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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   38143   clinical trials with a EudraCT protocol, of which   6264   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).
     
    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, randomized, open-label, multicenter clinical trial to assess the immunogenicity and safety of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A when co-administered with Pneumovax 23 in adults aged 50 years and older.

    Summary
    EudraCT number
    2012-005314-19
    Trial protocol
    EE  
    Global end of trial date
    17 Jun 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Jul 2017
    First version publication date
    08 Jul 2017
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    116889
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02045836
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Due 22/06/2017
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 44 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
    Final
    Date of interim/final analysis
    20 Mar 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the vaccine response rate (VRR) to the HZ/su vaccine (based on humoral immune response) one month after the last vaccine dose in the HZ/su – Pneumovax 23 co-administration (Co-Ad) group. To demonstrate non-inferiority of the humoral immune response to two doses of the HZ/su vaccine when Pneumovax 23 is co-administered with the first HZ/su vaccine dose compared to two doses of HZ/su vaccine (administered separately from Pneumovax 23), one month after the last vaccine dose. To demonstrate non-inferiority of the humoral immune response to Pneumovax 23 when co-administered with HZ/su vaccine at first vaccine dose compared to Pneumovax 23 (administered separately from HZ/su), for the following 12 serotypes included in Pneumovax 23, one month after the vaccine dose: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.
    Protection of trial subjects
    All subjects were supervised after vaccination/product administration with appropriate medical treatment readily available. Vaccines were administered by qualified ad trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 May 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
    Estonia: 400
    Country: Number of subjects enrolled
    Canada: 299
    Country: Number of subjects enrolled
    United States: 166
    Worldwide total number of subjects
    865
    EEA total number of subjects
    400
    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)
    502
    From 65 to 84 years
    356
    85 years and over
    7

    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.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Co-Ad group
    Arm description
    Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm .
    Arm type
    Experimental

    Investigational medicinal product name
    GSK1437173A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of the vaccine at Day 0 and a second dose at Month 2.

    Investigational medicinal product name
    Pneumovax 23
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of the vaccine at Day 0.

    Arm title
    Control group
    Arm description
    Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm .
    Arm type
    Active comparator

    Investigational medicinal product name
    GSK1437173A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of the vaccine at Day 0 and a second dose at Month 2.

    Investigational medicinal product name
    Pneumovax 23
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of the vaccine at Day 0.

    Number of subjects in period 1
    Co-Ad group Control group
    Started
    432
    433
    Completed
    423
    419
    Not completed
    9
    14
         Adverse event, non-fatal
    4
    4
         Consent withdrawn by subject
    1
    1
         Lost to follow-up
    4
    9

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Co-Ad group
    Reporting group description
    Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm .

    Reporting group title
    Control group
    Reporting group description
    Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm .

    Reporting group values
    Co-Ad group Control group Total
    Number of subjects
    432 433 865
    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)
    63.2 ± 63.2 8.4 ± 8.4 -
    Gender categorical
    Units: Subjects
        Female
    264 252 516
        Male
    168 181 349
    Race/Ethnicity, Customized
    Units: Subjects
        African Heritage / African American
    12 9 21
        American Indian or Alaskan Native
    1 3 4
        Asian - East Asian Heritage
    3 7 10
        Asian - Japanese Heritage
    0 1 1
        Asian - South East Asian Heritage
    4 2 6
        Other
    2 5 7
        White - Arabic / North African Heritage
    2 0 2
        White - Caucasian / European Heritage
    408 406 814

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Co-Ad group
    Reporting group description
    Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm .

    Reporting group title
    Control group
    Reporting group description
    Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm .

    Primary: Number of subjects with a vaccine response for anti-gE antibodies

    Close Top of page
    End point title
    Number of subjects with a vaccine response for anti-gE antibodies [1] [2]
    End point description
    Vaccine response rate for anti-gE antibody concentrations, as determined by enzyme-linked immunosorbent assay (ELISA), in subjects from the Co-Ad group. Vaccine response defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x 97 mIU/mL). For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
    End point type
    Primary
    End point timeframe
    At Month 3
    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: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As only the Co-ad Group received vaccination containing gE antigen, only this group had results.
    End point values
    Co-Ad group
    Number of subjects analysed
    401
    Units: Subjects
        Subjects
    394
    No statistical analyses for this end point

    Primary: Anti-glicoprotein E (gE) antibody concentrations

    Close Top of page
    End point title
    Anti-glicoprotein E (gE) antibody concentrations [3]
    End point description
    End point type
    Primary
    End point timeframe
    At one month post-dose 2 (Month 3 for the Co-Ad Group and Month 5 for the Control Group)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    Co-Ad group Control group
    Number of subjects analysed
    407
    402
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        mIU/mL
    49918 (47143 to 52856.3)
    50327.9 (47200.4 to 53662.7)
    No statistical analyses for this end point

    Primary: Anti-pneumococcal antibody titers

    Close Top of page
    End point title
    Anti-pneumococcal antibody titers [4]
    End point description
    End point type
    Primary
    End point timeframe
    At one month post-dose (Month 1)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    Co-Ad group Control group
    Number of subjects analysed
    410
    413
    Units: Titers
    geometric mean (confidence interval 95%)
        MOPA-1 [N=410, 413]
    65.1 (54.2 to 78.1)
    68.6 (56.9 to 82.7)
        MOPA-9V [N=410, 413]
    1898.4 (1618.1 to 2227.2)
    1991.3 (1716 to 2310.8)
        MOPA-14 [N=410, 413]
    2629.4 (2297.4 to 3009.3)
    2612.8 (2230.7 to 3060.3)
        MOPA-3 [N=410, 413]
    106.7 (92.6 to 122.9)
    107.4 (92.7 to 124.4)
        MOPA-4 [N=410, 412]
    1079.4 (924 to 1260.9)
    1328.8 (1141 to 1547.6)
        MOPA-5 [N=410, 413]
    161.4 (134.6 to 193.6)
    149.5 (123.5 to 181)
        MOPA-6B [N=410, 413]
    1619 (1354.5 to 1935)
    1564.4 (1303.5 to 1877.6)
        MOPA-7F [N=410, 413]
    2352.5 (2049.5 to 2700.3)
    2460.4 (2128.7 to 2843.8)
        MOPA-18C [N=410, 413]
    1077.4 (921.1 to 1260.2)
    1076 (918.2 to 1260.9)
        MOPA-19A [N=410, 413]
    1349.6 (1152.1 to 1580.8)
    1573.1 (1350.7 to 1832.2)
        MOPA-19F [N=409, 413]
    904.3 (779.6 to 1049)
    953 (814.8 to 1114.6)
        MOPA-23F [N=409, 413]
    431.4 (356.1 to 522.7)
    367.3 (300.8 to 448.5)
    No statistical analyses for this end point

    Primary: Adjusted ratios of Geometric Mean Titers (GMTs) between groups

    Close Top of page
    End point title
    Adjusted ratios of Geometric Mean Titers (GMTs) between groups
    End point description
    End point type
    Primary
    End point timeframe
    At 1 month after vaccination
    End point values
    Co-Ad group Control group
    Number of subjects analysed
    411
    408
    Units: Titers
    geometric mean (confidence interval 95%)
        MOPA-1 [N=411, 408]
    67.6 (56.9 to 80.2)
    65.6 (55.2 to 119.5)
        MOPA-3 [N=411, 408]
    105 (92.2 to 119.5)
    108.9 (95.7 to 124.1)
        MOPA-4 [N=409, 408]
    1264.1 (1089.9 to 1466.2)
    1117.2 (963.1 to 1296.1)
        MOPA-5 [N=411, 408]
    152.6 (129.1 to 180.3)
    159.8 (135.1 to 188.9)
        MOPA-6B [N=409, 408]
    1536.8 (1307.9 to 1805.7)
    1666.6 (1418 to 1958.6)
        MOPA-7F [N=409, 407]
    2491.3 (2179.8 to 2847.5)
    2324.7 (2033.3 to 2657.9)
        MOPA-9V [N=410, 406]
    1911.8 (1651.6 to 2212.9)
    1970.3 (1700.9 to 2282.3)
        MOPA-14 [N=411, 407]
    2610.1 (2281.6 to 2986)
    2678.1 (2339.4 to 3065.8)
        MOPA-18C [N=411, 405]
    1040.9 (902.7 to 1200.4)
    1099.8 (952.8 to 1269.6)
        MOPA-19A [N=406, 406]
    1558.6 (1361.8 to 1783.8)
    1350.5 (1180 to 1545.7)
        MOPA-19F [N=409, 407]
    938.2 (814.6 to 1080.7)
    914.1 (793.4 to 1053.3)
        MOPA-23F [N=410, 405]
    372.8 (316 to 439.8)
    419.1 (354.9 to 494.9)
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-1.
    Comparison groups
    Control group v Co-Ad group
    Number of subjects included in analysis
    819
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [5]
    Method
    ANCOVA
    Parameter type
    Adjusted GMT
    Point estimate
    1.03
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.81
         upper limit
    1.31
    Notes
    [5] - Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-3
    Comparison groups
    Control group v Co-Ad group
    Number of subjects included in analysis
    819
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [6]
    Method
    ANCOVA
    Parameter type
    Adjusted GMT
    Point estimate
    0.96
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.8
         upper limit
    1.16
    Notes
    [6] - Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-4
    Comparison groups
    Co-Ad group v Control group
    Number of subjects included in analysis
    819
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [7]
    Method
    ANCOVA
    Parameter type
    Adjusted GMT
    Point estimate
    1.13
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.92
         upper limit
    1.4
    Notes
    [7] - Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-5
    Comparison groups
    Co-Ad group v Control group
    Number of subjects included in analysis
    819
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [8]
    Method
    ANCOVA
    Parameter type
    Adjusted GMT
    Point estimate
    0.96
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.75
         upper limit
    1.21
    Notes
    [8] - Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-6B
    Comparison groups
    Co-Ad group v Control group
    Number of subjects included in analysis
    819
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    ANCOVA
    Parameter type
    Adjusted GMT
    Point estimate
    0.92
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.73
         upper limit
    1.16
    Statistical analysis title
    Statistical analysis 6
    Statistical analysis description
    Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-7F
    Comparison groups
    Co-Ad group v Control group
    Number of subjects included in analysis
    819
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [9]
    Method
    ANCOVA
    Parameter type
    Adjusted GMT
    Point estimate
    1.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.89
         upper limit
    1.29
    Notes
    [9] - Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.
    Statistical analysis title
    Statistical analysis 7
    Statistical analysis description
    Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-9V
    Comparison groups
    Co-Ad group v Control group
    Number of subjects included in analysis
    819
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [10]
    Method
    ANCOVA
    Parameter type
    Adjusted GMT
    Point estimate
    0.97
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.79
         upper limit
    1.19
    Notes
    [10] - Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.
    Statistical analysis title
    Statistical analysis 8
    Statistical analysis description
    Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-14
    Comparison groups
    Co-Ad group v Control group
    Number of subjects included in analysis
    819
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [11]
    Method
    ANCOVA
    Parameter type
    Adjusted GMT
    Point estimate
    0.97
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.81
         upper limit
    1.18
    Notes
    [11] - Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.
    Statistical analysis title
    Statistical analysis 9
    Statistical analysis description
    Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-18C
    Comparison groups
    Co-Ad group v Control group
    Number of subjects included in analysis
    819
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [12]
    Method
    ANCOVA
    Parameter type
    Adjusted GMT
    Point estimate
    0.95
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.77
         upper limit
    1.16
    Notes
    [12] - Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.
    Statistical analysis title
    Statistical analysis 10
    Statistical analysis description
    Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-19A
    Comparison groups
    Co-Ad group v Control group
    Number of subjects included in analysis
    819
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [13]
    Method
    ANCOVA
    Parameter type
    Adjusted GMT
    Point estimate
    1.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.95
         upper limit
    1.4
    Notes
    [13] - Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.
    Statistical analysis title
    Statistical analysis 11
    Statistical analysis description
    Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-19F
    Comparison groups
    Co-Ad group v Control group
    Number of subjects included in analysis
    819
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [14]
    Method
    ANCOVA
    Parameter type
    Adjusted GMT
    Point estimate
    1.03
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.84
         upper limit
    1.25
    Notes
    [14] - Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.
    Statistical analysis title
    Statistical analysis 12
    Statistical analysis description
    Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-23F
    Comparison groups
    Co-Ad group v Control group
    Number of subjects included in analysis
    819
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [15]
    Method
    ANCOVA
    Parameter type
    Adjusted GMT
    Point estimate
    0.89
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.7
         upper limit
    1.12
    Notes
    [15] - Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.

    Primary: Adjusted GMCs between groups

    Close Top of page
    End point title
    Adjusted GMCs between groups
    End point description
    The Adjusted ratios of GMCs between groups (Control group and Co-Ad group) was presented for anti-gE antibody ELISA concentrations
    End point type
    Primary
    End point timeframe
    At 1 month after last vaccine dose
    End point values
    Co-Ad group Control group
    Number of subjects analysed
    401
    402
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        mIU/mL
    49569 (46641.4 to 52680.4)
    50474.5 (47497.4 to 53638.2)
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Adjusted ratios of GMCs between groups (Control group and Co-Ad group) for anti-gE antibody ELISA concentrations
    Comparison groups
    Co-Ad group v Control group
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [16]
    Method
    ANCOVA
    Parameter type
    Adjusted GMT
    Point estimate
    1.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.93
         upper limit
    1.11
    Notes
    [16] - Non Inferiority criterion used: UL of the 95% CI for the anti-gE antibodies GMC ratio between the Control group and the Co-Ad group had to be below 1.5

    Secondary: Number of subjects with any and Grade 3 solicited local symptoms, by dose

    Close Top of page
    End point title
    Number of subjects with any and Grade 3 solicited local symptoms, by dose
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. The Co-Ad Group received only 2 vaccine doses.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Days 0 - 6) after each vaccination
    End point values
    Co-Ad group Control group
    Number of subjects analysed
    429
    431
    Units: Subjects
        Any Pain, Dose 1 [N=428, 431]
    344
    168
        Grade 3 Pain, Dose 1 [N=428, 431]
    46
    5
        Any Redness, Dose 1 [N=428, 431]
    182
    30
        Grade 3 Redness, Dose 1 [N=428, 431]
    15
    2
        Any Swelling, Dose 1 [N=428, 431]
    99
    18
        Grade 3 Swelling, Dose 1 [N=428, 431]
    4
    1
        Any Pain, Dose 2 [N=416, 422]
    298
    289
        Grade 3 Pain, Dose 2 [N=416, 422]
    35
    28
        Any Redness, Dose 2 [N=416, 422]
    144
    128
        Grade 3 Redness, Dose 2 [N=416, 422]
    15
    4
        Any Swelling, Dose 2 [N=416, 422]
    77
    64
        Grade 3 Swelling, Dose 2 [N=416, 422]
    4
    2
        Any Pain, Dose 3 [N=0, 419]
    0
    293
        Grade 3 Pain, Dose 3 [N=0, 419]
    0
    32
        Any Redness, Dose 3 [N=0, 419]
    0
    136
        Grade 3 Redness, Dose 3 [N=0, 419]
    0
    8
        Any Swelling, Dose 3 [N=0, 419]
    0
    74
        Grade 3 Swelling, Dose 3 [N=0, 419]
    0
    3
        Any Pain, Across Doses [N=429, 431]
    372
    356
        Grade 3 Pain, Across Doses [N=429, 431]
    68
    49
        Any Redness, Across Doses [N=429, 431]
    232
    192
        Grade 3 Redness, Across Doses [N=429, 431]
    27
    12
        Any Swelling, Across Doses [N=429, 431]
    135
    111
        Grade 3 Swelling, Across Doses [N=429, 431]
    7
    6
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms, across doses, by vaccine

    Close Top of page
    End point title
    Number of subjects with solicited local symptoms, across doses, by vaccine
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Days 0 - 6) after vaccination
    End point values
    Co-Ad group Control group
    Number of subjects analysed
    429
    431
    Units: Subjects
        Any Pain, GSK1437173A, Across Doses [N=429, 426]
    369
    343
        Any Pain, Pneumovax 23, Across Doses [N=428, 431]
    223
    168
        Any Redness, GSK1437173A, Across Doses [N=429, 431
    222
    185
        Any Redness, Pneumovax 23, Across Doses [N=428, 43
    69
    30
        Any Swelling, GSK1437173A, Across Doses [N=429, 42
    127
    106
        Any Swelling, Pneumovax 23, Across Doses [N=428, 4
    35
    18
    No statistical analyses for this end point

    Secondary: Number of days with any solicited local and general symptoms

    Close Top of page
    End point title
    Number of days with any solicited local and general symptoms
    End point description
    The Co-Ad Group received only 2 vaccine doses. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Days 0 - 6) after each vaccination
    End point values
    Co-Ad group Control group
    Number of subjects analysed
    344
    293
    Units: days
    median (inter-quartile range (Q1-Q3))
        Any Pain, Dose 1 [N=344, 169]
    3 (2 to 4)
    2 (1 to 3)
        Any Pain, Dose 2 [N=298, 290]
    3 (2 to 4)
    3 (2 to 4)
        Any Pain, Dose 3 [N=0, 293]
    0 (0 to 0)
    3 (2 to 4)
        Any Redness, Dose 1 [N=182, 31]
    3 (2 to 5)
    2 (1 to 3)
        Any Redness, Dose 2 [N=146, 129]
    3 (2 to 4)
    3 (2 to 5)
        Any Redness, Dose 3 [N=0, 136]
    0 (0 to 0)
    3 (2 to 4)
        Any Swelling, Dose 1 [N=99, 21]
    3 (2 to 5)
    2 (1 to 3)
        Any Swelling, Dose 2 [N=79, 67]
    3 (2 to 4)
    4 (2 to 5)
        Any Swelling, Dose 3 [N=0, 74]
    0 (0 to 0)
    3 (2 to 5)
        Any Fatigue, Dose 1 [N=194, 87]
    2 (1 to 4)
    2 (1 to 4)
        Any Fatigue, Dose 2 [N=191, 124]
    2 (1 to 3)
    2 (1 to 3)
        Any Fatigue, Dose 3 [N=0, 174]
    0 (0 to 0)
    2 (1 to 3)
        Any Gastrointestinal, Dose 1 [N=76, 31]
    2 (1 to 2.5)
    2 (1 to 3)
        Any Gastrointestinal, Dose 2 [N=61, 38]
    2 (1 to 3)
    2 (1 to 3)
        Any Gastrointestinal, Dose 3 [N=0, 47]
    0 (0 to 0)
    1 (1 to 2)
        Any Headache, Dose 1 [N=156, 72]
    2 (1 to 3)
    2 (1 to 2)
        Any Headache, Dose 2 [N=141, 104]
    2 (1 to 3)
    2 (1 to 2.5)
        Any Headache, Dose 3 [N=0, 144]
    0 (0 to 0)
    2 (1 to 2)
        Any Myalgia, Dose 1 [N=187, 87]
    2 (2 to 4)
    2 (1 to 3)
        Any Myalgia, Dose 2 [N=182, 124]
    2 (1 to 3)
    2 (1 to 3.5)
        Any Myalgia, Dose 3 [N=0, 162]
    0 (0 to 0)
    2 (2 to 3)
        Any Shivering, Dose 1 [N=91, 27]
    1 (1 to 2)
    2 (1 to 2)
        Any Shivering, Dose 2 [N=83, 30]
    1 (1 to 2)
    1 (1 to 2)
        Any Shivering, Dose 3 [N=0, 72]
    0 (0 to 0)
    1 (1 to 2)
        Any Temperature (Oral), Dose 1 [N=69, 12]
    1 (1 to 2)
    1 (1 to 2)
        Any Temperature (Oral), Dose 2 [N=67, 30]
    1 (1 to 2)
    1 (1 to 2)
        Any Temperature (Oral), Dose 3 [N=0, 67]
    1 (1 to 2)
    1 (1 to 2)
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited adverse events (AEs)

    Close Top of page
    End point title
    Number of subjects with unsolicited adverse events (AEs)
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    From the first dose up to 30 days post last vaccination period
    End point values
    Co-Ad group Control group
    Number of subjects analysed
    432
    433
    Units: Subjects
        Subjects with any AE(s)
    132
    138
        Subjects with grade 3 AE(s)
    16
    27
        Subjects with related AE(s)
    34
    27
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs)

    Close Top of page
    End point title
    Number of subjects with serious adverse events (SAEs)
    End point description
    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 the first dose up to 30 days post last vaccination period
    End point values
    Co-Ad group Control group
    Number of subjects analysed
    432
    433
    Units: Subjects
        Subjects with any SAE(s)
    7
    9
        Fatal SAEs
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with potential Immune Mediated Diseases (pIMDs)

    Close Top of page
    End point title
    Number of subjects with potential Immune Mediated Diseases (pIMDs)
    End point description
    Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
    End point type
    Secondary
    End point timeframe
    From first vaccination up to 30 days post last vaccination (Month 0 – Month 3 for the Co-Ad Group &amp; Month 0 – Month 5 for the Control Group)
    End point values
    Co-Ad group Control group
    Number of subjects analysed
    432
    433
    Units: Subjects
        Any pIMDs
    0
    1
        Related pIMDs
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with potential Immune Mediated Diseases (pIMDs)

    Close Top of page
    End point title
    Number of subjects with potential Immune Mediated Diseases (pIMDs)
    End point description
    Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
    End point type
    Secondary
    End point timeframe
    During the period starting after 30 days post last vaccination up to study end (Month 3 – Month 14 for the Co-Ad Group &amp; Month 5 – Month 16 for the Control Group)
    End point values
    Co-Ad group Control group
    Number of subjects analysed
    432
    433
    Units: Subjects
        Subjects
    1
    0
    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 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period. SAE(s) were collected during the entire study period (Month 0 to Month 16)
    Adverse event reporting additional description
    Individual SAEs remain blinded as long as the study is ongoing.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Co-Ad Group
    Reporting group description
    Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.

    Reporting group title
    Control Group
    Reporting group description
    Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.

    Serious adverse events
    Co-Ad Group Control Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 432 (3.94%)
    19 / 433 (4.39%)
         number of deaths (all causes)
    2
    2
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Aortic dissection
         subjects affected / exposed
    1 / 432 (0.23%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    0 / 432 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 432 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Angiomyolipoma
         subjects affected / exposed
    1 / 432 (0.23%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma stage iv
         subjects affected / exposed
    1 / 432 (0.23%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 432 (0.23%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 432 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma multiforme
         subjects affected / exposed
    0 / 432 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 432 (0.23%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Sarcoidosis
         subjects affected / exposed
    1 / 432 (0.23%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 432 (0.23%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 432 (0.00%)
    2 / 433 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    0 / 432 (0.00%)
    1 / 433 (0.23%)
         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
    Limb traumatic amputation
         subjects affected / exposed
    1 / 432 (0.23%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    3 / 432 (0.69%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 432 (0.46%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 432 (0.23%)
    2 / 433 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 432 (0.23%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    0 / 432 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 432 (0.23%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 432 (0.23%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 432 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    0 / 432 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    0 / 432 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 432 (0.00%)
    2 / 433 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 432 (0.23%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    1 / 432 (0.23%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbosacral radiculopathy
         subjects affected / exposed
    0 / 432 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 432 (0.23%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 432 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral artery dissection
         subjects affected / exposed
    0 / 432 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 432 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 432 (0.23%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 432 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 432 (0.23%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    1 / 432 (0.23%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperlipidaemia
         subjects affected / exposed
    0 / 432 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    0 / 432 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 432 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 432 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    1 / 432 (0.23%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    0 / 432 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 432 (0.23%)
    3 / 433 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Co-Ad Group Control Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    400 / 432 (92.59%)
    393 / 433 (90.76%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    210 / 432 (48.61%)
    209 / 433 (48.27%)
         occurrences all number
    306
    331
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    253 / 432 (58.56%)
    228 / 433 (52.66%)
         occurrences all number
    385
    385
    Pain
         subjects affected / exposed
    372 / 432 (86.11%)
    357 / 433 (82.45%)
         occurrences all number
    642
    754
    Pyrexia
         subjects affected / exposed
    112 / 432 (25.93%)
    97 / 433 (22.40%)
         occurrences all number
    138
    110
    Swelling
         subjects affected / exposed
    137 / 432 (31.71%)
    115 / 433 (26.56%)
         occurrences all number
    178
    162
    Erythema
         subjects affected / exposed
    234 / 432 (54.17%)
    194 / 433 (44.80%)
         occurrences all number
    330
    297
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    114 / 432 (26.39%)
    84 / 433 (19.40%)
         occurrences all number
    137
    116
    Chills
         subjects affected / exposed
    137 / 432 (31.71%)
    99 / 433 (22.86%)
         occurrences all number
    176
    130
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    257 / 432 (59.49%)
    227 / 433 (52.42%)
         occurrences all number
    370
    376

    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
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA