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    Clinical Trial Results:
    A Phase 1/2, randomized, observer-blind, controlled, multi-center study to evaluate safety, reactogenicity and immunogenicity of GSK Biologicals’ respiratory syncytial virus (RSV) investigational vaccine based on the RSV viral proteins F, N and M2-1 encoded by chimpanzee-derived adenovector (ChAd155-RSV) (GSK3389245A), when administered intramuscularly as a single dose or as two doses according to a 0, 1-month schedule, to infants aged 6 and 7 months

    Summary
    EudraCT number
    		 2018-000431-27
    Trial protocol
    		 FI   BE   ES   GB   PL   IT  
    Global end of trial date
    16 Nov 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 May 2022
    First version publication date
    29 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    204894
    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, 044 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 044 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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Feb 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jan 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Nov 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and reactogenicity of the RSV investigational vaccine when administered intramuscular (IM) as one (1.5x10^10 vp) dose or as two (5x10^10 vp) doses according to a 0, 1-month schedule, up to 60 days after Dose 1 (i.e., Day 61) in infants aged 6 and 7 months.
    Protection of trial subjects
    Subjects remained under observation for at least 60 minutes after first vaccination with study vaccine and were supervised for at least 30 minutes during subsequent vaccinations for the full course of the ChAd155-RSV (GSK3389245A) vaccine, with appropriate medical treatment readily available. Vaccines were always administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Apr 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 12
    Country: Number of subjects enrolled
    Colombia: 9
    Country: Number of subjects enrolled
    Brazil: 16
    Country: Number of subjects enrolled
    Finland: 11
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Mexico: 5
    Country: Number of subjects enrolled
    Panama: 56
    Country: Number of subjects enrolled
    Poland: 20
    Country: Number of subjects enrolled
    Spain: 45
    Country: Number of subjects enrolled
    Thailand: 3
    Country: Number of subjects enrolled
    Turkey: 17
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    201
    EEA total number of subjects
    78
    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)
    201
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All 201 subjects enrolled in the study received a study vaccination and were included in the Exposed Set.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    The study was conducted in an observer-blind manner.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 RSV1D Group
    Arm description
    		 Subjects received the interventions as follows: -Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). -Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSV (GSK3389245A) lower dose formulation vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of RSV (GSK3389245A) lower dose formulation vaccine administered intramuscularly at Day 1.

    Investigational medicinal product name
    GSK’s multicomponent meningococcal B vaccine
    Investigational medicinal product code
    Other name
    Bexsero
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses of GSK’s multicomponent meningococcal B vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 1, Day 61 and end of RSV season 1, depending on the vaccination schedule.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose or 2 doses of Placebo administered intramuscularly at Day 31, or at Day 1 and Day 31, or at Day 1 and Day 61, or at Day 1 and Day 121, or at Day 31 and Day 121, depending on the vaccination schedule.

    Investigational medicinal product name
    Pfizer’s meningococcal group A, C, W-135 and Y conjugate vaccine
    Investigational medicinal product code
    Other name
    Nimenrix
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses of Pfizer’s meningococcal group A, C, W-135 and Y conjugate vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 1, Day 61 and end of RSV season 1, depending on the vaccination schedule.

    Investigational medicinal product name
    GSK’s meningococcal group A, C, W-135 and Y conjugate vaccine
    Investigational medicinal product code
    Other name
    Menveo
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses of GSK’s meningococcal group A, C, W-135 and Y conjugate vaccine administered intramuscularly, at Day 61 and at the end of RSV season 1, or at Day 31 and end of RSV season 1, depending on the vaccination schedule.

    Investigational medicinal product name
    GSK’s pneumococcal polysaccharide conjugate vaccine
    Investigational medicinal product code
    Other name
    Synflorix
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses of GSK’s pneumococcal polysaccharide conjugate vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 31, Day 61 and end of RSV season 1, depending on the vaccination schedule.

    Arm title
    		 RSV2D Group
    Arm description
    		 Subjects received the interventions as follows: -Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). -Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pfizer’s meningococcal group A, C, W-135 and Y conjugate vaccine
    Investigational medicinal product code
    Other name
    Nimenrix
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses of Pfizer’s meningococcal group A, C, W-135 and Y conjugate vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 1, Day 61 and end of RSV season 1, depending on the vaccination schedule.

    Investigational medicinal product name
    RSV (GSK3389245A) higher dose formulation vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses of RSV (GSK3389245A) higher dose formulation vaccine administered intramuscularly, at Day 1 and Day 31.

    Investigational medicinal product name
    GSK’s multicomponent meningococcal B vaccine
    Investigational medicinal product code
    Other name
    Bexsero
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses of GSK’s multicomponent meningococcal B vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 1, Day 61 and end of RSV season 1, depending on the vaccination schedule.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose or 2 doses of Placebo administered intramuscularly at Day 31, or at Day 1 and Day 31, or at Day 1 and Day 61, or at Day 31 and Day 121, depending on the vaccination schedule.

    Investigational medicinal product name
    GSK’s meningococcal group A, C, W-135 and Y conjugate vaccine
    Investigational medicinal product code
    Other name
    Menveo
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses of GSK’s meningococcal group A, C, W-135 and Y conjugate vaccine administered intramuscularly, at Day 61 and at the end of RSV season 1, or at Day 31 and end of RSV season 1, depending on the vaccination schedule.

    Investigational medicinal product name
    GSK’s pneumococcal polysaccharide conjugate vaccine
    Investigational medicinal product code
    Other name
    Synflorix
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses of GSK’s pneumococcal polysaccharide conjugate vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 31, Day 61 and end of RSV season 1, depending on the vaccination schedule.

    Arm title
    		 Comparator_Placebo Group
    Arm description
    		 Subjects received either one of interventions schedules as follows: -3 doses of GSK’s multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). -3 doses of Pfizer’s meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). -3 doses of GSK’s pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). -2 doses of GSK’s meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) . -2 doses of Placebo alone (administered at Days 1 and 31).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    GSK’s multicomponent meningococcal B vaccine
    Investigational medicinal product code
    Other name
    Bexsero
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses of GSK’s multicomponent meningococcal B vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 1, Day 61 and end of RSV season 1, depending on the vaccination schedule.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose or 2 doses of Placebo administered intramuscularly at Day 31, or at Day 1 and Day 31, or at Day 1 and Day 61, or at Day 31 and Day 121, depending on the vaccination schedule.

    Investigational medicinal product name
    Pfizer’s meningococcal group A, C, W-135 and Y conjugate vaccine
    Investigational medicinal product code
    Other name
    Nimenrix
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses of Pfizer’s meningococcal group A, C, W-135 and Y conjugate vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 1, Day 61 and end of RSV season 1, depending on the vaccination schedule.

    Investigational medicinal product name
    GSK’s meningococcal group A, C, W-135 and Y conjugate vaccine
    Investigational medicinal product code
    Other name
    Menveo
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses of GSK’s meningococcal group A, C, W-135 and Y conjugate vaccine administered intramuscularly, at Day 61 and at the end of RSV season 1, or at Day 31 and end of RSV season 1, depending on the vaccination schedule.

    Investigational medicinal product name
    GSK’s pneumococcal polysaccharide conjugate vaccine
    Investigational medicinal product code
    Other name
    Synflorix
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses of GSK’s pneumococcal polysaccharide conjugate vaccine administered intramuscularly, at Day 61, Day 121 and at the end of RSV season 1, or at Day 31, Day 61 and end of RSV season 1, depending on the vaccination schedule.

    Number of subjects in period 1
    		RSV1D Group RSV2D Group Comparator_Placebo Group
    Started
    65
    71
    65
    Completed
    61
    71
    60
    Not completed
    4
    0
    5
         CONSENT WITHDRAWAL, NOT DUE TO AN AE AND/OR A SAE
    2
    -
    1
         NOT WILLING TO PARTICIPATE THIS VISIT
    1
    -
    2
         Adverse event, non-fatal
    -
    -
    1
         Not specified
    -
    -
    1
         Lost to follow-up
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RSV1D Group
    Reporting group description
    		 Subjects received the interventions as follows: -Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). -Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.

    Reporting group title
    RSV2D Group
    Reporting group description
    		 Subjects received the interventions as follows: -Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). -Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.

    Reporting group title
    Comparator_Placebo Group
    Reporting group description
    		 Subjects received either one of interventions schedules as follows: -3 doses of GSK’s multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). -3 doses of Pfizer’s meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). -3 doses of GSK’s pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). -2 doses of GSK’s meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) . -2 doses of Placebo alone (administered at Days 1 and 31).

