Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44352   clinical trials with a EudraCT protocol, of which   7379   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 3b, non-randomized, open label, multi-country, cohort study to describe the safety of study participants who received RSVPreF3 maternal vaccination (any dose) or controls from previous RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-010, RSV MAT-011, RSV MAT-009, RSV MAT-012 and RSV MAT-039) during any pregnancy conceived post vaccination/control

    Summary
    EudraCT number
    		 2022-003124-41
    Trial protocol
    		 FI   BE   DE   FR   ES  
    Global end of trial date
    15 Jan 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Jul 2025
    First version publication date
    31 Jul 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    219510
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05705440
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    79 New Oxford Street, London, WC1A 1DG, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, GlaxoSmithKline, 44 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 44 8664357343, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Mar 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jan 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the incidence of pregnancy outcomes, pregnancy related adverse events of special interest (AESIs) and infant AESIs during the first pregnancy conceived within 2 years post-vaccination in participants enrolled in RSV MAT studies (by study arm, those previously received RSVPreF3 and control) up to Day 42 post-delivery.
    Protection of trial subjects
    The investigator or his/her representative explained the nature of the study to the participant or his/her legally authorized representative and answered all questions regarding the study. Participants and/or their legally authorized representative were informed that their participation was voluntary. Participants or their legally authorized representative were required to sign a statement of informed consent that met the requirements of 21 Code of Federal Regulations (CFR) 50, local regulations, International Council for Harmonization (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA) requirements, privacy and data protection requirements, where applicable, and the Institutional Review Board/Independent Ethics Committee (IRB/IEC) or study center.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Feb 2023
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 206
    Country: Number of subjects enrolled
    France: 12
    Country: Number of subjects enrolled
    Germany: 32
    Country: Number of subjects enrolled
    Honduras: 20
    Country: Number of subjects enrolled
    India: 44
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Korea, Republic of: 91
    Country: Number of subjects enrolled
    New Zealand: 84
    Country: Number of subjects enrolled
    Panama: 448
    Country: Number of subjects enrolled
    Philippines: 258
    Country: Number of subjects enrolled
    South Africa: 401
    Country: Number of subjects enrolled
    Spain: 854
    Country: Number of subjects enrolled
    Taiwan: 87
    Country: Number of subjects enrolled
    Thailand: 49
    Country: Number of subjects enrolled
    United States: 376
    Country: Number of subjects enrolled
    Argentina: 76
    Country: Number of subjects enrolled
    Australia: 21
    Country: Number of subjects enrolled
    Bangladesh: 278
    Country: Number of subjects enrolled
    Belgium: 28
    Country: Number of subjects enrolled
    Brazil: 59
    Country: Number of subjects enrolled
    Canada: 290
    Country: Number of subjects enrolled
    Colombia: 115
    Country: Number of subjects enrolled
    Dominican Republic: 16
    Worldwide total number of subjects
    3855
    EEA total number of subjects
    1142
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    457
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    10
    Adults (18-64 years)
    3388
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 3855 participants (3398 mothers & 457 infants) completed the informed consent process, of which 475 mothers with pregnancy conceived within and beyond 2 years post-vaccination were included in the Maternal Full Analysis Set (FAS). 438 infants who were born to those mothers and had post-birth data were included in the Infant FAS.

    Pre-assignment
    Screening details
    		 Out of the 475 mothers included in the Maternal FAS, a total of 448 mothers who conceived within 2 years post-vaccination were considered for the primary, secondary and safety analyses. 411 infants born to the 448 mothers were considered for the primary, secondary and safety analyses.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 RSV MAT Group - Mother
    Arm description
    		 Maternal participants who received the RSVPreF3 vaccine during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-009, RSV MAT-010, RSV MAT-011, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study.
    Arm type
    		 No intervention

    Investigational medicinal product name
    RSVPreF3 vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    No intervention is administered in this extension study. Participants received the RSVPreF3 vaccine during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-010, RSV MAT-011, RSV MAT-009, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study. In all prior RSV MAT studies, participants received one dose of RSVPreF3 vaccine except in RSV MAT-011 study, where some participants received a second dose as well.

    Arm title
    		 Control Group - Mother
    Arm description
    		 Maternal participants who received any control (placebo, Tdap or influenza vaccine) during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-009, RSV MAT-010, RSV MAT-011, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study.
    Arm type
    		 No intervention

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    No intervention is administered in this extension study. Participants received any control (placebo, Tdap or influenza vaccine) during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-010, RSV MAT-011, RSV MAT-009, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study. In all prior RSV MAT studies, participants received one dose of any control (placebo, Tdap or influenza vaccine).

    Investigational medicinal product name
    Influenza vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    No intervention is administered in this extension study. Participants received any control (placebo, Tdap or influenza vaccine) during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-010, RSV MAT-011, RSV MAT-009, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study. In all prior RSV MAT studies, participants received one dose of any control (placebo, Tdap or influenza vaccine).

    Investigational medicinal product name
    Tdap vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    No intervention is administered in this extension study. Participants received any control (placebo, Tdap or influenza vaccine) during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-010, RSV MAT-011, RSV MAT-009, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study. In all prior RSV MAT studies, participants received one dose of any control (placebo, Tdap or influenza vaccine).

    Arm title
    		 RSV MAT Group - Infant
    Arm description
    		 This group consisted of infants live-born to maternal participants in the RSV MAT Group - Mother.
    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 live-born to maternal participants in the Control Group - Mother.
    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
    296
    152
    275
    136
    Completed
    269
    136
    256
    118
    Not completed
    27
    16
    19
    18
         Adverse Event leading to study discontinuation
    1
    -
    -
    -
         Adverse event, serious fatal
    -
    -
    1
    -
         Physician decision
    4
    -
    -
    -
         Migrated / moved from the study area
    -
    1
    -
    -
         Not specified
    18
    12
    17
    17
         Lost to follow-up
    4
    3
    1
    1
    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: A total of 3855 participants (3398 mothers & 457 infants) completed the informed consent process. Out of the 475 mothers included in the Maternal FAS, a total of 448 mothers who conceived within 2 years post-vaccination were considered for the primary, secondary and safety analyses. 411 infants born to the 448 mothers were considered for the primary, secondary and safety analyses.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    RSV MAT Group - Mother
    Reporting group description
    		 Maternal participants who received the RSVPreF3 vaccine during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-009, RSV MAT-010, RSV MAT-011, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study.

    Reporting group title
    Control Group - Mother
    Reporting group description
    		 Maternal participants who received any control (placebo, Tdap or influenza vaccine) during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-009, RSV MAT-010, RSV MAT-011, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study.

    Reporting group title
    RSV MAT Group - Infant
    Reporting group description
    		 This group consisted of infants live-born to maternal participants in the RSV MAT Group - Mother.

    Reporting group title
    Control Group - Infant
    Reporting group description
    		 This group consisted of infants live-born to maternal participants in the Control Group - Mother.

    Reporting group values
    		 RSV MAT Group - Mother Control Group - Mother RSV MAT Group - Infant Control Group - Infant Total
    Number of subjects
    		 296 152 275 136 859
    Age Categorical
    Descriptive summaries of age are presented for the maternal participants (age at the time of vaccination in prior RSV MAT studies) included in the RSV MAT Group - Mother and Control Group – Mother and for the infants included in the RSV MAT Group – Infant and Control Group - Infant.
    Units: Participants
        0 to 1 years of age
    		 0 0 275 136 411
        <18 years of age
    		 2 0 0 0 2
        18 to 24 years of age
    		 76 29 0 0 105
        25 to 34 years of age
    		 181 97 0 0 278
        >=35 years of age
    		 37 26 0 0 63
    Sex: Female, Male
    Units: Participants
        Female
    		 296 152 144 65 657
        Male
    		 0 0 131 71 202
    Race/Ethnicity, Customized
    The "All Other Races" category (i.e., American Indian Or Alaska Native, Black Or African American, and Native Hawaiian Or Other Pacific Islander where 0<n<11) are combined into one category to maintain participant confidentiality and privacy.
    Units: Subjects
        All Other Races
    		 26 19 22 12 79
        Asian
    		 41 22 39 19 121
        White
    		 199 102 179 92 572
        Multiple
    		 16 6 19 8 49
        Not Reported
    		 2 1 3 1 7
        Unknown, Not Specified
    		 12 2 13 4 31

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    RSV MAT Group - Mother
    Reporting group description
    		 Maternal participants who received the RSVPreF3 vaccine during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-009, RSV MAT-010, RSV MAT-011, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study.

