Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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

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

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase III, randomised, partially-blind, controlled, multi-centric, multi-country study to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals’ MenACWY-TT conjugate vaccine co-administered with Boostrix® administered intramuscularly versus MenACWY-TT alone administered intramuscularly, in healthy adolescents and young adults between 11 and 25 years of age.

    Summary
    EudraCT number
    		 2012-002737-11
    Trial protocol
    		 DE  
    Global end of trial date
    16 Jan 2014

    Results information
    Results version number
    		 v1
    This version publication date
    18 Apr 2016
    First version publication date
    06 Mar 2015
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    116705
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01767376
    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 Disclosure Advisor, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 044 2089904466, 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
    Interim
    Date of interim/final analysis
    11 Nov 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To demonstrate the non-inferiority of MenACWY-TT co-administered with Boostrix® compared to MenACWY-TT administered alone with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titres (GMTs) for serogroups A, C, W-135 and Y one month after MenACWY-TT vaccination. •To demonstrate the non-inferiority of Boostrix® co-administered with MenACWY-TT compared to Boostrix® administered alone in terms of anti-diphtheria toxoid (anti-D) and anti-tetanus toxoid (anti-T) antibody concentrations one month after Boostrix® vaccination. •To demonstrate the non-inferiority of Boostrix® co-administered with MenACWY-TT compared to Boostrix® administered alone with respect to geometric mean concentrations (GMCs) to each discrete pertussis antigen (pertussis toxoid [PT], filamentous haemagglutinin [FHA] and pertactin [PRN]) one month after Boostrix® vaccination.
    Protection of trial subjects
    All subjects were supervised for 30 min after vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jan 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
    Germany: 181
    Country: Number of subjects enrolled
    Dominican Republic: 180
    Country: Number of subjects enrolled
    Korea, Republic of: 331
    Worldwide total number of subjects
    692
    EEA total number of subjects
    181
    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)
    692
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Pre-assignment period milestones
    Number of subjects started
    		 692
    Number of subjects completed
    		 691

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 No vaccination reveiced: 1
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix™+ Boostrix® Group
    Arm description
    		 Subjects received Nimenrix™ co-administered with Boostrix® at Month 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    Meningococcal vaccine GSK134612
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly (IM) in the deltoid muscle of the arm at Month 0.

    Investigational medicinal product name
    Boostrix®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly (IM) in the deltoid of the right arm at Month 0.

    Arm title
    		 Nimenrix™ Group
    Arm description
    		 Subjects received Nimenrix™ at Month 0 and Boostrix® at Month 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    Meningococcal vaccine GSK134612
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly (IM) in the deltoid muscle of the arm at Month 0.

    Investigational medicinal product name
    Boostrix®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly (IM) in the deltoid of the left arm at Month 1.

    Arm title
    		 Boostrix® Group
    Arm description
    		 Subjects received Boostrix® at Month 0 and Nimenrix™ at Month 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    Meningococcal vaccine GSK134612
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly (IM) in the deltoid muscle of the arm at Month 1.

    Investigational medicinal product name
    Boostrix®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly (IM) in the deltoid of the left arm at Month 0.

    Number of subjects in period 1 [1]
    		Nimenrix™+ Boostrix® Group Nimenrix™ Group Boostrix® Group
    Started
    231
    228
    232
    Completed
    227
    225
    232
    Not completed
    4
    3
    0
         Consent withdrawn by subject
    1
    1
    -
         Lost to follow-up
    3
    2
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of the 692 subjects enrolled in this study, 1 subject in the Nimenrix™ + Boostrix® Group is missing since the subject was enrolled but did not receive any vaccination, hence only 691 subjects started the study.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Nimenrix™+ Boostrix® Group
    Reporting group description
    		 Subjects received Nimenrix™ co-administered with Boostrix® at Month 0.

    Reporting group title
    Nimenrix™ Group
    Reporting group description
    		 Subjects received Nimenrix™ at Month 0 and Boostrix® at Month 1.

    Reporting group title
    Boostrix® Group
    Reporting group description
    		 Subjects received Boostrix® at Month 0 and Nimenrix™ at Month 1.

    Reporting group values
    		 Nimenrix™+ Boostrix® Group Nimenrix™ Group Boostrix® Group Total
    Number of subjects
    		 231 228 232 691
    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
        geometric mean (standard deviation)
    		 18.1 ( 4.2 ) 18.2 ( 4.5 ) 18.3 ( 4.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 128 126 146 400
        Male
    		 103 102 86 291

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Nimenrix™+ Boostrix® Group
    Reporting group description
    		 Subjects received Nimenrix™ co-administered with Boostrix® at Month 0.

    Reporting group title
    Nimenrix™ Group
    Reporting group description
    		 Subjects received Nimenrix™ at Month 0 and Boostrix® at Month 1.

    Reporting group title
    Boostrix® Group
    Reporting group description
    		 Subjects received Boostrix® at Month 0 and Nimenrix™ at Month 1.

    Primary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers

    		 Close Top of page
    End point title
    		 rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers [1]
    End point description
    At the time of writing this record, data concerning immunogenicity results were not available. The record will be updated when these data become available.
    End point type
    Primary
    End point timeframe
    One month after Nimenrix™ vaccination.
    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: Statistical analyses will be provided if required upon data availability.
    End point values
    		 Nimenrix™+ Boostrix® Group Nimenrix™ Group Boostrix® Group
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: Titers
        geometric mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [2] - Results will be available at a later time.
    [3] - Results will be available at a later time.
    [4] - Results will be available at a later time.
    No statistical analyses for this end point

    Primary: Number of subjects with anti-D and anti-T concentrations ≥ 1.0 IU/mL

    		 Close Top of page
    End point title
    		 Number of subjects with anti-D and anti-T concentrations ≥ 1.0 IU/mL [5]
    End point description
    At the time of writing this record, data concerning immunogenicity results were not available. The record will be updated when these data become available.
    End point type
    Primary
    End point timeframe
    One month after Boostrix® vaccination.
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses will be provided if required upon data availability.
    End point values
    		 Nimenrix™+ Boostrix® Group Nimenrix™ Group Boostrix® Group
    Number of subjects analysed
    0 [6]
    0 [7]
    0 [8]
    Units: Subjects
    Notes
    [6] - Results will be available at a later time
    [7] - Results will be available at a later time
    [8] - Results will be available at a later time
    No statistical analyses for this end point

    Primary: Anti-PT, anti-FHA and anti-PRN antibody concentrations

    		 Close Top of page
    End point title
    		 Anti-PT, anti-FHA and anti-PRN antibody concentrations [9]
    End point description
    At the time of writing this record, data concerning immunogenicity results were not available. The record will be updated when these data become available.
    End point type
    Primary
    End point timeframe
    Prior to (i.e. Month 1) and one month afterNimenrix vaccination in the Boostrix Group.
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses will be provided if required upon data availability.
    End point values
    		 Nimenrix™+ Boostrix® Group Nimenrix™ Group Boostrix® Group
    Number of subjects analysed
    0 [10]
    0 [11]
    0 [12]
    Units: EU/mL
        median (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [10] - Results will be available at a later time.
    [11] - Results will be available at a later time.
    [12] - Results will be available at a later time.
    No statistical analyses for this end point

    Secondary: Anti-D and anti-T antibody concentrations

    		 Close Top of page
    End point title
    		 Anti-D and anti-T antibody concentrations
    End point description
    At the time of writing this record, data concerning immunogenicity results were not available. The record will be updated when these data become available.
    End point type
    Secondary
    End point timeframe
    Prior to (i.e. Month 0 for Nimenrix + Boostrix Group and Nimenrix Group and Month 1 for Boostrix Group) and one month after Nimenrix vaccination in all study groups
    End point values
    		 Nimenrix™+ Boostrix® Group Nimenrix™ Group Boostrix® Group
    Number of subjects analysed
    0 [13]
    0 [14]
    0 [15]
    Units: IU/mL
        median (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [13] - Results will be available at a later time.
    [14] - Results will be available at a later time.
    [15] - Results will be available at a later time.
    No statistical analyses for this end point

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres ≥ 1:8 and ≥ 1:128

    		 Close Top of page
    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres ≥ 1:8 and ≥ 1:128
    End point description
    At the time of writing this record, data concerning immunogenicity results were not available. The record will be updated when these data become available.
    End point type
    Secondary
    End point timeframe
    Prior to and one month after Nimenrix vaccination
    End point values
    		 Nimenrix™+ Boostrix® Group Nimenrix™ Group Boostrix® Group
    Number of subjects analysed
    0 [16]
    0 [17]
    0 [18]
    Units: Subjects
    Notes
    [16] - Results will be available at a later time
    [17] - Results will be available at a later time
    [18] - Results will be available at a later time
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5.0 EL/mL

    		 Close Top of page
    End point title
    		 Number of subjects with Anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5.0 EL/mL
    End point description
    At the time of writing this record, data concerning immunogenicity results were not available. The record will be updated when these data become available.
    End point type
    Secondary
    End point timeframe
    One month after Boostrix® vaccination.
    End point values
    		 Nimenrix™+ Boostrix® Group Nimenrix™ Group Boostrix® Group
    Number of subjects analysed
    0 [19]
    0 [20]
    0 [21]
    Units: Subjects
    Notes
    [19] - Results will be available at a later time
    [20] - Results will be available at a later time
    [21] - Results will be available at a later time
    No statistical analyses for this end point

    Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY vaccine response

    		 Close Top of page
    End point title
    		 rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY vaccine response
    End point description
    rSBA vaccine response for serogroups A, C, W-135 and Y is defined as:  For initially seronegative subjects (pre-vaccination titre below the cut-off of 1:8): number of subjects with rSBA antibody titres ≥ 1:32 one month after vaccination.  For initially seropositive subjects (pre-vaccination titre ≥ 1:8): number of subjects with rSBA antibody titres at least four times the pre-vaccination antibody titres, one month after vaccination. At the time of writing this record, data concerning immunogenicity results were not available. The record will be updated when these data become available.
    End point type
    Secondary
    End point timeframe
    Prior to (i.e. Month 0 for Nimenrix+Boostrix and Boostrix Groups and Month 1 for Nimenrix group) and one month after Boostrix® vaccination
    End point values
    		 Nimenrix™+ Boostrix® Group Nimenrix™ Group Boostrix® Group
    Number of subjects analysed
    0 [22]
    0 [23]
    0 [24]
    Units: Subjects
    Notes
    [22] - Results will be available at a later time
    [23] - Results will be available at a later time
    [24] - Results will be available at a later time
    No statistical analyses for this end point

    Secondary: Booster responses for anti-PT, anti-FHA and anti-PRN concentrations

    		 Close Top of page
    End point title
    		 Booster responses for anti-PT, anti-FHA and anti-PRN concentrations
    End point description
    Booster responses to the PT, FHA and PRN antigens, defined as:  For initially seronegative subjects (pre-vaccination concentration below cut-off: < 5 EU/mL): number of subjects with antibody concentration at least four times the cut-off (post-vaccination concentration ≥ 20 EU/mL).  For initially seropositive subjects with pre-vaccination concentrations ≥ 5 EU/mL and < 20 EU/mL: number of subjects with an increase in antibody concentrations of at least four times the pre-vaccination concentration.  For initially seropositive subjects with pre-vaccination concentrations ≥ 20 EU/mL: number of subjects with an increase in antibody concentrations of at least two times the pre-vaccination concentration. At the time of writing this record, data concerning immunogenicity results were not available. The record will be updated when these data become available.
    End point type
    Secondary
    End point timeframe
    One month after Boostrix vaccination
    End point values
    		 Nimenrix™+ Boostrix® Group Nimenrix™ Group Boostrix® Group
    Number of subjects analysed
    0 [25]
    0 [26]
    0 [27]
    Units: Subjects
    Notes
    [25] - Results will be available at a later time
    [26] - Results will be available at a later time
    [27] - Results will be available at a later time
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local symptoms

    		 Close Top of page
    End point title
    		 Number of subjects reporting solicited local symptoms
    End point description
    End point type
    Secondary
    End point timeframe
    Days 0-3 following each vaccination
    End point values
    		 Nimenrix™+ Boostrix® Group Nimenrix™ Group Boostrix® Group
    Number of subjects analysed
    229
    226
    231
    Units: Subjects
        Any Pain after Boostrix
    155
    121
    156
        Any Pain after Nimenrix
    121
    101
    92
        Any Redness after Boostrix
    64
    56
    65
        Any Redness after Nimenrix
    61
    54
    39
        Any Swelling after Boostrix
    57
    51
    54
        Any Swelling after Nimenrix
    48
    47
    33
    No statistical analyses for this end point

    Secondary: Number of subjects reporting general symptoms

    		 Close Top of page
    End point title
    		 Number of subjects reporting general symptoms
    End point description
    End point type
    Secondary
    End point timeframe
    Days 0-3 following each vaccination
    End point values
    		 Nimenrix™+ Boostrix® Group Nimenrix™ Group Boostrix® Group
    Number of subjects analysed
    229
    226
    231
    Units: Subjects
        Any Fatigue
    75
    77
    81
        Any Gastrointestinal symptoms
    23
    31
    25
        Any Headache
    51
    76
    65
        Any Fever (Oral)
    14
    17
    11
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events SAE(s)

    		 Close Top of page
    End point title
    		 Number of subjects with serious adverse events SAE(s)
    End point description
    End point type
    Secondary
    End point timeframe
    Throughout the study (Month 0 – Month 2)
    End point values
    		 Nimenrix™+ Boostrix® Group Nimenrix™ Group Boostrix® Group
    Number of subjects analysed
    231
    228
    232
    Units: Subjects
        Subjects with any SAEs
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with new onset of chronic diseases (NOCIs)

    		 Close Top of page
    End point title
    		 Number of subjects with new onset of chronic diseases (NOCIs)
    End point description
    End point type
    Secondary
    End point timeframe
    Throughout the study (Month 0 – Month 2)
    End point values
    		 Nimenrix™+ Boostrix® Group Nimenrix™ Group Boostrix® Group
    Number of subjects analysed
    231
    228
    232
    Units: Subjects
        Subjects with any NOCIs
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited adverse events AE(s)

    		 Close Top of page
    End point title
    		 Number of subjects with unsolicited adverse events AE(s)
    End point description
    End point type
    Secondary
    End point timeframe
    Days 0-30 following each vaccination
    End point values
    		 Nimenrix™+ Boostrix® Group Nimenrix™ Group Boostrix® Group
    Number of subjects analysed
    231
    228
    232
    Units: Subjects
        Subjects with any AEs
    36
    44
    58
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms: during the 4 days post vaccination Unsolicited and serious adverse events: up to study end
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Nimenrix™ + Boostrix® Group
    Reporting group description
    		 Subjects received Nimenrix™ co-administered with Boostrix® at Month 0.

    Reporting group title
    Nimenrix™ Group
    Reporting group description
    		 Subjects received Nimenrix™ at Month 0 and Boostrix® at Month 1.

    Reporting group title
    Boostrix® Group
    Reporting group description
    		 Subjects received Boostrix® at Month 0 and Nimenrix at Month 1.

    Serious adverse events
    		 Nimenrix™ + Boostrix® Group Nimenrix™ Group Boostrix® Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 228 (0.00%)
    3 / 232 (1.29%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Nervous system disorders
    Orthostatic intolerance
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 228 (0.00%)
    1 / 232 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 228 (0.00%)
    1 / 232 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 228 (0.00%)
    1 / 232 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nimenrix™ + Boostrix® Group Nimenrix™ Group Boostrix® Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    176 / 231 (76.19%)
    148 / 228 (64.91%)
    167 / 232 (71.98%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    176 / 231 (76.19%)
    148 / 228 (64.91%)
    167 / 232 (71.98%)
         occurrences all number
    176
    148
    167
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    81 / 231 (35.06%)
    75 / 228 (32.89%)
    76 / 232 (32.76%)
         occurrences all number
    81
    75
    76
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    71 / 231 (30.74%)
    71 / 228 (31.14%)
    68 / 232 (29.31%)
         occurrences all number
    71
    71
    68
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    75 / 231 (32.47%)
    77 / 228 (33.77%)
    81 / 232 (34.91%)
         occurrences all number
    75
    77
    81
    Gastrointestinal symptoms
    alternative assessment type: Systematic
         subjects affected / exposed
    23 / 231 (9.96%)
    31 / 228 (13.60%)
    25 / 232 (10.78%)
         occurrences all number
    23
    31
    25
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    51 / 231 (22.08%)
    76 / 228 (33.33%)
    65 / 232 (28.02%)
         occurrences all number
    51
    76
    65
    Fever(Oral)
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 231 (6.06%)
    17 / 228 (7.46%)
    11 / 232 (4.74%)
         occurrences all number
    14
    17
    11
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 231 (2.60%)
    8 / 228 (3.51%)
    15 / 232 (6.47%)
         occurrences all number
    6
    8
    15

    More information

    		 Close Top of page

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 08 05:46:16 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA