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    Clinical Trial Results:
    A Phase 1, Open-Label, age-Descending, Dose-Finding Study to Evaluate the Safety, Tolerability, and Immunogenicity of Respiratory Syncytial Virus Prefusion F Subunit Vaccine (RSVpreF) in Children 2 to <18 Years of age

    Summary
    EudraCT number
    		 2024-000422-17
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    29 Feb 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Nov 2024
    First version publication date
    28 Nov 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    C3671016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05900154
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002795-PIP02-21
    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
    09 Jul 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Feb 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the safety and tolerability of RSVpreF at each dose level in children 5 to less than (<) 18 years of age and children 2 to <5 years of age.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Jun 2023
    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: 127
    Worldwide total number of subjects
    127
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    88
    Adolescents (12-17 years)
    39
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted in United States only, from 22 June 2023 to 29 February 2024. A total of 127 participants were enrolled and in receipt of RSVpreF.

    Pre-assignment
    Screening details
    		 Participants were divided into 2 age groups: 5 to <18 years and 2 to < 5 years. All participants received single dose of RSVpreF vaccine.

    Period 1
    Period 1 title
    Period 1: Vaccination Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Healthy RSVpreF 120 micrograms (mcg)
    Arm description
    		 Healthy participants, 5 to < 18 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVpreF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    120 mcg of RSVpreF was administered intramuscularly as a single dose on Day 1.

    Arm title
    		 High Risk RSVpreF 120 mcg
    Arm description
    		 High risk participants, 5 to < 18 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVpreF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    120 mcg of RSVpreF was administered intramuscularly as a single dose on Day 1.

    Arm title
    		 2 to < 5 Years RSVpreF 120 mcg
    Arm description
    		 Participants, 2 to < 5 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVpreF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    120 mcg of RSVpreF was administered intramuscularly as a single dose on Day 1.

    Arm title
    		 Healthy RSVpreF 60 mcg
    Arm description
    		 Healthy participants, 5 to < 18 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVpreF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    60 mcg of RSVpreF was administered intramuscularly as a single dose on Day 1.

    Arm title
    		 High Risk RSVpreF 60 mcg
    Arm description
    		 High risk participants, 5 to < 18 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVpreF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    60 mcg of RSVpreF was administered intramuscularly as a single dose on Day 1.

    Arm title
    		 2 to < 5 Years RSVpreF 60 mcg
    Arm description
    		 Participants, 2 to < 5 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVpreF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    60 mcg of RSVpreF was administered intramuscularly as a single dose on Day 1.

    Number of subjects in period 1
    		Healthy RSVpreF 120 micrograms (mcg) High Risk RSVpreF 120 mcg 2 to < 5 Years RSVpreF 120 mcg Healthy RSVpreF 60 mcg High Risk RSVpreF 60 mcg 2 to < 5 Years RSVpreF 60 mcg
    Started
    25
    23
    24
    17
    18
    20
    Completed
    25
    23
    24
    17
    18
    20
    Period 2
    Period 2 title
    Period 2: Follow-Up Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Healthy RSVpreF 120 mcg
    Arm description
    		 Healthy participants, 5 to < 18 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVpreF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    120 mcg of RSVpreF was administered intramuscularly as a single dose on Day 1.

    Arm title
    		 High Risk RSVpreF 120 mcg
    Arm description
    		 High risk participants, 5 to < 18 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVpreF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    120 mcg of RSVpreF was administered intramuscularly as a single dose on Day 1.

    Arm title
    		 2 to < 5 Years RSVpreF 120 mcg
    Arm description
    		 Participants, 2 to < 5 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVpreF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    120 mcg of RSVpreF was administered intramuscularly as a single dose on Day 1.

    Arm title
    		 Healthy RSVpreF 60 mcg
    Arm description
    		 Healthy participants, 5 to < 18 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVpreF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    60 mcg of RSVpreF was administered intramuscularly as a single dose on Day 1.

    Arm title
    		 High Risk RSVpreF 60 mcg
    Arm description
    		 High risk participants, 5 to < 18 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVpreF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    60 mcg of RSVpreF was administered intramuscularly as a single dose on Day 1.

    Arm title
    		 2 to < 5 Years RSVpreF 60 mcg
    Arm description
    		 Participants, 2 to < 5 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVpreF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    60 mcg of RSVpreF was administered intramuscularly as a single dose on Day 1.