    Reporting group title
    Control Group - Mother
    Reporting group description
    		 Maternal participants who received any control (placebo, Tdap or influenza vaccine) during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-009, RSV MAT-010, RSV MAT-011, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study.

    Reporting group title
    RSV MAT Group - Infant
    Reporting group description
    		 This group consisted of infants live-born to maternal participants in the RSV MAT Group - Mother.

    Reporting group title
    Control Group - Infant
    Reporting group description
    		 This group consisted of infants live-born to maternal participants in the Control Group - Mother.

    Primary: Number of maternal participants with pregnancy outcomes from conception until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

    		 Close Top of page
    End point title
    		 Number of maternal participants with pregnancy outcomes from conception until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies [1] [2]
    End point description
    Assessed pregnancy outcomes were live infant with no apparent congenital anomaly (CA); spontaneous abortion with no apparent congenital anomaly (CA); ectopic pregnancy; elective termination with no apparent congenital anomaly (CA); live infant with congenital anomaly (CA), and stillbirth with congenital anomaly (CA). Analysis was performed on the Full Analysis set (first pregnancy) - Maternal, which included all maternal participants with first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies and with pregnancy outcomes data available for the specified analysis during the specified period of the first pregnancy.
    End point type
    Primary
    End point timeframe
    From conception until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
    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
    296 [3]
    151 [4]
    Units: Participants
        Live infant with no apparent CA
    249
    120
        Spontaneous abortion with no apparent CA
    28
    14
        Ectopic pregnancy
    1
    1
        Elective termination with no apparent CA
    1
    2
        Live infant with CA
    17
    13
        Stillbirth with CA
    0
    1
    Notes
    [3] - Number of participants analyzed in each row = 296.
    [4] - Number of participants analyzed in each row = 151.
    No statistical analyses for this end point

    Primary: Number of maternal participants with pregnancy-related adverse events of special interest (AESIs) from conception until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

    		 Close Top of page
    End point title
    		 Number of maternal participants with pregnancy-related adverse events of special interest (AESIs) from conception until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies [5] [6]
    End point description
    Assessed pregnancy-related AESIs were chorioamnionitis, fetal growth restriction, gestational diabetes mellitus, gestational hypertension, pre-eclampsia, pre-eclampsia with severe features including eclampsia, premature preterm ruptures of membranes, preterm labor and provider-initiated preterm birth. Analysis was performed on the Full Analysis set (first pregnancy) - Maternal, which included all maternal participants with first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies and with pregnancy-related AESIs data available for the specified analysis during the specified period of the first pregnancy.
    End point type
    Primary
    End point timeframe
    From conception until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
    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
    296 [7]
    151 [8]
    Units: Participants
        Chorioamnionitis
    2
    0
        Fetal growth restriction
    3
    3
        Gestational diabetes mellitus
    12
    7
        Gestational hypertension
    8
    1
        Pre-eclampsia
    0
    2
        Pre-eclampsia with severe features
    2
    3
        Premature preterm ruptures of membrane
    2
    1
        Preterm labor
    11
    3
        Provider-initiated preterm birth
    10
    3
    Notes
    [7] - Number of participants analyzed in each row = 296.
    [8] - Number of participants analyzed in each row = 151.
    No statistical analyses for this end point

    Primary: Number of infant participants with AESIs from birth until Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

    		 Close Top of page
    End point title
    		 Number of infant participants with AESIs from birth until Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies [9] [10]
    End point description
    Assessed AESIs were congenital anomalies (CA) with internal structural defects, congenital anomalies (CA) with major external structural defects, low birth weight [greater than or equal to (>=) 1500 grams (G) and below (<) 2500 G], very low birth weight (>=1000 G and <1500 G), neonatal death in a term live birth (>=37 weeks of gestational age), preterm birth (<37 weeks of gestational age) and small for gestational age. Analysis was performed on the Full Analysis Set (first pregnancy) - Infant, which included all infant participants born to maternal participants from the first study pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies and with post-birth AESIs data available for the specified analysis during the specified period.
    End point type
    Primary
    End point timeframe
    From birth until Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
    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 infant participants.
    End point values
    		 RSV MAT Group - Infant Control Group - Infant
    Number of subjects analysed
    265 [11]
    132 [12]
    Units: Participants
        CA with internal structural defects
    3
    0
        CA with major external structural defects
    1
    0
        Low birth weight
    18
    5
        Very low birth weight
    1
    1
        Neonatal death in a term live birth
    1
    0
        Preterm birth
    23
    8
        Small for gestational age
    18
    13
    Notes
    [11] - Number of participants analyzed in each row = 265.
    [12] - Number of participants analyzed in each row = 132.
    No statistical analyses for this end point

    Secondary: Number of pregnancies with pregnancy outcomes from conception until Day 42 post-delivery of any pregnancy conceived by maternal participants within 2 years post-vaccination received in prior RSV MAT studies

    		 Close Top of page
    End point title
    		 Number of pregnancies with pregnancy outcomes from conception until Day 42 post-delivery of any pregnancy conceived by maternal participants within 2 years post-vaccination received in prior RSV MAT studies [13]
    End point description
    Assessed pregnancy outcomes were live infant with no apparent congenital anomaly (CA); spontaneous abortion with no apparent congenital anomaly (CA); ectopic pregnancy; elective termination with no apparent congenital anomaly (CA); live infant with congenital anomaly (CA); molar pregnancy; stillbirth with congenital anomaly (CA) and stillbirth with no apparent congenital anomaly (CA). Analysis was performed on the Full Analysis set (any pregnancy) - Maternal, which included any pregnancies conceived by the maternal participants within 2 years post-vaccination received in prior RSV MAT studies and with pregnancy outcomes data available for the specified analysis during the specified period of any pregnancy.
    End point type
    Secondary
    End point timeframe
    From conception until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV MAT Group - Mother Control Group - Mother
    Number of subjects analysed
    296 [14]
    152 [15]
    Units: Pregnancies
        Live infant with no apparent CA
    257
    123
        Spontaneous abortion with no apparent CA
    31
    16
        Ectopic pregnancy
    1
    1
        Elective termination with no apparent CA
    1
    2
        Live infant with CA
    18
    14
        Molar pregnancy
    1
    1
        Stillbirth with CA
    0
    1
        Stillbirth with no apparent CA
    1
    0
    Notes
    [14] - Number of participants analyzed in each row = 296. Number of pregnancies analyzed in each row = 310.
    [15] - Number of participants analyzed in each row = 152. Number of pregnancies analyzed in each row = 158.
    No statistical analyses for this end point

    Secondary: Number of pregnancies with pregnancy-related AESIs from conception until Day 42 post-delivery of any pregnancy conceived by maternal participants within 2 years post-vaccination received in prior RSV MAT studies

    		 Close Top of page
    End point title
    		 Number of pregnancies with pregnancy-related AESIs from conception until Day 42 post-delivery of any pregnancy conceived by maternal participants within 2 years post-vaccination received in prior RSV MAT studies [16]
    End point description
    Assessed pregnancy-related AESIs were preterm labor, provider-initiated preterm birth, premature preterm rupture of membranes, gestational diabetes mellitus, gestational hypertension, pre-eclampsia with severe features including eclampsia, pre-eclampsia, fetal growth restriction and chorioamnionitis. Analysis was performed on the Full Analysis set (any pregnancy) - Maternal, which included any pregnancies conceived by the maternal participants within 2 years post-vaccination received in prior RSV MAT studies and with pregnancy-related AESIs data available for the specified analysis during the specified period of any pregnancy.
    End point type
    Secondary
    End point timeframe
    From conception until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV MAT Group - Mother Control Group - Mother
    Number of subjects analysed
    296 [17]
    152 [18]
    Units: Pregnancies
        Preterm labor
    12
    3
        Provider-initiated preterm birth
    10
    3
        Premature preterm ruptures of membranes
    2
    1
        Gestational diabetes mellitus
    12
    8
        Gestational hypertension
    10
    1
        Pre-eclampsia with severe features
    3
    3
        Pre-eclampsia
    1
    2
        Fetal growth restriction
    4
    3
        Chorioamnionitis
    2
    0
    Notes
    [17] - Number of participants analyzed in each row = 296. Number of pregnancies analyzed in each row = 310.
    [18] - Number of participants analyzed in each row = 152. Number of pregnancies analyzed in each row = 158.
    No statistical analyses for this end point

    Secondary: Number of infant participants with AESIs from birth until Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

    		 Close Top of page
    End point title
    		 Number of infant participants with AESIs from birth until Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies [19]
    End point description
    Assessed AESIs were congenital anomalies (CA) with internal structural defects, congenital anomalies (CA) with major external structural defects, low birth weight (>=1500 G and <2500 G), very low birth weight (>=1000 G and <1500 G), neonatal death in a term live birth (>=37 weeks of gestational age), preterm birth (<37 weeks of gestational age) and small for gestational age. Analysis was performed on the Full Analysis Set (any pregnancy) - Infant, which included all infant participants born to maternal participants from any study pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies and with post-birth AESIs data available for the specified analysis during the specified period.
    End point type
    Secondary
    End point timeframe
    From birth until Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the infant participants.
    End point values
    		 RSV MAT Group - Infant Control Group - Infant
    Number of subjects analysed
    275 [20]
    136 [21]
    Units: Participants
        CA with internal structural defects
    4
    0
        CA with major external structural defects
    1
    0
        Low birth weight
    20
    5
        Very low birth weight
    1
    1
        Neonatal death in a term live birth
    1
    0
        Preterm birth
    24
    8
        Small for gestational age
    20
    13
    Notes
    [20] - Number of participants analyzed in each row = 275.
    [21] - Number of participants analyzed in each row = 136.
    No statistical analyses for this end point

    Secondary: Number of pregnancies with preterm birth event stratified by selected risk factors, from Day 1 until Day 42 post-delivery of any pregnancy conceived by maternal participants within 2 years post-vaccination received in prior RSV MAT studies

    		 Close Top of page
    End point title
    		 Number of pregnancies with preterm birth event stratified by selected risk factors, from Day 1 until Day 42 post-delivery of any pregnancy conceived by maternal participants within 2 years post-vaccination received in prior RSV MAT studies [22]
    End point description
    The selected risk factors assessed were prior preterm delivery, pregnancy complications, gestational diabetes mellitus, chorioamnionitis during pregnancy, hypertensive disorders of pregnancy, pre-existing hypertension, pre-existing diabetes, vaginal bleeding during pregnancy, polyhydramnios or oligohydramnios during pregnancy and fetal growth restriction. The below presented data is read as follows: With PTB = the assessed pregnancy resulted in a preterm birth (PTB) event. Without PTB = the assessed pregnancy did not result in a preterm birth (PTB) event. Analysis was performed on the Full Analysis set (any pregnancy) - Maternal, which included any pregnancies that had an outcome of live birth and were conceived by the maternal participants within 2 years post-vaccination received in prior RSV MAT studies and with pre-term birth event (PTB) (stratified by selected risk factors) data available for the specified analysis during the specified period of any pregnancy.
    End point type
    Secondary
    End point timeframe
    From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the maternal participants.
    End point values
    		 RSV MAT Group - Mother Control Group - Mother
    Number of subjects analysed
    296 [23]
    152 [24]
    Units: Pregnancies
        Prior preterm delivery with PTB
    5
    1
        Pregnancy complications with PTB
    4
    0
        Gestational diabetes mellitus with PTB
    0
    0
        Chorioamnionitis during pregnancy with PTB
    0
    0
        Hypertensive disorders of preg. with PTB
    0
    0
        Pre-existing hypertension with PTB
    1
    0
        Pre-existing diabetes with PTB
    1
    0
        Vaginal bleeding during pregnancy with PTB
    1
    0
        Polyhydramnios/oligohydramnios with PTB
    1
    0
        Fetal growth restriction with PTB
    0
    0
        Prior preterm delivery without PTB
    2
    3
        Pregnancy complications without PTB
    28
    16
        Gestational diabetes mellitus without PTB
    13
    8
        Chorioamnionitis during pregnancy without PTB
    2
    0
        Hypertensive disorders of preg. without PTB
    0
    0
        Pre-existing hypertension without PTB
    1
    2
        Pre-existing diabetes without PTB
    0
    0
        Vaginal bleeding during pregnancy without PTB
    5
    2
        Polyhydramnios/oligohydramnios without PTB
    3
    1
        Fetal growth restriction without PTB
    4
    3
        No prior preterm delivery with PTB
    18
    6
        No pregnancy complications with PTB
    19
    7
        No gestational diabetes mellitus with PTB
    23
    7
        No chorioamnionitis during pregnancy with PTB
    23
    7
        No hypertensive disorders of preg. with PTB
    23
    7
        No pre-existing hypertension with PTB
    22
    7
        No pre-existing diabetes with PTB
    22
    7
        No vaginal bleeding during pregnancy with PTB
    22
    7
        No polyhydramnios/oligohydramnios with PTB
    22
    7
        No fetal growth restriction with PTB
    23
    7
        No prior preterm delivery without PTB
    250
    127
        No pregnancy complications without PTB
    224
    114
        No gestational diabetes mellitus without PTB
    239
    122
        No chorioamnionitis during pregnancy without PTB
    250
    130
        No hypertensive disorders of preg. without PTB
    252
    130
        No pre-existing hypertension without PTB
    251
    128
        No pre-existing diabetes without PTB
    252
    130
        No vaginal bleeding during pregnancy without PTB
    247
    128
        No Polyhydramnios/oligohydramnios without PTB
    249
    129
        No fetal growth restriction without PTB
    248
    127
    Notes
    [23] - Number of participants analyzed in each row = 296. Number of pregnancies analyzed in each row = 275.
    [24] - Number of participants analyzed in each row = 152. Number of pregnancies analyzed in each row = 137.
    No statistical analyses for this end point

    Secondary: Number of pregnancies with preterm birth event stratified by age group at vaccination, from Day 1 until Day 42 post-delivery of any pregnancy conceived by maternal participants within 2 years post-vaccination received in prior RSV MAT studies

    		 Close Top of page
    End point title
    		 Number of pregnancies with preterm birth event stratified by age group at vaccination, from Day 1 until Day 42 post-delivery of any pregnancy conceived by maternal participants within 2 years post-vaccination received in prior RSV MAT studies [25]
    End point description
    The age groups at vaccination assessed were <18 years, 18-24 years, 25-34 years and >=35 years. Analysis was performed on the Full Analysis set (any pregnancy) - Maternal, which included any pregnancies that had an outcome of live birth and were conceived by the maternal participants within 2 years post-vaccination received in prior RSV MAT studies and with preterm birth (PTB) event (stratified by age group) data available for the specified analysis during the specified period of any pregnancy.
    End point type
    Secondary
    End point timeframe
    From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
    Notes
    [25] - 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
    296 [26]
    152 [27]
    Units: Pregnancies
        <18 years: With PTB
    0
    0
        <18 years: Without PTB
    2
    0
        18-24 years: With PTB
    11
    2
        18-24 years: Without PTB
    61
    23
        25-34 years: With PTB
    11
    4
        25-34 years: Without PTB
    156
    85
        >= 35 years: With PTB
    1
    1
        >= 35 years: Without PTB
    33
    22
    Notes
    [26] - Number of participants analyzed in each row = 296. Number of pregnancies analyzed in each row = 275.
    [27] - Number of participants analyzed in each row = 152. Number of pregnancies analyzed in each row = 137.
    No statistical analyses for this end point

