results i+F2n abnormal pregnancy outcomes. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. Analysis was performed on the ES, which includes all participants who received at least 1 dose of the study treatment.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 30 (including Day 30)
    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 endpoint was descriptive, hence no statistical analysis was presented.
    End point values
    		 RSV pooled Group RSV+Flu pooled Group Flu+Placebo Group
    Number of subjects analysed
    661
    438
    440
    Units: Percentage of participants
        number (confidence interval 95%)
    0.2 (0 to 0.8)
    0 (0 to 0.8)
    0.2 (0 to 1.3)
    No statistical analyses for this end point

    Primary: Percentage of participants reporting SAEs in RSV pooled Group, RSV+Flu pooled Group and Flu+Placebo Group

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    End point title
    		 Percentage of participants reporting SAEs in RSV pooled Group, RSV+Flu pooled Group and Flu+Placebo Group [5]
    End point description
    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results in abnormal pregnancy outcomes.This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. Analysis was performed on the ES, which includes all participants who received at least 1 dose of the study treatment.
    End point type
    Primary
    End point timeframe
    From first vaccination up to study end (Day 1 to Day 181)
    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 endpoint was descriptive, hence no statistical analysis was presented.
    End point values
    		 RSV pooled Group RSV+Flu pooled Group Flu+Placebo Group
    Number of subjects analysed
    661
    438
    440
    Units: Percentage of participants
        number (confidence interval 95%)
    0.8 (0.2 to 1.8)
    0.9 (0.2 to 2.3)
    0.9 (0.2 to 2.3)
    No statistical analyses for this end point

    Primary: RSV MAT immunoglobulin G (IgG) concentrations for participants in RSV lot1, RSV lot2 and RSV lot3 groups at Day 31

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    End point title
    		 RSV MAT immunoglobulin G (IgG) concentrations for participants in RSV lot1, RSV lot2 and RSV lot3 groups at Day 31
    End point description
    Serological assays for the determination of IgG antibodies against RSV MAT were performed by Enzyme-Linked Immunosorbent Assay (ELISA). RSV MAT IgG concentrations were expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EU/mL). This objective analyzed the lot-to-lot consistency of 3 lots of the investigational RSV MAT vaccine based on GMC of RSV MAT IgG ELISA . Analysis was performed on the Per Protocol Set (PPS), only on the participants who received only 1 dose of RSV MAT vaccine (from RSV MAT vaccine Lot 1, Lot 2 or Lot 3), and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Primary
    End point timeframe
    At Day 31
    End point values
    		 RSV lot1 Group RSV lot2 Group RSV lot3 Group
    Number of subjects analysed
    201
    204
    207
    Units: EU/mL
        geometric mean (confidence interval 95%)
    102811.0 (95243.6 to 110979.6)
    100635.8 (92970.2 to 108933.4)
    108709.3 (101913.7 to 115958.0)
    Statistical analysis title
    		 RSV lot1 Group to RSV lot2 Group consistency
    Statistical analysis description
    To demonstrate lot-to-lot consistency of the immune responses of Lot 1 and Lot 2 of the RSV MAT vaccine, as measured by ELISA in terms of IgG GMCs at Day 31.
    Comparison groups
    RSV lot1 Group v RSV lot2 Group
    Number of subjects included in analysis
    405
    Analysis specification
    Pre-specified
    Analysis type
    		 [6]
    Method
    		 GMC ratio
    Parameter type
    		 GMC Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.13
    Notes
    [6] - The lot-to-lot consistency is demonstrated only if two-sided 95% confidence intervals (CI) for the 3 pair-wise geometric mean ratios of RSV MAT IgG ELISA concentration falls within 0.67 and 1.5.
    Statistical analysis title
    		 RSV lot1 Group to RSV lot3 Group consistency
    Statistical analysis description
    To demonstrate lot-to-lot consistency of the immune responses of Lot 1 and Lot 3 of the RSV MAT vaccine, as measured by ELISA in terms of IgG GMCs at Day 31.
    Comparison groups
    RSV lot1 Group v RSV lot3 Group
    Number of subjects included in analysis
    408
    Analysis specification
    Pre-specified
    Analysis type
    		 [7]
    Method
    		 GMC ratio
    Parameter type
    		 GMC ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.03
    Notes
    [7] - The lot-to-lot consistency is demonstrated only if two-sided 95% confidence intervals (CI) for the 3 pair-wise geometric mean ratios of RSV MAT IgG ELISA concentration falls within 0.67 and 1.5.
    Statistical analysis title
    		 RSV lot2 Group to RSV lot3 Group consistency
    Statistical analysis description
    To demonstrate lot-to-lot consistency of the immune responses of Lot 2 and Lot 3 of the RSV MAT vaccine, as measured by ELISA in terms of IgG GMCs at Day 31.
    Comparison groups
    RSV lot3 Group v RSV lot2 Group
    Number of subjects included in analysis
    411
    Analysis specification
    Pre-specified
    Analysis type
    		 [8]
    Method
    		 GMC ratio
    Parameter type
    		 GMC ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.05
    Notes
    [8] - The lot-to-lot consistency is demonstrated only if two-sided 95% confidence intervals (CI) for the 3 pair-wise geometric mean ratios of RSV MAT IgG ELISA concentration falls within 0.67 and 1.5.