    Number of subjects in period 2
    		Healthy RSVpreF 120 mcg High Risk RSVpreF 120 mcg 2 to < 5 Years RSVpreF 120 mcg Healthy RSVpreF 60 mcg High Risk RSVpreF 60 mcg 2 to < 5 Years RSVpreF 60 mcg
    Started
    25
    23
    24
    17
    18
    20
    Completed
    24
    21
    23
    17
    17
    19
    Not completed
    1
    2
    1
    0
    1
    1
         Lost to follow-up
    1
    2
    1
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Healthy RSVpreF 120 micrograms (mcg)
    Reporting group description
    		 Healthy participants, 5 to < 18 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group title
    High Risk RSVpreF 120 mcg
    Reporting group description
    		 High risk participants, 5 to < 18 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group title
    2 to < 5 Years RSVpreF 120 mcg
    Reporting group description
    		 Participants, 2 to < 5 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group title
    Healthy RSVpreF 60 mcg
    Reporting group description
    		 Healthy participants, 5 to < 18 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group title
    High Risk RSVpreF 60 mcg
    Reporting group description
    		 High risk participants, 5 to < 18 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group title
    2 to < 5 Years RSVpreF 60 mcg
    Reporting group description
    		 Participants, 2 to < 5 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group values
    		 Healthy RSVpreF 120 micrograms (mcg) High Risk RSVpreF 120 mcg 2 to < 5 Years RSVpreF 120 mcg Healthy RSVpreF 60 mcg High Risk RSVpreF 60 mcg 2 to < 5 Years RSVpreF 60 mcg Total
    Number of subjects
    		 25 23 24 17 18 20 127
    Age Categorical
    Units: Participants
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0
        Children (2-11 years)
    		 9 11 24 12 12 20 88
        Adolescents (12-17 years)
    		 16 12 0 5 6 0 39
        Adults (18-64 years)
    		 0 0 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.56 ( 4.55 ) 11.04 ( 3.50 ) 3.00 ( 0.78 ) 9.53 ( 3.57 ) 9.61 ( 3.40 ) 3.20 ( 0.77 ) -
    Gender Categorical
    Units: Participants
        Female
    		 15 11 13 5 7 7 58
        Male
    		 10 12 11 12 11 13 69
    Race
    Units: Subjects
        White
    		 16 17 17 13 9 15 87
        Black or African American
    		 7 6 3 2 6 4 28
        Asian
    		 2 0 0 0 0 0 2
        American Indian or Alaska Native
    		 0 0 1 0 0 0 1
        Multiracial
    		 0 0 3 2 3 1 9
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    		 5 0 1 3 4 5 18
        Non-Hispanic/non-Latino
    		 20 23 22 14 13 15 107
        Not reported
    		 0 0 1 0 1 0 2

    End points

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    End points reporting groups
    Reporting group title
    Healthy RSVpreF 120 micrograms (mcg)
    Reporting group description
    		 Healthy participants, 5 to < 18 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group title
    High Risk RSVpreF 120 mcg
    Reporting group description
    		 High risk participants, 5 to < 18 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group title
    2 to < 5 Years RSVpreF 120 mcg
    Reporting group description
    		 Participants, 2 to < 5 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group title
    Healthy RSVpreF 60 mcg
    Reporting group description
    		 Healthy participants, 5 to < 18 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group title
    High Risk RSVpreF 60 mcg
    Reporting group description
    		 High risk participants, 5 to < 18 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group title
    2 to < 5 Years RSVpreF 60 mcg
    Reporting group description
    		 Participants, 2 to < 5 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.
    Reporting group title
    Healthy RSVpreF 120 mcg
    Reporting group description
    		 Healthy participants, 5 to < 18 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group title
    High Risk RSVpreF 120 mcg
    Reporting group description
    		 High risk participants, 5 to < 18 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group title
    2 to < 5 Years RSVpreF 120 mcg
    Reporting group description
    		 Participants, 2 to < 5 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group title
    Healthy RSVpreF 60 mcg
    Reporting group description
    		 Healthy participants, 5 to < 18 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group title
    High Risk RSVpreF 60 mcg
    Reporting group description
    		 High risk participants, 5 to < 18 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group title
    2 to < 5 Years RSVpreF 60 mcg
    Reporting group description
    		 Participants, 2 to < 5 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Primary: Percentage of Participants With Local Reactions Within 7 Days After Vaccination