    Secondary: Number of pregnancies with preterm birth event stratified by pre-pregnancy body mass index (BMI), from Day 1 until Day 42 post-delivery of any pregnancy conceived by maternal participants within 2 years post-vaccination received in prior RSV MAT studies

    		 Close Top of page
    End point title
    		 Number of pregnancies with preterm birth event stratified by pre-pregnancy body mass index (BMI), from Day 1 until Day 42 post-delivery of any pregnancy conceived by maternal participants within 2 years post-vaccination received in prior RSV MAT studies [28]
    End point description
    The pre-pregnancy BMI categories assessed were < 30 kilogram per square meter (kg/m^2), >=30 kg/m^2 and missing (no pre-pregnancy BMI data available). Analysis was performed on the Full Analysis set (any pregnancy) - Maternal, which included any pregnancies that had an outcome of live birth and were conceived by the maternal participants within 2 years post-vaccination received in prior RSV MAT studies and with preterm birth (PTB) event (stratified by pre-pregnancy BMI) data available for the specified analysis during the specified period of any pregnancy.
    End point type
    Secondary
    End point timeframe
    From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
    Notes
    [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 maternal participants.
    End point values
    		 RSV MAT Group - Mother Control Group - Mother
    Number of subjects analysed
    296 [29]
    152 [30]
    Units: Pregnancies
        <30 kg/m^2: With PTB
    10
    2
        <30 kg/m^2: Without PTB
    163
    87
        >=30 kg/m^2: With PTB
    1
    3
        >=30 kg/m^2: Without PTB
    38
    10
        Missing: With PTB
    12
    2
        Missing: Without PTB
    51
    33
    Notes
    [29] - Number of participants analyzed in each row = 296. Number of pregnancies analyzed in each row = 275.
    [30] - Number of participants analyzed in each row = 152. Number of pregnancies analyzed in each row = 137.
    No statistical analyses for this end point

    Secondary: Number of pregnancies with preterm birth event stratified by race, from Day 1 until Day 42 post-delivery of any pregnancy conceived by maternal participants within 2 years post-vaccination received in prior RSV MAT studies

    		 Close Top of page
    End point title
    		 Number of pregnancies with preterm birth event stratified by race, from Day 1 until Day 42 post-delivery of any pregnancy conceived by maternal participants within 2 years post-vaccination received in prior RSV MAT studies [31]
    End point description
    The races assessed were American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White, Multiple, Not reported and Unknown. Analysis was performed on the Full Analysis set (any pregnancy) - Maternal, which included any pregnancies that had an outcome of live birth and were conceived by the maternal participants within 2 years post-vaccination received in prior RSV MAT studies and with preterm birth (PTB) event (stratified by race) data available for the specified analysis during the specified period of any pregnancy.
    End point type
    Secondary
    End point timeframe
    From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
    Notes
    [31] - 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
    296 [32]
    152 [33]
    Units: Pregnancies
        American Indian/Alaska Native: With PTB
    0
    1
        American Indian/Alaska Native: Without PTB
    5
    8
        Asian: With PTB
    6
    0
        Asian: Without PTB
    33
    20
        Black/African American: With PTB
    1
    1
        Black/African American: Without PTB
    14
    6
        Native Hawaiian/Other Pacific Islander:With PTB
    0
    0
        Native Hawaiian/Other Pacific Islander:Without PTB
    3
    1
        White: With PTB
    10
    4
        White: Without PTB
    178
    88
        Multiple: With PTB
    3
    0
        Multiple: Without PTB
    10
    5
        Not reported: With PTB
    0
    1
        Not reported: Without PTB
    2
    0
        Unknown: With PTB
    3
    0
        Unknown: Without PTB
    7
    2
    Notes
    [32] - Number of participants analyzed in each row = 296. Number of pregnancies analyzed in each row = 275.
    [33] - Number of participants analyzed in each row = 152. Number of pregnancies analyzed in each row = 137.
    No statistical analyses for this end point

    Secondary: Number of pregnancies with preterm birth event stratified by multiple gestation pregnancy, from Day 1 until Day 42 post-delivery of any pregnancy conceived by maternal participants within 2 years post-vaccination received in prior RSV MAT studies

    		 Close Top of page
    End point title
    		 Number of pregnancies with preterm birth event stratified by multiple gestation pregnancy, from Day 1 until Day 42 post-delivery of any pregnancy conceived by maternal participants within 2 years post-vaccination received in prior RSV MAT studies [34]
    End point description
    The multiple gestation pregnancy assessed were one gestation, two gestations and three gestations. Analysis was performed on the Full Analysis set (any pregnancy) - Maternal, which included any pregnancies that had an outcome of live birth and were conceived by the maternal participants within 2 years post-vaccination received in prior RSV MAT studies and with preterm birth (PTB) event (stratified by multiple gestation pregnancy) data available for the specified analysis during the specified period of any pregnancy.
    End point type
    Secondary
    End point timeframe
    From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
    Notes
    [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 maternal participants.
    End point values
    		 RSV MAT Group - Mother Control Group - Mother
    Number of subjects analysed
    296 [35]
    152 [36]
    Units: Pregnancies
        One gestation: With PTB
    22
    7
        One gestation: Without PTB
    242
    125
        Two gestations: With PTB
    1
    0
        Two gestations: Without PTB
    8
    5
        Three gestations: With PTB
    0
    0
        Three gestations: Without PTB
    2
    0
    Notes
    [35] - Number of participants analyzed in each row = 296. Number of pregnancies analyzed in each row = 275.
    [36] - Number of participants analyzed in each row = 152. Number of pregnancies analyzed in each row = 137.
    No statistical analyses for this end point

    Secondary: Number of pregnancies with preterm birth event stratified by geographic region, from Day 1 until Day 42 post-delivery of any pregnancy conceived by maternal participants within 2 years post-vaccination received in prior RSV MAT studies

    		 Close Top of page
    End point title
    		 Number of pregnancies with preterm birth event stratified by geographic region, from Day 1 until Day 42 post-delivery of any pregnancy conceived by maternal participants within 2 years post-vaccination received in prior RSV MAT studies [37]
    End point description
    The geographic regions assessed were Europe, Australasia, North America, Latin America and Africa. Analysis was performed on the Full Analysis set (any pregnancy) - Maternal, which included any pregnancies that had an outcome of live birth and were conceived by the maternal participants within 2 years post-vaccination received in prior RSV MAT studies and with preterm birth (PTB) event (stratified by geographic region) data available for the specified analysis during the specified period of any pregnancy.
    End point type
    Secondary
    End point timeframe
    From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
    Notes
    [37] - 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
    296 [38]
    152 [39]
    Units: Pregnancies
        Europe: With PTB
    6
    3
        Europe: Without PTB
    93
    51
        Australasia: With PTB
    6
    0
        Australasia: Without PTB
    43
    25
        North America: With PTB
    4
    1
        North America: Without PTB
    72
    31
        Latin America: With PTB
    7
    2
        Latin America: Without PTB
    36
    20
        Africa: With PTB
    0
    1
        Africa: Without PTB
    8
    3
    Notes
    [38] - Number of participants analyzed in each row = 296. Number of pregnancies analyzed in each row = 275.
    [39] - Number of participants analyzed in each row = 152. Number of pregnancies analyzed in each row = 137.
    No statistical analyses for this end point

    Secondary: Number of pregnancies with preterm birth event stratified by economic region, from Day 1 until Day 42 post-delivery of any pregnancy conceived by maternal participants within 2 years post-vaccination received in prior RSV MAT studies

    		 Close Top of page
    End point title
    		 Number of pregnancies with preterm birth event stratified by economic region, from Day 1 until Day 42 post-delivery of any pregnancy conceived by maternal participants within 2 years post-vaccination received in prior RSV MAT studies [40]
    End point description
    The economic regions assessed were low and middle-income countries (LMIC) and high-income countries (HIC). Analysis was performed on the Full Analysis set (any pregnancy) - Maternal, which included any pregnancies that had an outcome of live birth and were conceived by the maternal participants within 2 years post-vaccination received in prior RSV MAT studies and with preterm birth (PTB) event (stratified by economic region) data available for the specified analysis during the specified period of any pregnancy.
    End point type
    Secondary
    End point timeframe
    From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
    Notes
    [40] - 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
    296 [41]
    152 [42]
    Units: Pregnancies
        LMIC: With PTB
    13
    3
        LMIC: Without PTB
    66
    38
        HIC: With PTB
    10
    4
        HIC: Without PTB
    186
    92
    Notes
    [41] - Number of participants analyzed in each row = 296. Number of pregnancies analyzed in each row = 275.
    [42] - Number of participants analyzed in each row = 152. Number of pregnancies analyzed in each row = 137.
    No statistical analyses for this end point

    Secondary: Number of maternal participants with preterm birth event stratified by selected risk factors, from Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

    		 Close Top of page
    End point title
    		 Number of maternal participants with preterm birth event stratified by selected risk factors, from Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies [43]
    End point description
    The selected risk factors assessed were prior preterm delivery, pregnancy complications, gestational diabetes mellitus, chorioamnionitis during pregnancy, hypertensive disorders of pregnancy, pre-existing hypertension, pre-existing diabetes, vaginal bleeding during pregnancy, polyhydramnios or oligohydramnios during pregnancy and fetal growth restriction. Analysis was performed on the Full Analysis set (first pregnancy) - Maternal, which included all maternal participants with first pregnancy that had an outcome of live birth and was conceived within 2 years post-vaccination received in prior RSV MAT studies and with preterm birth (PTB) event (stratified by selected risk factors) data available for the specified analysis during the specified period of the first pregnancy.
    End point type
    Secondary
    End point timeframe
    From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
    Notes
    [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
    266 [44]
    133 [45]
    Units: Participants
        Prior preterm delivery with PTB
    5
    1
        Pregnancy complications with PTB
    4
    0
        Gestational diabetes mellitus with PTB
    0
    0
        Chorioamnionitis during pregnancy with PTB
    0
    0
        Hypertensive disorders of preg.with PTB
    0
    0
        Pre-existing hypertension with PTB
    1
    0
        Pre-existing diabetes with PTB
    1
    0
        Vaginal bleeding during pregnancy with PTB
    1
    0
        Polyhydramnios/oligohydramnios with PTB
    1
    0
        Fetal growth restriction with PTB
    0
    0
        Prior preterm delivery without PTB
    2
    3
        Pregnancy complications without PTB
    27
    15
        Gestational diabetes mellitus without PTB
    13
    7
        Chorioamnionitis during pregnancy without PTB
    2
    0
        Hypertensive disorders of preg. without PTB
    0
    0
        Pre-existing hypertension without PTB
    1
    2
        Pre-existing diabetes without PTB
    0
    0
        Vaginal bleeding during pregnancy without PTB
    5
    2
        Polyhydramnios/oligohydramnios without PTB
    3
    1
        Fetal growth restriction without PTB
    3
    3
        No prior preterm delivery with PTB
    17
    6
        No pregnancy complications with PTB
    18
    7
        No gestational diabetes mellitus with PTB
    22
    7
        No chorioamnionitis during pregnancy with PTB
    22
    7
        No hypertensive disorders of preg. with PTB
    22
    7
        No pre-existing hypertension with PTB
    21
    7
        No pre-existing diabetes with PTB
    21
    7
        No vaginal bleeding during pregnancy with PTB
    21
    7
        No Polyhydramnios/oligohydramnios with PTB
    21
    7
        No fetal growth restriction with PTB
    22
    7
        No prior preterm delivery without PTB
    242
    123
        No pregnancy complications without PTB
    217
    111
        No gestational diabetes mellitus without PTB
    231
    119
        No chorioamnionitis during pregnancy without PTB
    242
    126
        No hypertensive disorders of preg. without PTB
    244
    126
        No pre-existing hypertension without PTB
    243
    124
        No pre-existing diabetes without PTB
    244
    126
        No vaginal bleeding during pregnancy without PTB
    239
    124
        No polyhydramnios/oligohydramnios without PTB
    241
    125
        No fetal growth restriction without PTB
    241
    123
    Notes
    [44] - Number of participants analyzed in each row = 266.
    [45] - Number of participants analyzed in each row = 133.
    No statistical analyses for this end point

    Secondary: Number of maternal participants with preterm birth event stratified by age group at vaccination, from Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

    		 Close Top of page
    End point title
    		 Number of maternal participants with preterm birth event stratified by age group at vaccination, from Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies [46]
    End point description
    The age groups at vaccination assessed were <18 years, 18-24 years, 25-34 years and >=35 years. Analysis was performed on the Full Analysis set (first pregnancy) - Maternal, which included all maternal participants with first pregnancy that had an outcome of live birth and was conceived within 2 years post-vaccination received in prior RSV MAT studies and with preterm birth (PTB) event (stratified by age group at vaccination) data available for the specified analysis during the specified period of the first pregnancy.
    End point type
    Secondary
    End point timeframe
    From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
    Notes
    [46] - 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
    266 [47]
    133 [48]
    Units: Participants
        <18 years: With PTB
    0
    0
        <18 years: Without PTB
    2
    0
        18-24 years: With PTB
    11
    2
        18-24 years: Without PTB
    61
    22
        25-34 years: With PTB
    10
    4
        25-34 years: Without IPTB
    149
    83
        >= 35 years: With PTB
    1
    1
        >= 35 years: Without PTB
    32
    21
    Notes
    [47] - Number of participants analyzed in each row = 266.
    [48] - Number of participants analyzed in each row = 133.
    No statistical analyses for this end point

    Secondary: Number of maternal participants with preterm birth event stratified by pre-pregnancy BMI group, from Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

    		 Close Top of page
    End point title
    		 Number of maternal participants with preterm birth event stratified by pre-pregnancy BMI group, from Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies [49]
    End point description
    The pre-pregnancy BMI categories assessed were < 30 kilogram per square meter (kg/m^2), >=30 kg/m^2 and missing (no pre-pregnancy BMI data available). Analysis was performed on the Full Analysis set (first pregnancy) - Maternal, which included all maternal participants with first pregnancy that had an outcome of live birth and was conceived within 2 years post-vaccination received in prior RSV MAT studies and with preterm birth (PTB) event (stratified by pre-pregnancy BMI group) data available for the specified analysis during the specified period of the first pregnancy.
    End point type
    Secondary
    End point timeframe
    From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
    Notes
    [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 maternal participants.
    End point values
    		 RSV MAT Group - Mother Control Group - Mother
    Number of subjects analysed
    266 [50]
    133 [51]
    Units: Participants
        <30 kg/m^2: With PTB
    10
    2
        <30 kg/m^2: Without PTB
    161
    87
        >=30 kg/m^2: With PTB
    1
    3
        >=30 kg/m^2: Without PTB
    38
    10
        Missing: With PTB
    11
    2
        Missing: Without PTB
    45
    29
    Notes
    [50] - Number of participants analyzed in each row = 266.
    [51] - Number of participants analyzed in each row = 133.
    No statistical analyses for this end point

    Secondary: Number of maternal participants with preterm birth event stratified by race, from Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

    		 Close Top of page
    End point title
    		 Number of maternal participants with preterm birth event stratified by race, from Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies [52]
    End point description
    The races assessed were American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White, Multiple, Not reported and Unknown. Analysis was performed on the Full Analysis set (first pregnancy) - Maternal, which included all maternal participants with first pregnancy that had an outcome of live birth and was conceived within 2 years post-vaccination received in prior RSV MAT studies and with preterm birth (PTB) event (stratified by race) data available for the specified analysis during the specified period of the first pregnancy.
    End point type
    Secondary
    End point timeframe
    From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
    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
    266 [53]
    133 [54]
    Units: Participants
        American Indian/Alaska Native: With PTB
    0
    1
        American Indian/Alaska Native: Without PTB
    5
    8
        Asian: With PTB
    6
    0
        Asian: Without PTB
    33
    20
        Black/African American: With PTB
    1
    1
        Black/African American: Without PTB
    14
    6
        Native Hawaiian/Other Pacific Islander:With PTB
    0
    0
        Native Hawaiian/Other Pacific Islander:Without PTB
    3
    1
        White: With PTB
    9
    4
        White: Without PTB
    170
    84
        Multiple: With PTB
    3
    0
        Multiple: Without PTB
    10
    5
        Not reported: With PTB
    0
    1
        Not reported: Without PTB
    2
    0
        Unknown: With PTB
    3
    0
        Unknown: Without PTB
    7
    2
    Notes
    [53] - Number of participants analyzed in each row = 266.
    [54] - Number of participants analyzed in each row = 133.
    No statistical analyses for this end point

    Secondary: Number of maternal participants with preterm birth event stratified by multiple gestation pregnancy, from Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

    		 Close Top of page
    End point title
    		 Number of maternal participants with preterm birth event stratified by multiple gestation pregnancy, from Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies [55]
    End point description
    The multiple gestation pregnancy assessed were one gestation and two gestations. Analysis was performed on the Full Analysis set (first pregnancy) - Maternal, which included all maternal participants with first pregnancy that had an outcome of live birth and was conceived within 2 years post-vaccination received in prior RSV MAT studies and with preterm birth (PTB) event (stratified by multiple gestation pregnancy) data available for the specified analysis during the specified period of the first pregnancy.
    End point type
    Secondary
    End point timeframe
    From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
    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
    266 [56]
    133 [57]
    Units: Participants
        One gestation: With PTB
    22
    7
        One gestation: Without PTB
    242
    125
        Two gestations: With PTB
    0
    0
        Two gestations: Without PTB
    2
    1
    Notes
    [56] - Number of participants analyzed in each row = 266.
    [57] - Number of participants analyzed in each row = 133.
    No statistical analyses for this end point

    Secondary: Number of maternal participants with preterm birth event stratified by geographic region, from Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

    		 Close Top of page
    End point title
    		 Number of maternal participants with preterm birth event stratified by geographic region, from Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies [58]
    End point description
    The geographic regions assessed were Europe, Australasia, North America, Latin America and Africa. Analysis was performed on the Full Analysis set (first pregnancy) - Maternal, which included all maternal participants with first pregnancy that had an outcome of live birth and was conceived within 2 years post-vaccination received in prior RSV MAT studies and with preterm birth (PTB) event (stratified by geographic region) data available for the specified analysis during the specified period of the first pregnancy.
    End point type
    Secondary
    End point timeframe
    From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
    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 maternal participants.
    End point values
    		 RSV MAT Group - Mother Control Group - Mother
    Number of subjects analysed
    266 [59]
    133 [60]
    Units: Participants
        Europe: With PTB
    5
    3
        Europe: Without PTB
    90
    50
        Australasia: With PTB
    6
    0
        Australasia: Without PTB
    42
    25
        North America: With PTB
    4
    1
        North America: Without PTB
    68
    28
        Latin America: With PTB
    7
    2
        Latin America: Without PTB
    36
    20
        Africa: With PTB
    0
    1
        Africa: Without PTB
    8
    3
    Notes
    [59] - Number of participants analyzed in each row = 266.
    [60] - Number of participants analyzed in each row = 133.
    No statistical analyses for this end point

    Secondary: Number of maternal participants with preterm birth event stratified by economic region, from Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

    		 Close Top of page
    End point title
    		 Number of maternal participants with preterm birth event stratified by economic region, from Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies [61]
    End point description
    The economic regions assessed were LMIC and HIC. Analysis was performed on the Full Analysis set (first pregnancy) - Maternal, which included all maternal participants with first pregnancy that had an outcome of live birth and was conceived within 2 years post-vaccination received in prior RSV MAT studies and with preterm birth (PTB) event (stratified by economic region) data available for the specified analysis during the specified period of the first pregnancy.
    End point type
    Secondary
    End point timeframe
    From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
    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 the maternal participants.
    End point values
    		 RSV MAT Group - Mother Control Group - Mother
    Number of subjects analysed
    266 [62]
    133 [63]
    Units: Participants
        LMIC: With PTB
    13
    3
        LMIC: Without PTB
    66
    38
        HIC: With PTB
    9
    4
        HIC: Without PTB
    178
    88
    Notes
    [62] - Number of participants analyzed in each row = 266.
    [63] - Number of participants analyzed in each row = 133.
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Maternal groups: All-cause mortality, AESIs, and SAEs: From conception to Day 42 post-delivery of any pregnancy. Infant groups: All-cause mortality, AESIs, and SAEs: From birth to Day 42 post-birth of any pregnancy.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    RSV MAT Group - Mother
    Reporting group description
    		 Maternal participants who received the RSVPreF3 vaccine during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-009, RSV MAT-010, RSV MAT-011, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study.

    Reporting group title
    Control Group - Infant
    Reporting group description
    		 This group consisted of infants live-born to maternal participants in the Control Group - Mother.

    Reporting group title
    RSV MAT Group - Infant
    Reporting group description
    		 This group consisted of infants live-born to maternal participants in the RSV MAT Group - Mother.

    Reporting group title
    Control Group - Mother
    Reporting group description
    		 Maternal participants who received any control (placebo, Tdap or influenza vaccine) during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-009, RSV MAT-010, RSV MAT-011, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each 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
    60 / 296 (20.27%)
    17 / 136 (12.50%)
    39 / 275 (14.18%)
    37 / 152 (24.34%)
         number of deaths (all causes)
    0
    0
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign hydatidiform mole
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         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
    Surgical and medical procedures
    Medically induced preterm birth
         subjects affected / exposed
    3 / 296 (1.01%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         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
    Labour induction
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         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
    Abortion induced
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         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
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    28 / 296 (9.46%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    14 / 152 (9.21%)
         occurrences causally related to treatment / all
    1 / 31
    0 / 0
    0 / 0
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion spontaneous incomplete
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         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
    Abortion threatened
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    Anembryonic gestation
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         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
    Brow presentation
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    Breech presentation
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         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
    Asynclitic presentation
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    Ectopic pregnancy
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         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
    Foetal disorder
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    Foetal distress syndrome
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage in pregnancy
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         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
    Gestational hypertension
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         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
    Foetal growth restriction
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         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
    Hyperemesis gravidarum
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    Oligohydramnios
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         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
    Low birth weight baby
         subjects affected / exposed
    0 / 296 (0.00%)
    3 / 136 (2.21%)
    6 / 275 (2.18%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    1 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaundice neonatal
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    2 / 275 (0.73%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Placenta praevia
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    Postpartum haemorrhage
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    3 / 152 (1.97%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature labour
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences causally related to treatment / all
    0 / 2
    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 / 296 (0.00%)
    3 / 136 (2.21%)
    10 / 275 (3.64%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    1 / 10
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pre-eclampsia
         subjects affected / exposed
    4 / 296 (1.35%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    3 / 152 (1.97%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature separation of placenta
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         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
    Preterm premature rupture of membranes
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    Prolonged labour
         subjects affected / exposed
    3 / 296 (1.01%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Term baby
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    Superimposed pre-eclampsia
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    Stillbirth
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         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
    Small for dates baby
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    2 / 275 (0.73%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prolonged rupture of membranes
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    Threatened labour
         subjects affected / exposed
    4 / 296 (1.35%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         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
    Uterine hypertonus
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         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
    General disorders and administration site conditions
    Death neonatal
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    0 / 275 (0.00%)
    0 / 152 (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
    Immune system disorders
    ABO incompatibility
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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 asphyxia
         subjects affected / exposed
    0 / 296 (0.00%)
    3 / 136 (2.21%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal pneumothorax
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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 respiratory distress
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    2 / 275 (0.73%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal respiratory distress syndrome
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    6 / 275 (2.18%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    0 / 275 (0.00%)
    0 / 152 (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
    Transient tachypnoea of the newborn
         subjects affected / exposed
    0 / 296 (0.00%)
    2 / 136 (1.47%)
    2 / 275 (0.73%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    Investigations
    Medical observation
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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, familial and genetic disorders
    Congenital abdominal hernia
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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 hydronephrosis
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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
    Atrial septal defect
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital megaureter
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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
    Aorta hypoplasia
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    0 / 275 (0.00%)
    0 / 152 (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 syphilis
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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
    Constricted ear deformity
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    0 / 275 (0.00%)
    0 / 152 (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
    Haemangioma congenital
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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
    Ebstein's anomaly
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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
    DiGeorge's syndrome
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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
    Developmental hip dysplasia
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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
    Heart disease congenital
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         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
    Microcephaly
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    2 / 275 (0.73%)
    0 / 152 (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
    Tethered oral tissue
         subjects affected / exposed
    0 / 296 (0.00%)
    3 / 136 (2.21%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polydactyly
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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
    Polycystic liver disease
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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
    Penoscrotal fusion
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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
    Tuberous sclerosis complex
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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
    Cardiac disorders
    Bradycardia foetal
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    Foetal heart rate deceleration abnormality
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         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
    Nervous system disorders
    Encephalopathy neonatal
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    0 / 275 (0.00%)
    0 / 152 (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
    Paresis
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    0 / 275 (0.00%)
    0 / 152 (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
    Blood and lymphatic system disorders
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    0 / 275 (0.00%)
    0 / 152 (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
    Anaemia
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         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
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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
    Hepatobiliary disorders
    Hyperbilirubinaemia neonatal
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    Infections and infestations
    Amniotic cavity infection
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    COVID-19
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    Bronchiolitis
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bartholin's abscess
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    Dengue fever
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         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
    Enterovirus infection
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    2 / 275 (0.73%)
    0 / 152 (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
    Gastroenteritis
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    Pneumonia
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    0 / 275 (0.00%)
    0 / 152 (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 pneumonia
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    2 / 275 (0.73%)
    0 / 152 (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
    Genitourinary tract infection
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    Puerperal pyrexia
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         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
    Staphylococcal infection
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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
    Sepsis neonatal
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    0 / 275 (0.00%)
    0 / 152 (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
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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
    Urinary tract infection
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (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
    Metabolism and nutrition disorders
    Weight gain poor
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (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
    145 / 296 (48.99%)
    42 / 136 (30.88%)
    76 / 275 (27.64%)
    65 / 152 (42.76%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Melanocytic naevus
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Vascular disorders
    Thrombosis
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    1
    0
    0
    1
    Hypertension
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    1
    0
    0
    2
    Surgical and medical procedures
    Female sterilisation
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Medically induced preterm birth
         subjects affected / exposed
    7 / 296 (2.36%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    7
    0
    0
    1
    Salpingectomy
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    2
    0
    0
    1
    Sterilisation
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Caesarean section
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Maternal pre-pregnancy obesity
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abortion threatened
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Afterbirth pain
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Breech presentation
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Caput succedaneum
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Complication of delivery
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Foetal growth restriction
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    2
    0
    0
    2
    Foetal malpresentation
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Gestational diabetes
         subjects affected / exposed
    13 / 296 (4.39%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    8 / 152 (5.26%)
         occurrences all number
    13
    0
    0
    8
    Gestational hypertension
         subjects affected / exposed
    9 / 296 (3.04%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    9
    0
    0
    1
    Gestational hyperthyroidism
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Haemorrhage in pregnancy
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    2
    0
    0
    1
    Jaundice neonatal
         subjects affected / exposed
    0 / 296 (0.00%)
    2 / 136 (1.47%)
    5 / 275 (1.82%)
    0 / 152 (0.00%)
         occurrences all number
    0
    2
    5
    0
    Labour pain
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Large for dates baby
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Low birth weight baby
         subjects affected / exposed
    0 / 296 (0.00%)
    4 / 136 (2.94%)
    15 / 275 (5.45%)
    0 / 152 (0.00%)
         occurrences all number
    0
    4
    15
    0
    Delayed delivery
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Abnormal cord insertion
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Morning sickness
         subjects affected / exposed
    3 / 296 (1.01%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    3
    0
    0
    2
    Threatened labour
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Placenta praevia
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Placental insufficiency
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Polyhydramnios
         subjects affected / exposed
    4 / 296 (1.35%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    4
    0
    0
    1
    Postpartum haemorrhage
         subjects affected / exposed
    5 / 296 (1.69%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    3 / 152 (1.97%)
         occurrences all number
    5
    0
    0
    3
    Pre-eclampsia
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    0
    0
    0
    2
    Premature baby
         subjects affected / exposed
    0 / 296 (0.00%)
    5 / 136 (3.68%)
    14 / 275 (5.09%)
    0 / 152 (0.00%)
         occurrences all number
    0
    5
    14
    0
    Premature labour
         subjects affected / exposed
    12 / 296 (4.05%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    3 / 152 (1.97%)
         occurrences all number
    12
    0
    0
    4
    Premature rupture of membranes
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Premature separation of placenta
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Preterm premature rupture of membranes
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    1
    0
    0
    1
    Prolonged labour
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    1
    0
    0
    1
    Prolonged rupture of membranes
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Retained placenta or membranes
         subjects affected / exposed
    3 / 296 (1.01%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    3
    0
    0
    2
    Shoulder dystocia
         subjects affected / exposed
    2 / 296 (0.68%)
    1 / 136 (0.74%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    2
    1
    0
    2
    Small for dates baby
         subjects affected / exposed
    0 / 296 (0.00%)
    13 / 136 (9.56%)
    19 / 275 (6.91%)