    Reporting group values
    		 RSV1D Group RSV2D Group Comparator_Placebo Group Total
    Number of subjects
    		 65 71 65 201
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 65 71 65 201
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 6.4 ( 0.5 ) 6.5 ( 0.5 ) 6.5 ( 0.5 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 32 33 31 96
        Male
    		 33 38 34 105
    Race/Ethnicity, Customized
    Units: Subjects
        AMERICAN INDIAN OR ALASKA NATIVE
    		 1 1 2 4
        ASIAN
    		 1 1 1 3
        BLACK OR AFRICAN AMERICAN
    		 0 1 0 1
        OTHER, Not specified
    		 25 29 25 79
        WHITE
    		 38 39 37 114

    End points

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    End points reporting groups
    Reporting group title
    RSV1D Group
    Reporting group description
    		 Subjects received the interventions as follows: -Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). -Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.

    Reporting group title
    RSV2D Group
    Reporting group description
    		 Subjects received the interventions as follows: -Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). -Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.

    Reporting group title
    Comparator_Placebo Group
    Reporting group description
    		 Subjects received either one of interventions schedules as follows: -3 doses of GSK’s multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). -3 doses of Pfizer’s meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). -3 doses of GSK’s pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). -2 doses of GSK’s meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) . -2 doses of Placebo alone (administered at Days 1 and 31).

    Subject analysis set title
    Placebo Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received 2 doses of Placebo alone (administered at Days 1 and 31).

    Subject analysis set title
    Active Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received either one of interventions schedule as follows: -3 doses of GSK’s multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). -3 doses of Pfizer’s meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). -3 doses of GSK’s pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). -2 doses of GSK’s meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) .

    Subject analysis set title
    Placebo Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received 2 doses of Placebo alone (administered at Days 1 and 31).

    Subject analysis set title
    Active Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received either one of interventions schedule as follows: -3 doses of GSK’s multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). -3 doses of Pfizer’s meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). -3 doses of GSK’s pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). -2 doses of GSK’s meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) .

    Subject analysis set title
    Bexsero Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received 3 doses of GSK’s multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).

    Subject analysis set title
    Nimenrix Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received 3 doses of Pfizer’s meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).

    Subject analysis set title
    Synflorix Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received 3 doses of GSK’s pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121).

    Subject analysis set title
    Menveo Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received 2 doses of GSK’s meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61)

    Subject analysis set title
    Bexsero Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received 3 doses of GSK’s multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121).

    Primary: Number of subjects with any solicited local adverse events (AEs) during a 7-day follow-up period after the first vaccination (administered at Day 1)

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    End point title
    		 Number of subjects with any solicited local adverse events (AEs) during a 7-day follow-up period after the first vaccination (administered at Day 1) [1] [2]
    End point description
    Assessed solicited local AEs are erythema, pain and swelling at injection site. Any = occurrence of the adverse event regardless of intensity grade. Any redness and swelling = adverse event reported with a surface diameter greater than 0 millimeters. Analysis was performed on the Exposed set, which included all subjects with at least 1 study vaccine administration documented and diary card completed after first vaccination. Solicited local AEs were summarized by 4 groups to provide a comparison group with only placebo rather than a mixture of placebo and active comparators (Comparator_Placebo Group). Study interest was to collect solicited AEs during the follow-up period of study RSV vaccine, compared to placebo and routine pediatric vaccines.
    End point type
    Primary
    End point timeframe
    During a 7-day follow-up period after the first vaccination (administered at Day 1)
    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.
    [2] - 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: Solicited local AEs were summarized by 4 groups to provide a comparison group with only placebo rather than a mixture of placebo and active comparators (Comparator Placebo Group). Study Investigator’s interest was to check solicited AEs only during the follow-up period of experimental RSV vaccine.
    End point values
    		 RSV1D Group RSV2D Group Placebo Group Active Group
    Number of subjects analysed
    65
    71
    22
    42
    Units: Subjects
        Any Erythema
    5
    6
    0
    22
        Any Pain
    11
    10
    1
    17
        Any Swelling
    2
    3
    2
    11
    No statistical analyses for this end point

    Primary: Number of subjects with any solicited local adverse events (AEs) during a 7-day follow-up period after the second vaccination (administered at Day 31)

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    End point title
    		 Number of subjects with any solicited local adverse events (AEs) during a 7-day follow-up period after the second vaccination (administered at Day 31) [3] [4]
    End point description
    End point type
    Primary
    End point timeframe
    During a 7-day follow-up period after the second vaccination (administered at 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.
    [4] - 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: Solicited local AEs were summarized by 4 groups to provide a comparison group with only placebo rather than a mixture of placebo and active comparators (Comparator Placebo Group). Study Investigator’s interest was to check solicited AEs only during the follow-up period of experimental RSV vaccine.
    End point values
    		 RSV1D Group RSV2D Group Placebo Group Active Group
    Number of subjects analysed
    63
    71
    20
    41
    Units: Subjects
        Any Erythema
    8
    7
    0
    11
        Any Pain
    5
    9
    0
    6
        Any Swelling
    1
    3
    0
    6
    No statistical analyses for this end point

    Primary: Number of subjects with any solicited general AEs during a 7-day follow-up period after the first vaccination (administered at Day 1)

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    End point title
    		 Number of subjects with any solicited general AEs during a 7-day follow-up period after the first vaccination (administered at Day 1) [5] [6]
    End point description
    Assessed solicited general adverse events are drowsiness, fever [defined as temperature equal to or above (>=) 38.degrees Celsius (C)/100.4 Fahrenheit (F) by any route], irritability/fussiness and loss of appetite. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. Analysis was performed on the Exposed set, which included all subjects with at least 1 study vaccine administration documented and the diary card completed after first vaccination. Solicited general AEs were summarized by individual comparators (placebo, Bexsero, Nimenrix, Synflorix, Menveo) as the interest was to investigate solicited AEs during the follow-up period of study RSV vaccine, compared to placebo and routine pediatric vaccines, especially comparing to the rates of Bexsero-related fever.
    End point type
    Primary
    End point timeframe
    During a 7-day follow-up period after the first vaccination (administered at Day 1)
    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.
    [6] - 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: Solicited local AEs were summarized by 4 groups to provide a comparison group with only placebo rather than a mixture of placebo and active comparators (Comparator Placebo Group). Study Investigator’s interest was to check solicited AEs only during the follow-up period of experimental RSV vaccine.
    End point values
    		 RSV1D Group RSV2D Group Placebo Group Bexsero Group Nimenrix Group Synflorix Group Menveo Group
    Number of subjects analysed
    65
    71
    22
    28
    1
    1
    12
    Units: Subjects
        Any Drowsiness
    12
    19
    7
    11
    0
    1
    2
        Any Fever
    9
    24
    5
    11
    0
    0
    2
        Any Irritability/Fussiness
    25
    31
    9
    20
    0
    1
    4
        Any Loss of appetite
    12
    17
    8
    12
    0
    0
    2
    No statistical analyses for this end point

    Primary: Number of subjects with any solicited general AEs during a 7-day follow-up period after the second vaccination (administered at Day 31)

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    End point title
    		 Number of subjects with any solicited general AEs during a 7-day follow-up period after the second vaccination (administered at Day 31) [7] [8]
    End point description
    End point type
    Primary
    End point timeframe
    During a 7-day follow-up period after the second vaccination (administered at Day 31)
    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.
    [8] - 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: Solicited local AEs were summarized by 4 groups to provide a comparison group with only placebo rather than a mixture of placebo and active comparators (Comparator Placebo Group). Study Investigator’s interest was to check solicited AEs only during the follow-up period of experimental RSV vaccine.
    End point values
    		 RSV1D Group RSV2D Group Placebo Group Nimenrix Group Synflorix Group Menveo Group Bexsero Group
    Number of subjects analysed
    63
    71
    20
    1
    1
    12
    27
    Units: Subjects
        Any Drowsiness
    10
    18
    3
    0
    0
    4
    5
        Any Fever
    6
    28
    0
    0
    0
    3
    1
        Any Irritability/Fussiness
    18
    33
    3
    0
    0
    6
    9
        Any Loss of appetite
    7
    22
    3
    0
    0
    4
    4
    No statistical analyses for this end point

    Primary: Number of subjects with any unsolicited AEs

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    End point title
    		 Number of subjects with any unsolicited AEs [9]
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AEs are reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination. The analysis was performed on the Exposed set, which included all subjects with at least one study vaccine administration documented. Study interest was to check unsolicited AEs only during the follow-up period of study RSV vaccine.
    End point type
    Primary
    End point timeframe
    During a 30-day follow-up period across the 2 vaccinations administered at Day 1 and Day 31
    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
    		 RSV1D Group RSV2D Group Comparator_Placebo Group
    Number of subjects analysed
    65
    71
    65
    Units: Subjects
    34
    45
    36
    No statistical analyses for this end point

    Primary: Number of subjects with any serious adverse events (SAEs) from Day 1 up to Day 61

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    End point title
    		 Number of subjects with any serious adverse events (SAEs) from Day 1 up to Day 61 [10]
    End point description
    Assessed serious adverse events (SAEs) include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.
    End point type
    Primary
    End point timeframe
    From Day 1 up to Day 61
    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
    		 RSV1D Group RSV2D Group Comparator_Placebo Group
    Number of subjects analysed
    65
    71
    65
    Units: Subjects
    3
    3
    0
    No statistical analyses for this end point

    Primary: Number of subjects with episode of spontaneous or excessive bleeding (AE of special interest)

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    End point title
    		 Number of subjects with episode of spontaneous or excessive bleeding (AE of special interest) [11]
    End point description
    Any episode of spontaneous or excessive bleeding if occurring after vaccination was to be fully investigated with a full range of hematological tests to identify the underlying cause and reported as an AE of special interest. The analysis was performed on the Exposed set, which included all subjects with at least one study vaccine administration documented. Study interest was to check episode of spontaneous or excessive bleeding (AE of special interest) only during the follow-up period of study RSV vaccine.
    End point type
    Primary
    End point timeframe
    During a 30-day follow-up period across the 2 vaccinations administered at Day 1 and 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
    		 RSV1D Group RSV2D Group Comparator_Placebo Group
    Number of subjects analysed
    65
    71
    65
    Units: Subjects
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with respiratory tract infection associated with RSV infection (RSV-RTI), lower respiratory tract infection associated with RSV infection (RSV-LRTI), severe RSV-LRTI and very severe RSV-LRTI (according to standardized case definitions)

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    End point title
    		 Number of subjects with respiratory tract infection associated with RSV infection (RSV-RTI), lower respiratory tract infection associated with RSV infection (RSV-LRTI), severe RSV-LRTI and very severe RSV-LRTI (according to standardized case definitions)
    End point description
    According to standardized case definitions, RSV-RTI refers to subject having runny nose, OR blocked nose, OR cough AND confirmed RSV infection [RSV infection confirmed on nasal swab positive for RSV A or B by quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) performed at sponsor level]. RSV-LRTI refers to a subject having a history of cough OR difficulty breathing [based on history reported by parents] AND blood oxygen saturation (SpO2) lower than (<) 95 percent (%), OR respiratory rate (RR) increase [defined as RR higher than or equal to (≥) 50 per (/) minute (for 2-11 months of age) and ≥ 40/min (for 12 months of age or above)] AND confirmed RSV infection. Severe RSV-LRTI are cases meeting the RSV-LRTI case definition AND an SpO2 < 93 %, OR lower chest wall in-drawing. Very severe RSV-LRTI are cases meeting the case definition of RSV-LRTI AND an SpO2 <90%, OR inability to feed, OR failure to respond/unconscious.
    End point type
    Secondary
    End point timeframe
    From first vaccination (Day 1) up to the end of the first RSV transmission season (up to 1 year)
    End point values
    		 RSV1D Group RSV2D Group Comparator_Placebo Group
    Number of subjects analysed
    65
    71
    65
    Units: Subjects
        RSV-RTI
    21
    17
    27
        RSV-LRTI
    3
    3
    4
        Severe RSV-LRTI
    1
    1
    3
        Very severe RSV-LRTI
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with RSV-RTI, RSV-LRTI, severe RSV-LRTI and very severe RSV-LRTI (according to standardized case definitions)

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    End point title
    		 Number of subjects with RSV-RTI, RSV-LRTI, severe RSV-LRTI and very severe RSV-LRTI (according to standardized case definitions)
    End point description
    End point type
    Secondary
    End point timeframe
    From first vaccination (Day 1) up to the end of the second RSV transmission season (up to 2 years)
    End point values
    		 RSV1D Group RSV2D Group Comparator_Placebo Group
    Number of subjects analysed
    65
    71
    65
    Units: Subjects
        RSV-RTI
    23
    18
    30
        RSV-LRTI
    3
    3
    4
        Severe RSV-LRTI
    1
    1
    3
        Very severe RSV-LRTI
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with SAEs from first vaccination (Day 1) up to the end of the second RSV transmission season (up to 2 years)

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    End point title
    		 Number of subjects with SAEs from first vaccination (Day 1) up to the end of the second RSV transmission season (up to 2 years)
    End point description
    End point type
    Secondary
    End point timeframe
    From first vaccination (Day 1) up to the end of the second RSV transmission season (up to 2 years)
    End point values
    		 RSV1D Group RSV2D Group Comparator_Placebo Group
    Number of subjects analysed
    65
    71
    65
    Units: Subjects
    7
    11
    3
    No statistical analyses for this end point

    Secondary: Number of subjects with RSV-LRTI (AE of special interest) from first vaccination (Day 1) up to the end of the first RSV transmission season (up to 1 year)

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    End point title
    		 Number of subjects with RSV-LRTI (AE of special interest) from first vaccination (Day 1) up to the end of the first RSV transmission season (up to 1 year)
    End point description
    Subjects experiencing an LRTI associated with RSV infection were reported as AE of special interest. To identify RSV-LRTI for the purpose of AE of specific interest, the diagnosis was based on the investigators' clinical judgment taking into account the clinical history, the examination, relevant medical investigations and locally-available diagnostic test for RSV.
    End point type
    Secondary
    End point timeframe
    From first vaccination (Day 1) up to the end of the first RSV transmission season (up to 1 year)
    End point values
    		 RSV1D Group RSV2D Group Comparator_Placebo Group
    Number of subjects analysed
    65
    71
    65
    Units: Subjects
    7
    6
    7
    No statistical analyses for this end point

    Secondary: Number of subjects with RSV-LRTI (AE of special interest) from first vaccination (Day 1) up to the end of the second RSV transmission season (up to 2 years)

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    End point title
    		 Number of subjects with RSV-LRTI (AE of special interest) from first vaccination (Day 1) up to the end of the second RSV transmission season (up to 2 years)
    End point description
    End point type
    Secondary
    End point timeframe
    From first vaccination (Day 1) up to the end of the second RSV transmission season (up to 2 years)
    End point values
    		 RSV1D Group RSV2D Group Comparator_Placebo Group
    Number of subjects analysed
    65
    71
    65
    Units: Subjects
    7
    6
    7
    No statistical analyses for this end point

    Secondary: Number of RSV infected subjects with a negative RSV exposure status (at screening based on in-stream baseline serological testing) with very severe RSV-LRTI (according to standardized case definition)

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    End point title
    		 Number of RSV infected subjects with a negative RSV exposure status (at screening based on in-stream baseline serological testing) with very severe RSV-LRTI (according to standardized case definition)
    End point description
    Very severe RSV LRTI are cases meeting the case definition of RSV-LRTI AND a SpO2 <90%, OR inability to feed, OR failure to respond/unconscious. The analysis was performed on the Exposed set with a negative RSV exposure status, which included all vaccinated subjects assessed as RSV unexposed at screening based on in-stream baseline serological testing.
    End point type
    Secondary
    End point timeframe
    From first vaccination (Day 1) up to the end of the first RSV transmission season (up to 1 year)
    End point values
    		 RSV1D Group RSV2D Group Comparator_Placebo Group
    Number of subjects analysed
    49
    58
    52
    Units: Subjects
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Anti-RSV-A neutralizing antibody titers

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    End point title
    		 Anti-RSV-A neutralizing antibody titers
    End point description
    Humoral response to the investigational RSV vaccine was measured in terms of anti-RSV-A neutralizing antibody titers and expressed as geometric mean titers (GMTs) in Estimated Dilution 60 (ED60) titers. The analysis was performed on the Per-protocol set for analysis of immunogenicity, which included all subjects with at least one study vaccine administration documented, who complied with eligibility criteria, study procedures up to the end of the study and had immunogenicity results for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At pre-vaccination (Screening), Day 31, Day 61 and at the end of the first RSV transmission season (EOS1) (up to 1 year)
    End point values
    		 RSV1D Group RSV2D Group Comparator_Placebo Group
    Number of subjects analysed
    64
    71
    61
    Units: Titers
    geometric mean (confidence interval 95%)
        Screening (N=64,71,61)
    26.8 (20.7 to 34.6)
    29.6 (23.6 to 37.3)
    32.2 (24.9 to 41.6)
        Day 31 (N=63,69,61)
    60.2 (44.2 to 81.9)
    116.2 (87.6 to 153.9)
    18.9 (14.8 to 24.1)
        Day 61 (N=63,70,56)
    54.3 (37.7 to 78)
    259.4 (211.6 to 318.1)
    14.4 (11.8 to 17.7)
        EOS1 (N=60,70,61)
    165 (95 to 286.6)
    223.7 (154.7 to 323.4)
    66.3 (40.2 to 109.5)
    No statistical analyses for this end point

    Secondary: Anti-RSV-F antibody concentrations

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    End point title
    		 Anti-RSV-F antibody concentrations
    End point description
    Humoral response to the investigational RSV vaccine was measured in terms of anti-RSV-F antibody concentrations and expressed as geometric mean concentrations (GMCs) in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL). The analysis was performed on the Per-protocol set for analysis of immunogenicity, which included all subjects with at least one study vaccine administration documented, who complied with eligibility criteria, study procedures up to the end of the study and had immunogenicity results for the specified assay and time point.
    End point type
    Secondary
    End point timeframe
    At pre-vaccination (Screening), Day 31, Day 61 and at the end of the first RSV transmission season (EOS1) (up to 1 year)
    End point values
    		 RSV1D Group RSV2D Group Comparator_Placebo Group
    Number of subjects analysed
    64
    71
    61
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Screening (N=63,71,61)
    93.1 (72.7 to 119.1)
    81.9 (61.8 to 108.6)
    86 (65.5 to 112.7)
        Day 31 (N=64,70,60)
    2035.2 (1490 to 2779.9)
    4550.8 (3354.6 to 6173.7)
    46.2 (31.6 to 67.6)
        Day 61 (N=61,70,55)
    1976.5 (1346.2 to 2901.8)
    9287.9 (7885.5 to 10939.7)
    24.6 (18.3 to 33)
        EOS1 (N=60,69,60)
    5108.7 (3096.7 to 8428)
    4935.5 (3639.8 to 6692.4)
    345.1 (165.9 to 717.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs were collected during the 7-day follow-up period and unsolicited AEs during the 30-day follow-up period after any vaccination. SAEs were collected from Day 1 up to the end of the second RSV transmission season (up to 2 years).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    RSV1D Group
    Reporting group description
    		 Subjects received the interventions as follows: -Either 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31 and any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). -Or 1 dose of experimental RSV (GSK3389245A) lower dose formulation at Day 1, followed by 1 dose of Placebo at Day 31.

    Reporting group title
    Comparator_Placebo Group
    Reporting group description
    		 Subjects received either one of interventions schedules as follows: -3 doses of GSK’s multicomponent meningococcal B vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). -3 doses of Pfizer’s meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Days 1, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 31 and 121). -3 doses of GSK’s pneumococcal polysaccharide conjugate vaccine (administered at Days 31, 61 and at the end of RSV season 1) and 2 doses of Placebo (administered at Day 1 and Day 121). -2 doses of GSK’s meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 31 and at the end of RSV season 1) and 2 doses of Placebo (administered at Days 1 and 61) . -2 doses of Placebo alone (administered at Days 1 and 31).

    Reporting group title
    RSV2D Group
    Reporting group description
    		 Subjects received the interventions as follows: -Either 2 doses of experimental RSV (GSK3389245A) higher dose formulation (administered at Day 1 and Day 31) and followed by any one the following active comparators: 2 doses of GSK's meningococcal group A, C, W-135 and Y conjugate vaccine (administered at Day 61 and at the end of RSV season 1) or 3 doses of GSK's multicomponent meningococcal B vaccine or Pfizer's meningococcal group A, C, W-135 and Y conjugate vaccine or GSK's pneumococcal polysaccharide conjugate vaccine (administered at Days 61, 121 and at the end of RSV season 1). -Or 2 doses of experimental RSV (GSK3389245A) higher dose formulation administered at Day 1 and Day 31.

    Serious adverse events
    		 RSV1D Group Comparator_Placebo Group RSV2D Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 65 (10.77%)
    3 / 65 (4.62%)
    11 / 71 (15.49%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Foreign body in respiratory tract
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess neck
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    H1N1 influenza
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection viral
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parvovirus infection
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    2 / 71 (2.82%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 65 (1.54%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 RSV1D Group Comparator_Placebo Group RSV2D Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    57 / 65 (87.69%)
    57 / 65 (87.69%)
    67 / 71 (94.37%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    17 / 65 (26.15%)
    23 / 65 (35.38%)
    37 / 71 (52.11%)
         occurrences all number
    18
    25
    54
    Administration site erythema
         subjects affected / exposed
    9 / 65 (13.85%)
    26 / 65 (40.00%)
    11 / 71 (15.49%)
         occurrences all number
    13
    33
    13
    Administration site pain
         subjects affected / exposed
    13 / 65 (20.00%)
    19 / 65 (29.23%)
    12 / 71 (16.90%)
         occurrences all number
    16
    24
    19
    Administration site swelling
         subjects affected / exposed
    3 / 65 (4.62%)
    18 / 65 (27.69%)
    4 / 71 (5.63%)
         occurrences all number
    3
    19
    6
    Injection site bruising
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    2 / 71 (2.82%)
         occurrences all number
    1
    0
    2
    Chills
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    Feeling hot
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Hypopnoea
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    0
    Cough
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    1
    Sneezing
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    34 / 65 (52.31%)
    36 / 65 (55.38%)
    41 / 71 (57.75%)
         occurrences all number
    44
    53
    65
    Insomnia
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    Sleep disorder
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 65 (1.54%)
    2 / 71 (2.82%)
         occurrences all number
    0
    1
    2
    Head injury
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    Congenital, familial and genetic disorders
    Congenital pulmonary valve atresia
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    18 / 65 (27.69%)
    26 / 65 (40.00%)
    29 / 71 (40.85%)
         occurrences all number
    22
    33
    37
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 65 (1.54%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    1
    Monocytosis
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 65 (6.15%)
    4 / 65 (6.15%)
    3 / 71 (4.23%)
         occurrences all number
    4
    6
    3
    Vomiting
         subjects affected / exposed
    4 / 65 (6.15%)
    2 / 65 (3.08%)
    4 / 71 (5.63%)
         occurrences all number
    4
    2
    5
    Teething
         subjects affected / exposed
    4 / 65 (6.15%)
    1 / 65 (1.54%)
    4 / 71 (5.63%)
         occurrences all number
    4
    2
    4
    Constipation
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences all number
    1
    1
    0
    Abdominal pain
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    Toothache
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    Flatulence
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    1
    Gingival pain
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    1
    Mucous stools
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    1
    Hepatobiliary disorders
    Hepatosplenomegaly
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
         subjects affected / exposed
    4 / 65 (6.15%)
    3 / 65 (4.62%)
    2 / 71 (2.82%)
         occurrences all number
    5
    3
    2
    Rash
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 65 (0.00%)
    2 / 71 (2.82%)
         occurrences all number
    2
    0
    2
    Dermatitis contact
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    0
    Eczema
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    1
    0
    1
    Dry skin
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    Erythema
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    1
    Urticaria
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    12 / 65 (18.46%)
    15 / 65 (23.08%)
    13 / 71 (18.31%)
         occurrences all number
    14
    19
    15
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 65 (6.15%)
    5 / 65 (7.69%)
    8 / 71 (11.27%)
         occurrences all number
    6
    5
    11
    Gastroenteritis
         subjects affected / exposed
    3 / 65 (4.62%)
    2 / 65 (3.08%)
    7 / 71 (9.86%)
         occurrences all number
    3
    2
    7
    Otitis media acute
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 65 (1.54%)
    3 / 71 (4.23%)
         occurrences all number
    0
    1
    4
    Rhinitis
         subjects affected / exposed
    1 / 65 (1.54%)
    2 / 65 (3.08%)
    0 / 71 (0.00%)
         occurrences all number
    1
    2
    0
    Otitis media
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    2
    0
    1
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 65 (1.54%)
    2 / 71 (2.82%)
         occurrences all number
    0
    1
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    2 / 71 (2.82%)
         occurrences all number
    1
    0
    2
    Gastroenteritis viral
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences all number
    1
    1
    0
    Impetigo
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences all number
    1
    1
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences all number
    1
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences all number
    1
    1
    0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences all number
    1
    1
    0
    Acarodermatitis
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    0
    Bronchitis
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    4
    0
    0
    Tonsillitis
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    0
    Influenza
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    1
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    2
    0
    1
    Pyoderma
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 65 (1.54%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    1
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 65 (1.54%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    1
    Bronchiolitis
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    Ear infection
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    Exanthema subitum
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    Herpangina
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    Laryngitis
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    Otitis externa
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences all number
    0
    1
    0
    Viral infection
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0
    Croup infectious
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    17 / 65 (26.15%)
    25 / 65 (38.46%)
    32 / 71 (45.07%)
         occurrences all number
    19
    33
    39
    Malnutrition
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jul 2018
    Clarification added that the study will evaluate 2 regimens of the investigational vaccine. Synflorix vaccine was added as one of the potential active comparator vaccines to be considered in the countries where it is currently licensed.
    24 Jan 2019
    Clarification added that hypersensitivity to any component of comparator or control vaccines used in this study or contraindication to them is an exclusion criterion.
    21 Mar 2019
    Indication of Pneumonia was added for Synflorix. Exclusion criteria related to mothers participating in another clinical study was clarified to specified if breast-feeding. Cut off values for neutralization assay was added.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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