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    Clinical Trial Results:
    A Phase II, Randomized, Comparative, Observer-Blind, Multi-Center Study Evaluating the Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine in Healthy Non-Pregnant Women aged 18 to 40 Years.

    Summary
    EudraCT number
    		 2013-003111-22
    Trial protocol
    		 BE   CZ  
    Global end of trial date
    04 May 2016

    Results information
    Results version number
    		 v1
    This version publication date
    05 Oct 2016
    First version publication date
    05 Oct 2016
    Other versions
    		 v2 , v3

    Trial information

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    Trial identification
    Sponsor protocol code
    205220
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02270944
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, 1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, +44 20899 4466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, +44 20899 4466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Aug 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Apr 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    04 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Immunogenicity Objectives: To demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes Ia, Ib, and III, when administered to healthy non-pregnant women, as measured by Geometric Mean Concentrations (GMCs) at 30 days (Day 31) after a single vaccination. Safety Objectives: To evaluate the safety and tolerability of a single dose of liquid and lyophilized GBS trivalent vaccine formulations when administered to healthy non-pregnant women aged 18-40 years.
    Protection of trial subjects
    This clinical study was designed, implemented and reported in accordance with the ICH Harmonized Tripartite Guidelines for GCP, with applicable local regulations, including the European Directive 2001/20/EC, the US CFR Title 21, and the Japanese Ministry of Health, Labor, and Welfare, Novartis codes on the protection of human rights, and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Nov 2014
    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
    Belgium: 500
    Country: Number of subjects enrolled
    Czech Republic: 300
    Country: Number of subjects enrolled
    United States: 253
    Worldwide total number of subjects
    1053
    EEA total number of subjects
    800
    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)
    1053
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled at Belgium, US and Czech Republic sites.

    Pre-assignment
    Screening details
    		 All enrolled subjects will be included in the trial.

    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
    		 Liquid GBS trivalent vaccine
    Arm description
    		 Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trivalent Group B Streptococcus Glycoconjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL delivered by the intramuscular (IM) route, preferably the deltoid muscle in the non-dominant arm.

    Arm title
    		 Lyophilized GBS trivalent vaccine
    Arm description
    		 Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trivalent Group B Streptococcus Glycoconjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL delivered by the intramuscular (IM) route, preferably the deltoid muscle in the non-dominant arm.

    Number of subjects in period 1
    		Liquid GBS trivalent vaccine Lyophilized GBS trivalent vaccine
    Started
    530
    523
    Completed
    518
    516
    Not completed
    12
    7
         Consent withdrawn by subject
    3
    3
         Lost to follow-up
    9
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Liquid GBS trivalent vaccine
    Reporting group description
    		 Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine.

    Reporting group title
    Lyophilized GBS trivalent vaccine
    Reporting group description
    		 Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine.

    Reporting group values
    		 Liquid GBS trivalent vaccine Lyophilized GBS trivalent vaccine Total
    Number of subjects
    		 530 523 1053
    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)
    		 27.1 ( 6.24 ) 27.4 ( 6.05 ) -
    Gender categorical
    Units: Subjects
        Female
    		 530 523 1053
        Male
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    All Enrolled Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All screened subjects who signed the ICF and provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID.

    Subject analysis set title
    Exposed Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects in the enrolled population who received a study vaccination.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects in the enrolled population who: - Received a study vaccination - Provided at least 1 evaluable serum sample both before and after vaccination (both are required as the primary model is an ANCOVA which incorporates baseline concentrations). FAS populations were to be analyzed “as randomized” (ie, according to the vaccine a subject was designated to receive, which may be different from the vaccine the subject actually received).

    Subject analysis set title
    Per Protocol Set (PPS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the FAS immunogenicity population who: - Correctly received the study vaccine (i.e., received the vaccine to which the subjects were randomized and received the vaccine at the scheduled time point). - Have no major protocol deviation or other reasons to be excluded, (see section 7.3.8), as defined prior to unblinding. - Provided evaluable serum samples both before vaccination and at day 31 in the protocol required windows.

    Subject analysis set title
    Safety Set (solicited AEs and other signs of reactogenicity)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the exposed set who provided data on post vaccination local or systemic AEs or other signs of reactogenicity.

    Subject analysis set title
    Safety Set (unsolicited AEs)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the exposed set who provided information about post-vaccination unsolicited AEs.

    Subject analysis set title
    Safety Set (overall)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the exposed set who have either provided data on post-vaccination AEs or local or systemic AEs or other signs of reactogenicity.

    Subject analysis sets values
    		 All Enrolled Set Exposed Set Full Analysis Set (FAS) Per Protocol Set (PPS) Safety Set (solicited AEs and other signs of reactogenicity) Safety Set (unsolicited AEs) Safety Set (overall)
    Number of subjects
    1053
    1050
    1043
    1034
    1050
    1047
    1047
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    27.2 ( 6.14 )
    ( )
    27.2 ( 6.15 )
    27.2 ( 6.15 )
    ( )
    ( )
    27.2 ( 6.14 )
    Gender categorical
    Units: Subjects
        Female
    1053
    1050
    1043
    1034
    1050
    1047
    1047
        Male
    0
    0
    0
    0
    0
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Liquid GBS trivalent vaccine
    Reporting group description
    		 Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine.

    Reporting group title
    Lyophilized GBS trivalent vaccine
    Reporting group description
    		 Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine.

    Subject analysis set title
    All Enrolled Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All screened subjects who signed the ICF and provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID.

    Subject analysis set title
    Exposed Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects in the enrolled population who received a study vaccination.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects in the enrolled population who: - Received a study vaccination - Provided at least 1 evaluable serum sample both before and after vaccination (both are required as the primary model is an ANCOVA which incorporates baseline concentrations). FAS populations were to be analyzed “as randomized” (ie, according to the vaccine a subject was designated to receive, which may be different from the vaccine the subject actually received).

    Subject analysis set title
    Per Protocol Set (PPS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the FAS immunogenicity population who: - Correctly received the study vaccine (i.e., received the vaccine to which the subjects were randomized and received the vaccine at the scheduled time point). - Have no major protocol deviation or other reasons to be excluded, (see section 7.3.8), as defined prior to unblinding. - Provided evaluable serum samples both before vaccination and at day 31 in the protocol required windows.

    Subject analysis set title
    Safety Set (solicited AEs and other signs of reactogenicity)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the exposed set who provided data on post vaccination local or systemic AEs or other signs of reactogenicity.

    Subject analysis set title
    Safety Set (unsolicited AEs)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the exposed set who provided information about post-vaccination unsolicited AEs.

    Subject analysis set title
    Safety Set (overall)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the exposed set who have either provided data on post-vaccination AEs or local or systemic AEs or other signs of reactogenicity.

    Primary: 1. Equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotype Ia as measured by geometric mean concentration (GMC) at day 31 after a single vaccination.

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    End point title
    		 1. Equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotype Ia as measured by geometric mean concentration (GMC) at day 31 after a single vaccination.
    End point description
    To demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotype Ia when administered to healthy non-pregnant women, as measured by GMC at 30 days (Day 31) after a single vaccination.
    End point type
    Primary
    End point timeframe
    Day 31 after a single vaccination
    End point values
    		 Liquid GBS trivalent vaccine Lyophilized GBS trivalent vaccine
    Number of subjects analysed
    521
    513
    Units: GMC
    geometric mean (confidence interval 95%)
        Serogroup Ia
    6.81 (5.54 to 8.37)
    6.66 (5.4 to 8.21)
    Statistical analysis title
    		 Ratio of GMCs for anti-GBS antibody concentration
    Statistical analysis description
    The study would be considered a success if the two-sided 95% confidence interval (CIs) for the GMC ratio comparing the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotype Ia, at Day 31 after a single vaccination was entirely contained in the [0.5, 2.0] interval.
    Comparison groups
    Lyophilized GBS trivalent vaccine v Liquid GBS trivalent vaccine
    Number of subjects included in analysis
    1034
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of GMCs
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.32
    Notes
    [1] - The equivalence margin is two-fold (0.5, 2.0). If the two-sided 95% CIs for the GMC ratio at day 31 would be within this equivalence interval, the liquid GBS trivalent vaccine formulation and the lyophilized GBS trivalent vaccine formulation for serotypes Ia would be equivalent with respect to the immune vaccines.

    Primary: 2. Equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes Ib and III, as measured by GMCs at day 31 after a single vaccination.

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    End point title
    		 2. Equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes Ib and III, as measured by GMCs at day 31 after a single vaccination. [2]
    End point description
    To demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes Ib and III, when administered to healthy non-pregnant women, as measured by GMCs at 30 days (day 31) after a single vaccination.
    End point type
    Primary
    End point timeframe
    Day 31 after a single vaccination
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statistical analyses for serotypes Ib and III were not available at the time of writing.
    End point values
    		 Liquid GBS trivalent vaccine Lyophilized GBS trivalent vaccine
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: GMC
    geometric mean (confidence interval 95%)
        Serogroup Ib
    ( to )
    ( to )
        Serogroup III
    ( to )
    ( to )
    Notes
    [3] - Validated results for serotypes Ib and III were not available at the time of writing.
    [4] - Validated results for serotypes Ib and III were not available at the time of writing.
    No statistical analyses for this end point

    Secondary: 3. Number of subjects reporting solicited local and systemic Adverse Events (AEs)

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    End point title
    		 3. Number of subjects reporting solicited local and systemic Adverse Events (AEs)
    End point description
    Safety will be assessed as the number of subjects who reported solicited local and solicited systemic AEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations.
    End point type
    Secondary
    End point timeframe
    From Day 1 through Day 7
    End point values
    		 Liquid GBS trivalent vaccine Lyophilized GBS trivalent vaccine
    Number of subjects analysed
    524
    519
    Units: Subjects
        Any local AEs (N=524;519)
    247
    229
        Injection site Pain (N=520;518)
    227
    205
        Injection site Erythema (N=522;518)
    16
    9
        Injection site Swelling (N=522;519)
    12
    5
        Injection site Warmth (N=521;517)
    68
    57
        Injection site Induration (N=521;519)
    17
    15
        Injection site Ecchymosis (N=520;519)
    1
    6
        Any Systemic AEs (N=524;519)
    280
    278
        Chills (N=519;517)
    64
    56
        Myalgia (N=519;519)
    75
    78
        Malaise (N=519;519)
    104
    103
        Nausea (N=519;519)
    83
    77
        Headache (N=519;518)
    176
    187
        Fatigue (N=518;518)
    183
    190
        Rash (N=519;519)
    18
    15
        Arthralgia (N=518;518)
    49
    53
        Fever (≥38°C) (N=516;515)
    8
    7
        Analgesic/antipyretic use (prevention)(N=521;513)
    2
    3
        Analgesic/antipyretic use (treatment)(N=522;512)
    59
    69
    No statistical analyses for this end point

    Secondary: 4. Number of subjects reporting any unsolicited AEs

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    End point title
    		 4. Number of subjects reporting any unsolicited AEs
    End point description
    Safety was assessed as the number of subjects who reported unsolicited AEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 181 (study termination)
    End point values
    		 Liquid GBS trivalent vaccine Lyophilized GBS trivalent vaccine
    Number of subjects analysed
    526
    521
    Units: Subjects
        Any AEs
    272
    276
        At least possibly or probably related AEs
    57
    52
        Medically attended AEs
    165
    166
        AEs leading to Premature withdrawal
    0
    0
        AEs leading to Hospitalization
    5
    9
        AEs leading to Death
    0
    0
    No statistical analyses for this end point

    Secondary: 5. Number of subjects reporting any Serious Adverse Events (SAEs)

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    End point title
    		 5. Number of subjects reporting any Serious Adverse Events (SAEs)
    End point description
    Safety was assessed as the number of subjects who reported unsolicited SAEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 181 (study termination)
    End point values
    		 Liquid GBS trivalent vaccine Lyophilized GBS trivalent vaccine
    Number of subjects analysed
    526
    521
    Units: Subjects
        Any SAEs
    6
    9
        At least possibly or probably related SAEs
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Safety was assessed from day 1 to Day 181 (study termination)
    Adverse event reporting additional description
    The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. Solicited local and systemic AEs were collected daily from day 1 through day 7 after vaccination. All unsolicited AEs including SAEs were collected from day 1 through day 181 (study termination) after vaccination.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Liquid GBS trivalent vaccine
    Reporting group description
    		 Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine.

    Reporting group title
    Lyophilized GBS trivalent vaccine
    Reporting group description
    		 Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine.

    Serious adverse events
    		 Liquid GBS trivalent vaccine Lyophilized GBS trivalent vaccine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 526 (1.14%)
    9 / 521 (1.73%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 526 (0.00%)
    1 / 521 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ligament rupture
         subjects affected / exposed
    1 / 526 (0.19%)
    0 / 521 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    1 / 526 (0.19%)
    0 / 521 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 526 (0.00%)
    1 / 521 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Varicose vein
         subjects affected / exposed
    0 / 526 (0.00%)
    1 / 521 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 526 (0.19%)
    0 / 521 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    0 / 526 (0.00%)
    1 / 521 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 526 (0.00%)
    1 / 521 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 526 (0.00%)
    1 / 521 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 526 (0.00%)
    1 / 521 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    1 / 526 (0.19%)
    0 / 521 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometriosis
         subjects affected / exposed
    1 / 526 (0.19%)
    0 / 521 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax spontaneous
         subjects affected / exposed
    0 / 526 (0.00%)
    1 / 521 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 526 (0.00%)
    1 / 521 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    1 / 526 (0.19%)
    0 / 521 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    0 / 526 (0.00%)
    1 / 521 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 526 (0.19%)
    0 / 521 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 526 (0.00%)
    1 / 521 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 526 (0.00%)
    1 / 521 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Liquid GBS trivalent vaccine Lyophilized GBS trivalent vaccine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    439 / 526 (83.46%)
    430 / 521 (82.53%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    188 / 526 (35.74%)
    208 / 521 (39.92%)
         occurrences all number
    188
    208
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    67 / 526 (12.74%)
    57 / 521 (10.94%)
         occurrences all number
    67
    57
    Fatigue
         subjects affected / exposed
    186 / 526 (35.36%)
    194 / 521 (37.24%)
         occurrences all number
    186
    194
    Injection site erythema
         subjects affected / exposed
    88 / 526 (16.73%)
    84 / 521 (16.12%)
         occurrences all number
    88
    84
    Injection site haemorrhage
         subjects affected / exposed
    33 / 526 (6.27%)
    38 / 521 (7.29%)
         occurrences all number
    33
    38
    Injection site induration
         subjects affected / exposed
    69 / 526 (13.12%)
    60 / 521 (11.52%)
         occurrences all number
    69
    60
    Injection site pain
         subjects affected / exposed
    238 / 526 (45.25%)
    220 / 521 (42.23%)
         occurrences all number
    238
    220
    Injection site swelling
         subjects affected / exposed
    42 / 526 (7.98%)
    32 / 521 (6.14%)
         occurrences all number
    42
    32
    Injection site warmth
         subjects affected / exposed
    73 / 526 (13.88%)
    57 / 521 (10.94%)
         occurrences all number
    73
    57
    Malaise
         subjects affected / exposed
    105 / 526 (19.96%)
    104 / 521 (19.96%)
         occurrences all number
    105
    104
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    86 / 526 (16.35%)
    81 / 521 (15.55%)
         occurrences all number
    86
    81
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    55 / 526 (10.46%)
    57 / 521 (10.94%)
         occurrences all number
    55
    57
    Myalgia
         subjects affected / exposed
    76 / 526 (14.45%)
    80 / 521 (15.36%)
         occurrences all number
    76
    80
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    39 / 526 (7.41%)
    23 / 521 (4.41%)
         occurrences all number
    39
    23

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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