    0 / 152 (0.00%)
         occurrences all number
    0
    13
    19
    0
    Oligohydramnios
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Uterine atony
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Uterine hypotonus
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Uterine contractions during pregnancy
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    2
    0
    0
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    2
    0
    0
    2
    Disturbance of thermoregulation of newborn
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Influenza like illness
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Macrosomia
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Unevaluable event
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Immune system disorders
    Rhesus incompatibility
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Seasonal allergy
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    ABO incompatibility
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Reproductive system and breast disorders
    Genital ulceration
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dysmenorrhoea
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pelvic organ prolapse
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vaginal haemorrhage
         subjects affected / exposed
    5 / 296 (1.69%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    5
    0
    0
    2
    Uterine pain
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Vaginal discharge
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Varicose veins vulval
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vulvovaginal discomfort
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Shortened cervix
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Catarrh
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dyspnoea
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Irregular breathing
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Neonatal respiratory distress
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    2 / 275 (0.73%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    1
    0
    0
    1
    Tachypnoea
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Depressed mood
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Fear of pregnancy
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    1
    0
    0
    2
    Insomnia
         subjects affected / exposed
    3 / 296 (1.01%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    3
    0
    0
    1
    Perinatal depression
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Postpartum anxiety
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Restlessness
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hyperbilirubinaemia neonatal
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cholestasis of pregnancy
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Cholestasis
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    1
    0
    0
    1
    Cholelithiasis
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Investigations
    Weight increased
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    3 / 275 (1.09%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Blood glucose decreased
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    3 / 275 (1.09%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Blood iron decreased
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cardiac murmur
         subjects affected / exposed
    0 / 296 (0.00%)
    2 / 136 (1.47%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Foetal heart rate indeterminate
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Haemoglobin decreased
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    2
    0
    0
    1
    Human rhinovirus test positive
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Serum ferritin decreased
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Streptococcus test positive
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urine analysis abnormal
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    2 / 275 (0.73%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Injury, poisoning and procedural complications
    Vulvovaginal injury
         subjects affected / exposed
    8 / 296 (2.70%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    4 / 152 (2.63%)
         occurrences all number
    8
    0
    0
    4
    Arthropod bite
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tooth fracture
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Procedural pain
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Post lumbar puncture syndrome
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    2
    Perineal injury
         subjects affected / exposed
    15 / 296 (5.07%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    4 / 152 (2.63%)
         occurrences all number
    15
    0
    0
    4
    Ligament sprain
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    0
    0
    0
    2
    Genital injury
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    2
    0
    0
    2
    Fall
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Electric shock
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Congenital, familial and genetic disorders
    Congenital choroid plexus cyst
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Atrial septal defect
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Congenital naevus
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    3 / 275 (1.09%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Tethered oral tissue
         subjects affected / exposed
    0 / 296 (0.00%)
    6 / 136 (4.41%)
    4 / 275 (1.45%)
    0 / 152 (0.00%)
         occurrences all number
    0
    6
    4
    0
    Single umbilical artery
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Glucose-6-phosphate dehydrogenase deficiency
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Thalassaemia alpha
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cardiac disorders
    Bradycardia foetal
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Foetal heart rate deceleration abnormality
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tachycardia
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Pericarditis
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Bell's palsy
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dizziness
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Headache
         subjects affected / exposed
    3 / 296 (1.01%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    3
    0
    0
    2
    Hypoaesthesia
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Intracranial haematoma
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Somnolence
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Syncope
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia of pregnancy
         subjects affected / exposed
    4 / 296 (1.35%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    4
    0
    0
    2
    Antiphospholipid syndrome
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Anaemia
         subjects affected / exposed
    15 / 296 (5.07%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    13 / 152 (8.55%)
         occurrences all number
    15
    0
    1
    13
    Blood loss anaemia
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    1
    0
    0
    1
    Hypochromic anaemia
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Iron deficiency anaemia
         subjects affected / exposed
    8 / 296 (2.70%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    8
    0
    0
    2
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye disorders
    Eye discharge
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dacryostenosis acquired
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Chalazion
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    2
    0
    0
    2
    Abdominal pain
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    3
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    4 / 296 (1.35%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Dyschezia
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    1
    0
    0
    1
    Constipation
         subjects affected / exposed
    5 / 296 (1.69%)
    1 / 136 (0.74%)
    1 / 275 (0.36%)
    2 / 152 (1.32%)
         occurrences all number
    5
    1
    1
    2
    Abdominal pain upper
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    7 / 296 (2.36%)
    2 / 136 (1.47%)
    2 / 275 (0.73%)
    3 / 152 (1.97%)
         occurrences all number
    7
    2
    2
    3
    Gastritis
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Frequent bowel movements
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Palatal oedema
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nausea
         subjects affected / exposed
    16 / 296 (5.41%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    6 / 152 (3.95%)
         occurrences all number
    16
    0
    0
    6
    Mouth ulceration
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infantile colic
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haemorrhoids
         subjects affected / exposed
    3 / 296 (1.01%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    3
    0
    0
    1
    Toothache
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    1
    0
    0
    1
    Vomiting projectile
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    6 / 296 (2.03%)
    1 / 136 (0.74%)
    2 / 275 (0.73%)
    1 / 152 (0.66%)
         occurrences all number
    6
    1
    2
    1
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dermatitis diaper
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    2 / 275 (0.73%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Pruritus
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    1
    0
    0
    1
    Skin lesion
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dysuria
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    1
    0
    0
    1
    Hydronephrosis
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pollakiuria
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    2
    0
    0
    1
    Pyelocaliectasis
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Urinary incontinence
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urinary retention
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    3 / 296 (1.01%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    3
    0
    0
    2
    Thyroid dysfunction in pregnancy
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    0
    0
    0
    2
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Groin pain
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ligament pain
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    0
    0
    0
    2
    Arthralgia
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    0
    0
    0
    2
    Axillary mass
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Back pain
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    2
    0
    0
    2
    Infections and infestations
    Asymptomatic bacteriuria
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Amniotic cavity infection
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abscess oral
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Bacterial disease carrier
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 296 (0.00%)
    1 / 136 (0.74%)
    2 / 275 (0.73%)
    0 / 152 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Candida infection
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    COVID-19
         subjects affected / exposed
    10 / 296 (3.38%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    4 / 152 (2.63%)
         occurrences all number
    10
    0
    1
    4
    Bronchitis
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Bronchiolitis
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Beta haemolytic streptococcal infection
         subjects affected / exposed
    4 / 296 (1.35%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    3 / 152 (1.97%)
         occurrences all number
    4
    0
    0
    3
    Bacterial vulvovaginitis
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Bacterial vaginosis
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ear infection
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Endometritis
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    1
    0
    0
    2
    Gastrointestinal infection
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Genital herpes
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gonorrhoea
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Chlamydial infection
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Obstetric infection
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    3 / 152 (1.97%)
         occurrences all number
    0
    0
    1
    4
    Nail infection
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Mastitis
         subjects affected / exposed
    5 / 296 (1.69%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    4 / 152 (2.63%)
         occurrences all number
    5
    0
    0
    4
    Localised infection
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    1 / 275 (0.36%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Influenza
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Hordeolum
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Herpes zoster
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Syphilis
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Suspected COVID-19
         subjects affected / exposed
    6 / 296 (2.03%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    5 / 152 (3.29%)
         occurrences all number
    6
    0
    0
    5
    Sinusitis
         subjects affected / exposed
    4 / 296 (1.35%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    5
    0
    0
    2
    Respiratory tract infection
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    1
    0
    0
    2
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 296 (0.34%)
    2 / 136 (1.47%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Puerperal pyrexia
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    1
    0
    0
    1
    Postoperative wound infection
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Post procedural infection
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    2
    0
    0
    1
    Tonsillitis streptococcal
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    10 / 296 (3.38%)
    2 / 136 (1.47%)
    3 / 275 (1.09%)
    0 / 152 (0.00%)
         occurrences all number
    10
    2
    3
    0
    Urinary tract infection
         subjects affected / exposed
    18 / 296 (6.08%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    6 / 152 (3.95%)
         occurrences all number
    20
    0
    0
    7
    Vaginal infection
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    2 / 152 (1.32%)
         occurrences all number
    2
    0
    0
    3
    Vulvovaginal candidiasis
         subjects affected / exposed
    5 / 296 (1.69%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    6
    0
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    1
    0
    0
    2
    Wound infection
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    0
    0
    0
    1
    Tooth infection
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 296 (0.00%)
    2 / 136 (1.47%)
    2 / 275 (0.73%)
    0 / 152 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Hypoglycaemia neonatal
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    3 / 275 (1.09%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Iron deficiency
         subjects affected / exposed
    8 / 296 (2.70%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    4 / 152 (2.63%)
         occurrences all number
    8
    0
    0
    4
    Obesity
         subjects affected / exposed
    2 / 296 (0.68%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    1 / 152 (0.66%)
         occurrences all number
    2
    0
    0
    1
    Poor feeding infant
         subjects affected / exposed
    0 / 296 (0.00%)
    0 / 136 (0.00%)
    2 / 275 (0.73%)
    0 / 152 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 296 (0.34%)
    0 / 136 (0.00%)
    0 / 275 (0.00%)
    0 / 152 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jun 2023
    This amendment was done to include details pertaining to the exclusion criteria for women of nonchildbearing potential, the timeframe for the primary and secondary objectives and the Phase of the study (Phase 3b). It also includes updated information indicating that all the prior studies listed are collectively called ‘prior RSV MAT studies’ for both cohorts, to allow participants from any of the prior RSV MAT studies who are pregnant at enrollment to be enrolled in the prospective cohort. It further clarifies the method and source of data collection in the retrospective and prospective cohorts.

    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.

    European Medicines Agency © 1995-Thu Aug 07 04:12:22 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA