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    Clinical Trial Results:
    Phase II randomized, observer-blind, placebocontrolled, multi-country study in healthy non-pregnant women 18-45 years of age to evaluate the safety, reactogenicity and immunogenicity of a 1st intramuscular dose of GSK Biologicals’ investigational RSV maternal vaccine (GSK388550A) when given alone and given in co-administration with a single intramuscular dose of Boostrix (US formulation SB776423 or ex-US formulation SB263855) and to evaluate the safety, reactogenicity and immunogenicity of a 2nd dose of the RSV maternal vaccine.

    Summary
    EudraCT number
    		 2019-002258-22
    Trial protocol
    		 BE  
    Global end of trial date
    22 Nov 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    209141
    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, 20 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 20 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
    17 Feb 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Nov 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Safety: • To evaluate the safety and reactogenicity of 2 dose levels (60 and 120 μg) of RSVPreF3 when given alone or co-administered with dTpa from Vaccination up to Day 31. • To evaluate the safety of a 2nd dose of RSVPreF3 given from 12 up to 18 months post 1st dose up to Day 31 days post 2nd dose vaccination. Immunogenicity: • To evaluate the humoral immune response to 2 dose levels (60 and 120 μg) of RSVPreF3 when given alone and co-administered with dTpa, at Screening, Day 8 and Day 31 post 1st dose vaccination.
    Protection of trial subjects
    All subjects were supervised/observed for 60 minutes after vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that have no contraindications to any components of the vaccines. Subjects were followed-up for 181 days after each vaccination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Nov 2019
    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
    United States: 257
    Country: Number of subjects enrolled
    Belgium: 146
    Country: Number of subjects enrolled
    Canada: 106
    Worldwide total number of subjects
    509
    EEA total number of subjects
    146
    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)
    509
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Data reported in the participant flow, baseline characteristics and the immunogenicity outcome measures of the Extension Study were only analyzed for pooled groups, as the two formulations of dTpa vaccine (containing 300 micrograms(μg) or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 RSV120_dTpa_RSV120(Pooled)
    Arm description
    		 Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVPreF3 formulation 3 (120 μg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered in the deltoid muscle.

    Investigational medicinal product name
    dTpa - US formulation
    Investigational medicinal product code
    Other name
    Boostrix - US formulation
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered in the deltoid muscle.

    Investigational medicinal product name
    dTpa - ex-US formulation
    Investigational medicinal product code
    Other name
    Boostrix - ex-US formulation
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered in the deltoid muscle.

    Arm title
    		 RSV120_Placebo_RSV120(Pooled)
    Arm description
    		 Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
    Arm type
    		 Placebo

    Investigational medicinal product name
    RSVPreF3 formulation 3 (120 μg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered in the deltoid muscle.

    Investigational medicinal product name
    NaCl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered in the deltoid muscle.

    Arm title
    		 RSV60_dTpa_RSV120(Pooled)
    Arm description
    		 Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVPreF3 formulation 2 (60 μg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered in the deltoid muscle.

    Investigational medicinal product name
    dTpa - US formulation
    Investigational medicinal product code
    Other name
    Boostrix - US formulation
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered in the deltoid muscle.

    Investigational medicinal product name
    dTpa - ex-US formulation
    Investigational medicinal product code
    Other name
    Boostrix - ex-US formulation
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered in the deltoid muscle.

    Arm title
    		 RSV60_Placebo_RSV120(Pooled)
    Arm description
    		 Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
    Arm type
    		 Placebo

    Investigational medicinal product name
    RSVPreF3 formulation 2 (60 μg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered in the deltoid muscle.

    Investigational medicinal product name
    NaCl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered in the deltoid muscle.

    Arm title
    		 dTpa_Placebo_RSV120(Pooled)
    Arm description
    		 Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
    Arm type
    		 Placebo

    Investigational medicinal product name
    dTpa - ex-US
    Investigational medicinal product code
    Other name
    Boostrix - ex-US formulation
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered in the deltoid muscle.

    Investigational medicinal product name
    NaCl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered in the deltoid muscle.

    Investigational medicinal product name
    dTpa - US
    Investigational medicinal product code
    Other name
    Boostrix - US formulation
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered in the deltoid muscle.

    Number of subjects in period 1
    		RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Started
    101
    101
    103
    102
    102
    Completed
    95
    93
    100
    100
    98
    Not completed
    6
    8
    3
    2
    4
         ELIGIBILITY CRITERIA NOT FULFILLED
    3
    4
    2
    1
    -
         Lost to follow-up
    3
    4
    1
    1
    4
    Period 2
    Period 2 title
    Extension Study
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 RSV120_dTpa_RSV120(Pooled)
    Arm description
    		 Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVPreF3 formulation 3 (120 μg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered in the deltoid muscle.

    Arm title
    		 RSV120_Placebo_RSV120(Pooled)
    Arm description
    		 Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
    Arm type
    		 Placebo

    Investigational medicinal product name
    RSVPreF3 formulation 3 (120 μg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered in the deltoid muscle.

    Arm title
    		 RSV60_dTpa_RSV120(Pooled)
    Arm description
    		 Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVPreF3 formulation 3 (120 μg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered in the deltoid muscle.

    Arm title
    		 RSV60_Placebo_RSV120(Pooled)
    Arm description
    		 Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
    Arm type
    		 Placebo

    Investigational medicinal product name
    RSVPreF3 formulation 3 (120 μg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered in the deltoid muscle.

    Arm title
    		 dTpa_Placebo_RSV120(Pooled)
    Arm description
    		 Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
    Arm type
    		 Placebo

    Investigational medicinal product name
    RSVPreF3 formulation 3 (120 μg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered in the deltoid muscle.

    Number of subjects in period 2 [1]
    		RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Started
    39
    41
    46
    41
    46
    Completed
    38
    39
    45
    41
    45
    Not completed
    1
    2
    1
    0
    1
         Lost to follow-up
    1
    2
    1
    -
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RSV120_dTpa_RSV120(Pooled)
    Reporting group description
    		 Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Reporting group title
    RSV120_Placebo_RSV120(Pooled)
    Reporting group description
    		 Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Reporting group title
    RSV60_dTpa_RSV120(Pooled)
    Reporting group description
    		 Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Reporting group title
    RSV60_Placebo_RSV120(Pooled)
    Reporting group description
    		 Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Reporting group title
    dTpa_Placebo_RSV120(Pooled)
    Reporting group description
    		 Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Reporting group values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled) Total
    Number of subjects
    		 101 101 103 102 102 509
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 101 101 103 102 102 509
        From 65-84 years
    		 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0
    Age Continuous
    Age, Primary Study
    Units: Years
        arithmetic mean (standard deviation)
    		 31.4 ( 7.6 ) 31.0 ( 8.0 ) 30.8 ( 8.4 ) 30.5 ( 8.3 ) 30.4 ( 7.9 ) -
    Sex/Gender, Customized
    Sex/Gender, Primary Study
    Units: Participants
        Female
    		 101 101 103 102 102 509
        Male
    		 0 0 0 0 0 0
    Race/Ethnicity, Customized
    Race/Ethnicity, Primary Study
    Units: Subjects
        AMERICAN INDIAN OR ALASKA NATIVE
    		 3 0 1 1 0 5
        ASIAN
    		 1 3 2 4 4 14
        BLACK OR AFRICAN AMERICAN
    		 4 6 8 3 4 25
        OTHER Not specified
    		 2 2 2 2 3 11
        WHITE
    		 91 90 90 92 91 454
    Subject analysis sets

    Subject analysis set title
    RSV120_dTpa_RSV120(EX-US)-SSS-Primary Study
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.

    Subject analysis set title
    RSV120_Placebo_RSV120(EX-US)-SSS-Primary Study
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_dTpa_RSV120(EX-US)-SSS-Primary Study
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_Placebo_RSV120(EX-US)-SSS-Primary Study
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    dTpa_Placebo_RSV120(EX-US)-SSS-Primary Study
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV120_dTpa_RSV120(US)-SSS-Primary Study
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV120_Placebo_RSV120(US)-SSS-Primary Study
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_dTpa_RSV120(US)-SSS-Primary Study
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_Placebo_RSV120(US)-SSS-Primary Study
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    dTpa_Placebo_RSV120(US)-SSS-Primary Study
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV120_dTpa_RSV120(EX-US) - ES-Primary Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.

    Subject analysis set title
    RSV120_Placebo_RSV120(EX-US) - ES-Primary Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_dTpa_RSV120(EX-US) - ES-Primary Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_Placebo_RSV120(EX-US) - ES-Primary Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    dTpa_Placebo_RSV120(EX-US) - ES-Primary Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV120_dTpa_RSV120(US) - ES-Primary Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV120_Placebo_RSV120(US) - ES-Primary Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_dTpa_RSV120(US) - ES-Primary Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_Placebo_RSV120(US) - ES-Primary Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    dTpa_Placebo_RSV120(US) - ES-Primary Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV120_dTpa_RSV120(EX-US) - PPS-Primary Study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.

    Subject analysis set title
    RSV120_Placebo_RSV120(EX-US) - PPS-Primary Study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_dTpa_RSV120(EX-US) - PPS-Primary Study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_Placebo_RSV120(EX-US) - PPS-Primary Study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    dTpa_Placebo_RSV120(EX-US) - PPS-Primary Study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV120_dTpa_RSV120(US) - PPS-Primary Study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV120_Placebo_RSV120(US) - PPS-Primary Study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_dTpa_RSV120(US) - PPS-Primary Study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_Placebo_RSV120(US) - PPS-Primary Study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    dTpa_Placebo_RSV120(US) - PPS-Primary Study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis sets values
    		 RSV120_dTpa_RSV120(EX-US)-SSS-Primary Study RSV120_Placebo_RSV120(EX-US)-SSS-Primary Study RSV60_dTpa_RSV120(EX-US)-SSS-Primary Study RSV60_Placebo_RSV120(EX-US)-SSS-Primary Study dTpa_Placebo_RSV120(EX-US)-SSS-Primary Study RSV120_dTpa_RSV120(US)-SSS-Primary Study RSV120_Placebo_RSV120(US)-SSS-Primary Study RSV60_dTpa_RSV120(US)-SSS-Primary Study RSV60_Placebo_RSV120(US)-SSS-Primary Study dTpa_Placebo_RSV120(US)-SSS-Primary Study RSV120_dTpa_RSV120(EX-US) - ES-Primary Study RSV120_Placebo_RSV120(EX-US) - ES-Primary Study RSV60_dTpa_RSV120(EX-US) - ES-Primary Study RSV60_Placebo_RSV120(EX-US) - ES-Primary Study dTpa_Placebo_RSV120(EX-US) - ES-Primary Study RSV120_dTpa_RSV120(US) - ES-Primary Study RSV120_Placebo_RSV120(US) - ES-Primary Study RSV60_dTpa_RSV120(US) - ES-Primary Study RSV60_Placebo_RSV120(US) - ES-Primary Study dTpa_Placebo_RSV120(US) - ES-Primary Study RSV120_dTpa_RSV120(EX-US) - PPS-Primary Study RSV120_Placebo_RSV120(EX-US) - PPS-Primary Study RSV60_dTpa_RSV120(EX-US) - PPS-Primary Study RSV60_Placebo_RSV120(EX-US) - PPS-Primary Study dTpa_Placebo_RSV120(EX-US) - PPS-Primary Study RSV120_dTpa_RSV120(US) - PPS-Primary Study RSV120_Placebo_RSV120(US) - PPS-Primary Study RSV60_dTpa_RSV120(US) - PPS-Primary Study RSV60_Placebo_RSV120(US) - PPS-Primary Study dTpa_Placebo_RSV120(US) - PPS-Primary Study
    Number of subjects
    50
    49
    51
    51
    49
    51
    52
    52
    51
    50
    50
    49
    51
    51
    51
    51
    52
    52
    51
    51
    49
    51
    51
    51
    51
    51
    51
    52
    51
    51
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Adults (18-64 years)
    50
    49
    51
    51
    49
    51
    51
    52
    51
    50
    52
    51
    51
    49
    48
    50
    49
    50
    49
    50
    48
    49
    51
    49
    24
    31
    32
    29
    31
    14
        From 65-84 years
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Age Continuous
    Age, Primary Study
    Units: Years
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Sex/Gender, Customized
    Sex/Gender, Primary Study
    Units: Participants
        Female
    49
        Male
    0
    Race/Ethnicity, Customized
    Race/Ethnicity, Primary Study
    Units: Subjects
        AMERICAN INDIAN OR ALASKA NATIVE
        ASIAN
        BLACK OR AFRICAN AMERICAN
        OTHER Not specified
        WHITE

    End points

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    End points reporting groups
    Reporting group title
    RSV120_dTpa_RSV120(Pooled)
    Reporting group description
    		 Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Reporting group title
    RSV120_Placebo_RSV120(Pooled)
    Reporting group description
    		 Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Reporting group title
    RSV60_dTpa_RSV120(Pooled)
    Reporting group description
    		 Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Reporting group title
    RSV60_Placebo_RSV120(Pooled)
    Reporting group description
    		 Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Reporting group title
    dTpa_Placebo_RSV120(Pooled)
    Reporting group description
    		 Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
    Reporting group title
    RSV120_dTpa_RSV120(Pooled)
    Reporting group description
    		 Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Reporting group title
    RSV120_Placebo_RSV120(Pooled)
    Reporting group description
    		 Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Reporting group title
    RSV60_dTpa_RSV120(Pooled)
    Reporting group description
    		 Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Reporting group title
    RSV60_Placebo_RSV120(Pooled)
    Reporting group description
    		 Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Reporting group title
    dTpa_Placebo_RSV120(Pooled)
    Reporting group description
    		 Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV120_dTpa_RSV120(EX-US)-SSS-Primary Study
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.

    Subject analysis set title
    RSV120_Placebo_RSV120(EX-US)-SSS-Primary Study
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_dTpa_RSV120(EX-US)-SSS-Primary Study
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_Placebo_RSV120(EX-US)-SSS-Primary Study
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    dTpa_Placebo_RSV120(EX-US)-SSS-Primary Study
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV120_dTpa_RSV120(US)-SSS-Primary Study
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV120_Placebo_RSV120(US)-SSS-Primary Study
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_dTpa_RSV120(US)-SSS-Primary Study
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_Placebo_RSV120(US)-SSS-Primary Study
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    dTpa_Placebo_RSV120(US)-SSS-Primary Study
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV120_dTpa_RSV120(EX-US) - ES-Primary Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.

    Subject analysis set title
    RSV120_Placebo_RSV120(EX-US) - ES-Primary Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_dTpa_RSV120(EX-US) - ES-Primary Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_Placebo_RSV120(EX-US) - ES-Primary Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    dTpa_Placebo_RSV120(EX-US) - ES-Primary Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV120_dTpa_RSV120(US) - ES-Primary Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV120_Placebo_RSV120(US) - ES-Primary Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_dTpa_RSV120(US) - ES-Primary Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_Placebo_RSV120(US) - ES-Primary Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    dTpa_Placebo_RSV120(US) - ES-Primary Study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV120_dTpa_RSV120(EX-US) - PPS-Primary Study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine (12 to 18 months post 1st vaccination) and were followed up until the study end.

    Subject analysis set title
    RSV120_Placebo_RSV120(EX-US) - PPS-Primary Study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_dTpa_RSV120(EX-US) - PPS-Primary Study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_Placebo_RSV120(EX-US) - PPS-Primary Study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    dTpa_Placebo_RSV120(EX-US) - PPS-Primary Study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of Placebo and one dose of 500 μg dTpa vaccine (Ex-US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV120_dTpa_RSV120(US) - PPS-Primary Study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV120_Placebo_RSV120(US) - PPS-Primary Study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_dTpa_RSV120(US) - PPS-Primary Study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    RSV60_Placebo_RSV120(US) - PPS-Primary Study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Subject analysis set title
    dTpa_Placebo_RSV120(US) - PPS-Primary Study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one dose of Placebo and one dose of 300 μg dTpa vaccine (US formulation) on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Primary: Percentage of subjects with any solicited local adverse event (AEs) [Primary Study]

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    End point title
    		 Percentage of subjects with any solicited local adverse event (AEs) [Primary Study] [1]
    End point description
    Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. The analysis of this outcome measure was reported for the Pooled groups as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3. The analysis was performed on the Solicited Safety Set (SSS) - Primary Study which consisted of all subjects from the Exposed set (ES) - Primary Study for whom solicited safety data were available.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 8
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    101
    100
    103
    102
    99
    Units: Percentage of participants
    number (confidence interval 95%)
        RSVPreF3 (Left Arm), Erythema
    5.9 (2.2 to 12.5)
    5 (1.6 to 11.3)
    5.8 (2.2 to 12.2)
    5.9 (2.2 to 12.4)
    0 (0 to 3.7)
        RSVPreF3 (Left Arm), Pain
    51.5 (41.3 to 61.6)
    54 (43.7 to 64)
    52.4 (42.4 to 62.4)
    58.8 (48.6 to 68.5)
    19.2 (12 to 28.3)
        RSVPreF3 (Left Arm), Swelling
    2 (0.2 to 7)
    7 (2.9 to 13.9)
    2.9 (0.6 to 8.3)
    4.9 (1.6 to 11.1)
    0 (0 to 3.7)
        dTpa (Right Arm), Erythema
    4 (1.1 to 9.8)
    1 (0 to 5.4)
    4.9 (1.6 to 11)
    1 (0 to 5.3)
    6.1 (2.3 to 12.7)
        dTpa (Right Arm), Pain
    81.2 (72.2 to 88.3)
    25 (16.9 to 34.7)
    76.7 (67.3 to 84.5)
    18.6 (11.6 to 27.6)
    78.8 (69.4 to 86.4)
        dTpa (Right Arm), Swelling
    5 (1.6 to 11.2)
    0 (0 to 3.6)
    1.9 (0.2 to 6.8)
    1 (0 to 5.3)
    4 (1.1 to 10)
    No statistical analyses for this end point

    Primary: Percentage of subjects with any solicited general AEs [Primary Study]

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    End point title
    		 Percentage of subjects with any solicited general AEs [Primary Study] [2]
    End point description
    Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever (body temperature ≥ 38 degree Celcius/100.4 degree Fahrenheit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3. The analysis was performed on the SSS - Primary Study which consisted of all subjects from the ES - Primary Study for whom solicited safety data were available.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 8
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    101
    101
    103
    102
    99
    Units: Percentage of participants
    number (confidence interval 95%)
        Fatigue
    40.6 (30.9 to 50.8)
    39.6 (30 to 49.8)
    37.9 (28.5 to 48)
    32.4 (23.4 to 42.3)
    38.4 (28.8 to 48.7)
        Gastrointestinal symptoms
    23.8 (15.9 to 33.3)
    28.7 (20.1 to 38.6)
    27.2 (18.9 to 36.8)
    28.4 (19.9 to 38.2)
    28.3 (19.7 to 38.2)
        Headache
    44.6 (34.7 to 54.8)
    45.5 (35.6 to 55.8)
    35 (25.8 to 45)
    39.2 (29.7 to 49.4)
    37.4 (27.9 to 47.7)
        Temperature
    2 (0.2 to 7)
    4 (1.1 to 9.8)
    2.9 (0.6 to 8.3)
    3.9 (1.1 to 9.7)
    7.1 (2.9 to 14)
    No statistical analyses for this end point

    Primary: Percentage of subjects with any unsolicited AEs [Primary Study]

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    End point title
    		 Percentage of subjects with any unsolicited AEs [Primary Study] [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 to be reported as an unsolicited AE. The analysis of this outcome measure was reported for the Pooled groups as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3. The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 31
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    101
    101
    103
    102
    102
    Units: Percentage of participants
        number (confidence interval 95%)
    38.6 (29.1 to 48.8)
    34.7 (25.5 to 44.8)
    33 (24.1 to 43)
    37.3 (27.9 to 47.4)
    32.4 (23.4 to 42.3)
    No statistical analyses for this end point

    Primary: Number of subjects with any SAEs [Primary Study]

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    End point title
    		 Number of subjects with any SAEs [Primary Study] [4]
    End point description
    A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3. The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 31
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    101
    101
    103
    102
    102
    Units: Participants
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of subjects with any solicited local AEs [Extension Study]

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    End point title
    		 Percentage of subjects with any solicited local AEs [Extension Study] [5]
    End point description
    Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. The analysis of this outcome measure was reported for the Pooled groups as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3. The analysis was performed on the SSS - Extension Study which consisted of all subjects from the ES - Extension Study for whom solicited safety data were available.
    End point type
    Primary
    End point timeframe
    From the Day of 2nd vaccination to Day 8 post 2nd vaccination
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    39
    39
    46
    41
    44
    Units: Percentage of participants
    number (confidence interval 95%)
        Erythema
    17.9 (7.5 to 33.5)
    10.3 (2.9 to 24.2)
    8.7 (2.4 to 20.8)
    14.6 (5.6 to 29.2)
    2.3 (0.1 to 12)
        Pain
    87.2 (72.6 to 95.7)
    87.2 (72.6 to 95.7)
    80.4 (66.1 to 90.6)
    85.4 (70.8 to 94.4)
    38.6 (24.4 to 54.5)
        Swelling
    12.8 (4.3 to 27.4)
    7.7 (1.6 to 20.9)
    8.7 (2.4 to 20.8)
    4.9 (0.6 to 16.5)
    2.3 (0.1 to 12)
    No statistical analyses for this end point

    Primary: Percentage of subjects any solicited general AEs [Extension Period]

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    End point title
    		 Percentage of subjects any solicited general AEs [Extension Period] [6]
    End point description
    Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever(body temperature ≥ 38 degree Celcius/100.4 degree Fahrenheit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3. The analysis was performed on the SSS - Extension Study which consisted of all subjects from the ES - Extension Study for whom solicited safety data were available.
    End point type
    Primary
    End point timeframe
    From the Day of 2nd vaccination to Day 8 post 2nd vaccination
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    39
    39
    46
    41
    44
    Units: Percentage of participants
    number (confidence interval 95%)
        Fatigue
    25.6 (13 to 42.1)
    33.3 (19.1 to 50.2)
    37 (23.2 to 52.5)
    46.3 (30.7 to 62.6)
    34.1 (20.5 to 49.9)
        Gastrointestinal symptoms
    10.3 (2.9 to 24.2)
    20.5 (9.3 to 36.5)
    15.2 (6.3 to 28.9)
    24.4 (12.4 to 40.3)
    13.6 (5.2 to 27.4)
        Headache
    28.2 (15 to 44.9)
    33.3 (19.1 to 50.2)
    32.6 (19.5 to 48)
    56.1 (39.7 to 71.5)
    31.8 (18.6 to 47.6)
        Temperature
    0 (0 to 9)
    0 (0 to 9)
    2.2 (0.1 to 11.5)
    9.8 (2.7 to 23.1)
    2.3 (0.1 to 12)
    No statistical analyses for this end point

    Primary: Percentage of subjects with any unsolicited AEs [Extension Period]

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    End point title
    		 Percentage of subjects with any unsolicited AEs [Extension Period] [7]
    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 to be reported as an unsolicited AE. The analysis of this outcome measure was reported for the Pooled groups as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3. The analysis was performed on ES - Extension Study which consisted of all subjects who received at least 2 doses of the study treatment.
    End point type
    Primary
    End point timeframe
    From the Day of 2nd vaccination to Day 31 post 2nd vaccination
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    39
    41
    46
    41
    46
    Units: Percentage of participants
        number (confidence interval 95%)
    18 (8 to 34)
    20 (9 to 35)
    20 (9 to 34)
    29 (16 to 46)
    20 (9 to 34)
    No statistical analyses for this end point

    Primary: Number of subjects with any SAEs [Extension Period]

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    End point title
    		 Number of subjects with any SAEs [Extension Period] [8]
    End point description
    A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3. The analysis was performed on ES - Extension Study which consisted of all subjects who received at least 2 doses of the study treatment.
    End point type
    Primary
    End point timeframe
    From the Day of 2nd vaccination to Day 31 post 2nd vaccination
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    39
    41
    46
    41
    46
    Units: Participants
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: RSV A neutralizing antibody Geometric Mean Titers (GMTs) at Screening  [Primary Study]

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    End point title
    		 RSV A neutralizing antibody Geometric Mean Titers (GMTs) at Screening  [Primary Study] [9]
    End point description
    Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60 (Estimated Dilution 60). The analysis of this outcome measure was reported for the Pooled groups as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3. The analysis was performed on the Per Protocol Set (PPS) - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Primary
    End point timeframe
    At Screening (Day -7 to Day 1)
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    100
    100
    103
    102
    102
    Units: Titers (ED60)
        geometric mean (confidence interval 95%)
    875 (745 to 1027)
    1022 (856 to 1222)
    1135 (959 to 1342)
    771 (673 to 883)
    1050 (896 to 1231)
    No statistical analyses for this end point

    Primary: RSV A neutralizing antibody GMTs at Day 8 [Primary Study]

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    End point title
    		 RSV A neutralizing antibody GMTs at Day 8 [Primary Study] [10]
    End point description
    Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for the Pooled groups as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3. The analysis was performed on the Per Protocol Set (PPS) - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Primary
    End point timeframe
    At Day 8
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    98
    99
    100
    102
    100
    Units: Titers (ED 60)
        geometric mean (confidence interval 95%)
    14166 (12213 to 16431)
    14285 (11999 to 17008)
    10185 (8514 to 12183)
    10590 (8994 to 12469)
    783 (661 to 929)
    No statistical analyses for this end point

    Primary: RSV A neutralizing antibody GMTs at Day 31 [Primary Study]

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    End point title
    		 RSV A neutralizing antibody GMTs at Day 31 [Primary Study] [11]
    End point description
    Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for the Pooled groups as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3. The analysis was performed on the Per Protocol Set (PPS) - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures 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
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    98
    97
    102
    99
    97
    Units: Titers (ED60)
        geometric mean (confidence interval 95%)
    9836 (8252 to 11725)
    11038 (9160 to 13301)
    9214 (7806 to 10876)
    8739 (7561 to 10101)
    845 (705 to 1013)
    No statistical analyses for this end point

    Primary: RSV PreF3 IgG antibody Geometric Mean Concentration (GMCs) at Screening  [Primary Study]

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    End point title
    		 RSV PreF3 IgG antibody Geometric Mean Concentration (GMCs) at Screening  [Primary Study] [12]
    End point description
    Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA ). The analysis of this outcome measure was reported for the Pooled groups as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3. The analysis was performed on the Per Protocol Set (PPS) - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Primary
    End point timeframe
    At Screening (Day -7 to Day 1)
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    100
    100
    103
    102
    102
    Units: ELISA Units per milliliter (EU/mL)
        geometric mean (confidence interval 95%)
    6611 (5857 to 7461)
    6751 (5982 to 7620)
    7449 (6534 to 8492)
    6172 (5570 to 6840)
    6454 (5771 to 7217)
    No statistical analyses for this end point

    Primary: RSV PreF3 IgG GMCs at Day 8 [Primary Study]

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    End point title
    		 RSV PreF3 IgG GMCs at Day 8 [Primary Study] [13]
    End point description
    Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA). The analysis of this outcome measure was reported for the Pooled groups as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3. The analysis was performed on the Per Protocol Set (PPS) - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Primary
    End point timeframe
    At Day 8
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    99
    99
    100
    102
    100
    Units: EU/mL
        geometric mean (confidence interval 95%)
    156568 (137244 to 178613)
    146708 (128639 to 167315)
    101662 (89783 to 115113)
    118670 (106004 to 132850)
    5780 (5145 to 6494)
    No statistical analyses for this end point

    Primary: RSV PreF3 IgG GMCs at Day 31 [Primary Study]

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    End point title
    		 RSV PreF3 IgG GMCs at Day 31 [Primary Study] [14]
    End point description
    Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA). Analysis of this outcome measure was reported for the Pooled groups as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3. The analysis was performed on the Per Protocol Set (PPS) - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures 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
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    98
    97
    102
    99
    97
    Units: EU/mL
        geometric mean (confidence interval 95%)
    101813 (89290 to 116092)
    106082 (93597 to 120231)
    86273 (77415 to 96145)
    88938 (79738 to 99200)
    6149 (5474 to 6908)
    No statistical analyses for this end point

    Secondary: Percentage of subjects with any solicited local adverse event (AEs) by each Boostrix formulation [Primary Study]

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    End point title
    		 Percentage of subjects with any solicited local adverse event (AEs) by each Boostrix formulation [Primary Study]
    End point description
    Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3. The analysis was performed on the SSS - Primary Study which consisted of all subjects from the ES - Primary Study for whom solicited safety data were available.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 8
    End point values
    		 RSV120_dTpa_RSV120(EX-US)-SSS-Primary Study RSV120_Placebo_RSV120(EX-US)-SSS-Primary Study RSV60_dTpa_RSV120(EX-US)-SSS-Primary Study RSV60_Placebo_RSV120(EX-US)-SSS-Primary Study dTpa_Placebo_RSV120(EX-US)-SSS-Primary Study RSV120_dTpa_RSV120(US)-SSS-Primary Study RSV120_Placebo_RSV120(US)-SSS-Primary Study RSV60_dTpa_RSV120(US)-SSS-Primary Study RSV60_Placebo_RSV120(US)-SSS-Primary Study dTpa_Placebo_RSV120(US)-SSS-Primary Study
    Number of subjects analysed
    50
    49
    51
    51
    49
    51
    51
    52
    51
    50
    Units: Percentage of participants
    number (confidence interval 95%)
        Left Arm, Erythema
    6 (1.3 to 16.5)
    4.1 (0.5 to 14)
    5.9 (1.2 to 16.2)
    2 (0 to 10.4)
    0 (0 to 7.3)
    5.9 (1.2 to 16.2)
    5.9 (1.2 to 16.2)
    5.8 (1.2 to 15.9)
    9.8 (3.3 to 21.4)
    0 (0 to 7.1)
        Left Arm, Pain
    46 (31.8 to 60.7)
    53.1 (38.3 to 67.5)
    52.9 (38.5 to 67.1)
    60.8 (46.1 to 74.2)
    16.3 (7.3 to 29.7)
    56.9 (42.2 to 70.7)
    54.9 (40.3 to 68.9)
    51.9 (37.6 to 66)
    56.9 (42.2 to 70.7)
    22 (11.5 to 36)
        Left Arm, Swelling
    2 (0.1 to 10.6)
    6.1 (1.3 to 16.9)
    3.9 (0.5 to 13.5)
    2 (0 to 10.4)
    0 (0 to 7.3)
    2 (0 to 10.4)
    7.8 (2.2 to 18.9)
    1.9 (0 to 10.3)
    7.8 (2.2 to 18.9)
    0 (0 to 7.1)
        Right Arm, Erythema
    4 (0.5 to 13.7)
    2 (0.1 to 10.9)
    2 (0 to 10.4)
    2 (0 to 10.4)
    6.1 (1.3 to 16.9)
    3.9 (0.5 to 13.5)
    0 (0 to 7)
    7.7 (2.1 to 18.5)
    0 (0 to 7)
    6 (1.3 to 16.5)
        Right Arm, Pain
    86 (73.3 to 94.2)
    18.4 (8.8 to 32)
    88.2 (76.1 to 95.6)
    23.5 (12.8 to 37.5)
    79.6 (65.7 to 89.8)
    76.5 (62.5 to 87.2)
    31.4 (19.1 to 45.9)
    65.4 (50.9 to 78)
    13.7 (5.7 to 26.3)
    78 (64 to 88.5)
        Right Arm, Swelling
    6 (1.3 to 16.5)
    0 (0 to 7.3)
    3.9 (0.5 to 13.5)
    2 (0 to 10.4)
    6.1 (1.3 to 16.9)
    3.9 (0.5 to 13.5)
    0 (0 to 7)
    0 (0 to 6.8)
    0 (0 to 7)
    2 (0.1 to 10.6)
    No statistical analyses for this end point

    Secondary: Percentage of subjects with any solicited general AEs by each Boostrix formulation [Primary Study]

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    End point title
    		 Percentage of subjects with any solicited general AEs by each Boostrix formulation [Primary Study]
    End point description
    Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever(body temperature ≥ 38 degree Celcius/100.4 degree Fahrenheit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3. The analysis was performed on the SSS - Primary Study which consisted of all subjects from the ES - Primary Study for whom solicited safety data were available.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 8
    End point values
    		 RSV120_dTpa_RSV120(EX-US)-SSS-Primary Study RSV120_Placebo_RSV120(EX-US)-SSS-Primary Study RSV60_dTpa_RSV120(EX-US)-SSS-Primary Study RSV60_Placebo_RSV120(EX-US)-SSS-Primary Study dTpa_Placebo_RSV120(EX-US)-SSS-Primary Study RSV120_dTpa_RSV120(US)-SSS-Primary Study RSV120_Placebo_RSV120(US)-SSS-Primary Study RSV60_dTpa_RSV120(US)-SSS-Primary Study RSV60_Placebo_RSV120(US)-SSS-Primary Study dTpa_Placebo_RSV120(US)-SSS-Primary Study
    Number of subjects analysed
    50
    49
    51
    51
    49
    51
    52
    52
    51
    50
    Units: Percentage of participants
    number (confidence interval 95%)
        Fatigue
    36 (22.9 to 50.8)
    36.7 (23.4 to 51.7)
    39.2 (25.8 to 53.9)
    29.4 (17.5 to 43.8)
    34.7 (21.7 to 49.6)
    45.1 (31.1 to 59.7)
    42.3 (28.7 to 56.8)
    36.5 (23.6 to 51)
    35.3 (22.4 to 49.9)
    42 (28.2 to 56.8)
        Gastrointestinal symptoms
    22 (11.5 to 36)
    28.6 (16.6 to 43.3)
    23.5 (12.8 to 37.5)
    29.4 (17.5 to 43.8)
    30.6 (18.3 to 45.4)
    25.5 (14.3 to 39.6)
    28.8 (17.1 to 43.1)
    30.8 (18.7 to 45.1)
    27.5 (15.9 to 41.7)
    26 (14.6 to 40.3)
        Headache
    46 (31.8 to 60.7)
    38.8 (25.2 to 53.8)
    31.4 (19.1 to 45.9)
    45.1 (31.1 to 59.7)
    40.8 (27 to 55.8)
    43.1 (29.3 to 57.8)
    51.9 (37.6 to 66)
    38.5 (25.3 to 53)
    33.3 (20.8 to 47.9)
    34 (21.2 to 48.8)
        Temperature
    4 (0.5 to 13.7)
    6.1 (1.3 to 16.9)
    3.9 (0.5 to 13.5)
    5.9 (1.2 to 16.2)
    12.2 (4.6 to 24.8)
    0 (0 to 7)
    1.9 (0 to 10.3)
    1.9 (0 to 10.3)
    2 (0 to 10.4)
    2 (0.1 to 10.6)
    No statistical analyses for this end point

    Secondary: Percentage of subjects with any unsolicited AEs by each Boostrix formulation [Primary Study]

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    End point title
    		 Percentage of subjects with any unsolicited AEs by each Boostrix formulation [Primary Study]
    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 to be reported as an unsolicited AE. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3. The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 31
    End point values
    		 RSV120_dTpa_RSV120(EX-US) - ES-Primary Study RSV120_Placebo_RSV120(EX-US) - ES-Primary Study RSV60_dTpa_RSV120(EX-US) - ES-Primary Study RSV60_Placebo_RSV120(EX-US) - ES-Primary Study dTpa_Placebo_RSV120(EX-US) - ES-Primary Study RSV120_dTpa_RSV120(US) - ES-Primary Study RSV120_Placebo_RSV120(US) - ES-Primary Study RSV60_dTpa_RSV120(US) - ES-Primary Study RSV60_Placebo_RSV120(US) - ES-Primary Study dTpa_Placebo_RSV120(US) - ES-Primary Study
    Number of subjects analysed
    50
    49
    51
    51
    51
    51
    52
    52
    51
    51
    Units: Percentage of participants
        number (confidence interval 95%)
    38 (24.7 to 52.8)
    36.7 (23.4 to 51.7)
    39.2 (25.8 to 53.9)
    43.1 (29.3 to 57.8)
    33.3 (20.8 to 47.9)
    39.2 (25.8 to 53.9)
    32.7 (20.3 to 47.1)
    26.9 (15.6 to 41)
    31.4 (19.1 to 45.9)
    31.4 (19.1 to 45.9)
    No statistical analyses for this end point

    Secondary: Number of subjects with any SAEs by each Boostrix formulation [Primary Study]

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    End point title
    		 Number of subjects with any SAEs by each Boostrix formulation [Primary Study]
    End point description
    A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3. The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 31
    End point values
    		 RSV120_dTpa_RSV120(EX-US) - ES-Primary Study RSV120_Placebo_RSV120(EX-US) - ES-Primary Study RSV60_dTpa_RSV120(EX-US) - ES-Primary Study RSV60_Placebo_RSV120(EX-US) - ES-Primary Study dTpa_Placebo_RSV120(EX-US) - ES-Primary Study RSV120_dTpa_RSV120(US) - ES-Primary Study RSV120_Placebo_RSV120(US) - ES-Primary Study RSV60_dTpa_RSV120(US) - ES-Primary Study RSV60_Placebo_RSV120(US) - ES-Primary Study dTpa_Placebo_RSV120(US) - ES-Primary Study
    Number of subjects analysed
    50
    49
    51
    51
    51
    51
    52
    52
    51
    51
    Units: Participants
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with any SAEs from 1st vaccination to Day 181 [Primary Study]

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    End point title
    		 Number of subjects with any SAEs from 1st vaccination to Day 181 [Primary Study]
    End point description
    A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3. The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 181
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    101
    101
    103
    102
    102
    Units: Participants
    1
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with any SAEs from 1st vaccination to Day 181 by each Boostrix formulation [Primary Study]

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    End point title
    		 Number of subjects with any SAEs from 1st vaccination to Day 181 by each Boostrix formulation [Primary Study]
    End point description
    A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the safety response to RSVPreF3. The analysis was performed on the ES - Primary Study which consisted of all subjects who received at least 1 dose of the study treatment.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 181
    End point values
    		 RSV120_dTpa_RSV120(EX-US) - ES-Primary Study RSV120_Placebo_RSV120(EX-US) - ES-Primary Study RSV60_dTpa_RSV120(EX-US) - ES-Primary Study RSV60_Placebo_RSV120(EX-US) - ES-Primary Study dTpa_Placebo_RSV120(EX-US) - ES-Primary Study RSV120_dTpa_RSV120(US) - ES-Primary Study RSV120_Placebo_RSV120(US) - ES-Primary Study RSV60_dTpa_RSV120(US) - ES-Primary Study RSV60_Placebo_RSV120(US) - ES-Primary Study dTpa_Placebo_RSV120(US) - ES-Primary Study
    Number of subjects analysed
    50
    49
    51
    51
    51
    51
    52
    52
    51
    51
    Units: Participants
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with any SAEs from 2nd vaccination to Day 181 post 2nd vaccination [Extension Period]

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    End point title
    		 Number of subjects with any SAEs from 2nd vaccination to Day 181 post 2nd vaccination [Extension Period]
    End point description
    A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies, as the objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3. The analysis was performed on ES - Extension Study which consisted of all subjects who received at least 2 doses of the study treatment.
    End point type
    Secondary
    End point timeframe
    From the Day of 2nd vaccination to Day 181 post 2nd vaccination
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    39
    41
    46
    41
    46
    Units: Participants
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: RSV A neutralizing GMTs at Screening by each Boostrix formulation [Primary Study]

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    End point title
    		 RSV A neutralizing GMTs at Screening by each Boostrix formulation [Primary Study]
    End point description
    Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3. The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Screening (Day -7 to Day 1)
    End point values
    		 RSV120_dTpa_RSV120(EX-US) - PPS-Primary Study RSV120_Placebo_RSV120(EX-US) - PPS-Primary Study RSV60_dTpa_RSV120(EX-US) - PPS-Primary Study RSV60_Placebo_RSV120(EX-US) - PPS-Primary Study dTpa_Placebo_RSV120(EX-US) - PPS-Primary Study RSV120_dTpa_RSV120(US) - PPS-Primary Study RSV120_Placebo_RSV120(US) - PPS-Primary Study RSV60_dTpa_RSV120(US) - PPS-Primary Study RSV60_Placebo_RSV120(US) - PPS-Primary Study dTpa_Placebo_RSV120(US) - PPS-Primary Study
    Number of subjects analysed
    49
    49
    51
    51
    51
    51
    51
    52
    51
    51
    Units: Titers (ED60)
        geometric mean (confidence interval 95%)
    777 (625 to 966)
    1009 (798 to 1277)
    989 (749 to 1307)
    777 (631 to 956)
    956 (740 to 1236)
    981 (773 to 1245)
    1035 (786 to 1362)
    1298 (1070 to 1574)
    765 (638 to 917)
    1154 (952 to 1399)
    No statistical analyses for this end point

    Secondary: RSV A neutralizing GMTs at Day 8 by each Boostrix formulation [Primary Study]

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    End point title
    		 RSV A neutralizing GMTs at Day 8 by each Boostrix formulation [Primary Study]
    End point description
    Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3. The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Day 8
    End point values
    		 RSV120_dTpa_RSV120(EX-US) - PPS-Primary Study RSV120_Placebo_RSV120(EX-US) - PPS-Primary Study RSV60_dTpa_RSV120(EX-US) - PPS-Primary Study RSV60_Placebo_RSV120(EX-US) - PPS-Primary Study dTpa_Placebo_RSV120(EX-US) - PPS-Primary Study RSV120_dTpa_RSV120(US) - PPS-Primary Study RSV120_Placebo_RSV120(US) - PPS-Primary Study RSV60_dTpa_RSV120(US) - PPS-Primary Study RSV60_Placebo_RSV120(US) - PPS-Primary Study dTpa_Placebo_RSV120(US) - PPS-Primary Study
    Number of subjects analysed
    49
    48
    50
    51
    51
    49
    51
    50
    51
    49
    Units: Titers (ED60)
        geometric mean (confidence interval 95%)
    14523 (11831 to 17827)
    15458 (12424 to 19231)
    10677 (8146 to 13993)
    11128 (8885 to 13939)
    698 (530 to 918)
    13818 (11070 to 17248)
    13264 (10075 to 17462)
    9715 (7612 to 12400)
    10077 (7897 to 12858)
    884 (722 to 1082)
    No statistical analyses for this end point

    Secondary: RSV A neutralizing GMTs at Day 31 by each Boostrix formulation [Primary Study]

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    End point title
    		 RSV A neutralizing GMTs at Day 31 by each Boostrix formulation [Primary Study]
    End point description
    Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3. The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Day 31
    End point values
    		 RSV120_dTpa_RSV120(EX-US) - PPS-Primary Study RSV120_Placebo_RSV120(EX-US) - PPS-Primary Study RSV60_dTpa_RSV120(EX-US) - PPS-Primary Study RSV60_Placebo_RSV120(EX-US) - PPS-Primary Study dTpa_Placebo_RSV120(EX-US) - PPS-Primary Study RSV120_dTpa_RSV120(US) - PPS-Primary Study RSV120_Placebo_RSV120(US) - PPS-Primary Study RSV60_dTpa_RSV120(US) - PPS-Primary Study RSV60_Placebo_RSV120(US) - PPS-Primary Study dTpa_Placebo_RSV120(US) - PPS-Primary Study
    Number of subjects analysed
    49
    48
    51
    50
    48
    49
    49
    51
    49
    49
    Units: Titers (ED60)
        geometric mean (confidence interval 95%)
    9838 (7987 to 12118)
    10800 (8675 to 13446)
    8754 (6821 to 11236)
    8141 (6545 to 10125)
    767 (575 to 1023)
    9834 (7354 to 13152)
    11276 (8283 to 15351)
    9698 (7735 to 12159)
    9395 (7726 to 11425)
    930 (740 to 1168)
    No statistical analyses for this end point

    Secondary: RSV A neutralizing GMTs at single time point between 12 to 18 months post 1st vaccination by each Boostrix formulation [Primary Study]

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    End point title
    		 RSV A neutralizing GMTs at single time point between 12 to 18 months post 1st vaccination by each Boostrix formulation [Primary Study]
    End point description
    Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3. The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At a single timepoint between 12 to 18 months post 1st vaccination
    End point values
    		 RSV120_dTpa_RSV120(EX-US) - PPS-Primary Study RSV120_Placebo_RSV120(EX-US) - PPS-Primary Study RSV60_dTpa_RSV120(EX-US) - PPS-Primary Study RSV60_Placebo_RSV120(EX-US) - PPS-Primary Study dTpa_Placebo_RSV120(EX-US) - PPS-Primary Study RSV120_dTpa_RSV120(US) - PPS-Primary Study RSV120_Placebo_RSV120(US) - PPS-Primary Study RSV60_dTpa_RSV120(US) - PPS-Primary Study RSV60_Placebo_RSV120(US) - PPS-Primary Study dTpa_Placebo_RSV120(US) - PPS-Primary Study
    Number of subjects analysed
    24
    31
    32
    29
    31
    14
    9
    14
    12
    15
    Units: Titers (ED60)
        geometric mean (confidence interval 95%)
    2034 (1458 to 2836)
    2869 (1998 to 4119)
    3086 (2143 to 4445)
    2200 (1522 to 3180)
    675 (495 to 920)
    2014 (1190 to 3411)
    2960 (1190 to 7362)
    2474 (1741 to 3517)
    2569 (1586 to 4160)
    969 (602 to 1560)
    No statistical analyses for this end point

    Secondary: RSV A neutralizing GMTs at single time point between 12 to 18 months post 1st vaccination [Primary Study]

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    End point title
    		 RSV A neutralizing GMTs at single time point between 12 to 18 months post 1st vaccination [Primary Study]
    End point description
    Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. Analysis of this outcome measure was reported for the Pooled groups as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3. The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At a single timepoint between 12 to 18 months post 1st vaccination
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    38
    40
    46
    41
    46
    Units: Titers (ED60)
        geometric mean (confidence interval 95%)
    2027 (1546 to 2656)
    2889 (2086 to 4001)
    2885 (2204 to 3778)
    2302 (1730 to 3064)
    759 (588 to 980)
    No statistical analyses for this end point

    Secondary: RSV A neutralizing GMTs at Day 31 post 2nd vaccination [Extension Study]

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    End point title
    		 RSV A neutralizing GMTs at Day 31 post 2nd vaccination [Extension Study]
    End point description
    Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for the Pooled groups as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies, as the objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3. The analysis was performed on the PPS - Extension Study which consisted of all subjects from the ES - Extension Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Day 31 post 2nd vaccination
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    38
    37
    44
    39
    42
    Units: Titers (ED60)
        geometric mean (confidence interval 95%)
    3892 (3016 to 5022)
    5071 (3848 to 6683)
    4779 (3747 to 6094)
    4920 (3886 to 6231)
    8200 (6380 to 10539)
    No statistical analyses for this end point

    Secondary: RSV PreF3 IgG GMCs at Screening by each Boostrix formulation  [Primary Study]

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    End point title
    		 RSV PreF3 IgG GMCs at Screening by each Boostrix formulation  [Primary Study]
    End point description
    Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3. The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Screening (Day -7 to Day 1)
    End point values
    		 RSV120_dTpa_RSV120(EX-US) - PPS-Primary Study RSV120_Placebo_RSV120(EX-US) - PPS-Primary Study RSV60_dTpa_RSV120(EX-US) - PPS-Primary Study RSV60_Placebo_RSV120(EX-US) - PPS-Primary Study dTpa_Placebo_RSV120(EX-US) - PPS-Primary Study RSV120_dTpa_RSV120(US) - PPS-Primary Study RSV120_Placebo_RSV120(US) - PPS-Primary Study RSV60_dTpa_RSV120(US) - PPS-Primary Study RSV60_Placebo_RSV120(US) - PPS-Primary Study dTpa_Placebo_RSV120(US) - PPS-Primary Study
    Number of subjects analysed
    49
    49
    51
    51
    51
    51
    51
    52
    51
    51
    Units: EU/mL
        geometric mean (confidence interval 95%)
    6240 (5159 to 7548)
    6524 (5597 to 7604)
    7237 (5905 to 8869)
    6106 (5275 to 7067)
    5907 (5077 to 6873)
    6987 (5975 to 8170)
    6978 (5764 to 8447)
    7662 (6447 to 9107)
    6240 (5375 to 7245)
    7051 (5973 to 8324)
    No statistical analyses for this end point

    Secondary: RSV PreF3 IgG GMCs at Day 8 by each Boostrix formulation [Primary Study]

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    End point title
    		 RSV PreF3 IgG GMCs at Day 8 by each Boostrix formulation [Primary Study]
    End point description
    Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. The analysis of this outcome measure was reported for each formulation of the Boostrix (300 μg or 500 μg of aluminum). The objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of Boostrix formulation on the immunogenicity response to RSVPreF3. The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Day 8
    End point values
    		 RSV120_dTpa_RSV120(EX-US) - PPS-Primary Study RSV120_Placebo_RSV120(EX-US) - PPS-Primary Study RSV60_dTpa_RSV120(EX-US) - PPS-Primary Study RSV60_Placebo_RSV120(EX-US) - PPS-Primary Study dTpa_Placebo_RSV120(EX-US) - PPS-Primary Study RSV120_dTpa_RSV120(US) - PPS-Primary Study RSV120_Placebo_RSV120(US) - PPS-Primary Study RSV60_dTpa_RSV120(US) - PPS-Primary Study RSV60_Placebo_RSV120(US) - PPS-Primary Study dTpa_Placebo_RSV120(US) - PPS-Primary Study
    Number of subjects analysed
    49
    48
    50
    51
    51
    50
    51
    50
    51
    49
    Units: EU/mL
        geometric mean (confidence interval 95%)
    155721 (133435 to 181728)
    143104 (126138 to 162352)
    100064 (84699 to 118216)
    123475 (107405 to 141950)
    5523 (4700 to 6490)
    157403 (126554 to 195772)
    150184 (119250 to 189142)
    103286 (85400 to 124919)
    114053 (95089 to 136799)
    6061 (5097 to 7207)
    No statistical analyses for this end point

    Secondary: RSV PreF3 IgG GMCs at Day 31 by each Boostrix formulation [Primary Study]

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    End point title
    		 RSV PreF3 IgG GMCs at Day 31 by each Boostrix formulation [Primary Study]
    End point description
    Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum), as the objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of dTpa (Boostrix) formulation on the immunogenicity response to RSVPreF3. The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
     At Day 31
    End point values
    		 RSV120_dTpa_RSV120(EX-US) - PPS-Primary Study RSV120_Placebo_RSV120(EX-US) - PPS-Primary Study RSV60_dTpa_RSV120(EX-US) - PPS-Primary Study RSV60_Placebo_RSV120(EX-US) - PPS-Primary Study dTpa_Placebo_RSV120(EX-US) - PPS-Primary Study RSV120_dTpa_RSV120(US) - PPS-Primary Study RSV120_Placebo_RSV120(US) - PPS-Primary Study RSV60_dTpa_RSV120(US) - PPS-Primary Study RSV60_Placebo_RSV120(US) - PPS-Primary Study dTpa_Placebo_RSV120(US) - PPS-Primary Study
    Number of subjects analysed
    49
    48
    51
    49
    48
    49
    49
    51
    49
    49
    Units: EU/mL
        geometric mean (confidence interval 95%)
    94254 (80742 to 110026)
    95113 (83282 to 108624)
    84509 (72281 to 98805)
    81915 (70291 to 95460)
    5600 (4777 to 6565)
    109978 (88643 to 136446)
    118052 (95525 to 145892)
    88075 (75406 to 102872)
    96727 (82608 to 113258)
    6739 (5678 to 7999)
    No statistical analyses for this end point

    Secondary: RSV PreF3 IgG GMCs at single time point between 12 to 18 months post 1st vaccination by each Boostrix formulation [Primary Study]

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    End point title
    		 RSV PreF3 IgG GMCs at single time point between 12 to 18 months post 1st vaccination by each Boostrix formulation [Primary Study]
    End point description
    Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. The analysis of this outcome measure was reported for each formulation of the Boostrix (300 μg or 500 μg of aluminum). The objective of this endpoint was to analyze the impact of co-administration of RSVPreF3 with either 300 μg or 500 μg of Boostrix formulation on the immunogenicity response to RSVPreF3. The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At a single timepoint between 12 to 18 months post 1st vaccination
    End point values
    		 RSV120_dTpa_RSV120(EX-US) - PPS-Primary Study RSV120_Placebo_RSV120(EX-US) - PPS-Primary Study RSV60_dTpa_RSV120(EX-US) - PPS-Primary Study RSV60_Placebo_RSV120(EX-US) - PPS-Primary Study dTpa_Placebo_RSV120(EX-US) - PPS-Primary Study RSV120_dTpa_RSV120(US) - PPS-Primary Study RSV120_Placebo_RSV120(US) - PPS-Primary Study RSV60_dTpa_RSV120(US) - PPS-Primary Study RSV60_Placebo_RSV120(US) - PPS-Primary Study dTpa_Placebo_RSV120(US) - PPS-Primary Study
    Number of subjects analysed
    24
    31
    32
    29
    31
    14
    9
    14
    12
    15
    Units: EU/mL
        geometric mean (confidence interval 95%)
    18832 (15141 to 23423)
    20894 (16466 to 26512)
    23189 (18629 to 28864)
    20720 (16689 to 25726)
    5014 (3932 to 6392)
    18127 (10969 to 29958)
    19641 (9143 to 42195)
    22905 (17801 to 29471)
    22233 (15931 to 31029)
    6811 (5005 to 9269)
    No statistical analyses for this end point

    Secondary: RSV PreF3 IgG GMCs at single time point between 12 to 18 months post 1st vaccination [Primary Study]

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    End point title
    		 RSV PreF3 IgG GMCs at single time point between 12 to 18 months post 1st vaccination [Primary Study]
    End point description
    Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody concentration is expressed in EU/mL. The cut-off value for the assay is 25 EU/mL. Analysis of this outcome measure was reported for the Pooled groups as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3. The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At a single timepoint between 12 to 18 months post 1st vaccination
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    38
    40
    46
    41
    46
    Units: EU/mL
        geometric mean (confidence interval 95%)
    18570 (14961 to 23049)
    20605 (16333 to 25995)
    23102 (19586 to 27249)
    21152 (17777 to 25168)
    5540 (4581 to 6700)
    No statistical analyses for this end point

    Secondary: RSV PreF3 IgG GMCs at Day 31 post 2nd vaccination [Extension Study]

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    End point title
    		 RSV PreF3 IgG GMCs at Day 31 post 2nd vaccination [Extension Study]
    End point description
    Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The analysis of this outcome measure was reported for the Pooled groups as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies, as the objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3. The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Day 31 post 2nd vaccination
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    38
    37
    44
    39
    42
    Units: (IU/mL)
        geometric mean (confidence interval 95%)
    41399 (34806 to 49241)
    42943 (37226 to 49537)
    43977 (38784 to 49865)
    45680 (38574 to 54094)
    86934 (75442 to 100177)
    No statistical analyses for this end point

    Secondary: Pertussis toxoid (anti-PT), Filamentous hemagglutinin (anti-FHA) and Pertactin (anti-PRN) GMCs at Screening by each Boostrix formulation [Primary Study]

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    End point title
    		 Pertussis toxoid (anti-PT), Filamentous hemagglutinin (anti-FHA) and Pertactin (anti-PRN) GMCs at Screening by each Boostrix formulation [Primary Study]
    End point description
    Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum). The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Screening (Day -7 to Day 1)
    End point values
    		 RSV120_dTpa_RSV120(EX-US) - PPS-Primary Study RSV60_dTpa_RSV120(EX-US) - PPS-Primary Study dTpa_Placebo_RSV120(EX-US) - PPS-Primary Study RSV120_dTpa_RSV120(US) - PPS-Primary Study RSV60_dTpa_RSV120(US) - PPS-Primary Study dTpa_Placebo_RSV120(US) - PPS-Primary Study
    Number of subjects analysed
    49
    51
    51
    51
    52
    51
    Units: International Units Per mL (IU/mL)
    geometric mean (confidence interval 95%)
        anti-PT
    7.39 (5.11 to 10.68)
    7.64 (5.47 to 10.66)
    6.65 (4.66 to 9.47)
    7.55 (5.34 to 10.66)
    5.66 (4.06 to 7.88)
    7.17 (4.94 to 10.41)
        anti-FHA
    32.8 (23 to 46.7)
    34.5 (24.3 to 49.1)
    29.3 (22 to 38.9)
    31 (22.7 to 42.4)
    29.6 (22.5 to 38.9)
    28 (21 to 37.4)
        anti-PRN
    43.2 (27.9 to 66.7)
    39 (25.3 to 60.1)
    28.1 (18.2 to 43.4)
    42.1 (27.6 to 64.2)
    40.1 (26.9 to 60)
    28.7 (17.9 to 46.1)
    No statistical analyses for this end point

    Secondary: Pertussis toxoid (anti-PT), Filamentous hemagglutinin (anti-FHA) and Pertactin (anti-PRN) GMCs at Day 31 by each Boostrix formulation [Primary Study]

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    End point title
    		 Pertussis toxoid (anti-PT), Filamentous hemagglutinin (anti-FHA) and Pertactin (anti-PRN) GMCs at Day 31 by each Boostrix formulation [Primary Study]
    End point description
    Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum). The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Day 31
    End point values
    		 RSV120_dTpa_RSV120(EX-US) - PPS-Primary Study RSV60_dTpa_RSV120(EX-US) - PPS-Primary Study dTpa_Placebo_RSV120(EX-US) - PPS-Primary Study RSV120_dTpa_RSV120(US) - PPS-Primary Study RSV60_dTpa_RSV120(US) - PPS-Primary Study dTpa_Placebo_RSV120(US) - PPS-Primary Study
    Number of subjects analysed
    49
    51
    48
    49
    51
    49
    Units: (IU/mL)
    geometric mean (confidence interval 95%)
        anti-PT
    57.36 (41.82 to 78.69)
    54.95 (44.78 to 67.44)
    79.16 (62.67 to 99.98)
    43.76 (34.1 to 56.17)
    36.98 (28.25 to 48.42)
    44.99 (34.81 to 58.15)
        anti-FHA
    237.1 (194.1 to 289.5)
    210.6 (168.5 to 263.1)
    303.6 (241.6 to 381.5)
    186.5 (149.8 to 232.3)
    176.7 (139.3 to 224.1)
    232.9 (182.2 to 297.8)
        anti-PRN
    309.5 (226.7 to 422.6)
    214.7 (166.8 to 276.4)
    395.1 (290.3 to 537.6)
    217.7 (153.7 to 308.3)
    228.1 (161.9 to 321.5)
    331.4 (238.4 to 460.5)
    No statistical analyses for this end point

    Secondary: Diphtheria (Anti-D) GMC at Screening by each Boostrix formulation [Primary Study]

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    End point title
    		 Diphtheria (Anti-D) GMC at Screening by each Boostrix formulation [Primary Study]
    End point description
    Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum). The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Screening (Day -7 to Day 1)
    End point values
    		 RSV120_dTpa_RSV120(EX-US) - PPS-Primary Study RSV60_dTpa_RSV120(EX-US) - PPS-Primary Study dTpa_Placebo_RSV120(EX-US) - PPS-Primary Study RSV120_dTpa_RSV120(US) - PPS-Primary Study RSV60_dTpa_RSV120(US) - PPS-Primary Study dTpa_Placebo_RSV120(US) - PPS-Primary Study
    Number of subjects analysed
    49
    51
    49
    49
    52
    50
    Units: (IU/mL)
        geometric mean (confidence interval 95%)
    0.26 (0.18 to 0.39)
    0.27 (0.17 to 0.42)
    0.23 (0.16 to 0.32)
    0.46 (0.33 to 0.64)
    0.55 (0.42 to 0.73)
    0.58 (0.43 to 0.78)
    No statistical analyses for this end point

    Secondary: Diphtheria (Anti-D) GMCs at Day 31 by each Boostrix formulation [Primary Study]

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    End point title
    		 Diphtheria (Anti-D) GMCs at Day 31 by each Boostrix formulation [Primary Study]
    End point description
    Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum). The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Day 31
    End point values
    		 RSV120_dTpa_RSV120(EX-US) - PPS-Primary Study RSV60_dTpa_RSV120(EX-US) - PPS-Primary Study dTpa_Placebo_RSV120(EX-US) - PPS-Primary Study RSV120_dTpa_RSV120(US) - PPS-Primary Study RSV60_dTpa_RSV120(US) - PPS-Primary Study dTpa_Placebo_RSV120(US) - PPS-Primary Study
    Number of subjects analysed
    49
    51
    48
    47
    48
    49
    Units: (IU/mL)
        geometric mean (confidence interval 95%)
    1.3 (0.97 to 1.73)
    1.18 (0.85 to 1.63)
    1.76 (1.25 to 2.48)
    2.11 (1.61 to 2.76)
    2.2 (1.72 to 2.81)
    3.29 (2.62 to 4.14)
    No statistical analyses for this end point

    Secondary: Tetanus (Anti-T) GMCs at Screening by each Boostrix formulation [Primary Study]

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    End point title
    		 Tetanus (Anti-T) GMCs at Screening by each Boostrix formulation [Primary Study]
    End point description
    Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum). The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Screening (Day -7 to Day 1)
    End point values
    		 RSV120_dTpa_RSV120(EX-US) - PPS-Primary Study RSV60_dTpa_RSV120(EX-US) - PPS-Primary Study dTpa_Placebo_RSV120(EX-US) - PPS-Primary Study RSV120_dTpa_RSV120(US) - PPS-Primary Study RSV60_dTpa_RSV120(US) - PPS-Primary Study dTpa_Placebo_RSV120(US) - PPS-Primary Study
    Number of subjects analysed
    49
    51
    51
    51
    52
    51
    Units: (IU/mL)
        geometric mean (confidence interval 95%)
    1.14 (0.87 to 1.5)
    1.1 (0.78 to 1.54)
    0.88 (0.64 to 1.22)
    1.35 (1.01 to 1.81)
    1.56 (1.27 to 1.92)
    1.68 (1.29 to 2.19)
    No statistical analyses for this end point

    Secondary: Tetanus (Anti-T) GMCs at Day 31 by each Boostrix formulation [Primary Study]

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    End point title
    		 Tetanus (Anti-T) GMCs at Day 31 by each Boostrix formulation [Primary Study]
    End point description
    Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA. The analysis of this outcome measure was reported for each formulation of the dTpa (Boostrix) vaccine (300 μg or 500 μg of aluminum). The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Day 31
    End point values
    		 RSV120_dTpa_RSV120(EX-US) - PPS-Primary Study RSV60_dTpa_RSV120(EX-US) - PPS-Primary Study dTpa_Placebo_RSV120(EX-US) - PPS-Primary Study RSV120_dTpa_RSV120(US) - PPS-Primary Study RSV60_dTpa_RSV120(US) - PPS-Primary Study dTpa_Placebo_RSV120(US) - PPS-Primary Study
    Number of subjects analysed
    49
    51
    48
    49
    51
    49
    Units: (IU/mL)
        geometric mean (confidence interval 95%)
    5.57 (4.64 to 6.7)
    5.3 (4.52 to 6.21)
    6.74 (5.79 to 7.84)
    6.09 (4.98 to 7.45)
    6.27 (5.29 to 7.44)
    8.32 (6.88 to 10.05)
    No statistical analyses for this end point

    Secondary: Pertussis toxoid (anti-PT), Filamentous hemagglutinin (anti-FHA) and Pertactin (anti-PRN) GMCs at Screening [Primary Study]

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    End point title
    		 Pertussis toxoid (anti-PT), Filamentous hemagglutinin (anti-FHA) and Pertactin (anti-PRN) GMCs at Screening [Primary Study] [15]
    End point description
    Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA. Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Screening (Day -7 to Day 1)
    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: The analysis was only performed on the groups that received the dTpa vaccine.
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    100
    103
    102
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-PT
    7.47 (5.83 to 9.57)
    6.56 (5.20 to 8.28)
    6.90 (5.36 to 8.89)
        Anti-FHA
    31.9 (25.3 to 40.2)
    31.9 (25.6 to 39.8)
    28.6 (23.5 to 34.9)
        Anti-PRN
    42.6 (31.6 to 57.4)
    39.6 (29.6 to 52.9)
    28.4 (20.7 to 38.9)
    No statistical analyses for this end point

    Secondary: Pertussis toxoid (anti-PT), Filamentous hemagglutinin (anti-FHA) and Pertactin (anti-PRN) GMCs at Day 31 [Primary Study]

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    End point title
    		 Pertussis toxoid (anti-PT), Filamentous hemagglutinin (anti-FHA) and Pertactin (anti-PRN) GMCs at Day 31 [Primary Study] [16]
    End point description
    Serological assays for the determination of IgG antibodies against Bordetella pertussis: anti-PT, anti-FHA and anti-PRN were performed by ELISA. Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures 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
    [16] - 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: The analysis was only performed on the groups that received the dTpa vaccine.
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    98
    102
    97
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-PT
    50.10 (41.04 to 61.17)
    45.08 (38.00 to 53.48)
    59.51 (49.71 to 71.23)
        Anti-FHA
    210.3 (181.4 to 243.8)
    192.9 (164.2 to 226.6)
    265.6 (224.7 to 313.8)
        Anti-PRN
    259.6 (205.8 to 327.4)
    221.3 (179.5 to 272.9)
    361.1 (289.1 to 451.1)
    No statistical analyses for this end point

    Secondary: Diphtheria (Anti-D) GMCs at Screening [Primary Study]

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    End point title
    		 Diphtheria (Anti-D) GMCs at Screening [Primary Study] [17]
    End point description
    Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA. Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Screening (Day -7 to Day 1)
    Notes
    [17] - 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: The analysis was only performed on the groups that received the dTpa vaccine.
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    98
    103
    99
    Units: IU/mL
        geometric mean (confidence interval 95%)
    0.35 (0.27 to 0.45)
    0.39 (0.30 to 0.51)
    0.36 (0.28 to 0.47)
    No statistical analyses for this end point

    Secondary: Diphtheria (Anti-D) GMC at Day 31 [Primary Study]

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    End point title
    		 Diphtheria (Anti-D) GMC at Day 31 [Primary Study] [18]
    End point description
    Serological assays for the determination of IgG antibodies against anti-D were performed by ELISA. Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures 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
    [18] - 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: The analysis was only performed on the groups that received the dTpa vaccine.
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    96
    99
    97
    Units: IU/mL
        geometric mean (confidence interval 95%)
    1.65 (1.35 to 2.01)
    1.59 (1.29 to 1.97)
    2.42 (1.96 to 2.99)
    No statistical analyses for this end point

    Secondary: Tetanus (Anti-T) GMCs at Screening [Primary Study]

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    End point title
    		 Tetanus (Anti-T) GMCs at Screening [Primary Study] [19]
    End point description
    Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA. Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures and for whom immunogenicity results were available for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At Screening (Day -7 to Day 1)
    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: The analysis was only performed on the groups that received the dTpa vaccine.
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    100
    103
    102
    Units: IU/mL
        geometric mean (confidence interval 95%)
    1.24 (1.02 to 1.51)
    1.31 (1.08 to 1.60)
    1.22 (0.98 to 1.51)
    No statistical analyses for this end point

    Secondary: Tetanus (Anti-T) GMCs at Day 31 [Primary Study]

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    End point title
    		 Tetanus (Anti-T) GMCs at Day 31 [Primary Study] [20]
    End point description
    Serological assays for the determination of IgG antibodies against anti-T were performed by ELISA. Analysis of this outcome measure was reported for the Pooled groups [RSV120_dTpa_RSV120(Pooled), RSV60_dTpa_RSV120(Pooled) and dTpa_Placebo_RSV120(Pooled)] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The analysis was performed on the PPS - Primary Study which consisted of all subjects from the ES - Primary Study, who complied with protocol defined procedures 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
    [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: The analysis was only performed on the groups that received the dTpa vaccine.
    End point values
    		 RSV120_dTpa_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled)
    Number of subjects analysed
    98
    102
    97
    Units: IU/mL
        geometric mean (confidence interval 95%)
    5.83 (5.10 to 6.66)
    5.76 (5.13 to 6.47)
    7.49 (6.64 to 8.46)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited adverse events(AEs) were collected during the 7-day follow-up period and unsolicited AEs during the 30-day follow-up period after any vaccination. Serious AEs were collected from Day 1 (Primary Study) to the Study End (Day 181, Extension Study).
    Adverse event reporting additional description
    As per the analysis plan, AEs were reported for the pooled groups, as the 2 formulations of dTpa vaccine showed similar safety profiles in previous studies. Total number of subjects affected by Other AEs were obtained from the rows with the maximum number of events.Results of Other AEs were summarized by two periods (Primary & Extension Study).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    RSV120_dTpa_RSV120(Pooled)
    Reporting group description
    		 Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Reporting group title
    dTpa_Placebo_RSV120(Pooled)
    Reporting group description
    		 Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Reporting group title
    RSV60_Placebo_RSV120(Pooled)
    Reporting group description
    		 Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Reporting group title
    RSV120_Placebo_RSV120(Pooled)
    Reporting group description
    		 Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Reporting group title
    RSV60_dTpa_RSV120(Pooled)
    Reporting group description
    		 Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

    Serious adverse events
    		 RSV120_dTpa_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Radius fracture
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pyelonephritis
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 RSV120_dTpa_RSV120(Pooled) dTpa_Placebo_RSV120(Pooled) RSV60_Placebo_RSV120(Pooled) RSV120_Placebo_RSV120(Pooled) RSV60_dTpa_RSV120(Pooled)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    92 / 101 (91.09%)
    89 / 102 (87.25%)
    82 / 102 (80.39%)
    90 / 101 (89.11%)
    91 / 103 (88.35%)
    Vascular disorders
    Hypertension - Extension Study
         subjects affected / exposed [1]
    0 / 39 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    General disorders and administration site conditions
    Injection site pain - Primary Study
         subjects affected / exposed
    86 / 101 (85.15%)
    81 / 102 (79.41%)
    60 / 102 (58.82%)
    62 / 101 (61.39%)
    84 / 103 (81.55%)
         occurrences all number
    204
    170
    128
    136
    200
    Fatigue - Primary Study
         subjects affected / exposed
    42 / 101 (41.58%)
    38 / 102 (37.25%)
    34 / 102 (33.33%)
    40 / 101 (39.60%)
    39 / 103 (37.86%)
         occurrences all number
    86
    77
    69
    83
    79
    Injection site erythema - Primary Study
         subjects affected / exposed
    7 / 101 (6.93%)
    6 / 102 (5.88%)
    7 / 102 (6.86%)
    6 / 101 (5.94%)
    8 / 103 (7.77%)
         occurrences all number
    18
    12
    14
    12
    18
    Injection site swelling - Primary Study
         subjects affected / exposed
    5 / 101 (4.95%)
    4 / 102 (3.92%)
    6 / 102 (5.88%)
    8 / 101 (7.92%)
    3 / 103 (2.91%)
         occurrences all number
    12
    8
    12
    16
    6
    Pyrexia - Primary Study
         subjects affected / exposed
    2 / 101 (1.98%)
    7 / 102 (6.86%)
    4 / 102 (3.92%)
    4 / 101 (3.96%)
    3 / 103 (2.91%)
         occurrences all number
    4
    14
    8
    8
    6
    Injection site bruising - Primary Study
         subjects affected / exposed
    2 / 101 (1.98%)
    2 / 102 (1.96%)
    1 / 102 (0.98%)
    2 / 101 (1.98%)
    4 / 103 (3.88%)
         occurrences all number
    4
    4
    2
    6
    8
    Administration site erythema - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    3 / 101 (2.97%)
    4 / 103 (3.88%)
         occurrences all number
    0
    0
    1
    3
    4
    Administration site pain - Primary Study
         subjects affected / exposed
    2 / 101 (1.98%)
    1 / 102 (0.98%)
    1 / 102 (0.98%)
    1 / 101 (0.99%)
    3 / 103 (2.91%)
         occurrences all number
    2
    1
    1
    1
    3
    Injection site pruritus - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    3 / 102 (2.94%)
    1 / 102 (0.98%)
    2 / 101 (1.98%)
    0 / 103 (0.00%)
         occurrences all number
    2
    6
    2
    4
    0
    Injection site haemorrhage - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    2 / 101 (1.98%)
    1 / 103 (0.97%)
         occurrences all number
    0
    0
    2
    4
    2
    Administration site swelling - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    4 / 103 (3.88%)
         occurrences all number
    1
    0
    0
    0
    4
    Vaccination site nodule - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    2 / 103 (1.94%)
         occurrences all number
    2
    2
    0
    0
    4
    Malaise - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    2 / 101 (1.98%)
    0 / 103 (0.00%)
         occurrences all number
    2
    0
    0
    4
    0
    Pain - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    2
    2
    2
    0
    0
    Injection site warmth - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    2 / 102 (1.96%)
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences all number
    0
    4
    0
    2
    0
    Axillary pain - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences all number
    2
    0
    2
    0
    2
    Chills - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    2
    2
    0
    Injection site induration - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    Influenza like illness - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences all number
    0
    0
    2
    0
    2
    Feeling cold - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Hangover - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Injection site discomfort - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Injection site haematoma - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Injection site discolouration - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Injection site rash - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Injection site pain - Extension Study
         subjects affected / exposed [2]
    34 / 39 (87.18%)
    18 / 46 (39.13%)
    35 / 41 (85.37%)
    36 / 41 (87.80%)
    37 / 46 (80.43%)
         occurrences all number
    68
    38
    70
    74
    74
    Fatigue - Extension Study
         subjects affected / exposed [3]
    10 / 39 (25.64%)
    16 / 46 (34.78%)
    19 / 41 (46.34%)
    15 / 41 (36.59%)
    17 / 46 (36.96%)
         occurrences all number
    23
    32
    39
    31
    35
    Injection site erythema - Extension Study
         subjects affected / exposed [4]
    7 / 39 (17.95%)
    1 / 46 (2.17%)
    6 / 41 (14.63%)
    4 / 41 (9.76%)
    4 / 46 (8.70%)
         occurrences all number
    14
    2
    12
    8
    8
    Pyrexia - Extension Study
         subjects affected / exposed [5]
    0 / 39 (0.00%)
    1 / 46 (2.17%)
    5 / 41 (12.20%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    2
    10
    0
    2
    Injection site swelling - Extension Study
         subjects affected / exposed [6]
    5 / 39 (12.82%)
    1 / 46 (2.17%)
    2 / 41 (4.88%)
    3 / 41 (7.32%)
    4 / 46 (8.70%)
         occurrences all number
    10
    2
    4
    6
    8
    Injection site pruritus - Extension Study
         subjects affected / exposed [7]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    2 / 41 (4.88%)
    1 / 41 (2.44%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    4
    2
    0
    Malaise - Extension Study
         subjects affected / exposed [8]
    1 / 39 (2.56%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    2
    0
    0
    0
    2
    Administration site pain - Extension Study
         subjects affected / exposed [9]
    1 / 39 (2.56%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Injection site induration - Extension Study
         subjects affected / exposed [10]
    1 / 39 (2.56%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Inflammation - Extension Study
         subjects affected / exposed [11]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Influenza like illness - Extension Study
         subjects affected / exposed [12]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Injection site haemorrhage - Extension Study
         subjects affected / exposed [13]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Pain - Extension Study
         subjects affected / exposed [14]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Administration site swelling - Extension Study
         subjects affected / exposed [15]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    0
    0
    1
    Injection site lymphadenopathy - Extension Study
         subjects affected / exposed [16]
    0 / 39 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Immune system disorders
    Drug hypersensitivity - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Seasonal allergy - Extension Study
         subjects affected / exposed [17]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    0
    0
    2
    Reproductive system and breast disorders
    Dysmenorrhoea - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    Vaginal discharge - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences all number
    0
    0
    0
    0
    2
    Intermenstrual bleeding - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences all number
    0
    0
    0
    0
    2
    Dysmenorrhoea - Extension Study
         subjects affected / exposed [18]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain - Primary Study
         subjects affected / exposed
    3 / 101 (2.97%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    2 / 101 (1.98%)
    1 / 103 (0.97%)
         occurrences all number
    8
    0
    2
    4
    2
    Cough - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    2 / 102 (1.96%)
    1 / 101 (0.99%)
    1 / 103 (0.97%)
         occurrences all number
    0
    0
    4
    2
    2
    Rhinorrhoea - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    2
    2
    0
    Nasal congestion - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    2 / 103 (1.94%)
         occurrences all number
    0
    0
    0
    0
    4
    Oropharyngeal pain - Extension Study
         subjects affected / exposed [19]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    3 / 41 (7.32%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    0
    6
    2
    Nasal congestion - Extension Study
         subjects affected / exposed [20]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Rhinorrhoea - Extension Study
         subjects affected / exposed [21]
    0 / 39 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Psychiatric disorders
    Insomnia - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    1 / 101 (0.99%)
    1 / 103 (0.97%)
         occurrences all number
    0
    0
    2
    2
    2
    Affect lability - Extension Study
         subjects affected / exposed [22]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Poor quality sleep - Extension Study
         subjects affected / exposed [23]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    0
    0
    2
    Injury, poisoning and procedural complications
    Procedural pain - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences all number
    2
    0
    0
    2
    0
    Thermal burn - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    Muscle strain - Extension Study
         subjects affected / exposed [24]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Contusion - Extension Study
         subjects affected / exposed [25]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    0
    0
    2
    Cardiac disorders
    Palpitations - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Nervous system disorders
    Headache - Primary Study
         subjects affected / exposed
    47 / 101 (46.53%)
    37 / 102 (36.27%)
    42 / 102 (41.18%)
    47 / 101 (46.53%)
    38 / 103 (36.89%)
         occurrences all number
    105
    76
    92
    101
    81
    Dizziness - Primary Study
         subjects affected / exposed
    2 / 101 (1.98%)
    1 / 102 (0.98%)
    1 / 102 (0.98%)
    2 / 101 (1.98%)
    0 / 103 (0.00%)
         occurrences all number
    4
    2
    2
    4
    0
    Disturbance in attention - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Migraine - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Sciatica - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Head discomfort - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Neuralgia - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Sleep deficit - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Post-traumatic headache - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences all number
    0
    0
    0
    0
    2
    Headache - Extension Study
         subjects affected / exposed [26]
    11 / 39 (28.21%)
    16 / 46 (34.78%)
    23 / 41 (56.10%)
    15 / 41 (36.59%)
    15 / 46 (32.61%)
         occurrences all number
    24
    34
    50
    31
    32
    Migraine with aura - Extension Study
         subjects affected / exposed [27]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    0
    0
    2
    Blood and lymphatic system disorders
    Lymphadenopathy - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
    2 / 102 (1.96%)
    0 / 101 (0.00%)
    2 / 103 (1.94%)
         occurrences all number
    2
    0
    4
    0
    4
    Lymphadenitis - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Ear and labyrinth disorders
    Ear pain - Extension Study
         subjects affected / exposed [28]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Eye disorders
    Vision blurred - Extension Study
         subjects affected / exposed [29]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    0
    0
    2
    Gastrointestinal disorders
    Gastrointestinal disorder - Primary Study
         subjects affected / exposed
    24 / 101 (23.76%)
    28 / 102 (27.45%)
    29 / 102 (28.43%)
    29 / 101 (28.71%)
    28 / 103 (27.18%)
         occurrences all number
    50
    56
    58
    60
    57
    Nausea - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences all number
    2
    0
    2
    0
    2
    Dyspepsia - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    Toothache - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    1 / 103 (0.97%)
         occurrences all number
    0
    0
    0
    2
    2
    Abdominal distension - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Diarrhoea - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Hyperchlorhydria - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Abdominal pain - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences all number
    0
    0
    0
    0
    2
    Gastrointestinal disorder - Extension Study
         subjects affected / exposed [30]
    4 / 39 (10.26%)
    7 / 46 (15.22%)
    10 / 41 (24.39%)
    10 / 41 (24.39%)
    7 / 46 (15.22%)
         occurrences all number
    9
    14
    20
    20
    14
    Oesophageal spasm - Extension Study
         subjects affected / exposed [31]
    0 / 39 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    2
    0
    0
    2
    Abdominal pain - Extension Study
         subjects affected / exposed [32]
    1 / 39 (2.56%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Diarrhoea - Extension Study
         subjects affected / exposed [33]
    1 / 39 (2.56%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Vomiting - Extension Study
         subjects affected / exposed [34]
    1 / 39 (2.56%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Rash - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    1 / 103 (0.97%)
         occurrences all number
    0
    2
    0
    2
    2
    Dermatitis - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Dermatitis allergic - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Night sweats - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Night sweats - Extension Study
         subjects affected / exposed [35]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Rash - Extension Study
         subjects affected / exposed [36]
    0 / 39 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Myalgia - Primary Study
         subjects affected / exposed
    2 / 101 (1.98%)
    0 / 102 (0.00%)
    4 / 102 (3.92%)
    4 / 101 (3.96%)
    1 / 103 (0.97%)
         occurrences all number
    4
    0
    8
    8
    2
    Back pain - Primary Study
         subjects affected / exposed
    2 / 101 (1.98%)
    2 / 102 (1.96%)
    2 / 102 (1.96%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences all number
    4
    4
    4
    0
    2
    Neck pain - Primary Study
         subjects affected / exposed
    2 / 101 (1.98%)
    1 / 102 (0.98%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences all number
    4
    2
    0
    0
    2
    Arthralgia - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    2 / 102 (1.96%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    4
    2
    0
    Muscle tightness - Primary Study
         subjects affected / exposed
    2 / 101 (1.98%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    4
    0
    0
    0
    0
    Pain in extremity - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences all number
    2
    0
    0
    0
    2
    Musculoskeletal pain - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Musculoskeletal stiffness - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Pain in jaw - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Limb discomfort - Extension Study
         subjects affected / exposed [37]
    1 / 39 (2.56%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    Arthralgia - Extension Study
         subjects affected / exposed [38]
    1 / 39 (2.56%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Myalgia - Extension Study
         subjects affected / exposed [39]
    0 / 39 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 46 (0.00%)
         occurrences all number
    0
    2
    0
    2
    0
    Infections and infestations
    Upper respiratory tract infection - Primary Study
         subjects affected / exposed
    8 / 101 (7.92%)
    5 / 102 (4.90%)
    2 / 102 (1.96%)
    9 / 101 (8.91%)
    4 / 103 (3.88%)
         occurrences all number
    16
    10
    4
    18
    8
    Nasopharyngitis - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    3 / 102 (2.94%)
    7 / 102 (6.86%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences all number
    2
    6
    14
    2
    0
    Urinary tract infection - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    2 / 102 (1.96%)
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences all number
    2
    4
    2
    0
    2
    Sinusitis - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    2 / 102 (1.96%)
    3 / 102 (2.94%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    0
    4
    6
    0
    0
    Rhinitis - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
    1 / 102 (0.98%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences all number
    2
    2
    2
    2
    0
    Gastroenteritis - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
    2 / 102 (1.96%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences all number
    0
    2
    4
    2
    0
    Pharyngitis - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences all number
    2
    0
    2
    0
    2
    Tooth infection - Primary Study
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 102 (0.98%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    Conjunctivitis - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Pharyngitis bacterial - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Pharyngitis streptococcal - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Viral infection - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Chlamydial infection - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Bacterial vaginosis - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 102 (0.98%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Ear infection - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Cystitis - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Gingivitis - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Oral herpes - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences all number
    0
    0
    0
    0
    2
    Otitis media - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences all number
    0
    0
    0
    0
    2
    Otitis media acute - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences all number
    0
    0
    0
    0
    2
    Vaginitis chlamydial - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences all number
    0
    0
    0
    0
    2
    Vulvovaginal mycotic infection - Primary Study
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 102 (0.00%)
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences all number
    0
    0
    0
    0
    2
    Pharyngitis - Extension Study
         subjects affected / exposed [40]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    2 / 41 (4.88%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    4
    0
    0
    Nasopharyngitis - Extension Study
         subjects affected / exposed [41]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    2
    0
    2
    Bronchitis - Extension Study
         subjects affected / exposed [42]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Ear infection - Extension Study
         subjects affected / exposed [43]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Gastroenteritis - Extension Study
         subjects affected / exposed [44]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Pyelonephritis - Extension Study
         subjects affected / exposed [45]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Respiratory tract infection - Extension Study
         subjects affected / exposed [46]
    0 / 39 (0.00%)
    1 / 46 (2.17%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 46 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Tonsillitis - Extension Study
         subjects affected / exposed [47]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 46 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Sinusitis - Extension Study
         subjects affected / exposed [48]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    0
    0
    2
    Upper respiratory tract infection - Extension Study
         subjects affected / exposed [49]
    0 / 39 (0.00%)
    0 / 46 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    0
    0
    2
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [36] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [37] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [38] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [39] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [40] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [41] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [42] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [43] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [44] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [45] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [46] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [47] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [48] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).
    [49] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Out of 509 subjects who completed the Primary Study, 296 subjects did not participate in the Extension Study due to non-compliance of protocol requirements (e.g. completion of the diary card, return for follow-up visits, no willingness/no informed consent obtained).

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jan 2020
    The amendment has following changes: To collect immunogenicity data to 12 months post dosing. Long term persistence data will be useful to inform the boosting schedule for women entering successive pregnancies. Unblinding after Day 181 will still occur and the extended study (epoch 4) will be open label. In addition, several discrepancies with the protocol with the study procedures manual were aligned.
    03 Apr 2020
    The sponsor has decided not to implement the 6-month extension for prolonged immunogenicity described under Amendment 2. The rationale for taking this decision is that the sponsor intends to submit an amendment that will enrol new participants (Cohort 2) to allow a more robust assessment of non-inferiority of Boostrix response in co-administration with RSVPreF3. An assessment of antibody persistence will be included in these newly enrolled subjects. Hence the evaluation of prolonged immunogenicity in Cohort 1 has become redundant. Changes not related to the study design of the extension phase in Amendment 2 were not removed for this amendment.
    28 Aug 2020
    This study has been amended to administer a 2nd dose of the 120 μg RSVPreF3 Maternal investigational vaccine to all consenting subjects within a 6-month period from the beginning of 12 months to the beginning of 18 months following initial immunization (≥12 to <18 months).This extension part of the study will use non-pregnant women as a proxy for women who may require additional dosing in successive pregnancies. Specifically, this extension will provide information on: long term immunogenicity of a 1st dose of 60 μg or 120 μg RSVPreF3 vaccine and safety and immunogenicity of 2nd dose of 120 μg RSVPreF3 vaccine. In addition, this protocol amendment outlines measures that may be applicable during special circumstances (e.g., COVID-19 pandemic). The purpose of the amendment is to protect the subject’s welfare, and as far as possible ensure the potential benefit to the subject and promote data integrity.

    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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