    Primary: Flu D-QIV haemagglutinin inhibition (HI) antibody titers against 3 influenza strains for participants in Flu+Placebo Group and RSV+Flu pooled Group at Day 31

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    End point title
    		 Flu D-QIV haemagglutinin inhibition (HI) antibody titers against 3 influenza strains for participants in Flu+Placebo Group and RSV+Flu pooled Group at Day 31 [9]
    End point description
    Flu D-QIV HI antibody titers against 3 influenza strains (A/Tasmania/503/2020 (H3N2) IVR-221; B/Washington/02/2019; B/Phuket/3073/2013) were expressed as geometric mean titers (GMTs), as assessed by HI assay. This objective analyzed the humoral immune response to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine in terms of antibody titers against 3 influenza strains. Analysis was performed on the Per Protocol Set (PPS), only on the participants who received 1 dose of Flu D-QIV vaccine and optionally other study treatment, and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Primary
    End point timeframe
    At Day 31
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint cnsidered only participants who received Flu vaccination and optionally other study interventions, therefore only the Flu groups were considred for statistical analises.
    End point values
    		 RSV+Flu pooled Group Flu+Placebo Group
    Number of subjects analysed
    398
    404
    Units: Titers
    geometric mean (confidence interval 95%)
        A/Tasmania/503/2020 (H3N2)
    301.6 (274.0 to 331.9)
    421.3 (383.4 to 463.0)
        B/Washington/02/2019
    30.7 (27.3 to 34.6)
    33.0 (29.3 to 37.2)
        B/Phuket/3073/2013
    56.2 (50.7 to 62.3)
    69.9 (62.6 to 77.9)
    Statistical analysis title
    		 A/Tasmania/503/2020 (H3N2) IVR-221 strain
    Statistical analysis description
    To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the ratio of HI GMTs of Flu D-QIV antibody titers against A/Tasmania/503/2020 (H3N2) IVR-221 strain at 30 days post administration (Day 31).
    Comparison groups
    RSV+Flu pooled Group v Flu+Placebo Group
    Number of subjects included in analysis
    802
    Analysis specification
    Pre-specified
    Analysis type
    		 [10]
    Method
    		 GMC ratio
    Parameter type
    		 GMC ratio
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 0.82
    Notes
    [10] - The non-inferiority of Flu D-QIV vaccine is demonstrated for the A/Tasmania/503/2020 (H3N2) IVR-221 strain, if the lower limit (LL) of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by Flu D-QIV vaccine) is greater than 0.67 at Day 31 post vaccination.
    Statistical analysis title
    		 B/Phuket/3073/2013 strain
    Statistical analysis description
    To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the ratio of HI GMTs of Flu D-QIV antibody titers against B/Phuket/3073/2013 strain at 30 days post administration (Day 31).
    Comparison groups
    RSV+Flu pooled Group v Flu+Placebo Group
    Number of subjects included in analysis
    802
    Analysis specification
    Pre-specified
    Analysis type
    		 [11]
    Method
    		 GMC ratio
    Parameter type
    		 GMC ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 0.93
    Notes
    [11] - The non-inferiority of Flu D-QIV vaccine is demonstrated for B/Phuket/3073/2013 strain, if the lower limit (LL) of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by Flu D-QIV vaccine) is greater than 0.67 at Day 31 post vaccination.
    Statistical analysis title
    		 B/Washington/02/2019 strain
    Statistical analysis description
    To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the ratio of HI GMTs of Flu D-QIV antibody titers against B/Washington/02/2019 strain at 30 days post administration (Day 31).
    Comparison groups
    RSV+Flu pooled Group v Flu+Placebo Group
    Number of subjects included in analysis
    802
    Analysis specification
    Pre-specified
    Analysis type
    		 [12]
    Method
    		 GMC ratio
    Parameter type
    		 GMC ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.1
    Notes
    [12] - The non-inferiority of Flu D-QIV vaccine is demonstrated for B/Washington/02/2019 strain, if the lower limit (LL) of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by Flu D-QIV vaccine) is greater than 0.67 at Day 31 post vaccination.

    Secondary: RSV A neutralizing antibody titers for participants in RSV pooled Group and RSV+Flu pooled Group at Day 1 and Day 31

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    End point title
    		 RSV A neutralizing antibody titers for participants in RSV pooled Group and RSV+Flu pooled Group at Day 1 and Day 31 [13]
    End point description
    Serological assays for the determilnation of antibodies against RSV A were performed by neutralization assay. RSV A neutralizing antibody titers were expressed as geometric mean titers (GMTs), in in serum dilution inducing 60% inhibition in plaque forming units (ED60). This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV A neutralizing antibody. Analysis was performed on the Per Protocol Set (PPS), only on the participants who received 1 dose of RSV MAT vaccine (from one of the 3 lots used) and optionally other study treatment, and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Day 1 and Day 31
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis was presented.
    End point values
    		 RSV pooled Group RSV+Flu pooled Group
    Number of subjects analysed
    657
    436
    Units: ED60
    geometric mean (confidence interval 95%)
        Day 1 (N=657,436)
    721.6 (676.5 to 769.7)
    707.2 (653.4 to 765.5)
        Day 31 (N=611,398)
    8900.9 (8272.1 to 9577.5)
    7761.6 (7092.8 to 8493.6)
    Statistical analysis title
    		 RSV MAT compared with Flu D-QIV
    Statistical analysis description
    To demonstrate the immunological non-inferiority of the RSV MAT vaccine when co-administered with Flu D-QIV vaccine, compared to RSV MAT vaccine given alone as measured by the ratio of GMTs of RSV A neutralizing antibody titers at 30 days post administration (Day 31).
    Comparison groups
    RSV pooled Group v RSV+Flu pooled Group
    Number of subjects included in analysis
    1093
    Analysis specification
    Pre-specified
    Analysis type
    		 [14]
    Method
    		 GMC ratio
    Parameter type
    		 GMC ratio
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 0.97
    Notes
    [14] - The non-inferiority of RSV MAT vaccine is demonstrated for RSV A neutralizing antibody titers, if the LL of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by RSV MAT vaccine) is greater than 0.67 at Day 31 post vaccination.

    Secondary: Seroconversion rate (SCR) to Flu D-QIV HI antibody titers against 3 influenza strains for participants in Flu+Placebo group and RSV+Flu pooled group at Day 31

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    End point title
    		 Seroconversion rate (SCR) to Flu D-QIV HI antibody titers against 3 influenza strains for participants in Flu+Placebo group and RSV+Flu pooled group at Day 31 [15]
    End point description
    The SCR was defined as the percentage of participants with: a Day 1 (pre-vaccination) serum anti-HI titer <1:10 and a Day 31 (post-vaccination) serum anti-HI titer ≥1:40, or a Day 1 (pre-vaccination) serum anti-HI titer ≥ 1:10 and a fold increase (post/pre) ≥ 4 at Day 31. The 3 influenza strains assessed were: A/Tasmania/503/2020 (H3N2) IVR-221; B/Washington/02/2019; B/Phuket/3073/2013. This objective analyzed the seroconversion rate to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine. Analysis was performed on the Per Protocol Set (PPS), only on the participants who received 1 dose of Flu D-QIV vaccine and optionally other study treatment, and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Day 31
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint cnsidered only participants who received Flu vaccination and optionally other study interventions, therefore only the Flu groups were considred for statistical analises.
    End point values
    		 RSV+Flu pooled Group Flu+Placebo Group
    Number of subjects analysed
    398
    403
    Units: Percentage of participants
    number (confidence interval 95%)
        A/Tasmania/503/2020 (H3N2)
    42.5 (37.6 to 47.5)
    45.9 (41 to 50.9)
        B/Washington/02/2019
    25.4 (21.2 to 30)
    29.5 (25.1 to 34.2)
        B/Phuket/3073/2013
    31.4 (26.9 to 36.2)
    35.5 (30.8 to 40.4)
    Statistical analysis title
    		 A/Tasmania/503/2020 (H3N2) IVR-221 strain
    Statistical analysis description
    To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the difference of proportion of participants achieving seroconversion for HI antibody titers against A/Tasmania/503/2020 (H3N2) IVR-221 strain at 30 days post administration (Day 31).
    Comparison groups
    RSV+Flu pooled Group v Flu+Placebo Group
    Number of subjects included in analysis
    801
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [16]
    Method
    		 GMC ratio
    Parameter type
    		 Difference of Proportion
    Point estimate
    3.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.44
         upper limit
    		 10.29
    Notes
    [16] - The non-inferiority of Flu D-QIV vaccine is demonstrated with respect to the SCR difference for Flu D-QIV antibody titers against A/Tasmania/503/2020 (H3N2) IVR-221 strain, if the upper limit (UL) of the 95% CI on the SCR difference (Flu D-QIV vaccine minus RSV MAT + Flu D-QIV vaccine) is less than or equal to the pre-defined clinical limit of 10% at Day 31 post vaccination.
    Statistical analysis title
    		 B/Phuket/3073/2013 strain
    Statistical analysis description
    To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the difference of proportion of participants achieving seroconversion for HI antibody titers against B/Phuket/3073/2013 strain at 30 days post administration (Day 31).
    Comparison groups
    RSV+Flu pooled Group v Flu+Placebo Group
    Number of subjects included in analysis
    801
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [17]
    Method
    		 GMC ratio
    Parameter type
    		 Difference of Proportion
    Point estimate
    4.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.46
         upper limit
    		 10.58
    Notes
    [17] - The non-inferiority of Flu D-QIV vaccine is demonstrated with respect to the SCR difference for Flu D-QIV antibody titers against B/Phuket/3073/2013 strain, if the upper limit (UL) of the 95% CI on the SCR difference (Flu D-QIV vaccine minus RSV MAT + Flu D-QIV vaccine) is less than or equal to the pre-defined clinical limit of 10% at Day 31 post vaccination.
    Statistical analysis title
    		 B/Washington/02/2019 strain
    Statistical analysis description
    To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the difference of proportion of participants achieving seroconversion for HI antibody titers against B/Washington/02/2019 strain at 30 days post administration (Day 31).
    Comparison groups
    RSV+Flu pooled Group v Flu+Placebo Group
    Number of subjects included in analysis
    801
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [18]
    Method
    		 GMC ratio
    Parameter type
    		 Difference of Proportion
    Point estimate
    4.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.04
         upper limit
    		 10.32
    Notes
    [18] - The non-inferiority of Flu D-QIV vaccine is demonstrated with respect to the SCR difference for Flu D-QIV antibody titers against B/Washington/02/2019 strain, if the upper limit (UL) of the 95% CI on the SCR difference (Flu D-QIV vaccine minus RSV MAT + Flu D-QIV vaccine) is less than or equal to the pre-defined clinical limit of 10% at Day 31 post vaccination.

    Secondary: RSV B neutralizing antibody titers for participants in RSV pooled Group and RSV+Flu pooled Group at Day 1 and Day 31

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    End point title
    		 RSV B neutralizing antibody titers for participants in RSV pooled Group and RSV+Flu pooled Group at Day 1 and Day 31 [19]
    End point description
    Serological assays for the determination of antibodies against RSV B were performed by neutralization assay. RSV B neutralizing antibody titers were expressed as GMTs, in ED60. This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV B neutralizing antibody. Analysis was performed on the Per Protocol Set (PPS), only on the participants who received 1 dose of RSV MAT vaccine (from one of the 3 lots used) and optionally other study treatment, and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Day 1 and Day 31
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis was presented.
    End point values
    		 RSV pooled Group RSV+Flu pooled Group
    Number of subjects analysed
    656
    436
    Units: ED60
    geometric mean (confidence interval 95%)
        Day 1 (N=656,436)
    967.4 (909.5 to 1028.9)
    940.1 (871 to 1014.6)
        Day 31 (N=610,398)
    11030.5 (10344.5 to 11762)
    9162.3 (8483.3 to 9895.8)
    No statistical analyses for this end point

    Secondary: RSV MAT IgG concentrations for participants in RSV pooled Group and RSV+Flu pooled Group at Day 1 and Day 31

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    End point title
    		 RSV MAT IgG concentrations for participants in RSV pooled Group and RSV+Flu pooled Group at Day 1 and Day 31 [20]
    End point description
    Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as GMCs, in EU/mL. This objective analyzed the humoral immune response of RSV MAT vaccine when given alone and co-administered with Flu D-QIV in terms of RSV MAT IgG concentrations. Analysis was performed on the Per Protocol Set (PPS), only on the participants who received 1 dose of RSV MAT vaccine (from one of the 3 lots used) and optionally other study treatment, and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Day 1 and Day 31
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was specific only for groups that received only Lot 1, 2 or 3 from the RSVPreF3 vaccine, hence only for this sub-groups were presented statistical analyses.
    End point values
    		 RSV pooled Group RSV+Flu pooled Group
    Number of subjects analysed
    657
    436
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Day 1 (N=657,436)
    5522.7 (5285.7 to 5770.4)
    5772 (5455.8 to 6106.4)
        Day 31 (N=612,398)
    104025.1 (99714.5 to 108522.2)
    83937 (79640.9 to 88464.9)
    No statistical analyses for this end point

    Secondary: Flu D-QIV HI antibody titers against 3 influenza strains for participants in Flu+Placebo Group and RSV+Flu pooled Group at Day 1 and Day 31

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    End point title
    		 Flu D-QIV HI antibody titers against 3 influenza strains for participants in Flu+Placebo Group and RSV+Flu pooled Group at Day 1 and Day 31 [21]
    End point description
    Flu D-QIV HI antibody titers against 3 influenza strains (A/Tasmania/503/2020 (H3N2) IVR-221;B/Washington/02/2019; B/Phuket/3073/2013) were expressed as geometric mean titers (GMTs), as assessed by HI assay. This objective analyzed the humoral immune response to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine in terms of antibody titers against 3 influenza strains. Analysis was performed on the Per Protocol Set (PPS), only on the participants who received 1 dose of Flu D-QIV vaccine and optionally other study treatment, and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Day 1 and Day 31
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis was presented.
    End point values
    		 RSV+Flu pooled Group Flu+Placebo Group
    Number of subjects analysed
    436
    437
    Units: Titers
    geometric mean (confidence interval 95%)
        A/Tasmania/503/2020 (H3N2) , Day 1 (N=436,437)
    92.2 (81.2 to 104.8)
    110.3 (97.2 to 125.1)
        A/Tasmania/503/2020 (H3N2) , Day 31 (N=398,404)
    301.6 (274 to 331.9)
    421.3 (383.4 to 463)
        B/Washington/02/2019 , Day 1 (N=436,437)
    11.7 (10.6 to 13)
    10.3 (9.4 to 11.3)
        B/Washington/02/2019 , Day 31 (N=398,404)
    30.7 (27.3 to 34.6)
    33 (29.3 to 37.2)
        B/Phuket/3073/2013 , Day 1 (N=436,437)
    21.2 (19 to 23.7)
    21.9 (19.6 to 24.5)
        B/Phuket/3073/2013 , Day 31 (N=398,404)
    56.2 (50.7 to 62.3)
    69.9 (62.6 to 77.9)
    No statistical analyses for this end point

    Secondary: Seroprotection rate (SPR) to Flu D-QIV HI antibody titers for participants in Flu+Placebo Group and RSV+Flu pooled Group at Day 1 and Day 31

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    End point title
    		 Seroprotection rate (SPR) to Flu D-QIV HI antibody titers for participants in Flu+Placebo Group and RSV+Flu pooled Group at Day 1 and Day 31 [22]
    End point description
    SPR was measured by the percentage of participants achieving an HI antibody titer ≥1:40. This objective analyzed the seroprotection rate to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine. Analysis was performed on the Per Protocol Set (PPS), only on the participants who received 1 dose of Flu D-QIV vaccine and optionally other study treatment, and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Day 1 and Day 31
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis was presented.
    End point values
    		 RSV+Flu pooled Group Flu+Placebo Group
    Number of subjects analysed
    436
    437
    Units: Percentage of participants
    number (confidence interval 95%)
        A/Tasmania/503/2020 (H3N2) , Day 1 (N=436,437)
    78.7 (74.5 to 82.4)
    82.8 (79 to 86.3)
        A/Tasmania/503/2020 (H3N2) , Day 31 (N=398,404)
    98 (96.1 to 99.1)
    98.5 (96.8 to 99.5)
        B/Washington/02/2019 , Day 1 (N=436,437)
    19.7 (16.1 to 23.8)
    16.9 (13.5 to 20.8)
        B/Washington/02/2019 , Day 31 (N=398,404)
    48 (43 to 53)
    48.8 (43.8 to 53.8)
        B/Phuket/3073/2013 , Day 1 (N=436,437)
    36.7 (32.2 to 41.4)
    39.8 (35.2 to 44.6)
        B/Phuket/3073/2013 , Day 31 (N=398,404)
    74.4 (69.8 to 78.6)
    77.2 (72.8 to 81.2)
    No statistical analyses for this end point

    Secondary: RSV A neutralizing antibody titers for participants in RSV lot1, RSV lot2 and RSV lot3 groups at Day 1 and Day 31

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    End point title
    		 RSV A neutralizing antibody titers for participants in RSV lot1, RSV lot2 and RSV lot3 groups at Day 1 and Day 31
    End point description
    Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. RSV A neutralizing antibody titers were expressed as GMTs, in ED60. This objective analyzed the humoral immune response in 3 individual lots of RSV MAT vaccine in terms of RSV A neutralizing antibody titers. Analysis was performed on the Per Protocol Set (PPS), only on the participants who received only 1 dose of RSV MAT vaccine (from RSV MAT vaccine Lot 1, Lot 2 or Lot 3), and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Day 1 and Day 31
    End point values
    		 RSV lot1 Group RSV lot2 Group RSV lot3 Group
    Number of subjects analysed
    217
    223
    217
    Units: ED60
    geometric mean (confidence interval 95%)
        Day 1 (N=217, 223, 217)
    727.5 (652 to 811.6)
    758.4 (676.7 to 849.9)
    680.2 (607.4 to 761.7)
        Day 31 (N=201, 204, 206)
    8545.5 (7464.4 to 9783.2)
    8760.3 (7716.2 to 9945.8)
    9409.2 (8343.5 to 10611)
    No statistical analyses for this end point

    Secondary: RSV B neutralizing antibody titers for participants in RSV lot1, RSV lot2 and RSV lot3 groups at Day 1 and Day 31

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    End point title
    		 RSV B neutralizing antibody titers for participants in RSV lot1, RSV lot2 and RSV lot3 groups at Day 1 and Day 31
    End point description
    Serological assays for the determination of antibodies against RSV B were performed by neutralization assay. RSV B neutralizing antibody titers were expressed as GMTs, in ED60. This objective analyzed the humoral immune response in 3 individual lots of RSV MAT vaccine in terms of RSV B neutralizing antibody titers. Analysis was performed on the Per Protocol Set (PPS), only on the participants who received only 1 dose of RSV MAT vaccine (from RSV MAT vaccine Lot 1, Lot 2 or Lot 3), and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Day 1 and Day 31
    End point values
    		 RSV lot1 Group RSV lot2 Group RSV lot3 Group
    Number of subjects analysed
    216
    223
    217
    Units: ED60
    geometric mean (confidence interval 95%)
        Day 1 (N=216, 223, 217)
    895 (810.6 to 988.2)
    1030.3 (929.3 to 1142.3)
    979.7 (870.6 to 1102.4)
        Day 31 (N=201, 204, 205)
    10457 (9258.5 to 11810.6)
    11107.2 (9984.4 to 12356.4)
    11543.3 (10377.6 to 12840.1)
    No statistical analyses for this end point

    Secondary: RSV MAT IgG concentrations for participants in RSV lot1, RSV lot2 and RSV lot3 groups at Day 1 and Day 31

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    End point title
    		 RSV MAT IgG concentrations for participants in RSV lot1, RSV lot2 and RSV lot3 groups at Day 1 and Day 31
    End point description
    Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as GMCs, in EU/mL. This objective analyzed the humoral immune response in 3 individual lots of RSV MAT vaccine in terms of RSV IgG concentration. Analysis was performed on the Per Protocol Set (PPS), only on the participants who received only 1 dose of RSV MAT vaccine (from RSV MAT vaccine Lot 1, Lot 2 or Lot 3), and have post-vaccination data, from which are excluded participants with protocol deviations and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Day 1 and Day 31
    End point values
    		 RSV lot1 Group RSV lot2 Group RSV lot3 Group
    Number of subjects analysed
    217
    223
    217
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Day 1 (N=217, 223, 217)
    5691.9 (5276.8 to 6139.7)
    5613 (5197.8 to 6061.3)
    5270.1 (4883.6 to 5687.1)
        Day 31 (N=201, 204, 207)
    102811 (95243.6 to 110979.6)
    100635.8 (92970.2 to 108933.4)
    108709.3 (101913.7 to 115958)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events (SAEs) were collected through the entire period of the study (from Day 1 up to study end [Day 181]). Solicited AEs were collected from Day 1 to Day 7 included and unsolicited AEs were collected from Day 1 to Day 30 included.
    Adverse event reporting additional description
    All adverse events were presented for pooled group (RSV pooled Group, RSV+Flu pooled Group) and Flu+Placebo group, as pre-specified in the analysis plan.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    RSV pooled Group
    Reporting group description
    		 The RSV pooled Group consisted of participants pooled from RSV lot1, RSV lot2 and RSV lot3 groups. This pooled group was considered for the immunogenicity analysis of the RSV MAT vaccine.

    Reporting group title
    Flu+Placebo Group
    Reporting group description
    		 Participants randomized to the Flu+Placebo Group received one dose of Flu D-QIV vaccine co-administered with one dose of Placebo, intramuscularly, at Day 1.

    Reporting group title
    RSV+Flu pooled Group
    Reporting group description
    		 The RSV+Flu pooled Group consisted of participants pooled from RSV lot1+Flu, RSV lot2+Flu and RSV lot3+Flu groups. This pooled group was considered for the immunogenicity analysis of the RSV MAT vaccine and the Flu D-QIV vaccine.

    Serious adverse events
    		 RSV pooled Group Flu+Placebo Group RSV+Flu pooled Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 661 (0.76%)
    4 / 440 (0.91%)
    4 / 438 (0.91%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Fibula fracture
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Optic neuropathy
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Joint ankylosis
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Greater trochanteric pain syndrome
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 RSV pooled Group Flu+Placebo Group RSV+Flu pooled Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    569 / 661 (86.08%)
    396 / 440 (90.00%)
    409 / 438 (93.38%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    1
    0
    1
    Hypertension
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Administration site pain
         subjects affected / exposed
    354 / 661 (53.56%)
    327 / 440 (74.32%)
    360 / 438 (82.19%)
         occurrences all number
    354
    346
    440
    Fatigue
         subjects affected / exposed
    344 / 661 (52.04%)
    230 / 440 (52.27%)
    263 / 438 (60.05%)
         occurrences all number
    348
    233
    268
    Pyrexia
         subjects affected / exposed
    17 / 661 (2.57%)
    3 / 440 (0.68%)
    14 / 438 (3.20%)
         occurrences all number
    17
    3
    14
    Administration site erythema
         subjects affected / exposed
    29 / 661 (4.39%)
    7 / 440 (1.59%)
    18 / 438 (4.11%)
         occurrences all number
    29
    7
    19
    Administration site swelling
         subjects affected / exposed
    30 / 661 (4.54%)
    14 / 440 (3.18%)
    32 / 438 (7.31%)
         occurrences all number
    30
    14
    35
    Axillary pain
         subjects affected / exposed
    13 / 661 (1.97%)
    2 / 440 (0.45%)
    6 / 438 (1.37%)
         occurrences all number
    13
    3
    6
    Chest pain
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site pain
         subjects affected / exposed
    5 / 661 (0.76%)
    5 / 440 (1.14%)
    1 / 438 (0.23%)
         occurrences all number
    5
    5
    1
    Injection site lymphadenopathy
         subjects affected / exposed
    5 / 661 (0.76%)
    2 / 440 (0.45%)
    0 / 438 (0.00%)
         occurrences all number
    5
    3
    0
    Discomfort
         subjects affected / exposed
    3 / 661 (0.45%)
    3 / 440 (0.68%)
    4 / 438 (0.91%)
         occurrences all number
    5
    3
    5
    Pain
         subjects affected / exposed
    4 / 661 (0.61%)
    0 / 440 (0.00%)
    2 / 438 (0.46%)
         occurrences all number
    4
    0
    2
    Chills
         subjects affected / exposed
    2 / 661 (0.30%)
    1 / 440 (0.23%)
    6 / 438 (1.37%)
         occurrences all number
    2
    1
    6
    Malaise
         subjects affected / exposed
    2 / 661 (0.30%)
    1 / 440 (0.23%)
    3 / 438 (0.68%)
         occurrences all number
    2
    1
    4
    Injection site pruritus
         subjects affected / exposed
    2 / 661 (0.30%)
    0 / 440 (0.00%)
    2 / 438 (0.46%)
         occurrences all number
    2
    0
    2
    Injection site haematoma
         subjects affected / exposed
    1 / 661 (0.15%)
    2 / 440 (0.45%)
    1 / 438 (0.23%)
         occurrences all number
    1
    2
    1
    Injection site swelling
         subjects affected / exposed
    2 / 661 (0.30%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    2
    0
    0
    Asthenia
         subjects affected / exposed
    1 / 661 (0.15%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    1
    1
    0
    Influenza like illness
         subjects affected / exposed
    0 / 661 (0.00%)
    2 / 440 (0.45%)
    1 / 438 (0.23%)
         occurrences all number
    0
    2
    1
    Administration site warmth
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Injection site discomfort
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Injection site extravasation
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Vaccination site haematoma
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Vaccination site rash
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Chest discomfort
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Swelling
         subjects affected / exposed
    7 / 661 (1.06%)
    1 / 440 (0.23%)
    3 / 438 (0.68%)
         occurrences all number
    7
    1
    3
    Feeling hot
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Temperature regulation disorder
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Vaccination site pain
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site erythema
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Immunisation reaction
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Social circumstances
    High risk sexual behaviour
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Menstrual disorder
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Heavy menstrual bleeding
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Intermenstrual bleeding
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Menstruation irregular
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Menopausal symptoms
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    4
    0
    Dysmenorrhoea
         subjects affected / exposed
    1 / 661 (0.15%)
    2 / 440 (0.45%)
    0 / 438 (0.00%)
         occurrences all number
    1
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    11 / 661 (1.66%)
    6 / 440 (1.36%)
    6 / 438 (1.37%)
         occurrences all number
    11
    6
    6
    Cough
         subjects affected / exposed
    5 / 661 (0.76%)
    6 / 440 (1.36%)
    8 / 438 (1.83%)
         occurrences all number
    5
    6
    8
    Rhinorrhoea
         subjects affected / exposed
    7 / 661 (1.06%)
    5 / 440 (1.14%)
    3 / 438 (0.68%)
         occurrences all number
    7
    5
    3
    Nasal congestion
         subjects affected / exposed
    5 / 661 (0.76%)
    4 / 440 (0.91%)
    6 / 438 (1.37%)
         occurrences all number
    6
    4
    6
    Productive cough
         subjects affected / exposed
    1 / 661 (0.15%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    1
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 661 (0.00%)
    2 / 440 (0.45%)
    1 / 438 (0.23%)
         occurrences all number
    0
    3
    1
    Catarrh
         subjects affected / exposed
    0 / 661 (0.00%)
    3 / 440 (0.68%)
    0 / 438 (0.00%)
         occurrences all number
    0
    3
    0
    Sinus congestion
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Sneezing
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Paranasal sinus discomfort
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    2
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Asthma
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Throat irritation
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Pulmonary calcification
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Aphonia
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Bipolar disorder
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Irritability
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Body temperature increased
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Blood pressure decreased
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Smear cervix abnormal
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Fascial rupture
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Limb injury
         subjects affected / exposed
    2 / 661 (0.30%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    2
    0
    0
    Fall
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Lip injury
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Concussion
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Patella fracture
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Thermal burn
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Animal bite
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Arthropod bite
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle strain
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Congenital, familial and genetic disorders
    Supernumerary teeth
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    326 / 661 (49.32%)
    196 / 440 (44.55%)
    227 / 438 (51.83%)
         occurrences all number
    348
    209
    247
    Migraine
         subjects affected / exposed
    3 / 661 (0.45%)
    3 / 440 (0.68%)
    2 / 438 (0.46%)
         occurrences all number
    3
    3
    2
    Dizziness
         subjects affected / exposed
    3 / 661 (0.45%)
    1 / 440 (0.23%)
    2 / 438 (0.46%)
         occurrences all number
    3
    1
    2
    Hypoaesthesia
         subjects affected / exposed
    1 / 661 (0.15%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    1
    1
    0
    Paraesthesia
         subjects affected / exposed
    1 / 661 (0.15%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    1
    1
    0
    Idiopathic intracranial hypertension
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Syncope
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Dizziness exertional
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    18 / 661 (2.72%)
    4 / 440 (0.91%)
    6 / 438 (1.37%)
         occurrences all number
    19
    4
    6
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 661 (0.30%)
    1 / 440 (0.23%)
    2 / 438 (0.46%)
         occurrences all number
    2
    1
    2
    External ear inflammation
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Vertigo positional
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Excessive cerumen production
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Ear pain
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Eustachian tube disorder
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Eye symptom
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Eczema eyelids
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Blepharitis
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Vision blurred
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Frequent bowel movements
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    97 / 661 (14.67%)
    54 / 440 (12.27%)
    68 / 438 (15.53%)
         occurrences all number
    100
    56
    72
    Diarrhoea
         subjects affected / exposed
    82 / 661 (12.41%)
    77 / 440 (17.50%)
    59 / 438 (13.47%)
         occurrences all number
    84
    77
    64
    Abdominal pain
         subjects affected / exposed
    83 / 661 (12.56%)
    63 / 440 (14.32%)
    61 / 438 (13.93%)
         occurrences all number
    83
    64
    61
    Vomiting
         subjects affected / exposed
    15 / 661 (2.27%)
    11 / 440 (2.50%)
    9 / 438 (2.05%)
         occurrences all number
    15
    11
    9
    Flatulence
         subjects affected / exposed
    2 / 661 (0.30%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    2
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 661 (0.15%)
    1 / 440 (0.23%)
    1 / 438 (0.23%)
         occurrences all number
    1
    1
    1
    Gastritis
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    1
    0
    1
    Constipation
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    1
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Odynophagia
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Diarrhoea haemorrhagic
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Paraesthesia oral
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Volvulus
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Haemorrhoids thrombosed
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 661 (0.15%)
    1 / 440 (0.23%)
    3 / 438 (0.68%)
         occurrences all number
    1
    1
    3
    Pruritus
         subjects affected / exposed
    2 / 661 (0.30%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    2
    0
    0
    Erythema
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Dermatitis atopic
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Dermatitis
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Rash macular
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Rash pruritic
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Rash
         subjects affected / exposed
    2 / 661 (0.30%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    2
    0
    0
    Renal and urinary disorders
    Bladder pain
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Dysuria
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    7 / 661 (1.06%)
    5 / 440 (1.14%)
    4 / 438 (0.91%)
         occurrences all number
    7
    5
    4
    Arthralgia
         subjects affected / exposed
    4 / 661 (0.61%)
    3 / 440 (0.68%)
    3 / 438 (0.68%)
         occurrences all number
    4
    3
    3
    Pain in extremity
         subjects affected / exposed
    1 / 661 (0.15%)
    2 / 440 (0.45%)
    4 / 438 (0.91%)
         occurrences all number
    1
    3
    4
    Neck pain
         subjects affected / exposed
    2 / 661 (0.30%)
    1 / 440 (0.23%)
    2 / 438 (0.46%)
         occurrences all number
    2
    1
    2
    Synovial cyst
         subjects affected / exposed
    2 / 661 (0.30%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    2
    1
    0
    Back pain
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    3 / 438 (0.68%)
         occurrences all number
    0
    1
    3
    Muscle contracture
         subjects affected / exposed
    0 / 661 (0.00%)
    2 / 440 (0.45%)
    1 / 438 (0.23%)
         occurrences all number
    0
    2
    1
    Torticollis
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Groin pain
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    1 / 438 (0.23%)
         occurrences all number
    0
    1
    1
    Axillary mass
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Bone pain
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Muscular weakness
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Arthritis
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Pain in jaw
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Tendonitis
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    10 / 661 (1.51%)
    15 / 440 (3.41%)
    13 / 438 (2.97%)
         occurrences all number
    10
    15
    13
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 661 (1.06%)
    2 / 440 (0.45%)
    8 / 438 (1.83%)
         occurrences all number
    7
    3
    8
    COVID-19
         subjects affected / exposed
    6 / 661 (0.91%)
    2 / 440 (0.45%)
    7 / 438 (1.60%)
         occurrences all number
    6
    2
    7
    Urinary tract infection
         subjects affected / exposed
    3 / 661 (0.45%)
    3 / 440 (0.68%)
    3 / 438 (0.68%)
         occurrences all number
    3
    3
    3
    Sinusitis
         subjects affected / exposed
    4 / 661 (0.61%)
    2 / 440 (0.45%)
    1 / 438 (0.23%)
         occurrences all number
    4
    2
    1
    Influenza
         subjects affected / exposed
    4 / 661 (0.61%)
    0 / 440 (0.00%)
    2 / 438 (0.46%)
         occurrences all number
    4
    0
    2
    Bronchitis
         subjects affected / exposed
    3 / 661 (0.45%)
    3 / 440 (0.68%)
    1 / 438 (0.23%)
         occurrences all number
    3
    3
    1
    Pharyngotonsillitis
         subjects affected / exposed
    3 / 661 (0.45%)
    2 / 440 (0.45%)
    0 / 438 (0.00%)
         occurrences all number
    3
    2
    0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 661 (0.30%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    2
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 661 (0.15%)
    1 / 440 (0.23%)
    1 / 438 (0.23%)
         occurrences all number
    1
    1
    1
    Tonsillitis
         subjects affected / exposed
    1 / 661 (0.15%)
    1 / 440 (0.23%)
    1 / 438 (0.23%)
         occurrences all number
    1
    1
    1
    Nasal herpes
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Cystitis
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Eczema impetiginous
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Laryngitis
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Vulvovaginitis
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Ear infection
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Oral herpes
         subjects affected / exposed
    1 / 661 (0.15%)
    0 / 440 (0.00%)
    0 / 438 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    2 / 438 (0.46%)
         occurrences all number
    0
    0
    2
    Conjunctivitis
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    1 / 438 (0.23%)
         occurrences all number
    0
    1
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    1 / 438 (0.23%)
         occurrences all number
    0
    1
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    1 / 438 (0.23%)
         occurrences all number
    0
    1
    1
    Bacterial vulvovaginitis
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Fungal infection
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Gingivitis
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Otitis media acute
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Respiratory tract infection bacterial
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Suspected COVID-19
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1
    Bacterial vaginosis
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Otitis externa
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Pneumonia
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Streptococcal infection
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Viral infection
         subjects affected / exposed
    0 / 661 (0.00%)
    1 / 440 (0.23%)
    0 / 438 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 661 (0.00%)
    0 / 440 (0.00%)
    1 / 438 (0.23%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 May 2022
    This protocol has been amended to reflect the following: • Primary and secondary objectives were modified to evaluate only 3 influenza strains (A/Tasmania/503/2020 (H3N2), B/Washington/02/2019, B/Phuket/3073/2013). The A/Victoria/2570/2019 (H1N1) was evaluated as part of the tertiary objectives. • The secondary safety objective and its corresponding endpoint related to assessment of safety of RSV maternal vaccine when given alone and co-administered with Flu D-QIV from vaccination up to study end was recategorized as a primary objective. • The interim analysis was removed following GSK’s decision to stop enrollment and vaccination for active enrollment in all RSV MAT studies.

    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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