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    End point title
    		 Percentage of Participants With Local Reactions Within 7 Days After Vaccination [1]
    End point description
    Local reactions were collected in the electronic diary (e-diary) from Day 1 through Day 7 after vaccination. Local reactions included redness, swelling and pain at injection site. For participants greater than or equal to (>=) 2 years to <12 years of age, redness and swelling were graded as mild: 0.5 to 2.0 centimeter (cm), moderate: >2.0 to 7.0 cm, and severe: > 7 cm; for participants >=12 years of age, mild: > 2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, and severe: >10 cm. Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Percentage of participants reporting local reactions at injection site and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented in this endpoint. Safety population included all enrolled participants who received study intervention.
    End point type
    Primary
    End point timeframe
    Within 7 days after Vaccination
    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: Only descriptive data was planned to be analyzed
    End point values
    		 Healthy RSVpreF 120 micrograms (mcg) High Risk RSVpreF 120 mcg 2 to < 5 Years RSVpreF 120 mcg Healthy RSVpreF 60 mcg High Risk RSVpreF 60 mcg 2 to < 5 Years RSVpreF 60 mcg
    Number of subjects analysed
    25
    23
    24
    17
    18
    20
    Units: Percentage of participants
    number (confidence interval 95%)
        Pain at injection site: Mild
    36.0 (18.0 to 57.5)
    39.1 (19.7 to 61.5)
    8.3 (1.0 to 27.0)
    35.3 (14.2 to 61.7)
    33.3 (13.3 to 59.0)
    15.0 (3.2 to 37.9)
        Pain at injection site: Moderate
    8.0 (1.0 to 26.0)
    8.7 (1.1 to 28.0)
    0 (0.0 to 14.2)
    5.9 (0.1 to 28.7)
    22.2 (6.4 to 47.6)
    0 (0.0 to 16.8)
        Pain at injection site: Severe
    4.0 (0.1 to 20.4)
    0 (0.0 to 14.8)
    0 (0.0 to 14.2)
    0 (0.0 to 19.5)
    0 (0.0 to 18.5)
    0 (0.0 to 16.8)
        Redness: Mild
    12.0 (2.5 to 31.2)
    4.3 (0.1 to 21.9)
    12.5 (2.7 to 32.4)
    0 (0.0 to 19.5)
    11.1 (1.4 to 34.7)
    5.0 (0.1 to 24.9)
        Redness: Moderate
    12.0 (2.5 to 31.2)
    4.3 (0.1 to 21.9)
    0 (0.0 to 14.2)
    5.9 (0.1 to 28.7)
    0 (0.0 to 18.5)
    0 (0.0 to 16.8)
        Redness: Severe
    0 (0.0 to 13.7)
    0 (0.0 to 14.8)
    0 (0.0 to 14.2)
    0 (0.0 to 19.5)
    0 (0.0 to 18.5)
    0 (0.0 to 16.8)
        Swelling: Mild
    4.0 (0.1 to 20.4)
    0 (0.0 to 14.8)
    4.2 (0.1 to 21.1)
    0 (0.0 to 19.5)
    11.1 (1.4 to 34.7)
    0 (0.0 to 16.8)
        Swelling: Moderate
    8.0 (1.0 to 26.0)
    8.7 (1.1 to 28.0)
    0 (0.0 to 14.2)
    5.9 (0.1 to 28.7)
    11.1 (1.4 to 34.7)
    5.0 (0.1 to 24.9)
        Swelling: Severe
    0 (0.0 to 13.7)
    0 (0.0 to 14.8)
    0 (0.0 to 14.2)
    0 (0.0 to 19.5)
    0 (0.0 to 18.5)
    0 (0.0 to 16.8)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Systemic Events Within 7 Days After Vaccination

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    End point title
    		 Percentage of Participants With Systemic Events Within 7 Days After Vaccination [2]
    End point description
    Systemic events included fever, fatigue, headache, vomiting, diarrhea, muscle pain and joint pain and were recorded by participants using e-diary. Fever: oral temperature >=38.0 degree Celsius (deg C) and categorised as >=38.0 to 38.4 deg C (mild), >38.4 to 38.9 deg C (moderate), and >38.9 to 40.0 deg C (severe). Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity), and severe (prevented daily routine activity). Vomiting was graded mild: 1-2 times in 24 hours (h), moderate: >2 times in 24h, and severe: required intravenous hydration. Diarrhea was graded mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h and severe: 6 or more loose stools in 24h. Percentage of participants with systemic events within 7 days after vaccination and associated 2-sided 95% CI based on Clopper and Pearson method was presented. Safety population = all enrolled participants who received study intervention.
    End point type
    Primary
    End point timeframe
    Within 7 days after Vaccination
    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: Only descriptive data was planned to be analyzed
    End point values
    		 Healthy RSVpreF 120 micrograms (mcg) High Risk RSVpreF 120 mcg 2 to < 5 Years RSVpreF 120 mcg Healthy RSVpreF 60 mcg High Risk RSVpreF 60 mcg 2 to < 5 Years RSVpreF 60 mcg
    Number of subjects analysed
    25
    23
    24
    17
    18
    20
    Units: Percentage of participants
    number (confidence interval 95%)
        Fever: Mild
    0 (0.0 to 13.7)
    4.3 (0.1 to 21.9)
    4.2 (0.1 to 21.1)
    0 (0.0 to 19.5)
    0 (0.0 to 18.5)
    5.0 (0.1 to 24.9)
        Fever: Moderate
    0 (0.0 to 13.7)
    0 (0.0 to 14.8)
    0 (0.0 to 14.2)
    0 (0.0 to 19.5)
    5.6 (0.1 to 27.3)
    0 (0.0 to 16.8)
        Fever: Severe
    0 (0.0 to 13.7)
    0 (0.0 to 14.8)
    0 (0.0 to 14.2)
    5.9 (0.1 to 28.7)
    5.6 (0.1 to 27.3)
    0 (0.0 to 16.8)
        Fatigue: Mild
    20.0 (6.8 to 40.7)
    21.7 (7.5 to 43.7)
    20.8 (7.1 to 42.2)
    41.2 (18.4 to 67.1)
    16.7 (3.6 to 41.4)
    30.0 (11.9 to 54.3)
        Fatigue: Moderate
    12.0 (2.5 to 31.2)
    21.7 (7.5 to 43.7)
    8.3 (1.0 to 27.0)
    5.9 (0.1 to 28.7)
    33.3 (13.3 to 59.0)
    5.0 (0.1 to 24.9)
        Fatigue: Severe
    0 (0.0 to 13.7)
    0 (0.0 to 14.8)
    0 (0.0 to 14.2)
    0 (0.0 to 19.5)
    0 (0.0 to 18.5)
    0 (0.0 to 16.8)
        Headache: Mild
    16.0 (4.5 to 36.1)
    26.1 (10.2 to 48.4)
    0 (0.0 to 14.2)
    29.4 (10.3 to 56.0)
    16.7 (3.6 to 41.4)
    0 (0.0 to 16.8)
        Headache: Moderate
    12.0 (2.5 to 31.2)
    8.7 (1.1 to 28.0)
    4.2 (0.1 to 21.1)
    11.8 (1.5 to 36.4)
    16.7 (3.6 to 41.4)
    0 (0.0 to 16.8)
        Headache: Severe
    0 (0.0 to 13.7)
    0 (0.0 to 14.8)
    0 (0.0 to 14.2)
    0 (0.0 to 19.5)
    0 (0.0 to 18.5)
    0 (0.0 to 16.8)
        Muscle pain: Mild
    16.0 (4.5 to 36.1)
    21.7 (7.5 to 43.7)
    0 (0.0 to 14.2)
    23.5 (6.8 to 49.9)
    33.3 (13.3 to 59.0)
    0 (0.0 to 16.8)
        Muscle pain: Moderate
    4.0 (0.1 to 20.4)
    17.4 (5.0 to 38.8)
    0 (0.0 to 14.2)
    0 (0.0 to 19.5)
    5.6 (0.1 to 27.3)
    0 (0.0 to 16.8)
        Muscle pain: Severe
    0 (0.0 to 13.7)
    0 (0.0 to 14.8)
    0 (0.0 to 14.2)
    0 (0.0 to 19.5)
    0 (0.0 to 18.5)
    0 (0.0 to 16.8)
        Joint pain: Mild
    4.0 (0.1 to 20.4)
    4.3 (0.1 to 21.9)
    0 (0.0 to 14.2)
    0 (0.0 to 19.5)
    11.1 (1.4 to 34.7)
    0 (0.0 to 16.8)
        Joint pain: Moderate
    4.0 (0.1 to 20.4)
    0 (0.0 to 14.8)
    0 (0.0 to 14.2)
    0 (0.0 to 19.5)
    0 (0.0 to 18.5)
    0 (0.0 to 16.8)
        Joint pain: Severe
    0 (0.0 to 13.7)
    0 (0.0 to 14.8)
    0 (0.0 to 14.2)
    0 (0.0 to 19.5)
    0 (0.0 to 18.5)
    0 (0.0 to 16.8)
        Vomiting: Mild
    0 (0.0 to 13.7)
    0 (0.0 to 14.8)
    0 (0.0 to 14.2)
    5.9 (0.1 to 28.7)
    5.6 (0.1 to 27.3)
    10.0 (1.2 to 31.7)
        Vomiting: Moderate
    0 (0.0 to 13.7)
    0 (0.0 to 14.8)
    0 (0.0 to 14.2)
    0 (0.0 to 19.5)
    0 (0.0 to 18.5)
    0 (0.0 to 16.8)
        Vomiting: Severe
    0 (0.0 to 13.7)
    0 (0.0 to 14.8)
    0 (0.0 to 14.2)
    0 (0.0 to 19.5)
    0 (0.0 to 18.5)
    0 (0.0 to 16.8)
        Diarrhea: Mild
    4.0 (0.1 to 20.4)
    8.7 (1.1 to 28.0)
    4.2 (0.1 to 21.1)
    0 (0.0 to 19.5)
    5.6 (0.1 to 27.3)
    0 (0.0 to 16.8)
        Diarrhea: Moderate
    0 (0.0 to 13.7)
    0 (0.0 to 14.8)
    8.3 (1.0 to 27.0)
    0 (0.0 to 19.5)
    0 (0.0 to 18.5)
    0 (0.0 to 16.8)
        Diarrhea: Severe
    0 (0.0 to 13.7)
    0 (0.0 to 14.8)
    0 (0.0 to 14.2)
    0 (0.0 to 19.5)
    0 (0.0 to 18.5)
    0 (0.0 to 16.8)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination

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    End point title
    		 Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination [3]
    End point description
    AE was defined as any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. AEs included serious and non-serious AE. Serious AEs (SAEs) were defined as AE that, at any dose: resulted in death; life-threatening; required inpatient hospitalisation/prolongation of existing hospitalisation; resulted in persistent disability/incapacity; was congenital anomaly/birth defect; was suspected transmission via Pfizer product of infectious agent, pathogenic or nonpathogenic or was considered to be important medical event. Percentage of participants reporting AEs within 1 month after Vaccination were reported. Exact 2-sided CI was calculated using Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported. Safety population included all enrolled participants who received study intervention.
    End point type
    Primary
    End point timeframe
    Within 1 month after Vaccination
    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: Only descriptive data was planned to be analyzed
    End point values
    		 Healthy RSVpreF 120 micrograms (mcg) High Risk RSVpreF 120 mcg 2 to < 5 Years RSVpreF 120 mcg Healthy RSVpreF 60 mcg High Risk RSVpreF 60 mcg 2 to < 5 Years RSVpreF 60 mcg
    Number of subjects analysed
    25
    23
    24
    17
    18
    20
    Units: Percentage of participants
        number (confidence interval 95%)
    0 (0.0 to 13.7)
    17.4 (5.0 to 38.8)
    12.5 (2.7 to 32.4)
    0 (0.0 to 19.5)
    27.8 (9.7 to 53.5)
    15.0 (3.2 to 37.9)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study

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    End point title
    		 Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study [4]
    End point description
    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAEs were defined as an AE that, at any dose: resulted in death; was life-threatening; required inpatient hospitalisation or prolongation of existing hospitalisation; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic or that was considered to be an important medical event. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. Percentage of participants reporting SAEs within 1 month after Vaccination were reported in this endpoint. Safety population included all enrolled participants who received study intervention.
    End point type
    Primary
    End point timeframe
    From Day 1 up to 6-month follow-up visit after Day 1
    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: Only descriptive data was planned to be analyzed
    End point values
    		 Healthy RSVpreF 120 micrograms (mcg) High Risk RSVpreF 120 mcg 2 to < 5 Years RSVpreF 120 mcg Healthy RSVpreF 60 mcg High Risk RSVpreF 60 mcg 2 to < 5 Years RSVpreF 60 mcg
    Number of subjects analysed
    25
    23
    24
    17
    18
    20
    Units: Percentage of participants
        number (confidence interval 95%)
    0 (0.0 to 13.7)
    4.3 (0.1 to 21.9)
    0 (0.0 to 14.2)
    0 (0.0 to 19.5)
    5.6 (0.1 to 27.3)
    0 (0.0 to 16.8)
    No statistical analyses for this end point

    Primary: Percentage of Participants Reporting Newly Diagnosed Chronic Medical Condition (NDCMCs) Throughout the Study

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    End point title
    		 Percentage of Participants Reporting Newly Diagnosed Chronic Medical Condition (NDCMCs) Throughout the Study [5]
    End point description
    An NDCMC was defined as a disease or medical condition, which was not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. Percentage of participants reporting NDCMC throughout the study was reported in this endpoint. Safety population included all enrolled participants who received study intervention.
    End point type
    Primary
    End point timeframe
    From Day 1 up to 6-month follow-up visit after 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: Only descriptive data was planned to be analyzed
    End point values
    		 Healthy RSVpreF 120 micrograms (mcg) High Risk RSVpreF 120 mcg 2 to < 5 Years RSVpreF 120 mcg Healthy RSVpreF 60 mcg High Risk RSVpreF 60 mcg 2 to < 5 Years RSVpreF 60 mcg
    Number of subjects analysed
    25
    23
    24
    17
    18
    20
    Units: Percentage of participants
        number (confidence interval 95%)
    0 (0.0 to 13.7)
    0 (0.0 to 14.8)
    0 (0.0 to 14.2)
    0 (0.0 to 19.5)
    0 (0.0 to 18.5)
    0 (0.0 to 16.8)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer of the Neutralising Titers for RSV A and RSV B Before Vaccination and 1 Month After Vaccination

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    End point title
    		 Geometric Mean Titer of the Neutralising Titers for RSV A and RSV B Before Vaccination and 1 Month After Vaccination
    End point description
    Geometric mean titer (GMT) of neutralising titers of respiratory syncytial virus subgroup A and respiratory syncytial virus subgroup B (RSV A and RSV B) before vaccination and 1 month (M) after vaccination were reported in this endpoint. Assay results below the lower limit of quantification (LLOQ) were set to 0.5*LLOQ. The LLOQ for each neutralisation titer were: RSV A 50% = 242, RSV B 50% = 99. GMTs and corresponding 2-sided CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on Student's t distribution). Evaluable immunogenicity population (EIP) included all eligible participants who received the study intervention; had 1-month postvaccination blood collection 27 through 42 days after vaccination; had at least 1 valid and determinate assay result 1 month after vaccination; had no major protocol violations from vaccination through the 1-month postvaccination blood draw. Here, 'n' signifies participants evaluable for the specified rows.
    End point type
    Secondary
    End point timeframe
    Before vaccination and 1 month after vaccination
    End point values
    		 Healthy RSVpreF 120 micrograms (mcg) High Risk RSVpreF 120 mcg 2 to < 5 Years RSVpreF 120 mcg Healthy RSVpreF 60 mcg High Risk RSVpreF 60 mcg 2 to < 5 Years RSVpreF 60 mcg
    Number of subjects analysed
    24
    21
    24
    15
    18
    20
    Units: Titer
    geometric mean (confidence interval 95%)
        RSV A: Before vaccination (n=24,20,24,15,18,20)
    1168 (706 to 1932)
    2003 (1421 to 2823)
    529 (335 to 835)
    916 (653 to 1285)
    1667 (1035 to 2684)
    561 (309 to 1016)
        RSV A:1 M after vaccination (n=24,21,24,15,18,20)
    27862 (21493 to 36119)
    35503 (26876 to 46900)
    26146 (13301 to 51396)
    25341 (15394 to 41715)
    24053 (17440 to 33173)
    11004 (4287 to 28245)
        RSV B: Before vaccination (n= 24,20,24,15,18,20
    1206 (717 to 2027)
    1905 (1238 to 2930)
    391 (231 to 661)
    965 (668 to 1393)
    1760 (947 to 3272)
    499 (258 to 967)
        RSV B:1 M after vaccination(n= 24,21,24,15,18,20)
    30251 (21607 to 42355)
    29019 (18786 to 44827)
    16504 (8267 to 32948)
    33351 (23565 to 47202)
    31174 (21756 to 44668)
    10659 (3526 to 32228)
        RSVA/RSVB: Before vaccination(n=24,20,24,15,18,20)
    1187 (741 to 1900)
    1953 (1353 to 2820)
    455 (285 to 727)
    940 (698 to 1268)
    1713 (1017 to 2884)
    529 (295 to 950)
        A/B: 1 M after vaccination (n=24,21,24,15,18,20)
    29032 (22267 to 37853)
    32098 (23148 to 44509)
    20773 (10644 to 40543)
    29071 (19691 to 42920)
    27383 (20364 to 36820)
    10830 (3928 to 29860)
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Rise (GMFR) of the NTs for RSV A and RSV B From Before Vaccination to 1 Month After Vaccination

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    End point title
    		 Geometric Mean Fold Rise (GMFR) of the NTs for RSV A and RSV B From Before Vaccination to 1 Month After Vaccination
    End point description
    GMFR of neutralising titers of RSV A and RSV B from before vaccination to 1 month after vaccination were reported in this endpoint. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student's t distribution). Evaluable immunogenicity population included all eligible participants who received the study intervention; had 1-month postvaccination blood collection 27 through 42 days after vaccination; had at least 1 valid and determinate assay result 1 month after vaccination; had no major protocol violations from vaccination through the 1-month postvaccination blood draw.
    End point type
    Secondary
    End point timeframe
    From before vaccination to 1 month after vaccination
    End point values
    		 Healthy RSVpreF 120 micrograms (mcg) High Risk RSVpreF 120 mcg 2 to < 5 Years RSVpreF 120 mcg Healthy RSVpreF 60 mcg High Risk RSVpreF 60 mcg 2 to < 5 Years RSVpreF 60 mcg
    Number of subjects analysed
    24
    20
    24
    15
    18
    20
    Units: Fold rise
    geometric mean (confidence interval 95%)
        RSV A
    21.9 (14.46 to 33.08)
    18.6 (13.03 to 26.55)
    42.8 (23.41 to 78.16)
    27.7 (17.81 to 42.93)
    13.9 (8.75 to 22.03)
    17.7 (9.02 to 34.67)
        RSV B
    24.4 (15.53 to 38.26)
    16.3 (9.91 to 26.83)
    39.8 (22.96 to 69.08)
    34.6 (21.63 to 55.23)
    17.0 (9.25 to 31.40)
    20.6 (10.00 to 42.50)
        RSV A/ RSV B
    23.1 (15.17 to 35.16)
    17.4 (11.73 to 25.85)
    41.3 (23.49 to 72.51)
    30.9 (19.99 to 47.81)
    15.4 (9.12 to 25.94)
    19.1 (9.61 to 37.96)
    No statistical analyses for this end point

    Secondary: Median Frequencies of RSV F Antigen–Specific Cluster of Differentiation 4 (CD4+) Thymus-Derived Lymphocytes (T) Cells Expressing Interferon (IFN) Gamma and Interleukin-4 (IL-4) Before Vaccination and 1 Month After Vaccination

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    End point title
    		 Median Frequencies of RSV F Antigen–Specific Cluster of Differentiation 4 (CD4+) Thymus-Derived Lymphocytes (T) Cells Expressing Interferon (IFN) Gamma and Interleukin-4 (IL-4) Before Vaccination and 1 Month After Vaccination
    End point description
    Median frequencies of RSV F antigen–specific CD4+ T cells expressing IFN gamma and IL-4 before vaccination (vax) and 1M after vax were reported in this endpoint. RSV F enzyme-linked immune absorbent spot assay (ELISpot) limit of detection (LOD) values were IFN gamma=20 spot forming cell (SFC) per million peripheral blood mononuclear cell (PBMCs) and IL-4= 4 SFC/million PBMCs. Assay results below LOD=0.5*LOD for analysis, with exception of calculating fold-rise when before vax assay value was below LOD but corresponding after vax assay value was at LOD or above, where LOD was set for before vaccination. EIP= all eligible participants who received intervention; had 1-M postvaccination blood collection 27 to 42 days after vax; had at least 1 valid, determinate assay result 1 M after vax; had no major protocol violations from vax through 1M postvaccination blood draw. 'Number of Subjects Analysed'=participants evaluable for this endpoint and 'n'=participants evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    Before vaccination and 1 Month after vaccination
    End point values
    		 Healthy RSVpreF 120 micrograms (mcg) High Risk RSVpreF 120 mcg 2 to < 5 Years RSVpreF 120 mcg Healthy RSVpreF 60 mcg High Risk RSVpreF 60 mcg 2 to < 5 Years RSVpreF 60 mcg
    Number of subjects analysed
    23
    21
    22
    15
    18
    17
    Units: SFC/million PBMCs
    median (full range (min-max))
        INF gamma before vax (n=23, 19, 22, 14, 17, 17)
    47 (10 to 241)
    60 (10 to 193)
    10 (10 to 67)
    53 (10 to 277)
    41 (10 to 336)
    10 (10 to 79)
        INF gamma 1 month after vax (n=22,21,21,15,18,17)
    255 (10 to 829)
    293 (10 to 1339)
    61 (10 to 257)
    244 (23 to 1027)
    187 (10 to 780)
    45 (10 to 184)
        IL-4 before vax (n=23, 19, 22, 14, 17, 17)
    2 (2 to 2)
    2 (2 to 11)
    2 (2 to 2)
    2 (2 to 4)
    2 (2 to 5)
    2 (2 to 4)
        IL-4 1 month after vax (n= 22, 21, 21, 15, 18, 17)
    2 (2 to 16)
    4 (2 to 28)
    2 (2 to 7)
    2 (2 to 24)
    2 (2 to 15)
    2 (2 to 13)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Local reactions and systemic events: Within 7 days after vaccination. SAEs and other AEs: up to 6-month follow-up visit after Day 1
    Adverse event reporting additional description
    Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorised as serious in one participant and nonserious in another participant or one participant may have experienced both serious and non-serious event. Safety population included all enrolled participants who received study intervention.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Healthy RSVpreF 120 mcg
    Reporting group description
    		 Healthy participants, 5 to < 18 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group title
    High Risk RSVpreF 120 mcg
    Reporting group description
    		 High risk participants, 5 to < 18 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group title
    2 to < 5 Years RSVpreF 60 mcg
    Reporting group description
    		 Participants, 2 to < 5 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group title
    Healthy RSVpreF 60 mcg
    Reporting group description
    		 Healthy participants, 5 to < 18 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group title
    High Risk RSVpreF 60 mcg
    Reporting group description
    		 High risk participants, 5 to < 18 years of age received a single dose of 60 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Reporting group title
    2 to < 5 Years RSVpreF 120 mcg
    Reporting group description
    		 Participants, 2 to < 5 years of age received a single dose of 120 mcg RSVpreF as standard dose level intramuscularly into the deltoid muscle (Vaccination 1) on Day 1.

    Serious adverse events
    		 Healthy RSVpreF 120 mcg High Risk RSVpreF 120 mcg 2 to < 5 Years RSVpreF 60 mcg Healthy RSVpreF 60 mcg High Risk RSVpreF 60 mcg 2 to < 5 Years RSVpreF 120 mcg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 23 (4.35%)
    0 / 20 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 23 (4.35%)
    0 / 20 (0.00%)
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Healthy RSVpreF 120 mcg High Risk RSVpreF 120 mcg 2 to < 5 Years RSVpreF 60 mcg Healthy RSVpreF 60 mcg High Risk RSVpreF 60 mcg 2 to < 5 Years RSVpreF 120 mcg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 25 (68.00%)
    15 / 23 (65.22%)
    13 / 20 (65.00%)
    12 / 17 (70.59%)
    14 / 18 (77.78%)
    9 / 24 (37.50%)
    Injury, poisoning and procedural complications
    Skin laceration
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Nervous system disorders
    Headache (HEADACHE)
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 25 (28.00%)
    8 / 23 (34.78%)
    0 / 20 (0.00%)
    7 / 17 (41.18%)
    6 / 18 (33.33%)
    1 / 24 (4.17%)
         occurrences all number
    7
    8
    0
    7
    6
    1
    Syncope
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    General disorders and administration site conditions
    Axillary pain
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Fatigue
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 23 (8.70%)
    0 / 20 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    Fatigue (FATIGUE)
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 25 (32.00%)
    10 / 23 (43.48%)
    7 / 20 (35.00%)
    8 / 17 (47.06%)
    9 / 18 (50.00%)
    7 / 24 (29.17%)
         occurrences all number
    8
    10
    7
    8
    9
    7
    Injection site erythema
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 23 (8.70%)
    0 / 20 (0.00%)
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Injection site pain
         subjects affected / exposed
    2 / 25 (8.00%)
    3 / 23 (13.04%)
    0 / 20 (0.00%)
    1 / 17 (5.88%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
         occurrences all number
    2
    3
    0
    1
    1
    0
    Injection site pain (PAIN AT INJECTION SITE)
    alternative assessment type: Systematic
         subjects affected / exposed
    12 / 25 (48.00%)
    11 / 23 (47.83%)
    3 / 20 (15.00%)
    7 / 17 (41.18%)
    10 / 18 (55.56%)
    2 / 24 (8.33%)
         occurrences all number
    12
    11
    3
    7
    10
    2
    Injection site swelling
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    1 / 20 (5.00%)
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    0
    1
    0
    0
    2
    Pyrexia (FEVER)
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 23 (4.35%)
    1 / 20 (5.00%)
    1 / 17 (5.88%)
    2 / 18 (11.11%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    1
    1
    2
    1
    Swelling (SWELLING)
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 25 (12.00%)
    2 / 23 (8.70%)
    1 / 20 (5.00%)
    1 / 17 (5.88%)
    4 / 18 (22.22%)
    1 / 24 (4.17%)
         occurrences all number
    3
    2
    1
    1
    4
    1
    Immune system disorders
    Food allergy
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Diarrhoea (DIARRHEA)
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 23 (8.70%)
    0 / 20 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    3 / 24 (12.50%)
         occurrences all number
    1
    2
    0
    0
    1
    3
    Vomiting (VOMITING)
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    2 / 20 (10.00%)
    1 / 17 (5.88%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    2
    1
    1
    0
    Skin and subcutaneous tissue disorders
    Erythema (REDNESS)
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 25 (24.00%)
    2 / 23 (8.70%)
    1 / 20 (5.00%)
    1 / 17 (5.88%)
    2 / 18 (11.11%)
    3 / 24 (12.50%)
         occurrences all number
    6
    2
    1
    1
    2
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia (JOINT PAIN)
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 23 (4.35%)
    0 / 20 (0.00%)
    0 / 17 (0.00%)
    2 / 18 (11.11%)
    0 / 24 (0.00%)
         occurrences all number
    2
    1
    0
    0
    2
    0
    Myalgia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Myalgia (MUSCLE PAIN)
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 25 (20.00%)
    9 / 23 (39.13%)
    0 / 20 (0.00%)
    4 / 17 (23.53%)
    7 / 18 (38.89%)
    0 / 24 (0.00%)
         occurrences all number
    5
    9
    0
    4
    7
    0
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    COVID-19
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    0 / 20 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Viral infection
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 23 (0.00%)
    1 / 20 (5.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    1 / 24 (4.17%)
         occurrences all number
    0
    0
    1
    0
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Feb 2024
    Added the clinicaltrials.gov reference and sponsor legal address to the title page. Removed Phase 2/3 content.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    28 Jul 2023
    The study was interrupted due to reports of study intervention dosing errors at some investigational sites. The study was resumed after the site staff were retrained in preparation of study intervention.
    08 Aug 2023

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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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