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    Clinical Trial Results:
    A Phase III, double-blind, randomized, placebo-controlled study to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of unadjuvanted RSV Maternal vaccine, in high risk pregnant women aged 15 to 49 years and infants born to the vaccinated mothers

    Summary
    EudraCT number
    		 2021-000994-96
    Trial protocol
    		 FI   ES   IT   Outside EU/EEA  
    Global end of trial date
    30 May 2023

    Results information
    Results version number
    		 v1
    This version publication date
    14 Dec 2023
    First version publication date
    14 Dec 2023
    Other versions
    		 v2 , v3

    Trial information

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    Trial identification
    Sponsor protocol code
    214725
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04980391
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    GSK Response Center, GlaxoSmithKline, 44 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 44 8664357343, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002821-PIP01-20
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Oct 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 May 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    • To evaluate the safety and reactogenicity of a single IM dose of study intervention administered to maternal participants up to 42 days post-delivery. • To evaluate the pregnancy outcomes and pregnancy-related AESIs up to 42 days post-delivery, in maternal participants who received a single IM dose of study intervention. • To evaluate safety up to 42 days post-birth in infants born to maternal participants who received a single IM dose of study intervention. • To evaluate the safety of the vaccine in infants up to 365 days post-birth. • To evaluate the immunogenicity of a single IM dose of study intervention administered to maternal participants, at delivery. • To evaluate the transfer of RSV-specific antibodies from maternal participants who received a single IM dose of study intervention to their infants at delivery. • To evaluate the RSV-specific antibody levels at birth in infants born to maternal participants who received a single IM dose of study intervention.
    Protection of trial subjects
    Maternal participants remained under observation for 30 minutes after the administration of the study intervention to ensure that immediate treatment would be provided in the event of a hypersensitivity reaction, or syncope.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Aug 2021
    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
    Brazil: 21
    Country: Number of subjects enrolled
    Canada: 15
    Country: Number of subjects enrolled
    Finland: 15
    Country: Number of subjects enrolled
    India: 7
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Panama: 63
    Country: Number of subjects enrolled
    South Africa: 94
    Country: Number of subjects enrolled
    Spain: 81
    Country: Number of subjects enrolled
    United States: 83
    Worldwide total number of subjects
    384
    EEA total number of subjects
    101
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    37
    Newborns (0-27 days)
    161
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    20
    Adults (18-64 years)
    166
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Out of 384 participants who completed the informed consent process, 169 maternal participants were vaccinated, and 198 infants, including twins, were born to those exposed mothers (RSV_MAT Group-Mother and Control Group-Mother). Therefore, 367 participants were considered exposed.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study was originally double-blinded, but due to a safety signal, it was fully unblinded to ensure the safety monitoring of the participants.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 RSV_MAT Group-Mother
    Arm description
    		 Maternal participants randomized to the RSV_MAT Group received a single dose of the RSV MAT vaccine administered, between 24 and 36 weeks of gestation, at Day 1 in this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSV MAT
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose of the RSV MAT vaccine reconstituted with NaCl solution, administered intramuscularly in the non-dominant arm, at Day 1.

    Arm title
    		 Control Group-Mother
    Arm description
    		 Maternal participants randomized to the Control Group received a single dose of Placebo administered, between 24 and 36 weeks of gestation, at Day 1 in this study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose of Placebo, administered intramuscularly in the non-dominant arm, at Day 1.

    Arm title
    		 RSV_MAT Group-Infant
    Arm description
    		 This group consisted of infants born to mothers (from RSV_MAT Group-Mother) who received a single dose of RSV MAT vaccine during pregnancy.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Control Group-Infant
    Arm description
    		 This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1 [1]
    		RSV_MAT Group-Mother Control Group-Mother RSV_MAT Group-Infant Control Group-Infant
    Started
    113
    56
    132
    66
    Completed
    107
    52
    124
    61
    Not completed
    6
    4
    8
    5
         Death
    -
    -
    1
    1
         WITHDRAWAL BY SUBJECT'S PARENT(S)/LAR(S)
    -
    -
    3
    -
         MIGRATED / MOVED FROM THE STUDY AREA
    1
    1
    2
    1
         Lost to follow-up
    3
    3
    2
    3
         WITHDRAWAL BY SUBJECT, NOT DUE TO AN ADVERSE EVENT
    2
    -
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of 384 participants who completed the informed consent process, 169 maternal participants were vaccinated, and 198 infants, including twins, were born to those exposed mothers (RSV_MAT Group-Mother and Control Group-Mother). Therefore, 367 participants were considered exposed.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RSV_MAT Group-Mother
    Reporting group description
    		 Maternal participants randomized to the RSV_MAT Group received a single dose of the RSV MAT vaccine administered, between 24 and 36 weeks of gestation, at Day 1 in this study.

    Reporting group title
    Control Group-Mother
    Reporting group description
    		 Maternal participants randomized to the Control Group received a single dose of Placebo administered, between 24 and 36 weeks of gestation, at Day 1 in this study.

    Reporting group title
    RSV_MAT Group-Infant
    Reporting group description
    		 This group consisted of infants born to mothers (from RSV_MAT Group-Mother) who received a single dose of RSV MAT vaccine during pregnancy.

    Reporting group title
    Control Group-Infant
    Reporting group description
    		 This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.

    Reporting group values
    		 RSV_MAT Group-Mother Control Group-Mother RSV_MAT Group-Infant Control Group-Infant Total
    Number of subjects
    		 113 56 132 66 367
    Age Categorical
    Units: Participants
        0 to 1 years of age
    		 0 0 132 66 198
        15 < 18 years of age
    		 13 6 0 0 19
        18 to 49 years of age
    		 100 50 0 0 150
    Sex: Female, Male
    Units: Participants
        Female
    		 113 56 63 29 261
        Male
    		 0 0 69 37 106
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 4 1 4 1 10
        Black or African American
    		 33 18 33 18 102
        White
    		 52 24 67 34 177
        Other, unspecified
    		 24 13 28 13 78

    End points

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    End points reporting groups
    Reporting group title
    RSV_MAT Group-Mother
    Reporting group description
    		 Maternal participants randomized to the RSV_MAT Group received a single dose of the RSV MAT vaccine administered, between 24 and 36 weeks of gestation, at Day 1 in this study.

    Reporting group title
    Control Group-Mother
    Reporting group description
    		 Maternal participants randomized to the Control Group received a single dose of Placebo administered, between 24 and 36 weeks of gestation, at Day 1 in this study.

    Reporting group title
    RSV_MAT Group-Infant
    Reporting group description
    		 This group consisted of infants born to mothers (from RSV_MAT Group-Mother) who received a single dose of RSV MAT vaccine during pregnancy.

    Reporting group title
    Control Group-Infant
    Reporting group description
    		 This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.

    Subject analysis set title
    RSV_MAT Group
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    This group consisted of pairs of maternal participants from RSV_MAT Group - Mother and infant participants from RSV_MAT Group - Infant.

    Subject analysis set title
    Control Group
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    This group consisted of pairs of maternal participants from Control Group - Mother and infant participants from Control Group - Infant.

    Primary: Percentage of maternal participants reporting any solicited administration site events

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    End point title
    		 Percentage of maternal participants reporting any solicited administration site events [1] [2]
    End point description
    Assessed solicited administration site events included erythema, pain and swelling. Any pain = occurrence of the symptom regardless of intensity grade. Any erythema and swelling = symptom reported with a surface diameter greater than or equal to 20 millimeters. Analysis was performed on the Solicited Safety Set, which included all maternal participants who received 1 dose of a study intervention and who had solicited safety data available during the specified period.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 included
    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: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV_MAT Group-Mother Control Group-Mother
    Number of subjects analysed
    113
    54
    Units: Percentage of participants
    number (confidence interval 95%)
        Any Erythema
    0.9 (0.0 to 4.8)
    0 (0 to 6.6)
        Any Pain
    44.2 (34.9 to 53.9)
    14.8 (6.6 to 27.1)
        Any Swelling
    0 (0 to 3.2)
    1.9 (0.0 to 9.9)
    No statistical analyses for this end point

    Primary: Percentage of maternal participants reporting any solicited systemic events

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    End point title
    		 Percentage of maternal participants reporting any solicited systemic events [3] [4]
    End point description
    Assessed solicited systemic events included abdominal pain, diarrhea, fatigue, headache, nausea, fever [temperature equal to or above (>=) 38 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F), regardless of the location of measurement] and vomiting. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. Analysis was performed on the Solicited Safety Set, which included all maternal participants who received 1 dose of a study intervention and who had solicited safety data available during the specified period.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 included
    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: This endpoint is only reporting values for maternal participants.
    End point values
    		 RSV_MAT Group-Mother Control Group-Mother
    Number of subjects analysed
    113
    54
    Units: Percentage of participants
    number (confidence interval 95%)
        Any Abdominal pain
    20.4 (13.4 to 29.0)
    16.7 (7.9 to 29.3)
        Any Diarrhea
    20.4 (13.4 to 29.0)
    7.4 (2.1 to 17.9)
        Any Fatigue
    28.3 (20.2 to 37.6)
    27.8 (16.5 to 41.6)
        Any Headache
    39.8 (30.7 to 49.5)
    38.9 (25.9 to 53.1)
        Any Nausea
    24.8 (17.1 to 33.8)
    20.4 (10.6 to 33.5)
        Any Fever
    0 (0 to 3.2)
    0 (0 to 6.6)
        Any Vomiting
    8.0 (3.7 to 14.6)
    20.4 (10.6 to 33.5)
    No statistical analyses for this end point

    Primary: Percentage of maternal participants reporting any unsolicited adverse events (AEs)

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    End point title
    		 Percentage of maternal participants reporting any unsolicited adverse events (AEs) [5] [6]
    End point description
    An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Any = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 30 included
    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: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV_MAT Group-Mother Control Group-Mother
    Number of subjects analysed
    113
    56
    Units: Percentage of participants
        number (confidence interval 95%)
    34.5 (25.8 to 44.0)
    37.5 (24.9 to 51.5)
    No statistical analyses for this end point

    Primary: Percentage of live births with no congenital anomalies, live births with minor congenital anomaly(ies) and live births with at least 1 major congenital anomaly

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    End point title
    		 Percentage of live births with no congenital anomalies, live births with minor congenital anomaly(ies) and live births with at least 1 major congenital anomaly [7] [8]
    End point description
    The percentage of live births with no congenital anomalies, live births with minor congenital anomaly(ies) only and live births with at least 1 major congenital anomaly is reported. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/legally acceptable representatives (LARs) completed the informed consent process and signed the informed consent form.
    End point type
    Primary
    End point timeframe
    From Day 1 up to 42 days post-delivery
    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: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    132
    66
    Units: Percentage of participants
    number (confidence interval 95%)
        LIVE BIRTH WITH NO CONGENITAL ANOMALIES
    86.4 (79.3 to 91.7)
    84.8 (73.9 to 92.5)
        LIVE BIRTH WITH ONLY MINOR CONGENITAL ANOMALY(IES)
    10.6 (5.9 to 17.2)
    13.6 (6.4 to 24.3)
        LIVE BIRTH WITH >= ONE MAJOR CONGENITAL ANOMALY
    3.0 (0.8 to 7.6)
    1.5 (0.0 to 8.2)
    No statistical analyses for this end point

    Primary: Percentage of maternal participants reporting medically attended adverse events (MAEs) from Day 1 up to 42 days post-delivery

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    End point title
    		 Percentage of maternal participants reporting medically attended adverse events (MAEs) from Day 1 up to 42 days post-delivery [9] [10]
    End point description
    An MAE was defined as an unsolicited AE for which the participant received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
    End point type
    Primary
    End point timeframe
    From Day 1 up to 42 days post-delivery
    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.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV_MAT Group-Mother Control Group-Mother
    Number of subjects analysed
    113
    56
    Units: Percentage of participants
        number (confidence interval 95%)
    57.5 (47.9 to 66.8)
    58.9 (45.0 to 71.9)
    No statistical analyses for this end point

    Primary: Percentage of maternal participants reporting any serious adverse events (SAEs) from Day 1 up to 42 days post-delivery

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    End point title
    		 Percentage of maternal participants reporting any serious adverse events (SAEs) from Day 1 up to 42 days post-delivery [11] [12]
    End point description
    An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or resulted in abnormal pregnancy outcomes or in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
    End point type
    Primary
    End point timeframe
    From Day 1 up to 42 days post-delivery
    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.
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV_MAT Group-Mother Control Group-Mother
    Number of subjects analysed
    113
    56
    Units: Percentage of participants
        number (confidence interval 95%)
    29.2 (21.0 to 38.5)
    19.6 (10.2 to 32.4)
    No statistical analyses for this end point

    Primary: Number of maternal participants reporting (S)AEs leading to study withdrawal from Day 1 up to 42 days post-delivery

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    End point title
    		 Number of maternal participants reporting (S)AEs leading to study withdrawal from Day 1 up to 42 days post-delivery [13] [14]
    End point description
    A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
    End point type
    Primary
    End point timeframe
    From Day 1 up to 42 days post-delivery
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV_MAT Group-Mother Control Group-Mother
    Number of subjects analysed
    113
    56
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of maternal participants reporting pregnancy-related adverse events of special interest (AESIs) from Day 1 up to 42 days post-delivery

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    End point title
    		 Percentage of maternal participants reporting pregnancy-related adverse events of special interest (AESIs) from Day 1 up to 42 days post-delivery [15] [16]
    End point description
    Pregnancy-related AESIs included preterm labor, provider-initiated preterm birth, premature preterm rupture of membranes, pre-eclampsia, pre-eclampsia with severe features including eclampsia, gestational hypertension and fetal growth restriction. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
    End point type
    Primary
    End point timeframe
    From Day 1 up to 42 days post-delivery
    Notes
    [15] - 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.
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV_MAT Group-Mother Control Group-Mother
    Number of subjects analysed
    113
    56
    Units: Percentage of participants
    number (confidence interval 95%)
        Preterm labor
    8.0 (3.7 to 14.6)
    7.1 (2.0 to 17.3)
        Provider-initiated preterm birth
    3.5 (1.0 to 8.8)
    5.4 (1.1 to 14.9)
        Premature preterm rupture of membranes
    1.8 (0.2 to 6.2)
    5.4 (1.1 to 14.9)
        Pre-eclampsia
    4.4 (1.5 to 10.0)
    3.6 (0.4 to 12.3)
        Pre-eclampsia with severe features
    4.4 (1.5 to 10.0)
    0 (0 to 6.4)
        Gestational hypertension
    0.9 (0.0 to 4.8)
    3.6 (0.4 to 12.3)
        Fetal growth restriction
    1.8 (0.2 to 6.2)
    3.6 (0.4 to 12.3)
    No statistical analyses for this end point

    Primary: Percentage of maternal participants reporting worsening of pre-existing medical conditions and/or obstetric complications from Day 1 up to 42 days post-delivery

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    End point title
    		 Percentage of maternal participants reporting worsening of pre-existing medical conditions and/or obstetric complications from Day 1 up to 42 days post-delivery [17] [18]
    End point description
    Worsening of pre-existing medical condition and/or obstetric complication was considered by the investigator, using clinical judgment and the following criteria: - Change in medication and/or medication dose. - Medically attended event in relation to pre-existing condition and/or obstetric complication that are outside the routine management of the condition/complication. - SAE and/or hospitalization in relation to pre-existing condition and/or obstetric complication. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
    End point type
    Primary
    End point timeframe
    From Day 1 up to 42 days post-delivery
    Notes
    [17] - 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.
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV_MAT Group-Mother Control Group-Mother
    Number of subjects analysed
    113
    56
    Units: Percentage of participants
    number (confidence interval 95%)
        Change In Medication And/Or Medication Dose
    1.8 (0.2 to 6.2)
    1.8 (0.0 to 9.6)
        Medically Attended Event
    1.8 (0.2 to 6.2)
    7.1 (2.0 to 17.3)
        SAE And/Or Hospitalization
    1.8 (0.2 to 6.2)
    3.6 (0.4 to 12.3)
    No statistical analyses for this end point

    Primary: Percentage of infant participants reporting neonatal/infant AESIs from birth up to 42 days post-birth

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    End point title
    		 Percentage of infant participants reporting neonatal/infant AESIs from birth up to 42 days post-birth [19] [20]
    End point description
    Neonatal/infant AESIs included low birth weight (below [<] 2500 grams), very low birth weight (<1500 grams), extremely low birth weight (<1000 grams), preterm birth (<37 weeks of gestational age), small for gestational age (weight below 10th percentile for gestational age), congenital anomalies with internal structural defects and neonatal death in a preterm live birth (gestational age equal to or above [>=] 28 and <37 weeks). Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
    End point type
    Primary
    End point timeframe
    From birth up to 42 days post-birth
    Notes
    [19] - 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.
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    132
    66
    Units: Percentage of participants
    number (confidence interval 95%)
        Low Birth Weight (<2500 grams)
    16.7 (10.7 to 24.1)
    18.2 (9.8 to 29.6)
        Very Low Birth Weight (<1500 grams)
    2.3 (0.5 to 6.5)
    1.5 (0.0 to 8.2)
        Extremely Low Birth Weight (<1000 grams)
    0 (0 to 2.8)
    1.5 (0.0 to 8.2)
        Preterm Birth (<37 Weeks Of Gestational Age)
    18.2 (12.0 to 25.8)
    19.7 (10.9 to 31.3)
        Small For Gestational Age
    14.4 (8.9 to 21.6)
    27.3 (17.0 to 39.6)
        Congenital Anomalies
    3.0 (0.8 to 7.6)
    0 (0 to 5.4)
        Neonatal Death In A Preterm Live Birth
    0.8 (0.0 to 4.1)
    1.5 (0.0 to 8.2)
    No statistical analyses for this end point

    Primary: Percentage of infant participants reporting MAEs from birth up to 42 days post-birth

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    End point title
    		 Percentage of infant participants reporting MAEs from birth up to 42 days post-birth [21] [22]
    End point description
    An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
    End point type
    Primary
    End point timeframe
    From birth up to 42 days post-birth
    Notes
    [21] - 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.
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    132
    66
    Units: Percentage of participants
        number (confidence interval 95%)
    56.8 (47.9 to 65.4)
    54.5 (41.8 to 66.9)
    No statistical analyses for this end point

    Primary: Percentage of infant participants reporting any SAEs from birth up to 180 days post-birth

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    End point title
    		 Percentage of infant participants reporting any SAEs from birth up to 180 days post-birth [23] [24]
    End point description
    An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
    End point type
    Primary
    End point timeframe
    From birth up to 180 days post-birth
    Notes
    [23] - 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.
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    132
    66
    Units: Percentage of participants
        number (confidence interval 95%)
    25.0 (17.9 to 33.3)
    30.3 (19.6 to 42.9)
    No statistical analyses for this end point

    Primary: Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 42 days post-birth

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    End point title
    		 Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 42 days post-birth [25] [26]
    End point description
    A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
    End point type
    Primary
    End point timeframe
    From birth up to 42 days post-birth
    Notes
    [25] - 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.
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    132
    66
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of infant participants reporting any SAEs from birth up to 42 days post-birth

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    End point title
    		 Percentage of infant participants reporting any SAEs from birth up to 42 days post-birth [27] [28]
    End point description
    An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
    End point type
    Primary
    End point timeframe
    From birth up to 42 days post-birth
    Notes
    [27] - 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.
    [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    132
    66
    Units: Percentage of participants
        number (confidence interval 95%)
    20.5 (13.9 to 28.3)
    27.3 (17.0 to 39.6)
    No statistical analyses for this end point

    Primary: Percentage of infant participants reporting MAEs from birth up to 365 days post-birth

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    End point title
    		 Percentage of infant participants reporting MAEs from birth up to 365 days post-birth [29] [30]
    End point description
    An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
    End point type
    Primary
    End point timeframe
    From birth up to 365 days post-birth
    Notes
    [29] - 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.
    [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    132
    66
    Units: Percentage of participants
        number (confidence interval 95%)
    86.4 (79.3 to 91.7)
    75.8 (63.6 to 85.5)
    No statistical analyses for this end point

    Primary: Percentage of infant participants reporting any SAEs from birth up to 365 days post-birth

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    End point title
    		 Percentage of infant participants reporting any SAEs from birth up to 365 days post-birth [31] [32]
    End point description
    An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
    End point type
    Primary
    End point timeframe
    From birth up to 365 days post-birth
    Notes
    [31] - 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.
    [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    132
    66
    Units: Percentage of participants
        number (confidence interval 95%)
    26.5 (19.2 to 34.9)
    31.8 (20.9 to 44.4)
    No statistical analyses for this end point

    Primary: Percentage of infant participants reporting MAEs from birth up to 180 days post-birth

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    End point title
    		 Percentage of infant participants reporting MAEs from birth up to 180 days post-birth [33] [34]
    End point description
    An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
    End point type
    Primary
    End point timeframe
    From birth up to 180 days post-birth
    Notes
    [33] - 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.
    [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    132
    66
    Units: Percentage of participants
        number (confidence interval 95%)
    77.3 (69.2 to 84.1)
    69.7 (57.1 to 80.4)
    No statistical analyses for this end point

    Primary: Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 365 days post-birth

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    End point title
    		 Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 365 days post-birth [35] [36]
    End point description
    A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
    End point type
    Primary
    End point timeframe
    From birth up to 365 days post-birth
    Notes
    [35] - 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.
    [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    132
    66
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Primary: Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 180 days post-birth

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    End point title
    		 Number of infant participants reporting (S)AEs leading to study withdrawal from birth up to 180 days post-birth [37] [38]
    End point description
    A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
    End point type
    Primary
    End point timeframe
    From birth up to 180 days post-birth
    Notes
    [37] - 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.
    [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    132
    66
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Primary: Geometric Mean Ratio (GMR) between cord blood and maternal RSV MAT IgG-specific antibody concentrations

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    End point title
    		 Geometric Mean Ratio (GMR) between cord blood and maternal RSV MAT IgG-specific antibody concentrations [39]
    End point description
    The placental transfer ratio of IgG-specific antibody concentration was determined from cord blood (or infant blood sample collected within 72 hours after birth [if no cord blood could be obtained]) over that of the blood sample from mother at delivery (if no blood sample was collected during delivery). Analysis was performed on all pairs of maternal participants (from Per Protocol Set Immunogenicity - Maternal) and their infants (from Per Protocol Set Immunogenicity - Infant) with available results for this outcome measure at the specified time points.
    End point type
    Primary
    End point timeframe
    At delivery (for maternal participants) or within 72 hours after birth (for infant participants)
    Notes
    [39] - 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
    		 RSV_MAT Group Control Group
    Number of subjects analysed
    86
    37
    Units: Ratio
        geometric mean (confidence interval 95%)
    1.33 (1.04 to 1.70)
    2.30 (1.63 to 3.25)
    No statistical analyses for this end point

    Primary: RSV-A neutralizing titers for maternal participants at pre-dosing (Day 1)

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    End point title
    		 RSV-A neutralizing titers for maternal participants at pre-dosing (Day 1) [40] [41]
    End point description
    RSV-A neutralizing titers were determined by neutralization assay and expressed as geometric mean titers (GMTs). Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. pre-dosing [Day 1]), minus those participants with protocol deviations that lead to exclusion.
    End point type
    Primary
    End point timeframe
    At pre-dosing (Day 1)
    Notes
    [40] - 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.
    [41] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV_MAT Group-Mother Control Group-Mother
    Number of subjects analysed
    103
    48
    Units: Titers
        geometric mean (confidence interval 95%)
    681.5 (578.33 to 803.11)
    752.4 (580.25 to 975.50)
    No statistical analyses for this end point

    Primary: RSV MAT IgG-specific antibody concentrations for maternal participants at delivery

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    End point title
    		 RSV MAT IgG-specific antibody concentrations for maternal participants at delivery [42] [43]
    End point description
    RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. delivery), minus those participants with protocol deviations that lead to exclusion.
    End point type
    Primary
    End point timeframe
    At delivery
    Notes
    [42] - 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.
    [43] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV_MAT Group-Mother Control Group-Mother
    Number of subjects analysed
    99
    44
    Units: ELU/mL
        geometric mean (confidence interval 95%)
    70337.1 (60711.34 to 81489.07)
    4421 (3477.90 to 5619.80)
    No statistical analyses for this end point

    Primary: RSV MAT immunoglobulin G (IgG)-specific antibody concentrations for maternal participants at pre-dosing (Day 1)

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    End point title
    		 RSV MAT immunoglobulin G (IgG)-specific antibody concentrations for maternal participants at pre-dosing (Day 1) [44] [45]
    End point description
    RSV MAT IgG-specific antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (ELU/mL). Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. pre-dosing [Day 1]), minus those participants with protocol deviations that lead to exclusion.
    End point type
    Primary
    End point timeframe
    At pre-dosing (Day 1)
    Notes
    [44] - 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.
    [45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV_MAT Group-Mother Control Group-Mother
    Number of subjects analysed
    103
    48
    Units: ELU/mL
        geometric mean (confidence interval 95%)
    4981.6 (4405.14 to 5633.53)
    5981.7 (4908.71 to 7289.11)
    No statistical analyses for this end point

    Primary: RSV-A neutralizing titers for maternal participants at delivery

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    End point title
    		 RSV-A neutralizing titers for maternal participants at delivery [46] [47]
    End point description
    RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. delivery), minus those participants with protocol deviations that lead to exclusion.
    End point type
    Primary
    End point timeframe
    At delivery
    Notes
    [46] - 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.
    [47] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV_MAT Group-Mother Control Group-Mother
    Number of subjects analysed
    99
    44
    Units: Titers
        geometric mean (confidence interval 95%)
    6240.3 (5026.02 to 7747.88)
    612.8 (455.82 to 823.83)
    No statistical analyses for this end point

    Primary: RSV-A neutralizing titers for infant participants at delivery or within 72 hours after birth

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    End point title
    		 RSV-A neutralizing titers for infant participants at delivery or within 72 hours after birth [48] [49]
    End point description
    RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. The titers were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained). Analysis was performed on the Per Protocol Set Immunogenicity - Infant, which included all infant participants in the Exposed set who had post-delivery/birth immunogenicity data available for the specified analysis at the specified time points, minus those who (a) were born less than 4 weeks post-maternal participant dosing and/ or (b) have protocol deviations that lead to exclusion.
    End point type
    Primary
    End point timeframe
    At delivery or within 72 hours after birth
    Notes
    [48] - 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.
    [49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    91
    37
    Units: Titers
        geometric mean (confidence interval 95%)
    9080.2 (7449.56 to 11067.75)
    694.6 (495.72 to 973.37)
    No statistical analyses for this end point

    Primary: RSV MAT IgG-specific antibody concentrations for infant participants at delivery or within 72 hours after birth

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    End point title
    		 RSV MAT IgG-specific antibody concentrations for infant participants at delivery or within 72 hours after birth [50] [51]
    End point description
    RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. The antibody concentrations were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained). Analysis was performed on the Per Protocol Set Immunogenicity - Infant, which included all infant participants in the Exposed set who had post-delivery/birth immunogenicity data available for the specified analysis at the specified time points, minus those who (a) were born less than 4 weeks post-maternal participant dosing and/ or (b) had protocol deviations that lead to exclusion.
    End point type
    Primary
    End point timeframe
    At delivery or within 72 hours after birth
    Notes
    [50] - 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.
    [51] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    88
    37
    Units: ELU/mL
        geometric mean (confidence interval 95%)
    77625.1 (63706.97 to 94583.89)
    9228 (6540.47 to 13019.71)
    No statistical analyses for this end point

    Secondary: Number of maternal participants reporting (S)AEs leading to study withdrawal from Day 1 up to 180 days post-delivery

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    End point title
    		 Number of maternal participants reporting (S)AEs leading to study withdrawal from Day 1 up to 180 days post-delivery [52]
    End point description
    A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 180 days post-delivery
    Notes
    [52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV_MAT Group-Mother Control Group-Mother
    Number of subjects analysed
    113
    56
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of maternal participants reporting any SAEs from Day 1 up to 180 days post-delivery

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    End point title
    		 Percentage of maternal participants reporting any SAEs from Day 1 up to 180 days post-delivery [53]
    End point description
    An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or resulted in abnormal pregnancy outcomes or in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 180 days post-delivery
    Notes
    [53] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV_MAT Group-Mother Control Group-Mother
    Number of subjects analysed
    113
    56
    Units: Percentage of participants
        number (confidence interval 95%)
    29.2 (21.0 to 38.5)
    19.6 (10.2 to 32.4)
    No statistical analyses for this end point

    Secondary: Number of maternal participants reporting RSV-associated medically attended respiratory tract illnesses (MA-RTIs) from Day 1 up to 180 days post-delivery

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    End point title
    		 Number of maternal participants reporting RSV-associated medically attended respiratory tract illnesses (MA-RTIs) from Day 1 up to 180 days post-delivery [54]
    End point description
    RSV-associated MA-RTI was defined as a medically attended visit for RTI symptoms and confirmed RSV infection. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 180 days post-delivery
    Notes
    [54] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV_MAT Group-Mother Control Group-Mother
    Number of subjects analysed
    113
    56
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of maternal participants reporting MAEs from Day 1 up to 180 days post-delivery

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    End point title
    		 Percentage of maternal participants reporting MAEs from Day 1 up to 180 days post-delivery [55]
    End point description
    An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 180 days post-delivery
    Notes
    [55] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV_MAT Group-Mother Control Group-Mother
    Number of subjects analysed
    113
    56
    Units: Percentage of participants
        number (confidence interval 95%)
    61.1 (51.4 to 70.1)
    60.7 (46.8 to 73.5)
    No statistical analyses for this end point

    Secondary: Percentage of maternal participants reporting worsening of pre-existing medical conditions and/or obstetric complications from Day 1 up to 180 days post-delivery

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    End point title
    		 Percentage of maternal participants reporting worsening of pre-existing medical conditions and/or obstetric complications from Day 1 up to 180 days post-delivery [56]
    End point description
    Worsening of pre-existing medical condition and/or obstetric complication was considered by the investigator, using clinical judgement and the following criteria: - Change in medication and/or medication dose. - Medically attended event in relation to pre-existing condition and/or obstetric complication that are outside the routine management of the condition/complication. - SAE and/or hospitalization in relation to pre-existing condition and/or obstetric complication. Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 180 days post-delivery
    Notes
    [56] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV_MAT Group-Mother Control Group-Mother
    Number of subjects analysed
    113
    56
    Units: Percentage of participants
    number (confidence interval 95%)
        Change In Medication And/Or Medication Dose
    1.8 (0.2 to 6.2)
    1.8 (0.0 to 9.6)
        Medically Attended Event
    1.8 (0.2 to 6.2)
    7.1 (2.0 to 17.3)
        SAE And/Or Hospitalization
    1.8 (0.2 to 6.2)
    3.6 (0.4 to 12.3)
    No statistical analyses for this end point

    Secondary: RSV MAT IgG-specific antibody concentrations for maternal participants at Day 31 post-dosing

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    End point title
    		 RSV MAT IgG-specific antibody concentrations for maternal participants at Day 31 post-dosing [57]
    End point description
    RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. Day 31 post-dosing), minus those participants with protocol deviations that lead to exclusion.
    End point type
    Secondary
    End point timeframe
    At Day 31 post-dosing
    Notes
    [57] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV_MAT Group-Mother Control Group-Mother
    Number of subjects analysed
    89
    38
    Units: ELU/mL
        geometric mean (confidence interval 95%)
    113957.1 (102340.44 to 126892.37)
    5510.6 (4370.30 to 6948.51)
    No statistical analyses for this end point

    Secondary: Percentage of infant participants reporting medically assessed, RSV-associated hospitalizations from birth up to 365 days post-birth

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    End point title
    		 Percentage of infant participants reporting medically assessed, RSV-associated hospitalizations from birth up to 365 days post-birth [58]
    End point description
    RSV-associated hospitalization was defined as a confirmed RSV infection and hospitalized for acute medical condition. Hospitalization was defined as admission for observation or treatment based on the judgment of a health care provider. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent.
    End point type
    Secondary
    End point timeframe
    From birth up to 365 days post-birth
    Notes
    [58] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    132
    66
    Units: Percentage of participants
        number (confidence interval 95%)
    3.0 (0.8 to 7.6)
    10.6 (4.4 to 20.6)
    No statistical analyses for this end point

    Secondary: Percentage of infant participants reporting medically assessed, RSV-associated lower respiratory tract illness (LRTIs) of any severity and RSV-associated severe LRTIs from birth up to 365 days post-birth

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    End point title
    		 Percentage of infant participants reporting medically assessed, RSV-associated lower respiratory tract illness (LRTIs) of any severity and RSV-associated severe LRTIs from birth up to 365 days post-birth [59]
    End point description
    An RSV-associated LRTI is characterized by a history of cough OR difficulty in breathing, AND a blood oxygen saturation by pulse oximetry (SpO2) lower than (<) 95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI meets the case definition of RSV-LRTI AND is additionally characterized by a SpO2 <93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
    End point type
    Secondary
    End point timeframe
    From birth up to 365 days post-birth
    Notes
    [59] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    132
    66
    Units: Percentage of participants
    number (confidence interval 95%)
        Any RSV-associated LRTIs
    0.8 (0.0 to 4.1)
    3.0 (0.4 to 10.5)
        RSV-associated Severe LRTIs
    0 (0 to 2.8)
    0 (0 to 5.4)
    No statistical analyses for this end point

    Secondary: RSV-A neutralizing titers for maternal participants at Day 31 post-dosing

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    End point title
    		 RSV-A neutralizing titers for maternal participants at Day 31 post-dosing [60]
    End point description
    RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. Day 31 post-dosing), minus those participants with protocol deviations that lead to exclusion.
    End point type
    Secondary
    End point timeframe
    At Day 31 post-dosing
    Notes
    [60] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV_MAT Group-Mother Control Group-Mother
    Number of subjects analysed
    89
    38
    Units: Titers
        geometric mean (confidence interval 95%)
    9959.7 (8239.95 to 12038.40)
    575.2 (418.40 to 790.84)
    No statistical analyses for this end point

    Secondary: RSV-B neutralizing titers for maternal participants at pre-dosing (Day 1), Day 31 post-dosing and delivery

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    End point title
    		 RSV-B neutralizing titers for maternal participants at pre-dosing (Day 1), Day 31 post-dosing and delivery [61]
    End point description
    RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time points, minus those participants with protocol deviations that lead to exclusion.
    End point type
    Secondary
    End point timeframe
    At pre-dosing (Day 1), Day 31 post-dosing and delivery
    Notes
    [61] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for maternal participants.
    End point values
    		 RSV_MAT Group-Mother Control Group-Mother
    Number of subjects analysed
    103
    47
    Units: Titers
    geometric mean (confidence interval 95%)
        Day 1 (N=103; 47)
    756.6 (646.03 to 885.98)
    863.4 (664.87 to 1121.12)
        Day 31 (N=89; 38)
    9928.9 (8331.29 to 11832.87)
    640.7 (475.93 to 862.38)
        Delivery (N=99; 43)
    6336.9 (5261.95 to 7631.49)
    650.2 (492.25 to 858.82)
    No statistical analyses for this end point

    Secondary: RSV MAT IgG-specific antibody concentrations for infant participants at Day 121 post-birth

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    End point title
    		 RSV MAT IgG-specific antibody concentrations for infant participants at Day 121 post-birth [62]
    End point description
    RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 121 post-birth.
    End point type
    Secondary
    End point timeframe
    At Day 121 post-birth
    Notes
    [62] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    2
    3
    Units: ELU/mL
        geometric mean (confidence interval 95%)
    4365.1 (12.84 to 1484365.32)
    446.8 (151.14 to 1320.88)
    No statistical analyses for this end point

    Secondary: RSV-B neutralizing titers for infant participants at delivery or within 72 hours after birth

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    End point title
    		 RSV-B neutralizing titers for infant participants at delivery or within 72 hours after birth [63]
    End point description
    RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs. The titers were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained). Analysis was performed on the Per Protocol Set Immunogenicity - Infant, which included all infant participants in the Exposed set who had post-delivery/birth immunogenicity data available for the specified analysis at the specified time points, minus those who (a) were born less than 4 weeks post-maternal participant dosing and/ or (b) had protocol deviations that lead to exclusion.
    End point type
    Secondary
    End point timeframe
    At delivery or within 72 hours after birth
    Notes
    [63] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    91
    37
    Units: Titers
        geometric mean (confidence interval 95%)
    9145.5 (7458.74 to 11213.76)
    779.7 (566.83 to 1072.49)
    No statistical analyses for this end point

    Secondary: RSV MAT IgG-specific antibody concentrations for infant participants at Day 43 post-birth

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    End point title
    		 RSV MAT IgG-specific antibody concentrations for infant participants at Day 43 post-birth [64]
    End point description
    RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 43 post-birth.
    End point type
    Secondary
    End point timeframe
    At Day 43 post-birth
    Notes
    [64] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    16
    5
    Units: ELU/mL
        geometric mean (confidence interval 95%)
    29932.5 (22576.08 to 39686.04)
    1310 (546.48 to 3140.43)
    No statistical analyses for this end point

    Secondary: RSV-A neutralizing titers for infant participants at Day 181 post-birth

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    End point title
    		 RSV-A neutralizing titers for infant participants at Day 181 post-birth [65]
    End point description
    RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 181 post-birth. There was only one participant in the Control Group - Infant for whom blood sample was collected, hence the 95% confidence interval (CI) associated with geometric mean could not be calculated for single participant, and therefore the low value of the confidence interval was entered as "0" and the high value of the confidence interval was entered as "115".
    End point type
    Secondary
    End point timeframe
    At Day 181 post-birth
    Notes
    [65] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    2
    1
    Units: Titers
        geometric mean (confidence interval 95%)
    755 (0.45 to 1262151.64)
    115 (0 to 115)
    No statistical analyses for this end point

    Secondary: RSV-A neutralizing titers for infant participants at Day 43 post-birth

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    End point title
    		 RSV-A neutralizing titers for infant participants at Day 43 post-birth [66]
    End point description
    RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 43 post-birth.
    End point type
    Secondary
    End point timeframe
    At Day 43 post-birth
    Notes
    [66] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    17
    5
    Units: Titers
        geometric mean (confidence interval 95%)
    3203.8 (1919.77 to 5346.65)
    240.5 (53.94 to 1072.76)
    No statistical analyses for this end point

    Secondary: RSV MAT IgG-specific antibody concentrations for infant participants at Day 181 post-birth

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    End point title
    		 RSV MAT IgG-specific antibody concentrations for infant participants at Day 181 post-birth [67]
    End point description
    RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 181 post-birth. There was only one participant in the Control Group - Infant for whom blood sample was collected, hence the 95% confidence interval (CI) associated with geometric mean could not be calculated for single participant, and therefore the low value of the confidence interval was entered as "0" and the high value of the confidence interval was entered as "241".
    End point type
    Secondary
    End point timeframe
    At Day 181 post-birth
    Notes
    [67] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    2
    1
    Units: ELU/mL
        geometric mean (confidence interval 95%)
    2857.8 (1836.27 to 4447.53)
    241 (0 to 241)
    No statistical analyses for this end point

    Secondary: RSV-A neutralizing titers for infant participants at Day 121 post-birth

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    End point title
    		 RSV-A neutralizing titers for infant participants at Day 121 post-birth [68]
    End point description
    RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 121 post-birth.
    End point type
    Secondary
    End point timeframe
    At Day 121 post-birth
    Notes
    [68] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    2
    3
    Units: Titers
        geometric mean (confidence interval 95%)
    607.9 (0.28 to 1322707.87)
    94.1 (68.10 to 130.08)
    No statistical analyses for this end point

    Secondary: RSV-B neutralizing titers for infant participants at Day 181 post-birth

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    End point title
    		 RSV-B neutralizing titers for infant participants at Day 181 post-birth [69]
    End point description
    RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 181 post-birth. There was only one participant in the Control Group - Infant for whom blood sample was collected, hence the 95% confidence interval (CI) associated with geometric mean could not be calculated for single participant, and therefore the low value of the confidence interval was entered as "0" and the high value of the confidence interval was entered as "63".
    End point type
    Secondary
    End point timeframe
    At Day 181 post-birth
    Notes
    [69] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    2
    1
    Units: Titers
        geometric mean (confidence interval 95%)
    327.9 (6.57 to 16367.16)
    63 (0 to 63)
    No statistical analyses for this end point

    Secondary: RSV-B neutralizing titers for infant participants at Day 43 post-birth

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    End point title
    		 RSV-B neutralizing titers for infant participants at Day 43 post-birth [70]
    End point description
    RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 43 post-birth.
    End point type
    Secondary
    End point timeframe
    At Day 43 post-birth
    Notes
    [70] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    17
    5
    Units: Titers
        geometric mean (confidence interval 95%)
    3012.8 (1789.81 to 5071.60)
    273.3 (106.14 to 703.45)
    No statistical analyses for this end point

    Secondary: RSV-B neutralizing titers for infant participants at Day 121 post-birth

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    End point title
    		 RSV-B neutralizing titers for infant participants at Day 121 post-birth [71]
    End point description
    RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs. Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 121 post-birth.
    End point type
    Secondary
    End point timeframe
    At Day 121 post-birth
    Notes
    [71] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infants born to maternal participants.
    End point values
    		 RSV_MAT Group-Infant Control Group-Infant
    Number of subjects analysed
    2
    3
    Units: Titers
        geometric mean (confidence interval 95%)
    622.7 (2.98 to 129923.70)
    54.9 (27.69 to 108.83)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Maternal groups: Solicited AEs - from Day 1 to Day 7 (included) and Unsolicited AEs - from Day 1 to Day 30 (included) after vaccination. SAEs - from Day 1 up to 180 days post-delivery. Infant groups: SAEs - from birth up to 365 days post-birth.
    Adverse event reporting additional description
    Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post-vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in this study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    RSV_MAT Group-Mother
    Reporting group description
    		 Maternal participants randomized to the RSV_MAT Group received a single dose of the RSV MAT vaccine administered, between 24 and 36 weeks of gestation, at Day 1 in this study.

    Reporting group title
    Control Group-Infant
    Reporting group description
    		 This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.

    Reporting group title
    RSV_MAT Group-Infant
    Reporting group description
    		 This group consisted of infants born to mothers (from RSV_MAT Group-Mother) who received a single dose of RSV MAT vaccine during pregnancy.

    Reporting group title
    Control Group-Mother
    Reporting group description
    		 Maternal participants randomized to the Control Group received a single dose of Placebo administered, between 24 and 36 weeks of gestation, at Day 1 in this study.

    Serious adverse events
    		 RSV_MAT Group-Mother Control Group-Infant RSV_MAT Group-Infant Control Group-Mother
    Total subjects affected by serious adverse events
         subjects affected / exposed
    33 / 113 (29.20%)
    21 / 66 (31.82%)
    35 / 132 (26.52%)
    11 / 56 (19.64%)
         number of deaths (all causes)
    0
    1
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neuroblastoma
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Medically induced preterm birth
         subjects affected / exposed
    3 / 113 (2.65%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    2 / 56 (3.57%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Breech delivery
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaundice neonatal
         subjects affected / exposed
    0 / 113 (0.00%)
    7 / 66 (10.61%)
    5 / 132 (3.79%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intrapartum haemorrhage
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gestational hypertension
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    2 / 56 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal dystocia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Placenta praevia
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failed induction of labour
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cephalo-pelvic disproportion
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Low birth weight baby
         subjects affected / exposed
    0 / 113 (0.00%)
    4 / 66 (6.06%)
    8 / 132 (6.06%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oligohydramnios
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal distress syndrome
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small for dates baby
         subjects affected / exposed
    0 / 113 (0.00%)
    4 / 66 (6.06%)
    3 / 132 (2.27%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retained placenta or membranes
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Preterm premature rupture of membranes
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature labour
         subjects affected / exposed
    4 / 113 (3.54%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    2 / 56 (3.57%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature baby
         subjects affected / exposed
    0 / 113 (0.00%)
    5 / 66 (7.58%)
    14 / 132 (10.61%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 14
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pre-eclampsia
         subjects affected / exposed
    7 / 113 (6.19%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    2 / 56 (3.57%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postpartum haemorrhage
         subjects affected / exposed
    4 / 113 (3.54%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Superimposed pre-eclampsia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vasa praevia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical cord prolapse
         subjects affected / exposed
    3 / 113 (2.65%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Threatened labour
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death neonatal
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 66 (1.52%)
    1 / 132 (0.76%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    ABO incompatibility
         subjects affected / exposed
    0 / 113 (0.00%)
    2 / 66 (3.03%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Apnoea
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopulmonary dysplasia
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 66 (1.52%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meconium aspiration syndrome
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 66 (1.52%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal respiratory distress
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    3 / 132 (2.27%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal respiratory distress syndrome
         subjects affected / exposed
    0 / 113 (0.00%)
    2 / 66 (3.03%)
    5 / 132 (3.79%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal tachypnoea
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient tachypnoea of the newborn
         subjects affected / exposed
    0 / 113 (0.00%)
    2 / 66 (3.03%)
    4 / 132 (3.03%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Foetal monitoring abnormal
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Medical observation
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 66 (1.52%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Fibromatosis colli of infancy
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankyloglossia congenital
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 66 (1.52%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial septal defect
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital arterial malformation
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 66 (1.52%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital inguinal hernia
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytogenetic abnormality
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pectus excavatum
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 66 (1.52%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Newborn persistent pulmonary hypertension
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemangioma congenital
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary valve stenosis congenital
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular septal defect
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    2 / 132 (1.52%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia foetal
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary valve stenosis
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal heart rate deceleration abnormality
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia foetal
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Poor sucking reflex
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 66 (1.52%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Normochromic normocytic anaemia
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 66 (1.52%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 66 (1.52%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperbilirubinaemia neonatal
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    2 / 132 (1.52%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 66 (1.52%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 66 (1.52%)
    3 / 132 (2.27%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysentery
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Candida sepsis
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 66 (1.52%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 66 (1.52%)
    3 / 132 (2.27%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometritis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural cellulitis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 66 (1.52%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis neonatal
         subjects affected / exposed
    0 / 113 (0.00%)
    3 / 66 (4.55%)
    6 / 132 (4.55%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 66 (1.52%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Failure to thrive
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia neonatal
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    1 / 132 (0.76%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 RSV_MAT Group-Mother Control Group-Infant RSV_MAT Group-Infant Control Group-Mother
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    89 / 113 (78.76%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    38 / 56 (67.86%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Surgical and medical procedures
    Medically induced preterm birth
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    1
    0
    0
    1
    Pregnancy, puerperium and perinatal conditions
    Premature labour
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    2
    0
    0
    1
    Pre-eclampsia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gestational hypertension
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    0
    0
    0
    1
    Gestational diabetes
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Foetal hypokinesia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Foetal growth restriction
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0
    False labour
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Uterine atony
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    2 / 56 (3.57%)
         occurrences all number
    0
    0
    0
    2
    Postpartum haemorrhage
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    1
    0
    0
    1
    General disorders and administration site conditions
    Administration site erythema
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Administration site swelling
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    0
    0
    0
    1
    Fatigue
         subjects affected / exposed
    32 / 113 (28.32%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    15 / 56 (26.79%)
         occurrences all number
    32
    0
    0
    15
    Administration site pain
         subjects affected / exposed
    50 / 113 (44.25%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    8 / 56 (14.29%)
         occurrences all number
    50
    0
    0
    8
    Injection site bruising
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    0
    0
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Haematocrit decreased
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Seroma
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    0
    0
    0
    1
    Congenital, familial and genetic disorders
    Congenital central nervous system anomaly
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    46 / 113 (40.71%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    21 / 56 (37.50%)
         occurrences all number
    46
    0
    0
    21
    Migraine
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    1
    0
    0
    1
    Lymphadenopathy
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    9 / 113 (7.96%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    11 / 56 (19.64%)
         occurrences all number
    9
    0
    0
    11
    Nausea
         subjects affected / exposed
    28 / 113 (24.78%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    11 / 56 (19.64%)
         occurrences all number
    28
    0
    0
    11
    Abdominal pain
         subjects affected / exposed
    23 / 113 (20.35%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    10 / 56 (17.86%)
         occurrences all number
    23
    0
    0
    10
    Diarrhoea
         subjects affected / exposed
    23 / 113 (20.35%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    4 / 56 (7.14%)
         occurrences all number
    24
    0
    0
    4
    Haemorrhoids
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    2 / 56 (3.57%)
         occurrences all number
    0
    0
    0
    2
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    0
    0
    0
    1
    Neck pain
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Back pain
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Mastitis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 113 (2.65%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    4 / 56 (7.14%)
         occurrences all number
    3
    0
    0
    5
    COVID-19
         subjects affected / exposed
    5 / 113 (4.42%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    5
    0
    0
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    2
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    1
    0
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Bacterial disease carrier
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    0
    0
    0
    1
    Bacterial vaginosis
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    0
    0
    0
    1
    Vaginal infection
         subjects affected / exposed
    0 / 113 (0.00%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    0
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 66 (0.00%)
    0 / 132 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Mar 2022
    Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing participants at that time continued to be monitored as part of the study.

    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
    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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