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    Clinical Trial Results:
    A Phase II Randomized Observer-Blind, Multicentre, Controlled Study of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2010-020840-36
    Trial protocol
    		 BE   Outside EU/EEA  
    Global end of trial date
    17 Oct 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    04 Jun 2016
    First version publication date
    25 Apr 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    re-QC of study is required because of the EudraCT system glitch and updates are required.

    Trial information

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    Trial identification
    Sponsor protocol code
    V98_04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01446289
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics
    Sponsor organisation address
    Via Fiorentina, 1, Siena, Italy, 53100
    Public contact
    Posting Director, Novartis Vaccines and Diagnostics, RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines and Diagnostics, RegistryContactVaccinesUS@novartis.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
    14 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Apr 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Oct 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate placental transfer of anti-Group B streptococcus (GBS) capsular polysaccharide (CPS) antibodies against vaccine serotypes among infants born to vaccine and placebo injected mothers.
    Protection of trial subjects
    This clinical study was designed and was to be implemented and reported in accordance with the ICH Harmonized Tripartite Guidelines for Good Clinical Practice (GCPs), with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21, and Japanese Ministry of Health, Labor, and Welfare), and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Sep 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 60
    Country: Number of subjects enrolled
    Canada: 26
    Worldwide total number of subjects
    86
    EEA total number of subjects
    60
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    86
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from 5 centres.

    Pre-assignment
    Screening details
    		 A total of 86 pregnant subjects were enrolled in the study. 86 infants were enrolled in this study, delivered by 86 maternal subjects. There were 86 singleton deliveries.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mother GBS
    Arm description
    		 Pregnant women who received one injection of GBS vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trivalent Group B Streptococcus Glycoconjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL of vaccine (5/5/5 trivalent GBS diluted with WFI) is administered intramuscularly in the arm.

    Arm title
    		 Mothers Placebo
    Arm description
    		 Pregnant women who received one injection of saline solution.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL of sterile saline is administered intramuscularly in the arm.

    Number of subjects in period 1
    		Mother GBS Mothers Placebo
    Started
    51
    35
    Completed
    50
    35
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mother GBS
    Reporting group description
    		 Pregnant women who received one injection of GBS vaccine.

    Reporting group title
    Mothers Placebo
    Reporting group description
    		 Pregnant women who received one injection of saline solution.

    Reporting group values
    		 Mother GBS Mothers Placebo Total
    Number of subjects
    		 51 35 86
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 29.7 ( 4.9 ) 30 ( 5.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 51 35 86
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Mother GBS
    Reporting group description
    		 Pregnant women who received one injection of GBS vaccine.

    Reporting group title
    Mothers Placebo
    Reporting group description
    		 Pregnant women who received one injection of saline solution.

    Subject analysis set title
    PPS- Primary Objective
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    •Provide at least one evaluable serum sample result at delivery (or within 72 hours after) for maternal subjects •Provide at least one evaluable serum sample result at birth (Day 1, or within 72 hours after) for infants

    Subject analysis set title
    Infants-GBS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All infants born to maternal subjects who received GBS.

    Subject analysis set title
    Infants-Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All infants born to maternal subjects receiving placebo

    Subject analysis set title
    Safety Set –Overall
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All maternal subjects in the Exposed Set who have either provided data on postvaccination unsolicited AEs or local or systemic AEs or other signs of reactogenicity.

    Subject analysis set title
    PPS- Secondary Objective Maternal
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Provide at least one evaluable serum sample result at Day 1 (prior to vaccination), Study Day 31, delivery, or Day 91 postpartum.

    Subject analysis set title
    PPS- Secondary Objective Infants
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Provide at least one evaluable serum sample result at birth (Day 1, or within 72 hours) and Day 91 of age.

    Primary: 1. Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery

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    End point title
    		 1. Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery [1]
    End point description
    The Geometric mean transfer ratio of anti-GBS CPS antibodies against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery. The analysis was done on the Immunogenicity PPS.
    End point type
    Primary
    End point timeframe
    Day of delivery/birth
    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: No statistical analysis is associated to this endpoint. Analyses were run descriptively.
    End point values
    		 Mother GBS Mothers Placebo
    Number of subjects analysed
    45
    30
    Units: Ratio
    geometric mean (confidence interval 95%)
        GBS Ia
    0.81 (0.72 to 0.91)
    0.97 (0.85 to 1.11)
        GBS Ib (N=40, 22)
    0.77 (0.62 to 0.97)
    1.44 (1.06 to 1.94)
        GBS III (N=40, 25,)
    0.68 (0.59 to 0.78)
    0.99 (0.83 to 1.18)
    No statistical analyses for this end point

    Secondary: 2. GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects

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    End point title
    		 2. GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects
    End point description
    GMCs (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III in maternal subjects at study day 1, study day 31 and at day 91 post-partum after one administration of GBS vaccine or placebo are reported. The analysis was done on the Immunogenicity PPS.
    End point type
    Secondary
    End point timeframe
    Day 1, day 31 and day 91 post-delivery
    End point values
    		 Mother GBS Mothers Placebo
    Number of subjects analysed
    51
    35
    Units: µg/mL
    geometric mean (confidence interval 95%)
        GBS Ia (day 1)
    0.28 (0.19 to 0.41)
    0.37 (0.24 to 0.58)
        GBS Ia (day 31; N=49, 32)
    4.83 (2.89 to 8.06)
    0.36 (0.19 to 0.65)
        GBS Ia (day 91 post-delivery; N = 44, 34)
    5.89 (3.86 to 8.99)
    0.46 (0.29 to 0.75)
        GBS Ib (day 1; N= 50, 34)
    0.13 (0.084 to 0.19)
    0.084 (0.051 to 0.14)
        GBS Ib (day 31; N=49, 31)
    1.68 (0.97 to 2.92)
    0.14 (0.069 to 0.27)
        GBS Ib (day 91 post-delivery; N= 44, 33)
    3.46 (2.33 to 5.14)
    0.17 (0.11 to 0.27)
        GBS III (day 1)
    0.11 (0.07 to 0.16)
    0.093 (0.056 to 0.15)
        GBS III (day 31; N= 49, 32)
    1.46 (0.83 to 2.57)
    0.12 (0.06 to 0.23)
        GBS III (day 91 post-delivery; N=44, 34)
    2.69 (1.78 to 4.06)
    0.11 (0.07 to 0.18)
    No statistical analyses for this end point

    Secondary: 3. Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects

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    End point title
    		 3. Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects
    End point description
    GMRs of GMCs (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III, in maternal subjects at study day 31, at delivery and at day 91 post-partum versus day 1 (baseline) after one administration of GBS vaccine or placebo are reported. The analysis was done on the Immunogenicity PPS.
    End point type
    Secondary
    End point timeframe
    Day 31, day of delivery, day 91 post-delivery.
    End point values
    		 Mother GBS Mothers Placebo
    Number of subjects analysed
    51
    35
    Units: Ratio
    geometric mean (confidence interval 95%)
        GBS Ia (Day 31/day 1; N=49, 32)
    15 (9.12 to 25)
    1.22 (0.66 to 2.25)
        GBS Ia (Delivery/day 1)
    16 (11 to 25)
    1.2 (0.72 to 2.01)
        GBS Ia (day 91 post-delivery/day 1; N= 44, 34)
    19 (12 to 28)
    1.51 (0.94 to 2.42)
        GBS Ib (Day 31/day 1; N=48, 30)
    18 (9.94 to 32)
    1.14 (0.56 to 2.35)
        GBS Ib (Delivery/day 1; N=50, 34)
    23 (14 to 39)
    1.13 (0.63 to 2.05)
        GBS Ib (day 91 post-delivery/day 1; N=44, 32)
    33 (22 to 48)
    1.53 (0.96 to 2.43)
        GBS III (Day 31/day 1; N=49, 32)
    17 (9.17 to 30)
    1.19 (0.59 to 2.42)
        GBS III (Delivery/day 1)
    20 (12 to 33)
    1.08 (0.6 to 1.96)
        GBS III (day 91 post-delivery/day 1; N=44, 34)
    28 (18 to 43)
    1.11 (0.69 to 1.8)
    No statistical analyses for this end point

    Secondary: 4. GMC (ELISA) of Anti-GBS CPS Antibodies in Infants

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    End point title
    		 4. GMC (ELISA) of Anti-GBS CPS Antibodies in Infants
    End point description
    GMC (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III in infants at birth and at 3 months of age are reported. The analysis was done on the Immunogenicity PPS.
    End point type
    Secondary
    End point timeframe
    Day of birth and day 91 after birth
    End point values
    		 Infants-GBS Infants-Placebo
    Number of subjects analysed
    35
    25
    Units: µg/mL
    geometric mean (confidence interval 95%)
        GBS Ia (day of birth)
    5.14 (2.64 to 10)
    0.33 (0.15 to 0.71)
        GBS Ia (day 91 after birth)
    1.28 (0.76 to 2.16)
    0.25 (0.13 to 0.46)
        GBS Ib (day of birth; N=31, 20)
    2.93 (1.14 to 7.57)
    0.1 (0.031 to 0.32)
        GBS Ib (day 91 after birth)
    0.54 (0.25 to 19)
    0.063 (0.025 to 0.16)
        GBS III (day of birth; N=30, 22)
    1.93 (0.82 to 4.59)
    0.065 (0.024 to 0.18)
        GBS III (day 91 after birth)
    0.43 (0.21 to 0.86)
    0.065 (0.029 to 0.15)
    No statistical analyses for this end point

    Secondary: 5. GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth

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    End point title
    		 5. GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth
    End point description
    GMRs of anti-GBS CPS antibody GMCs (ELISA) against serotypes Ia, Ib and III in infants at 3 months of age (day 91 after birth) versus GMCs at birth are reported. The analysis was done on the Immunogenicity PPS.
    End point type
    Secondary
    End point timeframe
    Day 91 after birth
    End point values
    		 Infants-GBS Infants-Placebo
    Number of subjects analysed
    35
    25
    Units: Ratio
    geometric mean (confidence interval 95%)
        GBS Ia
    0.25 (0.19 to 0.32)
    0.76 (0.57 to 1.01)
        GBS Ib (N=31, 20 )
    0.22 (0.16 to 0.29)
    0.54 (0.38 to 0.78)
        GBS III (N=30, 22)
    0.25 (0.19 to 0.32)
    0.85 (0.62 to 1.16)
    No statistical analyses for this end point

    Secondary: 6. Percentages of Infant Subjects Showing Anti-diphtheria Antibody concentrations (ELISA) Over 0.1 IU/mL at 1 Month After the Last Routine Infant Immunization

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    End point title
    		 6. Percentages of Infant Subjects Showing Anti-diphtheria Antibody concentrations (ELISA) Over 0.1 IU/mL at 1 Month After the Last Routine Infant Immunization
    End point description
    Percentages of infant subjects showing anti-diphtheria antibody concentrations (ELISA) over 0.1 IU/mL in sera collected at 1 month after the last routine infant immunization (ie, either 5 months or 7 months after birth, depending on the vaccination schedule) are reported. The analysis was done on the Immunogenicity PPS.
    End point type
    Secondary
    End point timeframe
    1 month after the last routine infant immunization.
    End point values
    		 Infants-GBS Infants-Placebo
    Number of subjects analysed
    40
    27
    Units: Percentage
    number (confidence interval 95%)
        >=0.1 IU/mL
    100 (91 to 100)
    100 (87 to 100)
    No statistical analyses for this end point

    Secondary: 7. Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)

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    End point title
    		 7. Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
    End point description
    Percentage of maternal subjects reporting solicited local and systemic AEs and other indicators of reactogenicity from day 1 to 7 after vaccination are reported. The analysis was done on the Safety Set, ie, all subjects in the enrolled population who received a study vaccination, provided post vaccination safety data, provided post-baseline safety data.
    End point type
    Secondary
    End point timeframe
    From day 1 to 7 after vaccination.
    End point values
    		 Mother GBS Mothers Placebo
    Number of subjects analysed
    50
    34
    Units: Percentage of Subjects
        Induration (>=25 mm; N =49, 34)
    6
    0
        Swelling (>=25 mm; N =49, 34)
    4
    0
        Ecchymosis (>=25 mm; N =49, 34 )
    2
    0
        Erythema (>=25 mm; N =49, 34)
    6
    0
        Pain (N =49, 34)
    35
    12
        Chills (N =49, 34)
    4
    3
        Fatigue (N =49, 34)
    31
    26
        Malaise (N =49, 34)
    14
    9
        Myalgia (N =49, 34)
    27
    3
        Headache (N =49, 34)
    16
    21
        Rash (N =49, 34)
    2
    3
        Arthralgia (N =49, 34)
    4
    9
        Nausea (N =49, 34)
    6
    9
        Fever, body temperature >38° C (N =49, 33)
    0
    0
        Any other
    8
    3
        Stayed home (N =50, 34)
    2
    0
        Use of analgesics/antipyretics (N =49, 34)
    6
    3
    No statistical analyses for this end point

    Secondary: 8. Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs)

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    End point title
    		 8. Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs)
    End point description
    Percentage of maternal subjects reporting unsolicited AEs, SAEs, AEs requiring a non-routine physician’s visit, AEs leading to withdrawal are reported. The analysis was done on the Safety Set.
    End point type
    Secondary
    End point timeframe
    All AEs were recorded until delivery, after delivery all AEs requiring a non-routine physician's visit and AEs leading to withdrawal from the study. SAEs were collected for the duration of the trial.
    End point values
    		 Mother GBS Mothers Placebo
    Number of subjects analysed
    51
    35
    Units: Percentage of subjects
        Any unsolicited AE
    63
    74
        Any SAE
    14
    23
        Medically-attended AEs
    51
    54
        AEs leading to withdrawal
    0
    0
    No statistical analyses for this end point

    Secondary: 9. Percentages of Infants Reporting SAEs

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    End point title
    		 9. Percentages of Infants Reporting SAEs
    End point description
    Percentages of infants born from women who received either one injection of the study vaccine or placebo, reporting SAEs from birth until study termination are reported. The analysis was done on the Safety Set.
    End point type
    Secondary
    End point timeframe
    From birth until study termination
    End point values
    		 Infants-GBS Infants-Placebo
    Number of subjects analysed
    51
    35
    Units: Percentages of subjects
        Percentages of Infants Reporting SAEs
    24
    31
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited (systematic) AEs were collected from day 1 to 7 after vaccination; unsolicited (non-systematic) AEs from day 1 until delivery, SAE from day 1 until study termination (day 151 for subjects enrolled in Belgium, day 211 for subjects in Canada).
    Adverse event reporting additional description
    The analysis was done on the Safety Set and Aes>5% were based on meddra version 17.1
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Mother GBS
    Reporting group description
    		 Pregnant women who received one dose of GBS vaccine.

    Reporting group title
    Mother Placebo
    Reporting group description
    		 Pregnant women who received one injection of saline solution.

    Reporting group title
    Infants GBS
    Reporting group description
    		 Infants born to mothers who received one dose of GBS vaccine.

    Reporting group title
    Infants Placebo
    Reporting group description
    		 Infants born to mothers who received one injection of saline solution.

    Serious adverse events
    		 Mother GBS Mother Placebo Infants GBS Infants Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 51 (13.73%)
    8 / 35 (22.86%)
    12 / 51 (23.53%)
    11 / 35 (31.43%)
         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)
    HAEMANGIOMA
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    1 / 35 (2.86%)
         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
    CAESAREAN SECTION
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 35 (2.86%)
    0 / 51 (0.00%)
    0 / 35 (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
    UTERINE CERVIX DILATION PROCEDURE
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    0 / 35 (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 / 51 (1.96%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    0 / 35 (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
    CEPHALO-PELVIC DISPROPORTION
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 35 (2.86%)
    0 / 51 (0.00%)
    0 / 35 (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
    FOETAL DISTRESS SYNDROME
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    FOETAL GROWTH RESTRICTION
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 35 (2.86%)
    0 / 51 (0.00%)
    0 / 35 (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 / 51 (0.00%)
    0 / 35 (0.00%)
    1 / 51 (1.96%)
    0 / 35 (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
    PLACENTAL INSUFFICIENCY
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 35 (2.86%)
    0 / 51 (0.00%)
    0 / 35 (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
    PREMATURE DELIVERY
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 35 (2.86%)
    0 / 51 (0.00%)
    0 / 35 (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
    PRE-ECLAMPSIA
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 35 (2.86%)
    0 / 51 (0.00%)
    0 / 35 (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
    PREMATURE LABOUR
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 35 (5.71%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PREMATURE SEPARATION OF PLACENTA
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 35 (2.86%)
    0 / 51 (0.00%)
    0 / 35 (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
    SMALL FOR DATES BABY
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    1 / 35 (2.86%)
         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
    UMBILICAL CORD PROLAPSE
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 35 (2.86%)
    0 / 51 (0.00%)
    0 / 35 (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
    UNSTABLE FOETAL LIE
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 35 (2.86%)
    0 / 51 (0.00%)
    0 / 35 (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
    General disorders and administration site conditions
    CRYING
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    1 / 35 (2.86%)
         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
    PYREXIA
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    0 / 35 (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
    Reproductive system and breast disorders
    OVARIAN CYST
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    1 / 51 (1.96%)
    0 / 35 (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
    VAGINAL HAEMORRHAGE
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 35 (2.86%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    APPARENT LIFE THREATENING EVENT
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    1 / 51 (1.96%)
    0 / 35 (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
    ASPHYXIA
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    1 / 35 (2.86%)
         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 ASPHYXIA
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    1 / 51 (1.96%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    NEONATAL RESPIRATORY DISTRESS SYNDROME
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    1 / 35 (2.86%)
         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 DISTRESS
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    1 / 51 (1.96%)
    0 / 35 (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
    TACHYPNOEA
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    1 / 51 (1.96%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TRANSIENT TACHYPNOEA OF THE NEW BORN
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    1 / 35 (2.86%)
         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
    Psychiatric disorders
    ACUTE PSYCHOSIS
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    POSTPARTUM DEPRESSION
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    FOETAL MONITORING
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 35 (2.86%)
    0 / 51 (0.00%)
    0 / 35 (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
    Injury, poisoning and procedural complications
    POST PROCEDURAL HAEMORRHAGE
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 35 (2.86%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    CATARACT CONGENITAL
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    1 / 35 (2.86%)
         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
    RENAL DYSPLASIA
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    1 / 51 (1.96%)
    0 / 35 (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
    RENAL HYPOPLASIA
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    0 / 35 (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
    VENTRICULAR SEPTAL DEFECT
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    1 / 35 (2.86%)
         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
    TRISOMY 21
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    1 / 51 (1.96%)
    0 / 35 (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
    Nervous system disorders
    BRACHIAL PLEXOPATHY
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    1 / 35 (2.86%)
         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
    MYOCLONUS
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    1 / 35 (2.86%)
         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
    PRESYNCOPE
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    1 / 51 (1.96%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    JAUNDICE ACHOLURIC
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    1 / 35 (2.86%)
         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
    Hepatobiliary disorders
    JAUNDICE
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    1 / 51 (1.96%)
    0 / 35 (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
    HYPERBILIRUBINAEMIA
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    1 / 51 (1.96%)
    0 / 35 (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
    Renal and urinary disorders
    RENAL HYPERTROPHY
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    1 / 51 (1.96%)
    0 / 35 (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
    Musculoskeletal and connective tissue disorders
    FOOT DEFORMITY
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    1 / 51 (1.96%)
    0 / 35 (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
    Infections and infestations
    APPENDICITIS
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 35 (2.86%)
    0 / 51 (0.00%)
    0 / 35 (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
    GASTROENTERITIS
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    0 / 35 (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
    RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    1 / 51 (1.96%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    RESPIRATORY SYNCYTIAL VIRUS INFECTION
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    1 / 51 (1.96%)
    1 / 35 (2.86%)
         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
    SEPSIS NEONATAL
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    1 / 51 (1.96%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    1 / 35 (2.86%)
         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
    VIRAL INFECTION
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    1 / 51 (1.96%)
    1 / 35 (2.86%)
         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
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    1 / 35 (2.86%)
         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
    FAILURE TO THRIVE
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    1 / 51 (1.96%)
    0 / 35 (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
    FEEDING DISORDER
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 35 (0.00%)
    1 / 51 (1.96%)
    0 / 35 (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: 5%
    Non-serious adverse events
    		 Mother GBS Mother Placebo Infants GBS Infants Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 51 (64.71%)
    22 / 35 (62.86%)
    0 / 51 (0.00%)
    2 / 35 (5.71%)
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    8 / 51 (15.69%)
    10 / 35 (28.57%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    11
    13
    0
    0
    General disorders and administration site conditions
    FATIGUE
         subjects affected / exposed
    15 / 51 (29.41%)
    9 / 35 (25.71%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    17
    12
    0
    0
    INJECTION SITE ERYTHEMA
         subjects affected / exposed
    7 / 51 (13.73%)
    2 / 35 (5.71%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    9
    2
    0
    0
    INJECTION SITE INDURATION
         subjects affected / exposed
    6 / 51 (11.76%)
    1 / 35 (2.86%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    6
    1
    0
    0
    INJECTION SITE HAEMORRHAGE
         subjects affected / exposed
    2 / 51 (3.92%)
    3 / 35 (8.57%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    4
    0
    0
    INJECTION SITE PAIN
         subjects affected / exposed
    17 / 51 (33.33%)
    4 / 35 (11.43%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    17
    5
    0
    0
    INJECTION SITE SWELLING
         subjects affected / exposed
    4 / 51 (7.84%)
    1 / 35 (2.86%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    4
    1
    0
    0
    MALAISE
         subjects affected / exposed
    7 / 51 (13.73%)
    3 / 35 (8.57%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    7
    3
    0
    0
    Gastrointestinal disorders
    HAEMORRHOIDS
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 35 (8.57%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    3
    0
    0
    NAUSEA
         subjects affected / exposed
    4 / 51 (7.84%)
    5 / 35 (14.29%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    4
    6
    0
    0
    Reproductive system and breast disorders
    VAGINAL HAEMORRHAGE
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 35 (5.71%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Skin and subcutaneous tissue disorders
    RASH
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 35 (5.71%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Psychiatric disorders
    POSTPARTUM DEPRESSION
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 35 (5.71%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Musculoskeletal and connective tissue disorders
    MYALGIA
         subjects affected / exposed
    13 / 51 (25.49%)
    1 / 35 (2.86%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    13
    2
    0
    0
    ARTHRALGIA
         subjects affected / exposed
    2 / 51 (3.92%)
    3 / 35 (8.57%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Infections and infestations
    CYSTITIS
         subjects affected / exposed
    2 / 51 (3.92%)
    2 / 35 (5.71%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    2
    0
    0
    BRONCHITIS
         subjects affected / exposed
    3 / 51 (5.88%)
    0 / 35 (0.00%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    0
    0
    NASOPHARYNGITIS
         subjects affected / exposed
    3 / 51 (5.88%)
    3 / 35 (8.57%)
    0 / 51 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    4
    3
    0
    3
    URINARY TRACT INFECTION
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 35 (2.86%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    3
    1
    0
    0
    VIRAL INFECTION
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 35 (5.71%)
    0 / 51 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    3
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Oct 2011
    Reference to infant blood draw by heel stick as the primary method was removed. The upper limit of the gestational age was revised from 24-34 weeks to 24-35 Weeks. At Visit 1 for the infant, the site staff should collect 10 mL of cord blood from the infant. If cord blood is not available, 0.5-1.0 mL of blood should be drawn from the infant. New pregnancies occurring within twelve (12) weeks of study vaccination will be captured on the Clinical Trial Pregnancy Form and reported to Novartis Clinical Safety & Epidemiology Department. Any pregnancies occurring past twelve (12) weeks of study vaccination are not considered as having exposure to the study vaccination, and are therefore not captured in this study. Additional description of assignment of the subject number by the blinded site staff and randomization code by the unblinded staff was added for clarity and to ensure blinding of trial.
    05 Sep 2012
    The description of an additional lot of the Novartis Group B streptococcus. Trivalent Glycoconjugate vaccine has been included in the protocol.
    10 Aug 2013
    Scheduled immunogenicity analysis has been removed due to the delay in running the immunogenicity assays at the laboratory Secondary endpoints have been modified The exploratory endpoint has been changed

    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
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    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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