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    Clinical Trial Results:
    Maternal pertussis (Tdap) vaccination and its effects on the immune response of the newborn up to 12 months of age.

    Summary
    EudraCT number
    		 2013-003090-98
    Trial protocol
    		 NL  
    Global end of trial date
    22 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Nov 2023
    First version publication date
    05 Nov 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IIV-266
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 ABR: NL-45652.000.13, NTR: 4314
    Sponsors
    Sponsor organisation name
    RIVM
    Sponsor organisation address
    Antonie van Leeuwenhoeklaan 9, Bilthoven, Netherlands, 3721 MA
    Public contact
    Clinical Expertise Centre IIV, National Institute for Public Health and the Environment, mensgebonden-onderzoek@rivm.nl
    Scientific contact
    Clinical Expertise Centre IIV, National Institute for Public Health and the Environment, mensgebonden-onderzoek@rivm.nl
    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
    Interim
    Date of interim/final analysis
    19 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Apr 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate superiority of IgG antibody levels against pertussis toxin (Ptx), present in the acellular vaccines, in infants at the age of 3 months of mothers having received a pertussis vaccine during pregnancy versus infants of mothers who have been vaccinated postpartum.
    Protection of trial subjects
    All subjects were supervised after vaccination. Vaccination and blood-collection was done by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Most blood-collection were done by heel/finger stick. To reduce the burden of two 8 ml blood collections the children in each group were divided in two groups A, and B Half of the infants of each group had a 8 ml blood collection at the age of 11 months pre booster, the other half 7-9 days after booster vaccination. Half of the infants of each group had a 8 ml blood collection at the age of 4 years pre booster, the other half one month after booster vaccination at 4 years of age. To reduce the burden of 11-12 visits, home visits were performed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 236
    Worldwide total number of subjects
    236
    EEA total number of subjects
    236
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    118
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    118
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Pregnant women aged 18–40 years with a low risk of pregnancy complications were recruited through independent midwives at 36 midwife clinics. Women received a leaflet with information about the trial and a reply card around 20 weeks of pregnancy.

    Pre-assignment
    Screening details
    		 237 woman were assessed for eligibility, 119 women were excluded and 118 women were enrolled.

    Period 1
    Period 1 title
    primary vaccination series (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Woman immunized during pregnancy
    Arm description
    		 Women receiving a Tdap vaccine during pregnancy between 30 weeks and 32 weeks of gestation and their newborn
    Arm type
    		 Experimental

    Investigational medicinal product name
    Boostrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of Boostrix containing 2,5 limit of flocculation [Lf ] diphtheria toxoid, 5 Lf tetanus toxoid and B pertussis antigens; 8 μg pertussis toxin, 8 μg filamentous haemagglutinin, and 2,5 μg pertactin during weeks 30–32 of pregnancy.

    Arm title
    		 Woman immunized after pregnancy
    Arm description
    		 Women receiving a Tdap vaccine after giving birth and their newborn.
    Arm type
    		 control

    Investigational medicinal product name
    Boostrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of Boostrix containing 2,5 limit of flocculation [Lf ] diphtheria toxoid, 5 Lf tetanus toxoid and B pertussis antigens; 8 μg pertussis toxin, 8 μg filamentous haemagglutinin, and 2,5 μg pertactin 48 hours after giving birth.

    Arm title
    		 Newborns of woman immunized during pregnancy
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Boostrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of Boostrix containing 2,5 limit of flocculation [Lf ] diphtheria toxoid, 5 Lf tetanus toxoid and B pertussis antigens; 8 μg pertussis toxin, 8 μg filamentous haemagglutinin, and 2,5 μg pertactin during weeks 30–32 of pregnancy.

    Arm title
    		 Newborn of woman immunized after pregnancy
    Arm description
    		 -
    Arm type
    		 control

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Woman immunized during pregnancy Woman immunized after pregnancy Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Started
    58
    60
    58
    60
    Birth
    55
    56
    55
    56
    2 months
    55
    55
    55
    55
    3 months
    55
    54
    55
    54
    6 months
    54
    50
    54
    50
    11 months
    54
    50
    54
    50
    Completed
    53
    50
    53
    50
    Not completed
    5
    10
    5
    10
         Consent withdrawn by subject
    1
    5
    1
    5
         Physician decision
    1
    2
    1
    2
         premature delivery
    3
    2
    3
    2
         Lost to follow-up
    -
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Woman immunized during pregnancy
    Reporting group description
    		 Women receiving a Tdap vaccine during pregnancy between 30 weeks and 32 weeks of gestation and their newborn

    Reporting group title
    Woman immunized after pregnancy
    Reporting group description
    		 Women receiving a Tdap vaccine after giving birth and their newborn.

    Reporting group title
    Newborns of woman immunized during pregnancy
    Reporting group description
    		 -

    Reporting group title
    Newborn of woman immunized after pregnancy
    Reporting group description
    		 -

    Reporting group values
    		 Woman immunized during pregnancy Woman immunized after pregnancy Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy Total
    Number of subjects
    		 58 60 58 60 236
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 58 60 118
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 58 60 0 0 118
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Age mothers at delivery 0=no baseline characteristics available
    Units: years
        arithmetic mean (standard deviation)
    		 32.2 ( 3.3 ) 32.3 ( 3.9 ) 0 ( 0 ) 0 ( 0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 58 60 34 38 190
        Male
    		 0 0 24 22 46
    Gestational age at immunisation
    Gestational age of woman at immunisation 0=no baseline characteristics available
    Units: weeks
        arithmetic mean (standard deviation)
    		 31.2 ( 0.8 ) 0 ( 0 ) 0 ( 0 ) 0 ( 0 ) -
    gestational age
    0=no baseline characteristics available
    Units: weeks
        arithmetic mean (standard deviation)
    		 0 ( 0 ) 0 ( 0 ) 39.7 ( 1.5 ) 39.7 ( 1.2 ) -
    Birthweight
    0=no baseline characteristics available
    Units: gram(s)
        arithmetic mean (standard deviation)
    		 0 ( 0 ) 0 ( 0 ) 3425 ( 480 ) 3439 ( 456 ) -
    Interval between vaccination and delivery
    0=no baseline characteristics available
    Units: days
        arithmetic mean (standard deviation)
    		 61 ( 6 ) 0 ( 0 ) 0 ( 0 ) 0 ( 0 ) -
    Age at first infant blood sample
    Age of the infant at the moment of blood sampling 0=no baseline characteristics available
    Units: day
        arithmetic mean (standard deviation)
    		 0 ( 0 ) 0 ( 0 ) 61.0 ( 2.1 ) 61.0 ( 1.8 ) -
    Age at second blood sample and first Infanrix Hexa dose
    Age of the infant at the moment of blood sampling and vaccination 0=no baseline characteristics available
    Units: day
        arithmetic mean (standard deviation)
    		 0 ( 0 ) 0 ( 0 ) 91 ( 3.4 ) 91 ( 2.7 ) -
    Age at second Infanrix Hexa dose
    Age of the infant at the moment of vaccination 0=no baseline characteristics available
    Units: day
        arithmetic mean (standard deviation)
    		 0 ( 0 ) 0 ( 0 ) 153 ( 3.3 ) 153 ( 2.7 ) -
    Age at third blood sample, after primary vaccinations
    Age of the infant at the moment of blood sampling 0=no baseline characteristics available
    Units: day
        arithmetic mean (standard deviation)
    		 0 ( 0 ) 0 ( 0 ) 183 ( 3.5 ) 184 ( 3.9 ) -
    Age at fourth blood sample, before booster vaccination
    Age of the infant at the moment of blood sampling and vaccination 0=no baseline characteristics available
    Units: day
        arithmetic mean (standard deviation)
    		 0 ( 0 ) 0 ( 0 ) 335 ( 4.2 ) 334 ( 4.5 ) -
    Age at fifth blood sample, after booster vaccination
    Age of the infant at the moment of blood sampling 0=no baseline characteristics available
    Units: day
        arithmetic mean (standard deviation)
    		 0 ( 0 ) 0 ( 0 ) 365 ( 4.5 ) 364 ( 4.7 ) -

    End points

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    End points reporting groups
    Reporting group title
    Woman immunized during pregnancy
    Reporting group description
    		 Women receiving a Tdap vaccine during pregnancy between 30 weeks and 32 weeks of gestation and their newborn

    Reporting group title
    Woman immunized after pregnancy
    Reporting group description
    		 Women receiving a Tdap vaccine after giving birth and their newborn.

    Reporting group title
    Newborns of woman immunized during pregnancy
    Reporting group description
    		 -

    Reporting group title
    Newborn of woman immunized after pregnancy
    Reporting group description
    		 -

    Primary: serum IgG pertussis toxin antibody concentrations of infants at age 3 months

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    End point title
    		 serum IgG pertussis toxin antibody concentrations of infants at age 3 months [1]
    End point description
    Geometric mean concentrations and 95% confidence interval of IgG antibodies against Pertussis Toxin, Filamentous Haemagglutinin and Pertactin in infants after maternal Tdap vaccination at 30-32 weeks of gestation and control infants without maternal Tdap vaccination. All infants received DTaP-IPV-Hib-HepB and PhiD-CV10 at 3, 5 and 11 months of age.
    End point type
    Primary
    End point timeframe
    91 days +/- 5 days after birth
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No blood was drawn from the mothers of the newborns at this timepoint.
    End point values
    		 Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    54
    50
    Units: IU/ml
        geometric mean (confidence interval 95%)
    16.6 (12.6 to 21.9)
    1.0 (0.7 to 1.4)
    Statistical analysis title
    		 PT GMC ratio maternal vs control at 3 months
    Statistical analysis description
    PT GMC ratio of the maternal infant Tdap group vs the control infant group at the age of 3 months
    Comparison groups
    Newborns of woman immunized during pregnancy v Newborn of woman immunized after pregnancy
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Serum IgG antibody levels against pertussis vaccine antigens at birth

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    End point title
    		 Serum IgG antibody levels against pertussis vaccine antigens at birth
    End point description
    Geometric mean concentrations and 95% confidence interval of IgG antibodies against Pertussis Toxin, Filamentous Haemagglutinin and Pertactin in infants and mothers after maternal Tdap vaccination at 30-32 weeks of gestation and control group without maternal Tdap vaccination. All infants received DTaP-IPV-Hib-HepB and PhiD-CV10 at 3, 5 and 11 months of age.
    End point type
    Secondary
    End point timeframe
    blood collected through cordblood at birth or within 48 hours after birth.
    End point values
    		 Woman immunized during pregnancy Woman immunized after pregnancy Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    55
    55
    54
    53
    Units: IU/ml
    geometric mean (confidence interval 95%)
        Pertusis Toxin (Ptx)
    61.8 (46.8 to 81.7)
    3.4 (2.4 to 4.9)
    125.1 (94.0 to 166.3)
    5.6 (3.7 to 8.6)
        Filamentous Haemagglutinin (FHA)
    163.4 (130.5 to 204.59)
    8.6 (6.3 to 11.8)
    330.9 (261.2 to 419.3)
    15.6 (11.1 to 22.0)
        Pertactin (Prn)
    286.0 (182.4 to 448.3)
    6.4 (4.4 to 9.1)
    500.5 (322.5 to 776.7)
    11.4 (7.7 to 16.9)
    No statistical analyses for this end point

    Secondary: serum IgG antibody levels against pertussis vaccine antigens 2 months after birth

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    End point title
    		 serum IgG antibody levels against pertussis vaccine antigens 2 months after birth [2]
    End point description
    Geometric mean concentrations and 95% confidence interval of IgG antibodies against Pertussis Toxin, Filamentous Haemagglutinin and Pertactin in infants after maternal Tdap vaccination at 30-32 weeks of gestation and control infants without maternal Tdap vaccination. All infants received DTaP-IPV-Hib-HepB and PhiD-CV10 at 3, 5 and 11 months of age.
    End point type
    Secondary
    End point timeframe
    61 +/- 5 days after birth
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No blood was drawn from the mothers of the newborns at this timepoint.
    End point values
    		 Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    55
    53
    Units: IU/ml
    geometric mean (confidence interval 95%)
        Pertussis Toxin (Ptx)
    27.3 (20.1 to 37.1)
    1.8 (1.2 to 2.5)
        Filamentous Haemagglutinin (FHA)
    83.7 (67.4 to 103.9)
    5.0 (3.5 to 7.0)
        Pertactin (Prn)
    110.3 (71.6 to 170.0)
    3.6 (2.3 to 5.4)
    No statistical analyses for this end point

    Secondary: serum IgG antibody levels against pertussis vaccine antigens 3 months after birth

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    End point title
    		 serum IgG antibody levels against pertussis vaccine antigens 3 months after birth [3]
    End point description
    Geometric mean concentrations and 95% confidence interval of IgG antibodies against Pertussis Toxin, Filamentous Haemagglutinin and Pertactin in infants after maternal Tdap vaccination at 30-32 weeks of gestation and control infants without maternal Tdap vaccination. All infants received DTaP-IPV-Hib-HepB and PhiD-CV10 at 3, 5 and 11 months of age.
    End point type
    Secondary
    End point timeframe
    91 +/- 5 days after birth
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No blood was drawn from the mothers of the newborns at this timepoint.
    End point values
    		 Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    54
    50
    Units: IU/ml
    geometric mean (confidence interval 95%)
        Pertussis Toxin (Ptx)
    16.6 (12.6 to 21.9)
    1.0 (0.7 to 1.4)
        Filamentous Haemagglutinin (FHA)
    48.5 (38.5 to 61.1)
    2.8 (2.0 to 3.8)
        Pertactin (prn)
    65.5 (41.9 to 102.43)
    2.0 (1.4 to 2.8)
    No statistical analyses for this end point

    Secondary: Serum IgG antibody levels against pertussis vaccine antigens 6 months after birth

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    End point title
    		 Serum IgG antibody levels against pertussis vaccine antigens 6 months after birth
    End point description
    Geometric mean concentrations and 95% confidence interval of IgG antibodies against Pertussis Toxin, Filamentous Haemagglutinin and Pertactin in infants and mothers after maternal Tdap vaccination at 30-32 weeks of gestation and control group without maternal Tdap vaccination. All infants received DTaP-IPV-Hib-HepB and PhiD-CV10 at 3, 5 and 11 months of age.
    End point type
    Secondary
    End point timeframe
    183 days +/- 5 days after birth
    End point values
    		 Woman immunized during pregnancy Woman immunized after pregnancy Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    53
    50
    53
    50
    Units: IU/ml
    geometric mean (confidence interval 95%)
        Pertussis Toxin (Ptx)
    42.2 (30.5 to 58.3)
    26.6 (18.4 to 38.5)
    35.6 (28.1 to 45.0)
    83.0 (65.6 to 105.2)
        Filamentous Haemagglutinin (FHA)
    125.6 (96.3 to 163.7)
    144.5 (107.5 to 194.1)
    31.2 (25.8 to 37.8)
    82.6 (69.8 to 97.7)
        Pertactin (Prn)
    218.9 (139.5 to 343.3)
    214.8 (138.1 to 334.1)
    28.9 (21.9 to 38.0)
    61.9 (47.7 to 80.4)
    No statistical analyses for this end point

    Secondary: Serum IgG antibody levels against pertussis vaccine antigens 11 months after birth

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    End point title
    		 Serum IgG antibody levels against pertussis vaccine antigens 11 months after birth [4]
    End point description
    Geometric mean concentrations and 95% confidence interval of IgG antibodies against Pertussis Toxin, Filamentous Haemagglutinin and Pertactin in infants after maternal Tdap vaccination at 30-32 weeks of gestation and control infants without maternal Tdap vaccination. All infants received DTaP-IPV-Hib-HepB and PhiD-CV10 at 3, 5 and 11 months of age.
    End point type
    Secondary
    End point timeframe
    335 +/- 5 days after birth
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No blood was drawn from the mothers of the newborns at this timepoint.
    End point values
    		 Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    51
    48
    Units: IU/ml
    geometric mean (confidence interval 95%)
        Pertussis Toxin (Ptx)
    8.4 (6.1 to 11.5)
    16.6 (13.2 to 20.8)
        Filamentous Haemagglutinin (FHA)
    7.3 (5.3 to 10.1)
    19.9 (15.7 to 25.2)
        Pertactin (Prn)
    2.9 (2.2 to 3.8)
    8.4 (6.3 to 11.3)
    No statistical analyses for this end point

    Secondary: Serum IgG antibody levels against pertussis vaccine antigens 12 months after birth

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    End point title
    		 Serum IgG antibody levels against pertussis vaccine antigens 12 months after birth
    End point description
    Geometric mean concentrations and 95% confidence interval of IgG antibodies against Pertussis Toxin, Filamentous Haemagglutinin and Pertactin in infants and mothers after maternal Tdap vaccination at 30-32 weeks of gestation and control group without maternal Tdap vaccination. All infants received DTaP-IPV-Hib-HepB and PhiD-CV10 at 3, 5 and 11 months of age.
    End point type
    Secondary
    End point timeframe
    366 +/- 5 days after birth
    End point values
    		 Woman immunized during pregnancy Woman immunized after pregnancy Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    52
    50
    53
    50
    Units: IU/ml
    geometric mean (confidence interval 95%)
        Pertussis Toxin (Ptx)
    31.9 (23.0 to 44.4)
    17.4 (12.0 to 25.3)
    75.7 (62.0 to 92.3)
    157.7 (124.6 to 199.5)
        Filamentous Haemagglutinin (FHA)
    85.6 (64.6 to 113.4)
    84.9 (63.6 to 113.3)
    67.3 (54.9 to 82.6)
    125.5 (102.68 to 153.25)
        Pertactin (Prn)
    166.5 (104.6 to 265.1)
    124.4 (79.9 to 193.8)
    91.7 (69.2 to 121.4)
    142.0 (109.7 to 183.7)
    No statistical analyses for this end point

    Secondary: Serum IgG antibody levels against pertussis vaccine antigens during pregnancy, before DTaP vaccination

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    End point title
    		 Serum IgG antibody levels against pertussis vaccine antigens during pregnancy, before DTaP vaccination [5]
    End point description
    Geometric mean concentrations and 95% confidence interval of IgG antibodies against Pertussis Toxin, Filamentous Haemagglutinin and Pertactin in mothers after maternal Tdap vaccination at 30-32 weeks of gestation.
    End point type
    Secondary
    End point timeframe
    30-32 weeks pregnancy
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No blood was drawn from the mothers in the control group at this timepoint.
    End point values
    		 Woman immunized during pregnancy
    Number of subjects analysed
    58
    Units: IU/ml
    geometric mean (confidence interval 95%)
        Pertussis Toxin (Ptx)
    6.2 (4.0 to 9.8)
        Filamentous Haemagglutinin (FHA)
    9.86 (7.0 to 14.1)
        Pertactin (prn)
    9.3 (6.1 to 14.1)
    No statistical analyses for this end point

    Secondary: serum IgG antibody levels against Diphteria toxoid and Tetanus toxoid at birth

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    End point title
    		 serum IgG antibody levels against Diphteria toxoid and Tetanus toxoid at birth [6]
    End point description
    Geometric mean concentrations and 95% confidence interval of IgG antibodies for Diphteria toxoid (Dt) and Tetanus toxoid (Tt) in (IU/ml) in infants after maternal Tdap vaccination at 30-32 weeks of gestation and control infants without maternal Tdap vaccination. All infants received DTaP-IPV-Hib-HepB and PhiD-CV10 at 3, 5 and 11 months of age.
    End point type
    Secondary
    End point timeframe
    blood collected through cordblood at birth or within 48 hours after birth.
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: serum IgG antibody levels against Diphteria toxoid and Tetanus toxoid for the mothers were not measured. This was not one of the endpoints of this study. Only the levels for the children have been measured.
    End point values
    		 Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    54
    53
    Units: IU/ml
    geometric mean (confidence interval 95%)
        Diphteria toxoid (Dt)
    0.64 (0.48 to 0.86)
    0.12 (0.08 to 0.17)
        Tetanus toxoid (Tt)
    7.39 (6.19 to 8.82)
    1.82 (1.43 to 2.31)
    No statistical analyses for this end point

    Secondary: serum IgG antibody levels against Diphteria toxoid and Tetanus toxoid 2 months after birth

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    End point title
    		 serum IgG antibody levels against Diphteria toxoid and Tetanus toxoid 2 months after birth [7]
    End point description
    Geometric mean concentrations and 95% confidence interval of IgG antibodies for Diphteria toxoid (Dt) and Tetanus toxoid (Tt) in (IU/ml) in infants during the first year of life in infants after maternal Tdap vaccination at 30-32 weeks of gestation and control infants without maternal Tdap vaccination. All infants received DTaP-IPV-Hib-HepB and PhiD-CV10 at 3, 5 and 11 months of age.
    End point type
    Secondary
    End point timeframe
    61 +/- 5 days after birth
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No blood was drawn from the mothers of the newborns at this timepoint.
    End point values
    		 Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    55
    53
    Units: IU/ml
    geometric mean (confidence interval 95%)
        Diphteria toxoid (Dt)
    0.13 (0.10 to 0.17)
    0.03 (0.02 to 0.04)
        Tetanus toxoid (Tt)
    1.67 (1.42 to 1.97)
    0.49 (0.38 to 0.61)
    No statistical analyses for this end point

    Secondary: serum IgG antibody levels against Diphteria toxoid and Tetanus toxoid at 3 months after birth

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    End point title
    		 serum IgG antibody levels against Diphteria toxoid and Tetanus toxoid at 3 months after birth [8]
    End point description
    Geometric mean concentrations and 95% confidence interval of IgG antibodies for Diphteria toxoid (Dt) and Tetanus toxoid (Tt) in (IU/ml) in infants during the first year of life in infants after maternal Tdap vaccination at 30-32 weeks of gestation and control infants without maternal Tdap vaccination. All infants received DTaP-IPV-Hib-HepB and PhiD-CV10 at 3, 5 and 11 months of age.
    End point type
    Secondary
    End point timeframe
    91 +/- 5 days after birth
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No blood was drawn from the mothers of the newborns at this timepoint.
    End point values
    		 Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    54
    50
    Units: IU/ml
    geometric mean (confidence interval 95%)
        Diphteria toxoid (Dt)
    0.07 (0.06 to 0.10)
    0.01 (0.01 to 0.02)
        Tetanus toxoid (Tt)
    0.96 (0.81 to 1.14)
    0.29 (0.23 to 0.36)
    Attachments
    		 Untitled (Filename: Publication MIKI study Lancet Infect Dis vol 19 2019 Barug et al..pdf)
    No statistical analyses for this end point

    Secondary: serum IgG antibody levels against Diphteria toxoid and Tetanus toxoid 6 months after birth

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    End point title
    		 serum IgG antibody levels against Diphteria toxoid and Tetanus toxoid 6 months after birth [9]
    End point description
    Geometric mean concentrations and 95% confidence interval of IgG antibodies for Diphteria toxoid (Dt) and Tetanus toxoid (Tt) in (IU/ml) in infants during the first year of life in infants after maternal Tdap vaccination at 30-32 weeks of gestation and control infants without maternal Tdap vaccination. All infants received DTaP-IPV-Hib-HepB and PhiD-CV10 at 3, 5 and 11 months of age.
    End point type
    Secondary
    End point timeframe
    183 days +/- 5 days after birth
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: serum IgG antibody levels against Diphteria toxoid and Tetanus toxoid for the mothers were not measured. This was not one of the endpoints of this study. Only the levels for the children have been measured.
    End point values
    		 Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    53
    50
    Units: IU/ml
    geometric mean (confidence interval 95%)
        Diphteria toxoid (Dt)
    0.14 (0.10 to 0.18)
    0.35 (0.24 to 0.51)
        Tetanus toxoid (Tt)
    0.80 (0.68 to 0.95)
    0.92 (0.70 to 1.21)
    No statistical analyses for this end point

    Secondary: serum IgG antibody levels against Diphteria toxoid and Tetanus toxoid 11 months after birth

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    End point title
    		 serum IgG antibody levels against Diphteria toxoid and Tetanus toxoid 11 months after birth [10]
    End point description
    Geometric mean concentrations and 95% confidence interval of IgG antibodies for Diphteria toxoid (Dt) and Tetanus toxoid (Tt) in (IU/ml) in infants during the first year of life in infants after maternal Tdap vaccination at 30-32 weeks of gestation and control infants without maternal Tdap vaccination. All infants received DTaP-IPV-Hib-HepB and PhiD-CV10 at 3, 5 and 11 months of age.
    End point type
    Secondary
    End point timeframe
    335 +/- 5 days after birth
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No blood was drawn from the mothers of the newborns at this timepoint.
    End point values
    		 Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    51
    47
    Units: IU/ml
    geometric mean (confidence interval 95%)
        Diphteria toxoid (Dt)
    0.04 (0.03 to 0.05)
    0.07 (0.05 to 0.09)
        Tetanus toxoid (Tt)
    0.32 (0.26 to 0.39)
    0.30 (0.24 to 0.39)
    No statistical analyses for this end point

    Secondary: serum IgG antibody levels against Diphteria toxoid and Tetanus toxoid 12 months after birth

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    End point title
    		 serum IgG antibody levels against Diphteria toxoid and Tetanus toxoid 12 months after birth [11]
    End point description
    Geometric mean concentrations and 95% confidence interval of IgG antibodies for Diphteria toxoid (Dt) and Tetanus toxoid (Tt) in (IU/ml) in infants during the first year of life in infants after maternal Tdap vaccination at 30-32 weeks of gestation and control infants without maternal Tdap vaccination. All infants received DTaP-IPV-Hib-HepB and PhiD-CV10 at 3, 5 and 11 months of age.
    End point type
    Secondary
    End point timeframe
    366 +/- 5 days after birth
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: serum IgG antibody levels against Diphteria toxoid and Tetanus toxoid for the mothers were not measured. This was not one of the endpoints of this study. Only the levels for the children have been measured.
    End point values
    		 Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    53
    50
    Units: IU/ml
    geometric mean (confidence interval 95%)
        Diphteria toxoid (Dt)
    0.81 (0.65 to 1.00)
    1.24 (0.98 to 1.58)
        Tetanus toxoid (Tt)
    4.05 (3.36 to 4.90)
    4.05 (3.34 to 4.92)
    No statistical analyses for this end point

    Secondary: serum IgG antibody levels against Haemophilus influenzae type-b PRP at birth

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    End point title
    		 serum IgG antibody levels against Haemophilus influenzae type-b PRP at birth [12]
    End point description
    Geometric mean concentrations and 95% confidence interval of IgG antibodies for anti PRP IgG antibodies for Haemophilus influenzae type-b (ug/ml) in infants during the first year of life in infants after maternal Tdap vaccination at 30-32 weeks of gestation and control infants without maternal Tdap vaccination. All infants received DTaP-IPV-Hib-HepB and PhiD-CV10 at 3, 5 and 11 months of age.
    End point type
    Secondary
    End point timeframe
    blood collected through cordblood at birth or within 48 hours after birth.
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: serum IgG antibody levels against Haemophilus influenzae type-b PRP for the mothers were not measured. This was not one of the endpoints of this study. Only the levels for the children have been measured.
    End point values
    		 Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    52
    53
    Units: ug/ml
        geometric mean (confidence interval 95%)
    0.29 (0.18 to 0.48)
    0.33 (0.19 to 0.55)
    No statistical analyses for this end point

    Secondary: serum IgG antibody levels against Haemophilus influenzae type-b PRP 2 months after birth

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    End point title
    		 serum IgG antibody levels against Haemophilus influenzae type-b PRP 2 months after birth [13]
    End point description
    Geometric mean concentrations and 95% confidence interval of IgG antibodies for anti PRP IgG antibodies for Haemophilus influenzae type-b (ug/ml) in infants during the first year of life in infants after maternal Tdap vaccination at 30-32 weeks of gestation and control infants without maternal Tdap vaccination. All infants received DTaP-IPV-Hib-HepB and PhiD-CV10 at 3, 5 and 11 months of age.
    End point type
    Secondary
    End point timeframe
    61 +/- 5 days after birth
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No blood was drawn from the mothers of the newborns at this timepoint.
    End point values
    		 Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    55
    52
    Units: ug/ml
        geometric mean (confidence interval 95%)
    0.09 (0.06 to 0.13)
    0.09 (0.05 to 0.15)
    No statistical analyses for this end point

    Secondary: serum IgG antibody levels against Haemophilus influenzae type-b PRP 3 months after birth

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    End point title
    		 serum IgG antibody levels against Haemophilus influenzae type-b PRP 3 months after birth [14]
    End point description
    Geometric mean concentrations and 95% confidence interval of IgG antibodies for anti PRP IgG antibodies for Haemophilus influenzae type-b (ug/ml) in infants during the first year of life in infants after maternal Tdap vaccination at 30-32 weeks of gestation and control infants without maternal Tdap vaccination. All infants received DTaP-IPV-Hib-HepB and PhiD-CV10 at 3, 5 and 11 months of age.
    End point type
    Secondary
    End point timeframe
    91 +/- 5 days after birth
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No blood was drawn from the mothers of the newborns at this timepoint.
    End point values
    		 Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    54
    50
    Units: ug/ml
        geometric mean (confidence interval 95%)
    0.06 (0.04 to 0.09)
    0.06 (0.04 to 0.09)
    No statistical analyses for this end point

    Secondary: serum IgG antibody levels against Haemophilus influenzae type-b PRP 6 months after birth

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    End point title
    		 serum IgG antibody levels against Haemophilus influenzae type-b PRP 6 months after birth [15]
    End point description
    Geometric mean concentrations and 95% confidence interval of IgG antibodies for anti PRP IgG antibodies for Haemophilus influenzae type-b (ug/ml) in infants during the first year of life in infants after maternal Tdap vaccination at 30-32 weeks of gestation and control infants without maternal Tdap vaccination. All infants received DTaP-IPV-Hib-HepB and PhiD-CV10 at 3, 5 and 11 months of age.
    End point type
    Secondary
    End point timeframe
    183 days +/- 5 days after birth
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: serum IgG antibody levels against Haemophilus influenzae type-b PRP for the mothers were not measured. This was not one of the endpoints of this study. Only the levels for the children have been measured.
    End point values
    		 Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    50
    49
    Units: ug/ml
        geometric mean (confidence interval 95%)
    0.28 (0.17 to 0.44)
    0.30 (0.20 to 0.45)
    No statistical analyses for this end point

    Secondary: serum IgG antibody levels against Haemophilus influenzae type-b PRP 11 months after birth

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    End point title
    		 serum IgG antibody levels against Haemophilus influenzae type-b PRP 11 months after birth [16]
    End point description
    Geometric mean concentrations and 95% confidence interval of IgG antibodies for anti PRP IgG antibodies for Haemophilus influenzae type-b (ug/ml) in infants during the first year of life in infants after maternal Tdap vaccination at 30-32 weeks of gestation and control infants without maternal Tdap vaccination. All infants received DTaP-IPV-Hib-HepB and PhiD-CV10 at 3, 5 and 11 months of age.
    End point type
    Secondary
    End point timeframe
    335 +/- 5 days after birth
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No blood was drawn from the mothers of the newborns at this timepoint.
    End point values
    		 Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    47
    46
    Units: ug/ml
        geometric mean (confidence interval 95%)
    0.37 (0.24 to 0.57)
    0.40 (0.29 to 0.55)
    No statistical analyses for this end point

    Secondary: serum IgG antibody levels against Haemophilus influenzae type-b PRP 12 months after birth

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    End point title
    		 serum IgG antibody levels against Haemophilus influenzae type-b PRP 12 months after birth [17]
    End point description
    Geometric mean concentrations and 95% confidence interval of IgG antibodies for anti PRP IgG antibodies for Haemophilus influenzae type-b (ug/ml) in infants during the first year of life in infants after maternal Tdap vaccination at 30-32 weeks of gestation and control infants without maternal Tdap vaccination. All infants received DTaP-IPV-Hib-HepB and PhiD-CV10 at 3, 5 and 11 months of age.
    End point type
    Secondary
    End point timeframe
    366 +/- 5 days after birth
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: serum IgG antibody levels against Haemophilus influenzae type-b PRP for the mothers were not measured. This was not one of the endpoints of this study. Only the levels for the children have been measured.
    End point values
    		 Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    51
    47
    Units: ug/ml
        geometric mean (confidence interval 95%)
    10.24 (6.32 to 16.60)
    12.72 (8.39 to 19.31)
    No statistical analyses for this end point

    Secondary: serum IgG antibody levels against pneumococcal serotypes 6 months after birth

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    End point title
    		 serum IgG antibody levels against pneumococcal serotypes 6 months after birth [18]
    End point description
    Geometric mean concentrations (ug/ml) and their 95% confidence interval of IgG antibodies for serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F included in the 10 valent pneumococcal conjugate vaccine PhiD-CV10 and extra serotypes 3, 6A and 19A in infants one month post primary vaccinations at age 3 and 5 months and one month after booster vaccination with PhiD-CV10 at age 11 months.
    End point type
    Secondary
    End point timeframe
    183 days +/- 5 days after birth
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: serum IgG antibody levels against pneumococcal serotypes for the mothers were not measured. This was not one of the endpoints of this study. Only the levels for the children have been measured.
    End point values
    		 Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    52
    51
    Units: ug/ml
    geometric mean (confidence interval 95%)
        serotype 1
    2.48 (1.74 to 3.54)
    2.96 (2.09 to 4.20)
        serotype 4
    0.57 (0.42 to 0.77)
    0.67 (0.51 to 0.88)
        serotype 5
    1.64 (1.17 to 2.29)
    1.57 (1.15 to 2.14)
        serotype 6B
    0.33 (0.20 to 0.56)
    0.32 (0.19 to 0.53)
        serotype 7F
    3.95 (2.95 to 5.30)
    3.64 (2.75 to 4.82)
        serotype 9V
    1.43 (1.05 to 1.97)
    1.72 (1.34 to 2.21)
        serotype 14
    2.69 (1.97 to 3.66)
    2.86 (2.09 to 3.91)
        serotype 18C
    0.89 (0.58 to 1.37)
    0.97 (0.66 to 1.45)
        serotype 19F
    4.77 (2.99 to 7.61)
    11.45 (7.22 to 18.17)
        serotype 23 F
    0.59 (0.39 to 0.90)
    0.52 (0.34 to 0.80)
        serotype 3
    0.17 (0.14 to 0.20)
    0.16 (0.14 to 0.18)
        serotype 6A
    0.04 (0.03 to 0.07)
    0.05 (0.03 to 0.08)
        serotype 19A
    0.07 (0.04 to 0.10)
    0.12 (0.08 to 0.17)
    No statistical analyses for this end point

    Secondary: serum IgG antibody levels against pneumococcal serotypes 12 months after birth

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    End point title
    		 serum IgG antibody levels against pneumococcal serotypes 12 months after birth [19]
    End point description
    Geometric mean concentrations (ug/ml) and their 95% confidence interval of IgG antibodies for serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F included in the 10 valent pneumococcal conjugate vaccine PhiD-CV10 and extra serotypes 3, 6A and 19A in infants one month post primary vaccinations at age 3 and 5 months and one month after booster vaccination with PhiD-CV10 at age 11 months.
    End point type
    Secondary
    End point timeframe
    366 +/- 5 days after birth
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: serum IgG antibody levels against pneumococcal serotypes for the mothers were not measured. This was not one of the endpoints of this study. Only the levels for the children have been measured.
    End point values
    		 Newborns of woman immunized during pregnancy Newborn of woman immunized after pregnancy
    Number of subjects analysed
    51
    47
    Units: ug/ml
    geometric mean (confidence interval 95%)
        serotype 1
    9.11 (7.03 to 11.81)
    10.37 (7.84 to 13.70)
        serotype 4
    1.78 (1.46 to 2.19)
    1.83 (1.47 to 2.28)
        serotype 5
    5.30 (4.13 to 6.80)
    5.74 (4.32 to 7.61)
        serotype 6B
    5.52 (4.34 to 7.02)
    4.77 (3.67 to 6.19)
        serotype 7F
    10.36 (8.24 to 13.04)
    9.32 (7.47 to 11.64)
        serotype 9V
    5.56 (4.62 to 6.69)
    6.11 (4.85 to 7.71)
        serotype 14
    4.65 (3.54 to 6.10)
    4.86 (3.64 to 6.50)
        serotype 18C
    8.22 (6.47 to 10.46)
    7.43 (5.60 to 9.85)
        serotype 19F
    32.36 (25.16 to 41.64)
    40.56 (29.95 to 54.91)
        serotype 23F
    4.14 (3.26 to 5.26)
    3.73 (2.95 to 4.72)
        serotype 3
    0.25 (0.22 to 0.29)
    0.28 (0.24 to 0.34)
        serotype 6A
    0.58 (0.34 to 0.98)
    0.52 (0.30 to 0.91)
        serotype 19A
    0.45 (0.29 to 0.70)
    0.73 (0.48 to 1.11)
    No statistical analyses for this end point

    Secondary: Frequency of local and systemic reactions after Booster vaccination during pregnancy

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    End point title
    		 Frequency of local and systemic reactions after Booster vaccination during pregnancy [20]
    End point description
    MedDRA version 22.0. Assessed solicited local symptoms were: Vaccination site reaction (= any occurrence of the symptoms), Vaccination site pain, Vaccination site erythema, Vaccination site plaque, Vaccination site bruising and Vaccination site swelling. Regardless of intensity grade. Assessed systemic symptoms were: Post vaccination systemic reaction (= any systemic reaction), Post vaccination fever*, Headache, Fatique Arthralgia and Myalgia. *defined as body temperature of 38 degrees Celsius or higher. No cases >39.5 degrees Celsius were reported. The number of local site reactions and systemic reactions within 7 days after the Boostrix vaccination in pregnant women were in accordance with the European Public Assessment Report for Boostrix, although more accounts of fatigue and pain were recorded. Fatigue was also reported before Tdap vaccination and did not increase afterwards.
    End point type
    Secondary
    End point timeframe
    0-14 days after maternal vaccination
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only woman immunized during pregnancy have systematical reported local and systemic adverse events up to 15 days after vaccination.
    End point values
    		 Woman immunized during pregnancy
    Number of subjects analysed
    57
    Units: N/A
        Vaccination site reaction (any)
    100
        Vaccination site erythema
    13
        Vaccination site swelling
    7
        Vaccination site plaque
    8
        Vaccination site bruising
    8
        Vaccination site pain
    48
        Vaccination site warmth
    1
        Injection site pruritus
    2
        Vaccination site movement impairment
    13
        systemic reaction (any)
    93
        Pyrexia
    1
        Headache
    8
        Fatigue
    25
        Myalgia
    37
        Arthralgia
    1
        Malaise
    12
        Tachycardia foetal
    1
        Rash pruritic
    1
        Erythema
    1
        Nausea
    4
        Vomiting
    1
        Dizziness
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Potential related SAE’s to Boostrix vaccination of pregnant woman were reported till 6 months after vaccination. SAE’s related to pertussis disease or unrelated SAE's resulting in death were reported till the end of the trial.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Maternal Tdap group Woman
    Reporting group description
    		 -

    Reporting group title
    control group Woman
    Reporting group description
    		 no maternal Tdap vaccination

    Reporting group title
    Maternal Tdap group Infants
    Reporting group description
    		 -

    Reporting group title
    control group Infants
    Reporting group description
    		 -

    Serious adverse events
    		 Maternal Tdap group Woman control group Woman Maternal Tdap group Infants control group Infants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    27 / 58 (46.55%)
    17 / 60 (28.33%)
    6 / 58 (10.34%)
    11 / 60 (18.33%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Nephroblastoma
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Burns third degree
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perineal injury
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia neonatal
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal tachycardia
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Labour stimulation
         subjects affected / exposed
    6 / 58 (10.34%)
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Caesarean section
         subjects affected / exposed
    7 / 58 (12.07%)
    4 / 60 (6.67%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Labour induction
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retained placenta operation
         subjects affected / exposed
    3 / 58 (5.17%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vacuum extractor delivery
         subjects affected / exposed
    1 / 58 (1.72%)
    5 / 60 (8.33%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Loss of consciousness
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Arrested labour
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breech presentation
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gestational diabetes
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gestational hypertension
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Induced labour
         subjects affected / exposed
    2 / 58 (3.45%)
    3 / 60 (5.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intrapartum haemorrhage
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Labour pain
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Low birth weight baby
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meconium in amniotic fluid
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstructed labour
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postpartum haemorrhage
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Precipitate labour
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retained placenta or membranes
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prolonged rupture of membranes
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prolonged labour
         subjects affected / exposed
    7 / 58 (12.07%)
    3 / 60 (5.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature rupture of membranes
         subjects affected / exposed
    2 / 58 (3.45%)
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature delivery
    Additional description: Born before 37 weeks gestational age
         subjects affected / exposed
    3 / 58 (5.17%)
    2 / 60 (3.33%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fever neonatal
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infantile vomiting
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Kidney congestion
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacterial infection
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis enteroviral
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal infection
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal scalded skin syndrome
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal insufficient breast milk syndrome
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Maternal Tdap group Woman control group Woman Maternal Tdap group Infants control group Infants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    57 / 58 (98.28%)
    5 / 60 (8.33%)
    19 / 58 (32.76%)
    18 / 60 (30.00%)
    Surgical and medical procedures
    Ear tube insertion
    Additional description: systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    4 / 60 (6.67%)
         occurrences all number
    0
    0
    1
    5
    Tonsillectomy
    Additional description: systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    3 / 60 (5.00%)
         occurrences all number
    0
    0
    1
    3
    Nervous system disorders
    Headache
    Additional description: Systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    8 / 58 (13.79%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    8
    0
    0
    0
    General disorders and administration site conditions
    Vaccination site erythema
    Additional description: systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    13 / 58 (22.41%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    13
    0
    0
    0
    Vaccination site swelling
    Additional description: Systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    7 / 58 (12.07%)
    1 / 60 (1.67%)
    1 / 58 (1.72%)
    1 / 60 (1.67%)
         occurrences all number
    7
    1
    2
    1
    Vaccination site movement impairment
    Additional description: Systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    13 / 58 (22.41%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    13
    0
    0
    0
    Vaccination site pain
    Additional description: Systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    48 / 58 (82.76%)
    2 / 60 (3.33%)
    0 / 58 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    48
    2
    0
    1
    Vaccination site haematoma
    Additional description: Systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    8 / 58 (13.79%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    8
    0
    0
    3
    Fatigue
    Additional description: Systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    25 / 58 (43.10%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    25
    0
    0
    0
    Vaccination site plaque
    Additional description: Systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    8 / 58 (13.79%)
    0 / 60 (0.00%)
    4 / 58 (6.90%)
    5 / 60 (8.33%)
         occurrences all number
    8
    0
    7
    8
    Malaise
    Additional description: systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    12 / 58 (20.69%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    12
    0
    0
    1
    Pyrexia
    Additional description: systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 60 (1.67%)
    4 / 58 (6.90%)
    2 / 60 (3.33%)
         occurrences all number
    1
    1
    4
    2
    Nausea
    Additional description: systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    4 / 58 (6.90%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Immune system disorders
    Milk allergy
    Additional description: systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    3 / 58 (5.17%)
    0 / 60 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
    Additional description: systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    5 / 58 (8.62%)
    4 / 60 (6.67%)
         occurrences all number
    0
    0
    5
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
    Additional description: systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 60 (1.67%)
    1 / 58 (1.72%)
    2 / 60 (3.33%)
         occurrences all number
    1
    1
    1
    3
    Skin and subcutaneous tissue disorders
    Eczema
    Additional description: systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    0
    0
    0
    3
    Musculoskeletal and connective tissue disorders
    Myalgia
    Additional description: Systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    38 / 58 (65.52%)
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    38
    0
    0
    0
    Infections and infestations
    Gastroenteritis viral
    Additional description: systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    2 / 60 (3.33%)
         occurrences all number
    0
    0
    1
    3
    Otitis media
    Additional description: systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 60 (0.00%)
    6 / 58 (10.34%)
    3 / 60 (5.00%)
         occurrences all number
    0
    0
    9
    7
    Respiratory tract infection
    Additional description: systematic assessment was only done by woman vaccinated during pregnancy by means of a questionnaire. Woman vaccinated after birth were asked to self report AE's
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 60 (1.67%)
    1 / 58 (1.72%)
    3 / 60 (5.00%)
         occurrences all number
    0
    1
    1
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Aug 2014
    Adding collection of breast milk, comparison of pain related to blood collection methods, collection of serum sample at visit 7 and 8
    30 Apr 2015
    interim analysis of primary endpoint, change in recruitment strategy, addition of an 2nd participating center
    19 Feb 2016
    extension of follow-up period to 1 month after Pertussis booster vaccination at 4 years of age to evaluate if maternal pertussis vaccination has a longterm effect on the immune response to this booster dose.
    31 Oct 2017
    optional blood collection by venipuncture at visit 11 or 12 to asses cellular immunity.

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

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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32448624
    http://www.ncbi.nlm.nih.gov/pubmed/30938299
    http://www.ncbi.nlm.nih.gov/pubmed/31250812
    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
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