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    Clinical Trial Results:
    A Phase 2/3, Placebo-Controlled, Randomized, Observer-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a SARS-COV-2 RNA Vaccine Candidate (BNT162b2) Against COVID-19 in Healthy Pregnant Women 18 Years of age and Older

    Summary
    EudraCT number
    		 2020-005444-35
    Trial protocol
    		 ES  
    Global end of trial date
    15 Jul 2022

    Results information
    Results version number
    		 v1
    This version publication date
    30 Jul 2023
    First version publication date
    30 Jul 2023
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    C4591015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04754594
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    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
    29 Mar 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the safety and tolerability of prophylactic BNT162b2 when administered to maternal subjects 18 years of age or older vaccinated at 24 to 34 weeks’ gestation. To describe the immune response to prophylactic BNT162b2 in maternal subjects 18 years of age or older vaccinated at 24 to 34 weeks’ gestation and reference to the immune response in nonpregnant women 18 years of age or older from the C4591001 study without evidence of past SARS-CoV-2 infection. To describe the immune response to prophylactic BNT162b2 in maternal subjects 18 years of age or older vaccinated at 24 to 34 weeks’ gestation and reference to the immune response in nonpregnant women 18 years of age or older from the C4591001 study with and without evidence of prior SARS-CoV-2 infection.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Feb 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Brazil: 95
    Country: Number of subjects enrolled
    South Africa: 192
    Country: Number of subjects enrolled
    Spain: 75
    Country: Number of subjects enrolled
    United Kingdom: 28
    Country: Number of subjects enrolled
    United States: 336
    Worldwide total number of subjects
    726
    EEA total number of subjects
    75
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    10
    Newborns (0-27 days)
    325
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    391
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted in 2 periods-Blinded Period (from Day 1 to 1 month post-delivery) and Unblinded Period (1 to 6 Months Post-Delivery for those maternal subjects who initially received BNT162b2 and first dose of BNT162b2 to 1 month after second dose of BNT162b2 for those maternal subjects who initially received placebo).

    Pre-assignment
    Screening details
    		 A total of 726 subjects were enrolled in this study. 391 were maternal subjects who signed informed consent form and were enrolled out of which 41 were screen failures and 2 subjects were not randomised. Eventually 348 maternal subjects were randomised to receive treatment. 335 were infants born to maternal subjects.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Maternal Subjects: BNT162b2 30 mcg
    Arm description
    		 Maternal subjects received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Subjects were followed-up until 6 months post-delivery.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 30 mcg of BNT162b2 as an intramuscular injection.

    Arm title
    		 Maternal Subjects: Placebo then BNT162b2 30 mcg
    Arm description
    		 Maternal subjects received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. After unblinding at 1 month post-delivery, subjects were administered 2 doses of BNT162b2 vaccine as an intramuscular injection separated by 21 days. Subjects were followed-up until 1 month after last dose of vaccination.
    Arm type
    		 Placebo

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 30 mcg of BNT162b2 as an intramuscular injection.

    Arm title
    		 Infant Subjects: BNT162b2 30 mcg
    Arm description
    		 Infant subjects who were born to maternal subjects vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant subjects were followed up to 6 months of age.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Infant Subject: Placebo
    Arm description
    		 Infant subjects who were born to maternal subjects vaccinated with placebo during pregnancy were included. Infant subjects were followed up to 6 months of age.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1 [1]
    		Maternal Subjects: BNT162b2 30 mcg Maternal Subjects: Placebo then BNT162b2 30 mcg Infant Subjects: BNT162b2 30 mcg Infant Subject: Placebo
    Started
    173
    173
    167
    168
    Completed
    173
    173
    167
    168
    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 726 subjects were enrolled in this study. 391 were maternal subjects who signed informed consent form and were enrolled out of which 41 were screen failures and 2 subjects were not randomized. Eventually 348 maternal subjects were randomized to receive treatment. 335 were infants born to maternal subjects.
    Period 2
    Period 2 title
    Blinded Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Maternal Subjects: BNT162b2 30 mcg
    Arm description
    		 Maternal subjects received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Subjects were followed-up until 6 months post-delivery.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 30 mcg of BNT162b2 as an intramuscular injection.

    Arm title
    		 Maternal Subjects: Placebo then BNT162b2 30 mcg
    Arm description
    		 Maternal subjects received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. After unblinding at 1 month post-delivery, subjects were administered 2 doses of BNT162b2 vaccine as an intramuscular injection separated by 21 days. Subjects were followed-up until 1 month after last dose of vaccination.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received placebo (normal saline) as an intramuscular injection.

    Number of subjects in period 2 [2]
    		Maternal Subjects: BNT162b2 30 mcg Maternal Subjects: Placebo then BNT162b2 30 mcg
    Started
    173
    173
    Vaccination 1
    173
    173
    Vaccination 2
    170
    170
    Completed
    167
    162
    Not completed
    6
    11
         Consent withdrawn by subject
    4
    9
         Lost to follow-up
    1
    1
         Protocol deviation
    1
    1
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: For blinded period, only maternal subjects were included.
    Period 3
    Period 3 title
    Unblinded Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Maternal Subjects: BNT162b2 30 mcg
    Arm description
    		 Maternal subjects received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Subjects were followed-up until 6 months post-delivery.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Maternal Subjects: Placebo then BNT162b2 30 mcg
    Arm description
    		 Maternal subjects received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. After unblinding at 1 month post-delivery, subjects were administered 2 doses of BNT162b2 vaccine as an intramuscular injection separated by 21 days. Subjects were followed-up until 1 month after last dose of vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 30 mcg of BNT162b2 as an intramuscular injection.

    Number of subjects in period 3
    		Maternal Subjects: BNT162b2 30 mcg Maternal Subjects: Placebo then BNT162b2 30 mcg
    Started
    167
    162
    Vaccination 3
    0 [3]
    152
    Vaccination 4
    0 [4]
    148
    Completed
    151
    147
    Not completed
    16
    15
         Consent withdrawn by subject
    6
    8
         Unspecified
    3
    -
         Lost to follow-up
    5
    3
         Protocol deviation
    2
    4
    Notes
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No maternal subjects received vaccination during the unblinded phase.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No maternal subjects received vaccination during the unblinded phase.
    Period 4
    Period 4 title
    Infant Subjects
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Infant Subjects: BNT162b2 30 mcg
    Arm description
    		 Infant subjects who were born to maternal subjects vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant subjects were followed up to 6 months of age.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Infant Subjects: Placebo
    Arm description
    		 Infant subjects who were born to maternal subjects vaccinated with placebo during pregnancy were included. Infant subjects were followed up to 6 months of age.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4
    		Infant Subjects: BNT162b2 30 mcg Infant Subjects: Placebo
    Started
    167
    168
    Completed
    152
    139
    Not completed
    15
    29
         Death
    1
    1
         Unspecified
    1
    1
         Lost to follow-up
    4
    10
         Withdrawal by parent/guardian
    9
    17

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Maternal Subjects: BNT162b2 30 mcg
    Reporting group description
    		 Maternal subjects received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Subjects were followed-up until 6 months post-delivery.

    Reporting group title
    Maternal Subjects: Placebo then BNT162b2 30 mcg
    Reporting group description
    		 Maternal subjects received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. After unblinding at 1 month post-delivery, subjects were administered 2 doses of BNT162b2 vaccine as an intramuscular injection separated by 21 days. Subjects were followed-up until 1 month after last dose of vaccination.

    Reporting group title
    Infant Subjects: BNT162b2 30 mcg
    Reporting group description
    		 Infant subjects who were born to maternal subjects vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant subjects were followed up to 6 months of age.

    Reporting group title
    Infant Subject: Placebo
    Reporting group description
    		 Infant subjects who were born to maternal subjects vaccinated with placebo during pregnancy were included. Infant subjects were followed up to 6 months of age.

    Reporting group values
    		 Maternal Subjects: BNT162b2 30 mcg Maternal Subjects: Placebo then BNT162b2 30 mcg Infant Subjects: BNT162b2 30 mcg Infant Subject: Placebo Total
    Number of subjects
    		 173 173 167 168 681
    Age Categorical
    Units: Subjects
        Less than (<) 18 years
    		 0 0 167 168 335
        Greater than or equal to (>=) 18 and <= 45 years
    		 173 173 0 0 346
    Sex: Female, Male
    Units: Subjects
        Female
    		 173 173 85 73 504
        Male
    		 0 0 82 95 177
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 1 1 1 2 5
        Asian
    		 5 9 3 7 24
        Native Hawaiian or Other Pacific Islander
    		 0 1 0 0 1
        Black or African American
    		 47 43 40 40 170
        White
    		 117 118 115 104 454
        More than one race
    		 1 0 0 6 7
        Unknown or Not Reported
    		 2 1 8 9 20
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 70 63 65 60 258
        Not Hispanic or Latino
    		 103 110 98 104 415
        Unknown or Not Reported
    		 0 0 4 4 8

    End points

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    End points reporting groups
    Reporting group title
    Maternal Subjects: BNT162b2 30 mcg
    Reporting group description
    		 Maternal subjects received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Subjects were followed-up until 6 months post-delivery.

    Reporting group title
    Maternal Subjects: Placebo then BNT162b2 30 mcg
    Reporting group description
    		 Maternal subjects received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. After unblinding at 1 month post-delivery, subjects were administered 2 doses of BNT162b2 vaccine as an intramuscular injection separated by 21 days. Subjects were followed-up until 1 month after last dose of vaccination.

    Reporting group title
    Infant Subjects: BNT162b2 30 mcg
    Reporting group description
    		 Infant subjects who were born to maternal subjects vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant subjects were followed up to 6 months of age.

    Reporting group title
    Infant Subject: Placebo
    Reporting group description
    		 Infant subjects who were born to maternal subjects vaccinated with placebo during pregnancy were included. Infant subjects were followed up to 6 months of age.
    Reporting group title
    Maternal Subjects: BNT162b2 30 mcg
    Reporting group description
    		 Maternal subjects received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Subjects were followed-up until 6 months post-delivery.

    Reporting group title
    Maternal Subjects: Placebo then BNT162b2 30 mcg
    Reporting group description
    		 Maternal subjects received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. After unblinding at 1 month post-delivery, subjects were administered 2 doses of BNT162b2 vaccine as an intramuscular injection separated by 21 days. Subjects were followed-up until 1 month after last dose of vaccination.
    Reporting group title
    Maternal Subjects: BNT162b2 30 mcg
    Reporting group description
    		 Maternal subjects received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Subjects were followed-up until 6 months post-delivery.

    Reporting group title
    Maternal Subjects: Placebo then BNT162b2 30 mcg
    Reporting group description
    		 Maternal subjects received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. After unblinding at 1 month post-delivery, subjects were administered 2 doses of BNT162b2 vaccine as an intramuscular injection separated by 21 days. Subjects were followed-up until 1 month after last dose of vaccination.
    Reporting group title
    Infant Subjects: BNT162b2 30 mcg
    Reporting group description
    		 Infant subjects who were born to maternal subjects vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant subjects were followed up to 6 months of age.

    Reporting group title
    Infant Subjects: Placebo
    Reporting group description
    		 Infant subjects who were born to maternal subjects vaccinated with placebo during pregnancy were included. Infant subjects were followed up to 6 months of age.

    Primary: Percentage of Maternal Subjects Reporting Local Reactions Within 7 Days After Dose 1

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    End point title
    		 Percentage of Maternal Subjects Reporting Local Reactions Within 7 Days After Dose 1 [1]
    End point description
    Local reactions recorded by subjects in electronic diary (e-diary). Redness & swelling recorded in measuring device units (mdu, range 1 to 21) & converted to cm. 1 mdu=0.5 cm & graded mild: > 2.0-5.0 cm, moderate: >5.0-10.0 cm, severe: >10.0 cm, grade 4: necrosis/exfoliative dermatitis (redness) & necrosis (swelling). Pain at injection site graded mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity & grade 4: emergency room visit/hospitalisation for severe pain. Grade 4 classified by investigator/medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Exact 2-sided 95% CI based on Clopper & Pearson method. Safety population=all randomised subjects receiving at least 1 dose of study intervention. N=subjects evaluable for this endpoint. HIV positive subjects excluded as pre-specified in statistical analysis plan (SAP).
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 after dose 1
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed.
    End point values
    		 Maternal Subjects: BNT162b2 30 mcg Maternal Subjects: Placebo then BNT162b2 30 mcg
    Number of subjects analysed
    161
    163
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: Mild
    2.5 (0.7 to 6.2)
    0.6 (0.0 to 3.4)
        Redness: Moderate
    0.6 (0.0 to 3.4)
    0 (0.0 to 2.2)
        Redness: Severe
    0 (0.0 to 2.3)
    0 (0.0 to 2.2)
        Redness: Grade 4
    0 (0.0 to 2.3)
    0 (0.0 to 2.2)
        Swelling: Mild
    4.3 (1.8 to 8.8)
    0 (0.0 to 2.2)
        Swelling: Moderate
    0.6 (0.0 to 3.4)
    0 (0.0 to 2.2)
        Swelling: Severe
    0.6 (0.0 to 3.4)
    0 (0.0 to 2.2)
        Swelling: Grade 4
    0 (0.0 to 2.3)
    0 (0.0 to 2.2)
        Pain at the injection site: Mild
    59.0 (51.0 to 66.7)
    9.8 (5.7 to 15.5)
        Pain at the injection site: Moderate
    23.6 (17.3 to 30.9)
    0 (0.0 to 2.2)
        Pain at the injection site: Severe
    0 (0.0 to 2.3)
    0 (0.0 to 2.2)
        Pain at the injection site: Grade 4
    0 (0.0 to 2.3)
    0 (0.0 to 2.2)
    No statistical analyses for this end point

    Primary: Percentage of Maternal Subjects Reporting Local Reactions Within 7 Days After Dose 2

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    End point title
    		 Percentage of Maternal Subjects Reporting Local Reactions Within 7 Days After Dose 2 [2]
    End point description
    Local reactions recorded by subjects in e-diary. Redness & swelling recorded in mdu (range 1 to 21) & converted to cm. 1 mdu=0.5 cm & graded mild: > 2.0-5.0 cm, moderate: >5.0-10.0 cm, severe: >10.0 cm, grade 4: necrosis/exfoliative dermatitis (redness) & necrosis (swelling). Pain at injection site graded mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity & grade 4: emergency room visit/hospitalisation for severe pain. Grade 4 classified by investigator/medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Exact 2-sided 95% CI based on Clopper & Pearson method. Safety population=all randomised subjects receiving at least 1 dose of study intervention. N=subjects evaluable for this endpoint. HIV positive subjects excluded as pre-specified in SAP.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 after dose 2
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed.
    End point values
    		 Maternal Subjects: BNT162b2 30 mcg Maternal Subjects: Placebo then BNT162b2 30 mcg
    Number of subjects analysed
    148
    146
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: Mild
    3.4 (1.1 to 7.7)
    0 (0.0 to 2.5)
        Redness: Moderate
    2.0 (0.4 to 5.8)
    0 (0.0 to 2.5)
        Redness: Severe
    0 (0.0 to 2.5)
    0 (0.0 to 2.5)
        Redness: Grade 4
    0 (0.0 to 2.5)
    0 (0.0 to 2.5)
        Swelling: Mild
    4.1 (1.5 to 8.6)
    0.7 (0.0 to 3.8)
        Swelling: Moderate
    2.7 (0.7 to 6.8)
    0 (0.0 to 2.5)
        Swelling: Severe
    0 (0.0 to 2.5)
    0 (0.0 to 2.5)
        Swelling: Grade 4
    0 (0.0 to 2.5)
    0 (0.0 to 2.5)
        Pain at the injection site: Mild
    54.7 (46.3 to 62.9)
    12.3 (7.5 to 18.8)
        Pain at the injection site: Moderate
    19.6 (13.5 to 26.9)
    4.1 (1.5 to 8.7)
        Pain at the injection site: Severe
    0.7 (0.0 to 3.7)
    0 (0.0 to 2.5)
        Pain at the injection site: Grade 4
    0 (0.0 to 2.5)
    0 (0.0 to 2.5)
    No statistical analyses for this end point

    Primary: Percentage of Maternal Subjects Reporting Systemic Events Within 7 Days After Dose 1

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    End point title
    		 Percentage of Maternal Subjects Reporting Systemic Events Within 7 Days After Dose 1 [3]
    End point description
    Systemic events recorded by subject in e-diary. Fever: oral temperature ≥38 °C & categorised as ≥38.0-38.4°C, >38.4-38.9°C, >38.9-40.0°C & >40.0°C. Fatigue, headache, chills, new/worsened muscle pain & new/worsened joint pain: mild: did not interfere with activity, moderate: some interference with activity & severe: prevented daily routine activity. Vomiting: mild: 1-2 times in 24h, moderate: >2 times in 24h & severe: required IV hydration. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h & severe: 6 or more loose stools in 24h. Except fever, Grade 4= emergency room visit/hospitalisation. Grade 4 events classified by investigator/medically qualified person. Systemic events reported as AEs in CRF within 7 days of vaccination also included. Exact 95% CI based on Clopper & Pearson method. Safety population=all randomised subjects receiving at least 1 dose. N=subjects evaluable for this endpoint. HIV positive subjects excluded as pre-specified in SAP.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 after dose 1
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed.
    End point values
    		 Maternal Subjects: BNT162b2 30 mcg Maternal Subjects: Placebo then BNT162b2 30 mcg
    Number of subjects analysed
    161
    163
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: >=38.0 to 38.4 deg C
    0.6 (0.0 to 3.4)
    1.2 (0.1 to 4.4)
        Fever: >38.4 to 38.9 deg C
    0 (0.0 to 2.3)
    0 (0.0 to 2.2)
        Fever: >38.9 to 40.0 deg C
    0.6 (0.0 to 3.4)
    0.6 (0.0 to 3.4)
        Fever: >40 deg C
    0 (0.0 to 2.3)
    0 (0.0 to 2.2)
        Fatigue/tiredness: Mild
    26.1 (19.5 to 33.6)
    20.9 (14.9 to 27.9)
        Fatigue/tiredness: Moderate
    23.0 (16.7 to 30.3)
    21.5 (15.4 to 28.6)
        Fatigue/tiredness: Severe
    0.6 (0.0 to 3.4)
    0.6 (0.0 to 3.4)
        Fatigue/tiredness: Grade 4
    0 (0.0 to 2.3)
    0 (0.0 to 2.2)
        Headache: Mild
    20.5 (14.5 to 27.6)
    22.1 (16.0 to 29.2)
        Headache: Moderate
    11.8 (7.3 to 17.8)
    12.9 (8.2 to 19.0)
        Headache: Severe
    1.9 (0.4 to 5.3)
    0.6 (0.0 to 3.4)
        Headache: Grade 4
    0 (0.0 to 2.3)
    0 (0.0 to 2.2)
        Chills: Mild
    5.0 (2.2 to 9.6)
    5.5 (2.6 to 10.2)
        Chills: Moderate
    1.9 (0.4 to 5.3)
    0 (0.0 to 2.2)
        Chills: Severe
    0 (0.0 to 2.3)
    0 (0.0 to 2.2)
        Chills: Grade 4
    0 (0.0 to 2.3)
    0 (0.0 to 2.2)
        Vomiting: Mild
    5.0 (2.2 to 9.6)
    6.1 (3.0 to 11.0)
        Vomiting: Moderate
    0 (0.0 to 2.3)
    3.1 (1.0 to 7.0)
        Vomiting: Severe
    0 (0.0 to 2.3)
    0 (0.0 to 2.2)
        Vomiting: Grade 4
    0 (0.0 to 2.3)
    0 (0.0 to 2.2)
        Diarrhea: Mild
    11.2 (6.8 to 17.1)
    7.4 (3.9 to 12.5)
        Diarrhea: Moderate
    0.6 (0.0 to 3.4)
    1.2 (0.1 to 4.4)
        Diarrhea: Severe
    0 (0.0 to 2.3)
    0 (0.0 to 2.2)
        Diarrhea: Grade 4
    0 (0.0 to 2.3)
    0 (0.0 to 2.2)
        New or worsened muscle pain: Mild
    6.8 (3.5 to 11.9)
    6.1 (3.0 to 11.0)
        New or worsened muscle pain: Moderate
    5.6 (2.6 to 10.3)
    5.5 (2.6 to 10.2)
        New or worsened muscle pain: Severe
    0 (0.0 to 2.3)
    0 (0.0 to 2.2)
        New or worsened muscle pain: Grade 4
    0 (0.0 to 2.3)
    0 (0.0 to 2.2)
        New or worsened joint pain: Mild
    1.2 (0.2 to 4.4)
    2.5 (0.7 to 6.2)
        New or worsened joint pain: Moderate
    1.9 (0.4 to 5.3)
    2.5 (0.7 to 6.2)
        New or worsened joint pain: Severe
    0 (0.0 to 2.3)
    0 (0.0 to 2.2)
        New or worsened joint pain: Grade 4
    0 (0.0 to 2.3)
    0 (0.0 to 2.2)
    No statistical analyses for this end point

    Primary: Percentage of Maternal Subjects Reporting Systemic Events Within 7 Days After Dose 2

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    End point title
    		 Percentage of Maternal Subjects Reporting Systemic Events Within 7 Days After Dose 2 [4]
    End point description
    Systemic events recorded by subjects in e-diary. Fever: oral temperature ≥38 °C & categorised as ≥38.0-38.4°C, >38.4-38.9°C, >38.9-40.0°C & >40.0°C. Fatigue, headache, chills, new/worsened muscle pain & new/worsened joint pain: mild: did not interfere with activity, moderate: some interference with activity & severe: prevented daily routine activity. Vomiting: mild: 1-2 times in 24h, moderate: >2 times in 24h & severe: required IV hydration. Diarrhea: mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h & severe: 6 or more loose stools in 24h. Except fever, Grade 4= emergency room visit/hospitalisation. Grade 4 events classified by investigator/medically qualified person. Systemic events reported as AEs in CRF within 7 days of vaccination also included. Exact 95% CI based on Clopper & Pearson method. Safety population=all randomised subjects receiving at least 1 dose. N=subjects evaluable for this endpoint. HIV positive subjects excluded as pre-specified in SAP.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 7 after dose 2
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed.
    End point values
    		 Maternal Subjects: BNT162b2 30 mcg Maternal Subjects: Placebo then BNT162b2 30 mcg
    Number of subjects analysed
    148
    146
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: >=38.0 to 38.4 deg C
    1.4 (0.2 to 4.8)
    0.7 (0.0 to 3.8)
        Fever: >38.4 to 38.9 deg C
    0.7 (0.0 to 3.7)
    0 (0.0 to 2.5)
        Fever: >38.9 to 40.0 deg C
    0 (0.0 to 2.5)
    0 (0.0 to 2.5)
        Fever: >40 deg C
    0 (0.0 to 2.5)
    0 (0.0 to 2.5)
        Fatigue/tiredness: Mild
    15.5 (10.1 to 22.4)
    15.8 (10.3 to 22.7)
        Fatigue/tiredness: Moderate
    32.4 (25.0 to 40.6)
    18.5 (12.6 to 25.8)
        Fatigue/tiredness: Severe
    2.0 (0.4 to 5.8)
    0 (0.0 to 2.5)
        Fatigue/tiredness: Grade 4
    0 (0.0 to 2.5)
    0 (0.0 to 2.5)
        Headache: Mild
    25.0 (18.3 to 32.8)
    13.7 (8.6 to 20.4)
        Headache: Moderate
    14.9 (9.6 to 21.6)
    10.3 (5.9 to 16.4)
        Headache: Severe
    1.4 (0.2 to 4.8)
    0 (0.0 to 2.5)
        Headache: Grade 4
    0 (0.0 to 2.5)
    0 (0.0 to 2.5)
        Chills: Mild
    4.7 (1.9 to 9.5)
    0.7 (0.0 to 3.8)
        Chills: Moderate
    7.4 (3.8 to 12.9)
    0 (0.0 to 2.5)
        Chills: Severe
    0.7 (0.0 to 3.7)
    0 (0.0 to 2.5)
        Chills: Grade 4
    0 (0.0 to 2.5)
    0 (0.0 to 2.5)
        Vomiting: Mild
    8.8 (4.8 to 14.6)
    2.1 (0.4 to 5.9)
        Vomiting: Moderate
    0 (0.0 to 2.5)
    1.4 (0.2 to 4.9)
        Vomiting: Severe
    0 (0.0 to 2.5)
    0 (0.0 to 2.5)
        Vomiting: Grade 4
    0 (0.0 to 2.5)
    0 (0.0 to 2.5)
        Diarrhea: Mild
    6.1 (2.8 to 11.2)
    4.1 (1.5 to 8.7)
        Diarrhea: Moderate
    0 (0.0 to 2.5)
    1.4 (0.2 to 4.9)
        Diarrhea: Severe
    0 (0.0 to 2.5)
    0 (0.0 to 2.5)
        Diarrhea: Grade 4
    0 (0.0 to 2.5)
    0 (0.0 to 2.5)
        New or worsened muscle pain: Mild
    13.5 (8.5 to 20.1)
    4.8 (1.9 to 9.6)
        New or worsened muscle pain: Moderate
    12.8 (7.9 to 19.3)
    2.1 (0.4 to 5.9)
        New or worsened muscle pain: Severe
    0.7 (0.0 to 3.7)
    0 (0.0 to 2.5)
        New or worsened muscle pain: Grade 4
    0 (0.0 to 2.5)
    0 (0.0 to 2.5)
        New or worsened joint pain: Mild
    7.4 (3.8 to 12.9)
    4.8 (1.9 to 9.6)
        New or worsened joint pain: Moderate
    6.1 (2.8 to 11.2)
    1.4 (0.2 to 4.9)
        New or worsened joint pain: Severe
    0 (0.0 to 2.5)
    0 (0.0 to 2.5)
        New or worsened joint pain: Grade 4
    0 (0.0 to 2.5)
    0 (0.0 to 2.5)
    No statistical analyses for this end point

    Primary: Percentage of Maternal Subjects With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 - Blinded Follow-up Period

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    End point title
    		 Percentage of Maternal Subjects With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 - Blinded Follow-up Period [5]
    End point description
    An AE was any untoward medical occurrence in a subject temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population (maternal) included all randomised subjects who received at least 1 dose of the study intervention. Here, "Number of Subjects Analysed" signifies subjects evaluable for this endpoint. HIV positive subjects were excluded from analysis as pre-specified in the SAP.
    End point type
    Primary
    End point timeframe
    From dose 1 on Day 1 through 1 month after dose 2 (approximately 2 months)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed.
    End point values
    		 Maternal Subjects: BNT162b2 30 mcg Maternal Subjects: Placebo then BNT162b2 30 mcg
    Number of subjects analysed
    161
    163
    Units: Percentage of subjects
        number (confidence interval 95%)
    23.6 (17.3 to 30.9)
    22.7 (16.5 to 29.9)
    No statistical analyses for this end point

    Primary: Percentage of Maternal Subjects Reporting Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Delivery - Blinded Follow-up Period

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    End point title
    		 Percentage of Maternal Subjects Reporting Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Delivery - Blinded Follow-up Period [6]
    End point description
    An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population (maternal) included all randomised subjects who received at least 1 dose of the study intervention. Here, "Number of Subjects Analysed" signifies subjects evaluable for this endpoint. HIV positive subjects were excluded from analysis as pre-specified in the SAP.
    End point type
    Primary
    End point timeframe
    From dose 1 on Day 1 through 1 month after delivery
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed.
    End point values
    		 Maternal Subjects: BNT162b2 30 mcg Maternal Subjects: Placebo then BNT162b2 30 mcg
    Number of subjects analysed
    161
    163
    Units: Percentage of subjects
        number (confidence interval 95%)
    13.0 (8.3 to 19.2)
    14.1 (9.2 to 20.4)
    No statistical analyses for this end point

    Primary: GMR of SARS-CoV-2 Neutralising Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Maternal Subjects With and Without Evidence of Prior SARS-CoV-2 Infection

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    End point title
    		 GMR of SARS-CoV-2 Neutralising Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Maternal Subjects With and Without Evidence of Prior SARS-CoV-2 Infection [7]
    End point description
    GMR of SARS-CoV-2 neutralising titers in pregnant women to those in nonpregnant women from study C4591001 (NCT04368728) for evaluable maternal subjects with and without evidence of prior SARS-CoV-2 infection will be reported in this endpoint. Results for this endpoint will be posted by July 2024.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 2
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed.
    End point values
    		 Maternal Subjects: BNT162b2 30 mcg
    Number of subjects analysed
    0 [8]
    Units: Ratio
        geometric mean (confidence interval 95%)
    ( to )
    Notes
    [8] - Results for this endpoint will be posted by July 2024.
    No statistical analyses for this end point

    Primary: Geometric Mean Ratio (GMR) of the SARS-CoV-2 Neutralising Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Maternal Subjects Without Evidence of Prior SARS-CoV-2 Infection

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    End point title
    		 Geometric Mean Ratio (GMR) of the SARS-CoV-2 Neutralising Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Maternal Subjects Without Evidence of Prior SARS-CoV-2 Infection [9]
    End point description
    Geometric Mean Ratio (GMR) of the SARS-CoV-2 neutralising titers in pregnant women to those in nonpregnant women from study C4591001 (NCT04368728) for evaluable maternal subjects without evidence of prior SARS-CoV-2 infection will be reported in this endpoint. Results for this endpoint will be posted by July 2024.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 2
    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: Only descriptive data was planned to be analysed.
    End point values
    		 Maternal Subjects: BNT162b2 30 mcg
    Number of subjects analysed
    0 [10]
    Units: Ratio
        geometric mean (confidence interval 95%)
    ( to )
    Notes
    [10] - Results for this endpoint will be posted by July 2024.
    No statistical analyses for this end point

    Secondary: COVID-19 Incidence per 1000 Person-Years of Blinded Follow-Up in Evaluable Maternal Subjects With or Without Evidence of Prior SARS-CoV-2 Infection

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    End point title
    		 COVID-19 Incidence per 1000 Person-Years of Blinded Follow-Up in Evaluable Maternal Subjects With or Without Evidence of Prior SARS-CoV-2 Infection
    End point description
    100 x (1-illness rate ratio [IRR]) (ratio of confirmed COVID-19 illness from 7 days after Dose 2 through 1 month after delivery per 1000 person-years of blinded follow-up in evaluable maternal subjects with or without evidence of prior SARS-CoV-2 infection [prior to 7 days after receipt of Dose 2]) for BNT162b2 to the placebo group will be reported in this endpoint. Results for this endpoint will be posted by July 2024.
    End point type
    Secondary
    End point timeframe
    From 7 days after Dose 2 up to 1 month after delivery
    End point values
    		 Maternal Subjects: BNT162b2 30 mcg
    Number of subjects analysed
    0 [11]
    Units: Ratio of COVID-19 illness per 1000 PY
        number (confidence interval 95%)
    ( to )
    Notes
    [11] - Results for this endpoint will be posted by July 2024.
    No statistical analyses for this end point

    Secondary: COVID-19 Incidence per 1000 Person-Years of Blinded Follow-Up in Evaluable Maternal Subjects Without Evidence of Prior SARS-CoV-2 Infection

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    End point title
    		 COVID-19 Incidence per 1000 Person-Years of Blinded Follow-Up in Evaluable Maternal Subjects Without Evidence of Prior SARS-CoV-2 Infection
    End point description
    100 x (1-illness rate ratio [IRR]) (ratio of confirmed COVID-19 illness from 7 days after Dose 2 through 1 month after delivery per 1000 person-years [PY] of blinded follow-up in evaluable maternal subjects without evidence of prior SARS-CoV-2 infection [prior to 7 days after receipt of Dose 2]) for BNT162b2 to the placebo group will be reported in this endpoint. Results for this endpoint will be posted by July 2024.
    End point type
    Secondary
    End point timeframe
    From 7 days after Dose 2 up to 1 month after delivery
    End point values
    		 Maternal Subjects: BNT162b2 30 mcg
    Number of subjects analysed
    0 [12]
    Units: Ratio of COVID-19 illness per 1000 PY
        number (confidence interval 95%)
    ( to )
    Notes
    [12] - Results for this endpoint will be posted by July 2024.
    No statistical analyses for this end point

    Secondary: Incidence of Asymptomatic Infection of SARS-CoV-2 Through 1 Month After Delivery in Evaluable Maternal Subjects Without Evidence of Prior SARS-CoV-2 Infection

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    End point title
    		 Incidence of Asymptomatic Infection of SARS-CoV-2 Through 1 Month After Delivery in Evaluable Maternal Subjects Without Evidence of Prior SARS-CoV-2 Infection
    End point description
    100 × (1 – IRR) [ratio of incidence of asymptomatic infection per 1000 person-years of follow-up in the active vaccine group to the corresponding infection rate in the placebo group through 1 month after delivery in evaluable maternal subjects without evidence of prior SARS-CoV-2 infection for BNT162b2 to the placebo group will be reported in this endpoint. Results for this endpoint will be posted by July 2024.
    End point type
    Secondary
    End point timeframe
    Up to 1 month after delivery
    End point values
    		 Maternal Subjects: BNT162b2 30 mcg
    Number of subjects analysed
    0 [13]
    Units: Ratio of asymptomatic infection/1000 PY
        number (confidence interval 95%)
    ( to )
    Notes
    [13] - Results for this endpoint will be posted by July 2024.
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralising Titers in Evaluable Maternal Subjects

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    End point title
    		 Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralising Titers in Evaluable Maternal Subjects
    End point description
    GMTs of SARS-CoV-2 neutralising titers in evaluable maternal subjects at baseline, 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery will be reported in this endpoint. Results for this endpoint will be posted by July 2024.
    End point type
    Secondary
    End point timeframe
    Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery
    End point values
    		 Maternal Subjects: BNT162b2 30 mcg
    Number of subjects analysed
    0 [14]
    Units: Titer
        geometric mean (confidence interval 95%)
    ( to )
    Notes
    [14] - Results for this endpoint will be posted by July 2024.
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Subjects

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    End point title
    		 Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Subjects
    End point description
    GMCs of full-length S-binding IgG levels in evaluable maternal subjects at baseline, 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery will be reported in this endpoint. Results for this endpoint will be posted by July 2024.
    End point type
    Secondary
    End point timeframe
    Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery
    End point values
    		 Maternal Subjects: BNT162b2 30 mcg
    Number of subjects analysed
    0 [15]
    Units: Milligram per liter
        geometric mean (confidence interval 95%)
    ( to )
    Notes
    [15] - Results for this endpoint will be posted by July 2024.
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Subjects

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    End point title
    		 Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Subjects
    End point description
    GMFR from before vaccination to each subsequent time point after vaccination for full-length S-binding IgG levels in evaluable maternal subjects at 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery will be reported in this endpoint. Results for this endpoint will be posted by July 2024.
    End point type
    Secondary
    End point timeframe
    Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery
    End point values
    		 Maternal Subjects: BNT162b2 30 mcg
    Number of subjects analysed
    0 [16]
    Units: Fold rise
        geometric mean (confidence interval 95%)
    ( to )
    Notes
    [16] - Results for this endpoint will be posted by July 2024.
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralising Titers in Evaluable Maternal Subjects

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    End point title
    		 Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralising Titers in Evaluable Maternal Subjects
    End point description
    GMFR from before vaccination to each subsequent time point after vaccination for SARS-CoV-2 neutralising titers in evaluable maternal subjects at 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery will be reported in this endpoint. Results for this endpoint will be posted by July 2024.
    End point type
    Secondary
    End point timeframe
    Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery
    End point values
    		 Maternal Subjects: BNT162b2 30 mcg
    Number of subjects analysed
    0 [17]
    Units: Fold rise
        geometric mean (confidence interval 95%)
    ( to )
    Notes
    [17] - Results for this endpoint will be posted by July 2024.
    No statistical analyses for this end point

    Secondary: Percentage of Infant Subjects Reporting Specific Birth Outcomes

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    End point title
    		 Percentage of Infant Subjects Reporting Specific Birth Outcomes
    End point description
    Percentage of infant subjects reporting specific birth outcomes (normal, congenital malformation/anomaly, other neonatal problems) were reported in this endpoint. Safety population for infant subjects included all infant subjects born to maternal subjects who received at least 1 dose of the study intervention. As this endpoint was measured at birth, HIV positive infant subjects were included in this endpoint.
    End point type
    Secondary
    End point timeframe
    At birth
    End point values
    		 Infant Subjects: BNT162b2 30 mcg Infant Subjects: Placebo
    Number of subjects analysed
    167
    168
    Units: Percentage of subjects
    number (confidence interval 95%)
        Normal
    91.6 (86.3 to 95.3)
    89.3 (83.6 to 93.5)
        Congenital malformation/anomaly
    6.0 (2.9 to 10.7)
    3.6 (1.3 to 7.6)
        Other neonatal problem
    1.8 (0.4 to 5.2)
    6.5 (3.3 to 11.4)
        Missing
    0.6 (0.0 to 3.3)
    0.6 (0.0 to 3.3)
    No statistical analyses for this end point

    Secondary: Percentage of Infant Subjects Reporting Adverse Events From Birth Through 1 Month of age

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    End point title
    		 Percentage of Infant Subjects Reporting Adverse Events From Birth Through 1 Month of age
    End point description
    An AE was any untoward medical occurrence in a subject temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population for infant subjects included all infant subjects born to maternal subjects who received at least 1 dose of the study intervention. Here, "Number of Subjects Analysed" signifies subjects evaluable for this endpoint. HIV positive subjects were excluded from analysis as pre-specified in the SAP.
    End point type
    Secondary
    End point timeframe
    From birth through 1 month of age
    End point values
    		 Infant Subjects: BNT162b2 30 mcg Infant Subjects: Placebo
    Number of subjects analysed
    156
    159
    Units: Percentage of subjects
        number (confidence interval 95%)
    35.3 (27.8 to 43.3)
    37.1 (29.6 to 45.1)
    No statistical analyses for this end point

    Secondary: Percentage of Infant Subjects Reporting Serious Adverse Events (SAE) From Birth Through 6 Months of age

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    End point title
    		 Percentage of Infant Subjects Reporting Serious Adverse Events (SAE) From Birth Through 6 Months of age
    End point description
    An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population for infant subjects included all infant subjects born to maternal subjects who received at least 1 dose of the study intervention. Here, "Number of Subjects Analysed" signifies subjects evaluable for this endpoint. HIV positive subjects were excluded from analysis as pre-specified in the SAP.
    End point type
    Secondary
    End point timeframe
    From birth through 6 months of age
    End point values
    		 Infant Subjects: BNT162b2 30 mcg Infant Subjects: Placebo
    Number of subjects analysed
    156
    159
    Units: Percentage of subjects
        number (confidence interval 95%)
    13.5 (8.5 to 19.8)
    15.1 (9.9 to 21.6)
    No statistical analyses for this end point

    Secondary: GMCs of Full-Length S-Binding IgG Levels at Birth and 6 Months of age in Infant Subjects Born to Evaluable Maternal Subjects

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    End point title
    		 GMCs of Full-Length S-Binding IgG Levels at Birth and 6 Months of age in Infant Subjects Born to Evaluable Maternal Subjects
    End point description
    GMCs of full-length S-binding IgG levels at birth and 6 months of age in infant subjects born to evaluable maternal subjects will be reported in this endpoint. Results for this endpoint will be posted by July 2024.
    End point type
    Secondary
    End point timeframe
    At birth and 6 months of age
    End point values
    		 Infant Subjects: BNT162b2 30 mcg Infant Subjects: Placebo
    Number of subjects analysed
    0 [18]
    0 [19]
    Units: Milligram per liter
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [18] - Results for this endpoint will be posted by July 2024.
    [19] - Results for this endpoint will be posted by July 2024.
    No statistical analyses for this end point

    Secondary: Percentage of Infant Subjects Reporting Adverse Event of Special Interest (AESI) From Birth Through 6 Months of age

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    End point title
    		 Percentage of Infant Subjects Reporting Adverse Event of Special Interest (AESI) From Birth Through 6 Months of age
    End point description
    Percentage of infant subjects who reported AESI including major congenital anomalies and developmental delay from birth through 6 months of age were reported in this endpoint. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population for infant subjects included all infant subjects born to maternal subjects who received at least 1 dose of the study intervention. Here, "Number of Subjects Analysed" signifies subjects evaluable for this endpoint. HIV positive subjects were excluded from analysis as pre-specified in the SAP.
    End point type
    Secondary
    End point timeframe
    From birth through 6 months of age
    End point values
    		 Infant Subjects: BNT162b2 30 mcg Infant Subjects: Placebo
    Number of subjects analysed
    156
    159
    Units: Percentage of subjects
        number (confidence interval 95%)
    5.1 (2.2 to 9.9)
    1.3 (0.2 to 4.5)
    No statistical analyses for this end point

    Secondary: GMFR of Full-Length S-Binding IgG Levels From Birth to 6 Months of age in Infant Subjects Born to Evaluable Maternal Subjects

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    End point title
    		 GMFR of Full-Length S-Binding IgG Levels From Birth to 6 Months of age in Infant Subjects Born to Evaluable Maternal Subjects
    End point description
    GMFR of full-length S-binding IgG levels from birth to 6 months of age in infant subjects born to evaluable maternal subjects will be reported in this endpoint. Results for this endpoint will be posted by July 2024.
    End point type
    Secondary
    End point timeframe
    From birth to 6 months of age
    End point values
    		 Infant Subjects: BNT162b2 30 mcg Infant Subjects: Placebo
    Number of subjects analysed
    0 [20]
    0 [21]
    Units: Fold rise
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [20] - Results for this endpoint will be posted by July 2024.
    [21] - Results for this endpoint will be posted by July 2024.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Local reactions/systemic events up to Day 7 after dose 1&2. AEs:up to 1 month (M) after each dose (from birth to 1 M for infants). SAEs:dose 1 to 6 M post-delivery/1 M post-delivery (placebo)/1 M after dose 4(placebo then BNT)/from birth to 6 M(infants)
    Adverse event reporting additional description
    Same event may appear as non-SAE and SAE but are distinct events. Event may be an SAE in 1 subject and non-SAE in other, or subject may have both non-SAE and SAE. Safety population for maternal and infants was evaluated. Systematic events are local reactions and systemic events recorded in e-diary, non-systematic events are all other AEs.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Maternal Subjects: BNT162b2 30 mcg
    Reporting group description
    		 Maternal subjects received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Subjects were followed-up until 6 months post-delivery. HIV positive maternal subjects were excluded.

    Reporting group title
    Maternal Subjects: Placebo then BNT162b2
    Reporting group description
    		 Subjects who originally received 2 doses of blinded placebo were administered 2 doses of 30 mcg BNT162b2 vaccine as intramuscular injection separated by 21 days after unblinding at 1 month post-delivery. Subjects were followed-up until 1 month after last vaccination. HIV positive maternal subjects were excluded.

    Reporting group title
    Infant Subjects: BNT162b2 30 mcg
    Reporting group description
    		 Infant subjects who were born to maternal subjects vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant subjects were followed up to 6 months of age. HIV positive infant subjects born to HIV positive maternal subjects were excluded.

    Reporting group title
    Maternal Subjects: Placebo
    Reporting group description
    		 Maternal subjects received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. HIV positive maternal subjects were excluded.

    Reporting group title
    Infant Subjects: Placebo
    Reporting group description
    		 Infant subjects who were born to maternal subjects vaccinated with placebo during pregnancy were included. Infant subjects were followed up to 6 months of age. HIV positive infant subjects born to HIV positive maternal subjects were excluded.

    Reporting group title
    HIV Positive Maternal Subjects: BNT162b2 30 mcg
    Reporting group description
    		 Maternal subjects who were HIV positive received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Subjects were followed-up until 6 months post-delivery.

    Reporting group title
    HIV Positive Maternal Subjects: Placebo
    Reporting group description
    		 Maternal subjects who were HIV positive received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.

    Reporting group title
    HIV Positive Infant Subjects: BNT162b2 30 mcg
    Reporting group description
    		 Infant subjects who were born to HIV positive maternal subjects vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant subjects were followed up to 6 months of age.

    Reporting group title
    HIV Positive Infant Subjects: Placebo
    Reporting group description
    		 Infant subjects who were born to HIV positive maternal subjects vaccinated with placebo during pregnancy were included. Infant subjects were followed up to 6 months of age.

    Reporting group title
    HIV Positive Maternal Subjects: Placebo then BNT162b2
    Reporting group description
    		 HIV positive maternal subjects who originally received 2 doses of blinded placebo were administered 2 doses of 30 mcg BNT162b2 vaccine as intramuscular injection separated by 21 days after unblinding at 1 month post-delivery. Subjects were followed-up until 1 month after last vaccination.

    Serious adverse events
    		 Maternal Subjects: BNT162b2 30 mcg Maternal Subjects: Placebo then BNT162b2 Infant Subjects: BNT162b2 30 mcg Maternal Subjects: Placebo Infant Subjects: Placebo HIV Positive Maternal Subjects: BNT162b2 30 mcg HIV Positive Maternal Subjects: Placebo HIV Positive Infant Subjects: BNT162b2 30 mcg HIV Positive Infant Subjects: Placebo HIV Positive Maternal Subjects: Placebo then BNT162b2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 161 (13.04%)
    0 / 144 (0.00%)
    21 / 156 (13.46%)
    23 / 163 (14.11%)
    24 / 159 (15.09%)
    2 / 12 (16.67%)
    4 / 10 (40.00%)
    1 / 11 (9.09%)
    2 / 9 (22.22%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    Vascular disorders
    Hypoperfusion
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subgaleal hemorrhage
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Arrested labor
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    1 / 163 (0.61%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breech presentation
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cephalo-pelvic disproportion
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    3 / 163 (1.84%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failed induction of labor
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fetal distress syndrome
         subjects affected / exposed
    3 / 161 (1.86%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    2 / 163 (1.23%)
    0 / 159 (0.00%)
    1 / 12 (8.33%)
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fetal growth restriction
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gestational hypertension
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    1 / 163 (0.61%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fetal hypokinesia
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    1 / 163 (0.61%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemorrhage in pregnancy
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meconium stain
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meconium in amniotic fluid
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    1 / 163 (0.61%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Omphalorrhexis
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    1 / 163 (0.61%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Placental insufficiency
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    1 / 163 (0.61%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postpartum hemorrhage
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    2 / 163 (1.23%)
    0 / 159 (0.00%)
    1 / 12 (8.33%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pre-eclampsia
         subjects affected / exposed
    4 / 161 (2.48%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    2 / 163 (1.23%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature separation of placenta
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    3 / 163 (1.84%)
    0 / 159 (0.00%)
    1 / 12 (8.33%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Preterm premature rupture of membranes
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    1 / 163 (0.61%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retained placenta or membranes
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prolonged rupture of membranes
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    1 / 163 (0.61%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Caput succedaneum
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaundice neonatal
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    7 / 156 (4.49%)
    0 / 163 (0.00%)
    4 / 159 (2.52%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 7
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Low birth weight baby
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature baby
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small for dates baby
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Weight decrease neonatal
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failed trial of labor
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fetal death
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    1 / 12 (8.33%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine disorder
         subjects affected / exposed
    2 / 161 (1.24%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Meconium aspiration syndrome
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    2 / 156 (1.28%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal pneumothorax
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal respiratory distress
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    2 / 159 (1.26%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal respiratory distress syndrome
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal respiratory failure
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachypnoea
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Fetal heart rate abnormal
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    1 / 163 (0.61%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ultrasound fetal abnormal
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    1 / 163 (0.61%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac murmur
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Traumatic intracranial hemorrhage
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury to brachial plexus due to birth trauma
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract procedural complication
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    1 / 163 (0.61%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Ankyloglossia congenital
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    2 / 159 (1.26%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DiGeorge's syndrome
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital skin dimples
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital rubella syndrome
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial septal defect
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    3 / 156 (1.92%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polydactyly
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Patent ductus arteriosus
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mucopolysaccharidosis
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syndactyly
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Microcephaly
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular septal defect
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Trisomy 21
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Non reassuring fetal heart rate pattern
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    2 / 163 (1.23%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradycardia fetal
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Coma
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorder
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxic-ischemic encephalopathy
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy neonatal
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Superior sagittal sinus thrombosis
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anemia
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    1 / 12 (8.33%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal wall haematoma
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Allergic colitis
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Allergic gastroenteritis
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meconium plug syndrome
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumoperitoneum
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    1 / 163 (0.61%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperbilirubinaemia neonatal
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Vesicoureteric reflux
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Endometritis
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    1 / 163 (0.61%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    1 / 163 (0.61%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal pneumonia
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    2 / 156 (1.28%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis neonatal
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    2 / 159 (1.26%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycemia neonatal
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Maternal Subjects: BNT162b2 30 mcg Maternal Subjects: Placebo then BNT162b2 Infant Subjects: BNT162b2 30 mcg Maternal Subjects: Placebo Infant Subjects: Placebo HIV Positive Maternal Subjects: BNT162b2 30 mcg HIV Positive Maternal Subjects: Placebo HIV Positive Infant Subjects: BNT162b2 30 mcg HIV Positive Infant Subjects: Placebo HIV Positive Maternal Subjects: Placebo then BNT162b2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    143 / 161 (88.82%)
    21 / 144 (14.58%)
    29 / 156 (18.59%)
    119 / 163 (73.01%)
    33 / 159 (20.75%)
    12 / 12 (100.00%)
    10 / 10 (100.00%)
    1 / 11 (9.09%)
    3 / 9 (33.33%)
    1 / 8 (12.50%)
    Surgical and medical procedures
    Episiotomy
         subjects affected / exposed
    3 / 161 (1.86%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Gestational diabetes
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    2 / 163 (1.23%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Abnormal labor
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    2 / 163 (1.23%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Fetal hypokinesia
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    2 / 163 (1.23%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Gestational hypertension
         subjects affected / exposed
    2 / 161 (1.24%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Oligohydramnios
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    2 / 163 (1.23%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Pre-eclampsia
         subjects affected / exposed
    2 / 161 (1.24%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Premature delivery
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    2 / 163 (1.23%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Uterine contractions during pregnancy
         subjects affected / exposed
    2 / 161 (1.24%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Caput succedaneum
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    3 / 156 (1.92%)
    0 / 163 (0.00%)
    3 / 159 (1.89%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    3
    0
    3
    0
    0
    0
    0
    0
    Jaundice neonatal
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    12 / 156 (7.69%)
    0 / 163 (0.00%)
    13 / 159 (8.18%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    12
    0
    13
    0
    0
    0
    1
    0
    Large for dates baby
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    2 / 156 (1.28%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Low birth weight baby
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    2 / 156 (1.28%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    Small for dates baby
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    4 / 159 (2.52%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    4
    0
    0
    1
    0
    0
    Umbilical cord around neck
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    5 / 159 (3.14%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    5
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Chills (CHILLS)
    alternative assessment type: Systematic
         subjects affected / exposed
    28 / 161 (17.39%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    10 / 163 (6.13%)
    0 / 159 (0.00%)
    1 / 12 (8.33%)
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    30
    0
    0
    10
    0
    1
    2
    0
    0
    0
    Fatigue (FATIGUE)
    alternative assessment type: Systematic
         subjects affected / exposed
    101 / 161 (62.73%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    82 / 163 (50.31%)
    0 / 159 (0.00%)
    8 / 12 (66.67%)
    8 / 10 (80.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    154
    0
    0
    120
    0
    15
    11
    0
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 161 (0.00%)
    3 / 144 (2.08%)
    0 / 156 (0.00%)
    2 / 163 (1.23%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    3
    0
    2
    0
    0
    0
    0
    0
    0
    Erythema (REDNESS)
    alternative assessment type: Systematic
         subjects affected / exposed
    11 / 161 (6.83%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    1 / 163 (0.61%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    13
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Injection site pain (PAIN AT INJECTION SITE)
    alternative assessment type: Systematic
         subjects affected / exposed
    138 / 161 (85.71%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    30 / 163 (18.40%)
    0 / 159 (0.00%)
    12 / 12 (100.00%)
    4 / 10 (40.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    244
    0
    0
    39
    0
    21
    6
    0
    0
    0
    Swelling (SWELLING)
    alternative assessment type: Systematic
         subjects affected / exposed
    17 / 161 (10.56%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    1 / 163 (0.61%)
    0 / 159 (0.00%)
    1 / 12 (8.33%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    19
    0
    0
    1
    0
    2
    0
    0
    0
    0
    Pyrexia (FEVER)
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 161 (3.73%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    4 / 163 (2.45%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    6
    0
    0
    4
    0
    0
    1
    0
    0
    0
    Injection site erythema
         subjects affected / exposed
    0 / 161 (0.00%)
    3 / 144 (2.08%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 161 (0.00%)
    5 / 144 (3.47%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    5
    0
    0
    0
    0
    0
    0
    0
    0
    Pain
         subjects affected / exposed
    0 / 161 (0.00%)
    3 / 144 (2.08%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    Hypothermia
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    2 / 159 (1.26%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    2
    0
    0
    0
    0
    0
    Chills
         subjects affected / exposed
    0 / 161 (0.00%)
    2 / 144 (1.39%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Injection site pain
         subjects affected / exposed
    0 / 161 (0.00%)
    13 / 144 (9.03%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    18
    0
    0
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Vaginal hemorrhage
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    2 / 163 (1.23%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Vaginal discharge
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    1 / 12 (8.33%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Investigations
    Streptococcus test positive
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    2 / 163 (1.23%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Cardiac murmur
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    2 / 156 (1.28%)
    0 / 163 (0.00%)
    2 / 159 (1.26%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    2
    0
    2
    0
    0
    0
    0
    0
    Apgar score low
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    4 / 156 (2.56%)
    0 / 163 (0.00%)
    2 / 159 (1.26%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    4
    0
    2
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Skin laceration
         subjects affected / exposed
    2 / 161 (1.24%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Exposure to communicable disease
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Congenital, familial and genetic disorders
    Congenital naevus
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    3 / 156 (1.92%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    3
    0
    1
    0
    0
    0
    0
    0
    Ankyloglossia congenital
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    2 / 159 (1.26%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    2
    0
    0
    0
    0
    0
    Hydrocele
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    2 / 156 (1.28%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Polydactyly
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    2 / 161 (1.24%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Headache (HEADACHE)
    alternative assessment type: Systematic
         subjects affected / exposed
    85 / 161 (52.80%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    72 / 163 (44.17%)
    0 / 159 (0.00%)
    7 / 12 (58.33%)
    7 / 10 (70.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    116
    0
    0
    93
    0
    10
    10
    0
    0
    0
    Headache
         subjects affected / exposed
    2 / 161 (1.24%)
    7 / 144 (4.86%)
    0 / 156 (0.00%)
    2 / 163 (1.23%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    2
    9
    0
    2
    0
    0
    0
    0
    0
    1
    Hypotonia
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    2 / 156 (1.28%)
    0 / 163 (0.00%)
    1 / 159 (0.63%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    4 / 161 (2.48%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    2 / 163 (1.23%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    4
    0
    0
    2
    0
    0
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 161 (1.86%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    3 / 163 (1.84%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    3
    0
    0
    3
    0
    0
    0
    0
    0
    0
    Constipation
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    2 / 163 (1.23%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Diarrhoea (DIARRHEA)
    alternative assessment type: Systematic
         subjects affected / exposed
    24 / 161 (14.91%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    21 / 163 (12.88%)
    0 / 159 (0.00%)
    3 / 12 (25.00%)
    3 / 10 (30.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    28
    0
    0
    22
    0
    3
    4
    0
    0
    0
    Gastroesophageal reflux disease
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    2 / 163 (1.23%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Hemorrhoids
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    2 / 163 (1.23%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Vomiting (VOMITING)
    alternative assessment type: Systematic
         subjects affected / exposed
    18 / 161 (11.18%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    16 / 163 (9.82%)
    0 / 159 (0.00%)
    3 / 12 (25.00%)
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    21
    0
    0
    20
    0
    4
    2
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Hepatobiliary disorders
    Hyperbilirubinemia neonatal
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    1 / 156 (0.64%)
    0 / 163 (0.00%)
    4 / 159 (2.52%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    4
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Renal and urinary disorders
    Leukocyturia
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia (NEW OR WORSENED JOINT PAIN)
    alternative assessment type: Systematic
         subjects affected / exposed
    22 / 161 (13.66%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    13 / 163 (7.98%)
    0 / 159 (0.00%)
    1 / 12 (8.33%)
    5 / 10 (50.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    25
    0
    0
    17
    0
    2
    5
    0
    0
    0
    Back pain
         subjects affected / exposed
    2 / 161 (1.24%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Myalgia (NEW OR WORSENED MUSCLE PAIN)
    alternative assessment type: Systematic
         subjects affected / exposed
    53 / 161 (32.92%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    26 / 163 (15.95%)
    0 / 159 (0.00%)
    5 / 12 (41.67%)
    3 / 10 (30.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    60
    0
    0
    29
    0
    8
    5
    0
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 161 (0.00%)
    4 / 144 (2.78%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    0
    0
    0
    0
    0
    Arthralgia
         subjects affected / exposed
    0 / 161 (0.00%)
    2 / 144 (1.39%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    4 / 161 (2.48%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    1 / 163 (0.61%)
    0 / 159 (0.00%)
    1 / 12 (8.33%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    4
    0
    0
    1
    0
    1
    0
    0
    0
    0
    Amniotic cavity infection
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    2 / 163 (1.23%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    COVID-19
         subjects affected / exposed
    0 / 161 (0.00%)
    2 / 144 (1.39%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Body tinea
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    0 / 159 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Hypoglycemia neonatal
         subjects affected / exposed
    0 / 161 (0.00%)
    0 / 144 (0.00%)
    0 / 156 (0.00%)
    0 / 163 (0.00%)
    2 / 159 (1.26%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Jan 2021
    Based on availability of BNT162b2 in high-risk pregnant women and evidence of safety in the real-world setting, the sentinel cohort of N=50 in Phase 2 was removed. Based on feedback from an external advisory board, inclusion criterion 10 was updated to allow enrollment of subjects with a pre pregnancy BMI of ≤40 kg/m2.
    02 Mar 2021
    Section 8.2.3: clarified that stopping rules are in place during Phase 2 only, with no overlap into Phase 3. Clarified that a study pause may not prevent administration of Dose 2 for enrolled subjects. Modified stopping rule 7 to include a trigger of preterm premature rupture of membranes. Stopping rule 4: removed assessment of laboratory abnormalities, as these data are not collected in this study. Section 8.11.1, Visit 1: removed the requirement of a repeat fetal scan to clarify that an earlier scan done at ≥18 weeks’ GA can be used to confirm singleton pregnancy and rule out fetal anomalies.
    14 May 2021
    Reduced the study sample size based on regulatory feedback and evolving global availability of COVID-19 vaccines for pregnant women.
    08 Mar 2022
    Enrollment of study subjects was terminated with fewer study subjects enrolled than originally planned due to enrollment challenges into a placebo-controlled trial as a result of universal recommendations for COVID-19 vaccination of pregnant women and the increased global availability of COVID-19 vaccines.

    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.
    The evolving nature of the pandemic has required serology work to be focused on newly emerging strains as a matter of urgent priority, which has delayed serology work on earlier trials. Hence data is not yet available for all serology endpoints.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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