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    Clinical Trial Results:
    A Phase IIIB, randomized, open-label, multicenter clinical trial to assess the immunogenicity and safety of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A when co-administered with Prevenar13 in adults aged 50 years and older.

    Summary
    EudraCT number
    		 2017-001220-22
    Trial protocol
    		 DE   EE  
    Global end of trial date
    03 Mar 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    21 Jan 2022
    First version publication date
    11 Mar 2021
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    204487
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03439657
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    GSK Response Center, GlaxoSmithKline, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 044 2089-904466, 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
    18 Jan 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To determine the vaccine response rate (VRR) to HZ/su (based on humoral immune response) one month after the second vaccine dose, when the first dose of HZ/su is co-administered with Prevenar13 (Co-Ad group). • To demonstrate non-inferiority of the humoral immune response to two doses of HZ/su at one month after the last vaccine dose, when the first dose of HZ/su is co-administered with Prevenar13 (Co-Ad group) compared to when two doses of HZ/su are administered subsequent to Prevenar13 (Control Group). • To demonstrate non-inferiority of the humoral immune response to Prevenar13 at one month after the vaccine dose, when Prevenar13 is co-administered with the first HZ/su dose (Co-Ad group) compared to when Prevenar13 is administered separately from HZ/su (Control group), for the 13 serotypes included in Prevenar13 analyzed sequentially.
    Protection of trial subjects
    All subjects were supervised for 30 min after vaccination/product administration with appropriate medical treatment readily available. Vaccines/products were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines/products. Subjects were followed-up for 12 months after the last vaccination/product administration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Apr 2018
    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
    Canada: 362
    Country: Number of subjects enrolled
    Estonia: 122
    Country: Number of subjects enrolled
    Germany: 290
    Country: Number of subjects enrolled
    United States: 139
    Worldwide total number of subjects
    913
    EEA total number of subjects
    412
    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)
    536
    From 65 to 84 years
    368
    85 years and over
    9

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in 4 countries (Canada, Estonia, Germany & United States)

    Pre-assignment
    Screening details
    		 Out of 913 subjects enrolled in the study, 1 subject violated protocol prior to randomization. 912 subjects were vaccinated and included in the Exposed Set, 901 subjects completed the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This is not applicable as there was no blinding in this study (open-label)

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Co-Ad Group
    Arm description
    		 Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    HZ/su vaccine GSK1437173A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection, Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses of 0.5 mL of the vaccine in a 0,2 Months schedule. Administered by intramuscular injection into the deltoid muscle of the non-dominant arm.

    Investigational medicinal product name
    Prevenar13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of 0.5 mL of the vaccine. Administered by intramuscu-lar injection into the deltoid muscle of the dominant arm.

    Arm title
    		 Control Group
    Arm description
    		 Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
    Arm type
    		 Placebo

    Investigational medicinal product name
    HZ/su vaccine GSK1437173A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection, Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses of 0.5 mL of the vaccine in a 0,2 Months schedule. Administered by intramuscular injection into the deltoid muscle of the non-dominant arm.

    Investigational medicinal product name
    Prevenar13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of 0.5 mL of the vaccine. Administered by intramuscu-lar injection into the deltoid muscle of the dominant arm.

    Number of subjects in period 1 [1]
    		Co-Ad Group Control Group
    Started
    449
    463
    Completed
    442
    459
    Not completed
    7
    4
         Adverse event, non-fatal
    2
    3
         Lost to follow-up
    1
    -
         Consent withdrawal, not due to an Adverse Event
    3
    -
         Protocol deviation
    1
    1
    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 913 subjects enrolled in the study, 1 subject violated protocol. 912 subjects were vaccinated and included in the Exposed Set.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Co-Ad Group
    Reporting group description
    		 Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm

    Reporting group title
    Control Group
    Reporting group description
    		 Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm

    Reporting group values
    		 Co-Ad Group Control Group Total
    Number of subjects
    		 449 463 912
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 271 265 536
        From 65-84 years
    		 175 192 367
        85 years and over
    		 3 6 9
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.1 ± 8.3 63.2 ± 8.4 -
    Sex: Female, Male
    Units: Participants
        Female
    		 259 284 543
        Male
    		 190 179 369
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian Or Alaska Native
    		 1 0 1
        Black Or African American
    		 8 8 16
        Mixed Origin
    		 0 2 2
        White - Arabic / North African Heritage
    		 1 1 2
        White - Caucasian / European Heritage
    		 439 452 891

    End points

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    End points reporting groups
    Reporting group title
    Co-Ad Group
    Reporting group description
    		 Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm

    Reporting group title
    Control Group
    Reporting group description
    		 Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm

    Primary: Percentage of subjects with a Vaccine response for Anti-glycoprotein E (Anti-gE) in Co-Ad Group

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    End point title
    		 Percentage of subjects with a Vaccine response for Anti-glycoprotein E (Anti-gE) in Co-Ad Group [1] [2]
    End point description
    Vaccine response rate (VRR) for Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) humoral immunogenicity was determined by Enzyme Limked Immunosorbent Assay (ELISA). The VRR for anti-gE is defined as the percentage of subjects who had at least: a 4-fold increase in the anti-gE antibodies concentration as compared to the pre-vaccination anti-gE antibodies concentration, for subjects who are seropositive at baseline, or, a 4-fold increase in the anti-gE antibodies concentration as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who are seronegative at baseline. Analysis was performed on the Per-Protocol Set (PPS) for immunogenicity that included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis and for whom data concerning immunogenicity outcome measures were available.
    End point type
    Primary
    End point timeframe
    One month post-dose 2 (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 endpoint was descriptive, no statistical analyses were conducted.
    [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: This endpoint only required results for the Co-Ad group.
    End point values
    		 Co-Ad Group
    Number of subjects analysed
    426
    Units: Percentage of subjects
        number (confidence interval 95%)
    99.1 (97.6 to 99.7)
    No statistical analyses for this end point

    Primary: Anti-gE antibody concentrations

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    End point title
    		 Anti-gE antibody concentrations [3]
    End point description
    Anti-gE antibody concentrations in terms of Geometric Mean concentrations (GMC) were determined by ELISA and expressed as milli-international units per milliliter (mIU/mL). Analysis was performed on the PPS for immunogenicity that included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis and for whom data concerning immunogenicity outcome measures were available.
    End point type
    Primary
    End point timeframe
    One month post-dose 2 (at Month 3 for the Co-Ad 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 endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    426
    436
    Units: mlU/mL
        geometric mean (confidence interval 95%)
    54789.9 (51586.3 to 58192.4)
    59126.7 (55973.8 to 62457.1)
    No statistical analyses for this end point

    Primary: Anti-pneumococcal antibody titers

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    End point title
    		 Anti-pneumococcal antibody titers [4]
    End point description
    Anti-pneumococcal antibody titers for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) were determined by Multiplex Opsonophagocytosis Assay (MOPA). Analysis was performed on the PPS for immunogenicity that included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis and for whom data concerning immunogenicity outcome measures were available.
    End point type
    Primary
    End point timeframe
    At one month post-dose 1 (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 endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    425
    434
    Units: Titers
    geometric mean (confidence interval 95%)
        MOPA-1 [N=425,434]
    144.2 (120.5 to 172.6)
    151.5 (126.0 to 182.1)
        MOPA-3 [N=425,434]
    99.8 (87.2 to 114.1)
    100.2 (88.0 to 114.1)
        MOPA-4 [N=425,434]
    1127.2 (975.5 to 1302.5)
    1392.4 (1206.5 to 1607.0)
        MOPA-5 [N=424,434]
    279.4 (231.2 to 337.7)
    292.8 (243.5 to 352.1)
        MOPA-6A [N=425,434]
    1839.3 (1570.0 to 2154.9)
    2354.9 (2015.0 to 2752.2)
        MOPA-6B [N=425,433]
    1499.4 (1241.2 to 1811.4)
    2025.9 (1715.5 to 2392.4)
        MOPA-7F [N=425,434]
    1981 (1735.2 to 2261.5)
    2387.5 (2112.7 to 2698.0)
        MOPA-9V [N=425,434]
    2541.9 (2219.2 to 2911.7)
    3049.3 (2693.7 to 3451.9)
        MOPA-14 [N=424,432]
    1752.6 (1505.2 to 2040.6)
    2096 (1796.6 to 2445.2)
        MOPA-18C [N=425,434]
    1450.3 (1262.5 to 1666.1)
    1606.6 (1402.6 to 1840.4)
        MOPA-19A [N=425,434]
    1684.9 (1477.2 to 1921.9)
    1664.3 (1465.7 to 1889.7)
        MOPA-19F [N=425,434]
    712 (617.1 to 821.6)
    802.4 (696.2 to 924.8)
        MOPA-23F [N=425,434]
    758.1 (644.9 to 891.2)
    925.5 (782.5 to 1094.7)
    No statistical analyses for this end point

    Primary: Adjusted Geometric Mean Concentrations (GMCs) for anti-gE antibody

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    End point title
    		 Adjusted Geometric Mean Concentrations (GMCs) for anti-gE antibody
    End point description
    Anti-gE antibody concentrations (GMCs) adjusted for age and baseline concentrations were determined using Analysis Of Covariance (ANCOVA) model. Adjusted GMCs were expressed in milli-international units per milliliter (mIU/mL). Analysis was performed on the PPS for immunogenicity that included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis and for whom data concerning immunogenicity outcome measures were available.
    End point type
    Primary
    End point timeframe
    One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    426
    435
    Units: mlU/mL
        geometric mean (confidence interval 95%)
    54634.9 (51546.0 to 57909.0)
    58526.8 (55248.5 to 61999.7)
    Statistical analysis title
    		 Anti-gE GMCs (non-inferiority)
    Statistical analysis description
    Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean concentrations (GMCs) for anti-gE antibodies, one month after the administration of last vaccine dose.
    Comparison groups
    Control Group v Co-Ad Group
    Number of subjects included in analysis
    861
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    		 ANCOVA
    Parameter type
    		 GMC ratio
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.99
         upper limit
    		 1.16
    Notes
    [5] - Upper limit (UL) of the 95% confidence interval (CI) for the anti-gE antibodies Geometric Mean Concentration (GMC) ratio between the Control group and the Co-Ad group should be <1.5.

    Primary: Adjusted Geometric Mean Titers (GMTs) of anti-pneumococcal antibodies

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    End point title
    		 Adjusted Geometric Mean Titers (GMTs) of anti-pneumococcal antibodies
    End point description
    Geometric mean antibody (anti-pneumococcal antibodies: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) titers adjusted for age and baseline concentration were determined using ANCOVA model. Analysis was performed on the PPS for immunogenicity that included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis and for whom data concerning immunogenicity outcome measures were available.
    End point type
    Primary
    End point timeframe
    At one month post-dose 1 (Month 1)
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    425
    433
    Units: Titers
    geometric mean (confidence interval 95%)
        MOPA-1 [N=433,425]
    141.2 (118.7 to 167.9)
    147.1 (123.9 to 174.7)
        MOPA-3 [N=431,425]
    97.3 (86.0 to 110.0)
    99.6 (88.1 to 112.6)
        MOPA-4 [N=432,423]
    1066.9 (924.2 to 1231.5)
    1331.6 (1155.2 to 1535.0)
        MOPA-5 [N=433,423]
    269.1 (225.8 to 320.8)
    278.9 (234.4 to 331.8)
        MOPA-6A [N=433,424]
    1784.4 (1530.2 to 2080.8)
    2253.8 (1935.6 to 2624.3)
        MOPA-6B [N=431,424]
    1445.4 (1219.3 to 1713.4)
    1967.3 (1661.5 to 2329.3)
        MOPA-7F [N=432,423]
    1935.1 (1704.3 to 2197.1)
    2337.3 (2061.2 to 2650.5)
        MOPA-9V [N=431,420]
    2553.5 (2244.2 to 2905.4)
    2955.8 (2601.9 to 3357.9)
        MOPA-14 [N=430,423]
    1730.7 (1491.3 to 2008.5)
    1992.3 (1718.5 to 2309.7)
        MOPA-18C [N=433,423]
    1403.8 (1226.4 to 1606.8)
    1558.9 (1363.9 to 1781.9)
        MOPA-19A [N=431,425]
    1619.2 (1433.7 to 1828.7)
    1663.5 (1474.0 to 1877.2)
        MOPA-19F [N=433,424]
    696.4 (608.2 to 797.3)
    760.2 (664.8 to 869.2)
        MOPA-23F [N=432,425]
    748.2 (637.6 to 878.0)
    896.6 (765.0 to 1050.9)
    Statistical analysis title
    		 Anti-pneumococcal antibody titers
    Statistical analysis description
    Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-1), one month after the administration of Prevnar 13 vaccine dose.
    Comparison groups
    Control Group v Co-Ad Group
    Number of subjects included in analysis
    858
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    		 ANCOVA
    Parameter type
    		 GMT ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.33
    Notes
    [6] - Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be <2.
    Statistical analysis title
    		 Anti-pneumococcal antibody titers
    Statistical analysis description
    Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-3), one month after the administration of Prevnar 13 vaccine dose.
    Comparison groups
    Co-Ad Group v Control Group
    Number of subjects included in analysis
    858
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    		 ANCOVA
    Parameter type
    		 GMT ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.22
    Notes
    [7] - Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be <2.
    Statistical analysis title
    		 Anti-pneumococcal antibody titers
    Statistical analysis description
    Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-4), one month after the administration of Prevnar 13 vaccine dose.
    Comparison groups
    Co-Ad Group v Control Group
    Number of subjects included in analysis
    858
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    		 ANCOVA
    Parameter type
    		 GMT ratio
    Point estimate
    1.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.02
         upper limit
    		 1.52
    Notes
    [8] - Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be <2.
    Statistical analysis title
    		 Anti-pneumococcal antibody titers
    Statistical analysis description
    Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-5), one month after the administration of Prevnar 13 vaccine dose.
    Comparison groups
    Co-Ad Group v Control Group
    Number of subjects included in analysis
    858
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    		 ANCOVA
    Parameter type
    		 GMT ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.32
    Notes
    [9] - Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be <2.
    Statistical analysis title
    		 Anti-pneumococcal antibody titers
    Statistical analysis description
    Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-6B), one month after the administration of Prevnar 13 vaccine dose.
    Comparison groups
    Co-Ad Group v Control Group
    Number of subjects included in analysis
    858
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    Method
    		 ANCOVA
    Parameter type
    		 GMT ratio
    Point estimate
    1.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 1.73
    Notes
    [10] - Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be <2.
    Statistical analysis title
    		 Anti-pneumococcal antibody titers
    Statistical analysis description
    Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-6A), one month after the administration of Prevnar 13 vaccine dose.
    Comparison groups
    Co-Ad Group v Control Group
    Number of subjects included in analysis
    858
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [11]
    Method
    		 ANCOVA
    Parameter type
    		 GMT ratio
    Point estimate
    1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.02
         upper limit
    		 1.56
    Notes
    [11] - Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be <2.
    Statistical analysis title
    		 Anti-pneumococcal antibody titers
    Statistical analysis description
    Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-7F), one month after the administration of Prevnar 13 vaccine dose.
    Comparison groups
    Co-Ad Group v Control Group
    Number of subjects included in analysis
    858
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [12]
    Method
    		 ANCOVA
    Parameter type
    		 GMT ratio
    Point estimate
    1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.44
    Notes
    [12] - Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be <2.
    Statistical analysis title
    		 Anti-pneumococcal antibody titers
    Statistical analysis description
    Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-9V), one month after the administration of Prevnar 13 vaccine dose.
    Comparison groups
    Co-Ad Group v Control Group
    Number of subjects included in analysis
    858
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [13]
    Method
    		 ANCOVA
    Parameter type
    		 GMT ratio
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.39
    Notes
    [13] - Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be <2.
    Statistical analysis title
    		 Anti-pneumococcal antibody titers
    Statistical analysis description
    Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-14), one month after the administration of Prevnar 13 vaccine dose.
    Comparison groups
    Co-Ad Group v Control Group
    Number of subjects included in analysis
    858
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [14]
    Method
    		 ANCOVA
    Parameter type
    		 GMT ratio
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.42
    Notes
    [14] - Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be <2.
    Statistical analysis title
    		 Anti-pneumococcal antibody titers
    Statistical analysis description
    Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-18C), one month after the administration of Prevnar 13 vaccine dose.
    Comparison groups
    Co-Ad Group v Control Group
    Number of subjects included in analysis
    858
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [15]
    Method
    		 ANCOVA
    Parameter type
    		 GMT ratio
    Point estimate
    1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.34
    Notes
    [15] - Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be <2.
    Statistical analysis title
    		 Anti-pneumococcal antibody titers
    Statistical analysis description
    Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-19A), one month after the administration of Prevnar 13 vaccine dose.
    Comparison groups
    Control Group v Co-Ad Group
    Number of subjects included in analysis
    858
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [16]
    Method
    		 ANCOVA
    Parameter type
    		 GMT ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.22
    Notes
    [16] - Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be <2.
    Statistical analysis title
    		 Anti-pneumococcal antibody titers
    Statistical analysis description
    Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-19F), one month after the administration of Prevnar 13 vaccine dose.
    Comparison groups
    Control Group v Co-Ad Group
    Number of subjects included in analysis
    858
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [17]
    Method
    		 ANCOVA
    Parameter type
    		 GMT ratio
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.32
    Notes
    [17] - Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be <2.
    Statistical analysis title
    		 Anti-pneumococcal antibody titers
    Statistical analysis description
    Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-23F), one month after the administration of Prevnar 13 vaccine dose.
    Comparison groups
    Control Group v Co-Ad Group
    Number of subjects included in analysis
    858
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [18]
    Method
    		 ANCOVA
    Parameter type
    		 GMT ratio
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.5
    Notes
    [18] - Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be <2.

    Secondary: Number of subjects with any and grade 3 solicited local symptoms by vaccine and dose

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    End point title
    		 Number of subjects with any and grade 3 solicited local symptoms by vaccine and dose
    End point description
    Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 erythema/swelling = erythema/swelling that had spread beyond 100 millimeters (mm) of injection site. The Co-Ad Group received only 2 vaccine doses. Analysis was performed on Exposed Set (ES) which included all subjects with at least one vaccine administration documented and who provided solicited safety data.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Day 1 - 7) after each vaccination
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    447
    463
    Units: Participants
        Any Erythema, GSK1437173A, Dose1 [N=447,0]
    120
    0
        Grade3 Erythema, GSK1437173A, Dose1 [N=447,0]
    5
    0
        Any Erythema, Prevenar13, Dose1 [N=447,463]
    48
    31
        Grade3 Erythema, Prevenar13, Dose1 [N=447,463]
    2
    1
        Any Pain, GSK1437173A, Dose1 [N=447,0]
    332
    0
        Grade3 Pain, GSK1437173A, Dose1 [N=447,0]
    25
    0
        Any Pain, Prevenar13, Dose1 [N=447,463]
    233
    241
        Grade3 Pain, Prevenar13, Dose1 [N=447,463]
    11
    9
        Any Swelling, GSK1437173A, Dose1 [N=447,0]
    69
    0
        Grade3 Swelling, GSK1437173A, Dose1 [N=447,0]
    0
    0
        Any Swelling, Prevenar13, Dose1 [N=447,463]
    33
    21
        Grade3 Swelling, Prevenar13, Dose1 [N=447,463]
    1
    0
        Any Erythema, GSK1437173A, Dose2 [N=444,458]
    147
    128
        Grade3 Erythema, GSK1437173A, Dose2 [N=444,458]
    9
    5
        Any Pain, GSK1437173A, Dose2 [N=444,458]
    326
    359
        Grade3 Pain, GSK1437173A, Dose2 [N=444,458]
    28
    32
        Any Swelling, GSK1437173A, Dose2 [N=444,458]
    70
    72
        Grade3 Swelling, GSK1437173A, Dose2 [N=444,458]
    1
    2
        Any Erythema, GSK1437173A, Dose3 [N=0,459]
    0
    123
        Grade3 Erythema, GSK1437173A, Dose3 [N=0,459]
    0
    1
        Any Pain, GSK1437173A, Dose3 [N=0,459]
    0
    350
        Grade3 Pain, GSK1437173A, Dose3 [N=0,459]
    0
    41
        Any Swelling, GSK1437173A, Dose3 [N=0,459]
    0
    60
        Grade3 Swelling, GSK1437173A, Dose3 [N=0,459]
    0
    0
    No statistical analyses for this end point

    Secondary: Number of days with each solicited local symptoms

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    End point title
    		 Number of days with each solicited local symptoms
    End point description
    The number of days with any local symptoms had been assessed during the post-vaccination period. Analysis was performed on ES which included all subjects with at least one vaccine administration documented and who provided solicited safety data and for those who experienced the specified symptom for the specific dose.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Day 1 - 7) after each vaccination
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    347
    359
    Units: Days
    median (inter-quartile range (Q1-Q3))
        Any erythema,Dose1 [N=131,31]
    3 (2 to 5)
    2 (1 to 4)
        Any pain,Dose1 [N=347,241]
    3 (2 to 4)
    2 (1 to 2)
        Any swelling, Dose1 [N=76,21]
    2 (2 to 4)
    2 (1 to 3)
        Any erythema, Dose2 [N=147,128]
    3 (2 to 4)
    2 (2 to 4)
        Any pain,Dose2 [N=326,359]
    3 (2 to 4)
    3 (2 to 4)
        Any swelling, Dose2 [N=70,72]
    3 (2 to 4)
    2 (1.5 to 4)
        Any erythema,Dose3 [N=0,123]
    0 (0 to 0)
    2 (2 to 3)
        Any pain,Dose3 [N=0,350]
    0 (0 to 0)
    3 (2 to 3)
        Any swelling,Dose3 [N=0,60]
    0 (0 to 0)
    2 (1 to 4)
    No statistical analyses for this end point

    Secondary: Number of subjects with any, Grade 3 and related solicited general symptoms

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    End point title
    		 Number of subjects with any, Grade 3 and related solicited general symptoms
    End point description
    Assessed solicited general symptoms were fatigue, fever [defined as oral temperature ≥ 38.0 degrees Celsius (°C)/ 100.4 degrees Fahrenheit (°F)], GastroIntestinal (GI) symptoms, headache, myalgia and shivering. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Analysis was performed on ES which included all subjects with at least one vaccine administration documented and who provided solicited safety data.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Day 1 - 7) after each vaccination
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    448
    463
    Units: Participants
        Any Fatigue, Dose1 [N=448,463]
    166
    85
        Grade3 Fatigue, Dose1 [N=448,463]
    21
    5
        Related Fatigue, Dose1 [N=448,463]
    149
    67
        Any Fever, Dose1 [N=448,463]
    10
    2
        Grade3 Fever, Dose1 [N=448,463]
    1
    0
        Related Fever, Dose1 [N=448,463]
    8
    0
        Any GI symptoms, Dose1 [N=448,463]
    61
    37
        Grade3 GI symptoms, Dose1 [N=448,463]
    6
    1
        Related GI symptoms, Dose1 [N=448,463]
    55
    30
        Any Headache, Dose1 [N=448,463]
    130
    72
        Grade3 Headache, Dose1 [N=448,463]
    10
    0
        Related Headache, Dose1 [N=448,463]
    113
    59
        Any Myalgia, Dose1 [N=448,463]
    168
    102
        Grade3 Myalgia, Dose1 [N=448,463]
    17
    4
        Related Myalgia, Dose1 [N=448,463]
    150
    86
        Any Shivering, Dose1 [N=448,463]
    78
    7
        Grade3 Shivering, Dose1 [N=448,463]
    9
    0
        Related Shivering, Dose1 [N=448,463]
    71
    7
        Any Fatigue, Dose2 [N=444,458]
    192
    152
        Grade3 Fatigue, Dose2 [N=444,458]
    22
    17
        Related Fatigue, Dose2 [N=444,458]
    177
    141
        Any Fever, Dose2 [N=444,458]
    16
    7
        Grade3 Fever, Dose2 [N=444,458]
    2
    2
        Related Fever, Dose2 [N=444,458]
    10
    2
        Any GI symptoms, Dose2 [N=444,458]
    57
    47
        Grade3 GI symptoms, Dose2 [N=444,458]
    8
    4
        Related GI symptoms, Dose2 [N=444,458]
    50
    44
        Any Headache, Dose2 [N=444,458]
    156
    115
        Grade3 Headache, Dose2 [N=444,458]
    18
    7
        Related Headache, Dose2 [N=444,458]
    143
    99
        Any Myalgia, Dose2 [N=444,458]
    203
    174
        Grade3 Myalgia, Dose2 [N=444,458]
    23
    24
        Related Myalgia, Dose2 [N=444,458]
    186
    163
        Any Shivering, Dose2 [N=444,458]
    95
    50
        Grade3 Shivering, Dose2 [N=444,458]
    12
    8
        Related Shivering, Dose2 [N=444,458]
    86
    47
        Any Fatigue, Dose3 [N=0,459]
    0
    210
        Grade3 Fatigue, Dose3 [N=0,459]
    0
    27
        Related Fatigue, Dose3 [N=0,459]
    0
    202
        Any Fever, Dose3 [N=0,459]
    0
    23
        Grade3 Fever, Dose3 [N=0,459]
    0
    2
        Related Fever, Dose3 [N=0,459]
    0
    17
        Any GI symptoms, Dose3 [N=0,459]
    0
    69
        Grade3 GI symptoms, Dose3 [N=0,459]
    0
    3
        Related GI symptoms, Dose3 [N=0,459]
    0
    63
        Any Headache, Dose3 [N=0,459]
    0
    180
        Grade3 Headache, Dose3 [N=0,459]
    0
    23
        Related Headache, Dose3 [N=0,459]
    0
    168
        Any Myalgia, Dose3 [N=0,459]
    0
    224
        Grade3 Myalgia, Dose3 [N=0,459]
    0
    37
        Related Myalgia, Dose3 [N=0,459]
    0
    215
        Any Shivering, Dose3 [N=0,459]
    0
    122
        Grade3 Shivering, Dose3 [N=0,459]
    0
    20
        Related Shivering, Dose3 [N=0,459]
    0
    117
    No statistical analyses for this end point

    Secondary: Number of days with solicited general symptoms

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    End point title
    		 Number of days with solicited general symptoms
    End point description
    The number of days with any general symptoms had been assessed during the post-vaccination period. Assessed solicited general symptoms were fatigue, fever, GastroIntestinal (GI) symptoms, headache, myalgia and shivering. Analysis was performed on ES which included all subjects with at least one vaccine administration documented and who provided solicited safety data and for those who experienced the specified symptom for the specific dose.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Day 1 - 7) after each vaccination
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    203
    224
    Units: Days
    median (inter-quartile range (Q1-Q3))
        Any fatigue,Dose1 [N=166,85]
    2 (1 to 3)
    2 (1 to 3)
        Any GI symptoms,Dose1 [N=61,37]
    2 (1 to 2)
    1 (1 to 2)
        Any headache,Dose1 [N=130,72]
    2 (1 to 3)
    1 (1 to 2)
        Any myalgia,Dose1 [N=168,102]
    2 (1 to 3)
    2 (1 to 3)
        Any shivering,Dose1 [N=78,7]
    1 (1 to 2)
    1 (1 to 3)
        Any fever,Dose1 [N=10,2]
    1 (1 to 1)
    1 (1 to 1)
        Any fatigue,Dose2 [N=192,152]
    2 (1 to 3)
    2 (1 to 3)
        Any GI symptoms,Dose2 [N=57,47]
    1 (1 to 2)
    1 (1 to 2)
        Any headache,Dose2 [N=156,115]
    2 (1 to 3)
    2 (1 to 3)
        Any myalgia,Dose2 [N=203,174]
    2 (1 to 3)
    2 (1 to 3)
        Any shivering,Dose2 [N=95,50]
    1 (1 to 2)
    1 (1 to 2)
        Any fever,Dose2 [N=16,7]
    1 (1 to 1)
    1 (1 to 3)
        Any fatigue,Dose3 [N=0,210]
    0 (0 to 0)
    2 (1 to 3)
        Any GI symptoms,Dose3 [N=0,69]
    0 (0 to 0)
    1 (1 to 2)
        Any headache,Dose3 [N=0,180]
    0 (0 to 0)
    1.5 (1 to 2)
        Any myalgia,Dose3 [N=0,224]
    0 (0 to 0)
    2 (1 to 3)
        Any shivering,Dose3 [N=0,122]
    0 (0 to 0)
    1 (1 to 2)
        Any fever,Dose3 [N=0,23]
    0 (0 to 0)
    1 (1 to 1)
    No statistical analyses for this end point

    Secondary: Number of subjects with any, Grade 3 and related unsolicited Adverse Events (AE)

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    End point title
    		 Number of subjects with any, Grade 3 and related unsolicited Adverse Events (AE)
    End point description
    An unsolicited AE covered 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. Analysis was performed on ES which included all subjects with at least one vaccine administered.
    End point type
    Secondary
    End point timeframe
    Within 30 days (Day 1 to 30) after each vaccination
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    449
    463
    Units: Participants
        Subjects with any AEs
    95
    107
        Subjects with Grade 3 AEs
    9
    13
        Subjects with related AEs
    35
    25
    No statistical analyses for this end point

    Secondary: Number of subjects with any and related Serious Adverse Events (SAE) from Day 1 to 30 days post last vaccination

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    End point title
    		 Number of subjects with any and related Serious Adverse Events (SAE) from Day 1 to 30 days post last vaccination
    End point description
    SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs= SAEs assessed by the investigator as causally related to the study vaccination. Analysis was performed on ES which included all subjects with at least one vaccine administered.
    End point type
    Secondary
    End point timeframe
    From first vaccination at Day 1 up to 30 days post last vaccination
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    449
    463
    Units: Participants
        Subjects with any SAEs
    7
    8
        Subjects with related SAEs
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with any and related SAEs from 30 days post last vaccination up to study end.

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    End point title
    		 Number of subjects with any and related SAEs from 30 days post last vaccination up to study end.
    End point description
    Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs= SAEs assessed by the investigator as causally related to the study vaccination. Analysis was performed on ES which included all subjects with at least one vaccine administered.
    End point type
    Secondary
    End point timeframe
    From 30 days post last vaccination up to study end (Month 14 for the Co-Ad group and Month 16 for the Control group)
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    449
    463
    Units: Participants
        Subjects with any SAEs
    10
    10
        Subjects with related SAEs
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with any and related Potential immune-mediated diseases (pIMDs) from Day 1 to 30 days post last vaccination

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    End point title
    		 Number of subjects with any and related Potential immune-mediated diseases (pIMDs) from Day 1 to 30 days post last vaccination
    End point description
    pIMDs assessed were a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not had an autoimmune aetiology. Related pIMDs= pIMDs assessed by the investigator as causally related to the study vaccination. Analysis was performed on ES which included all subjects with at least one vaccine administered.
    End point type
    Secondary
    End point timeframe
    From first vaccination at Day 1 up to 30 days post last vaccination.
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    449
    463
    Units: Participants
        Subjects with any pIMDs
    1
    1
        Subjects with related pIMDs
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with any pIMDs from 30 days post last vaccination up to study end.

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    End point title
    		 Number of subjects with any pIMDs from 30 days post last vaccination up to study end.
    End point description
    pIMDs assessed were a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not had an autoimmune aetiology. Analysis was performed on ES which included all subjects with at least one vaccine administered.
    End point type
    Secondary
    End point timeframe
    From 30 days post last vaccination up to study end (Month 14 for the Co-Ad group and Month 16 for the Control group)
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    449
    463
    Units: Participants
    1
    0
    No statistical analyses for this end point

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

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    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, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 erythema/swelling = erythema/swelling that had spread beyond 100 millimeters (mm) of injection site. The Co-Ad Group received only 2 vaccine doses. Analysis was performed on Exposed Set (ES) which included all subjects with at least one vaccine administration documented and who provided solicited safety data.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Day 1 - 7) after each vaccination
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    448
    463
    Units: Participants
        Any Erythema, Dose1 [N=448,463]
    131
    31
        Grade3 Erythema, Dose1 [N=448,463]
    7
    1
        Any Pain, Dose1 [N=448,463]
    347
    241
        Grade3 Pain, Dose1 [N=448,463]
    28
    9
        Any Swelling, Dose1 [N=448,463]
    76
    21
        Grade3 Swelling, Dose1 [N=448,463]
    1
    0
        Any Erythema, Dose2 [N=444,458]
    147
    128
        Grade3 Erythema, Dose2 [N=444,458]
    9
    5
        Any Pain, Dose2 [N=444,458]
    326
    359
        Grade3 Pain, Dose2 [N=444,458]
    28
    32
        Any Swelling, Dose2 [N=444,458]
    70
    72
        Grade3 Swelling, Dose2 [N=444,458]
    1
    2
        Any Erythema, Dose3 [N=0,459]
    0
    123
        Grade3 Erythema, Dose3 [N=0,459]
    0
    1
        Any Pain, Dose3 [N=0,459]
    0
    350
        Grade3 Pain, Dose3 [N=0,459]
    0
    41
        Any Swelling, Dose3 [N=0,459]
    0
    60
        Grade3 Swelling, Dose3 [N=0,459]
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs:throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Control Group
    Reporting group description
    		 Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm

    Reporting group title
    Co-Ad Group
    Reporting group description
    		 Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm

    Serious adverse events
    		 Control Group Co-Ad Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 463 (3.46%)
    16 / 449 (3.56%)
         number of deaths (all causes)
    4
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Endometrial adenocarcinoma
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastatic carcinoma of the bladder
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neoplasm malignant
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Monoclonal gammopathy
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (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
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (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
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         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
    Road traffic accident
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Congenital, familial and genetic disorders
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 463 (0.22%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 463 (0.22%)
    2 / 449 (0.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dressler's syndrome
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Cerebral haematoma
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (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
    Nephrotic syndrome
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         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
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 463 (0.22%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Control Group Co-Ad Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    427 / 463 (92.22%)
    419 / 449 (93.32%)
    Vascular disorders
    Aortic stenosis
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Hypertension
         subjects affected / exposed
    5 / 463 (1.08%)
    3 / 449 (0.67%)
         occurrences all number
    5
    3
    Circulatory collapse
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Lymphoedema
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Administration site pruritus
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Asthenia
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Feeling hot
         subjects affected / exposed
    2 / 463 (0.43%)
    2 / 449 (0.45%)
         occurrences all number
    2
    2
    Fatigue
         subjects affected / exposed
    261 / 463 (56.37%)
    243 / 449 (54.12%)
         occurrences all number
    448
    361
    Chills
         subjects affected / exposed
    143 / 463 (30.89%)
    139 / 449 (30.96%)
         occurrences all number
    179
    174
    Chest pain
         subjects affected / exposed
    0 / 463 (0.00%)
    2 / 449 (0.45%)
         occurrences all number
    0
    2
    Axillary pain
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Influenza like illness
         subjects affected / exposed
    0 / 463 (0.00%)
    2 / 449 (0.45%)
         occurrences all number
    0
    2
    Injection site bruising
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Injection site erythema
         subjects affected / exposed
    190 / 463 (41.04%)
    192 / 449 (42.76%)
         occurrences all number
    286
    278
    Injection site hypoaesthesia
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Injection site movement impairment
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Injection site oedema
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Injection site pain
         subjects affected / exposed
    406 / 463 (87.69%)
    389 / 449 (86.64%)
         occurrences all number
    952
    673
    Injection site pruritus
         subjects affected / exposed
    7 / 463 (1.51%)
    7 / 449 (1.56%)
         occurrences all number
    10
    9
    Injection site rash
         subjects affected / exposed
    0 / 463 (0.00%)
    2 / 449 (0.45%)
         occurrences all number
    0
    2
    Injection site reaction
         subjects affected / exposed
    1 / 463 (0.22%)
    1 / 449 (0.22%)
         occurrences all number
    1
    1
    Injection site swelling
         subjects affected / exposed
    117 / 463 (25.27%)
    108 / 449 (24.05%)
         occurrences all number
    156
    146
    Injection site warmth
         subjects affected / exposed
    2 / 463 (0.43%)
    1 / 449 (0.22%)
         occurrences all number
    2
    1
    Peripheral swelling
         subjects affected / exposed
    0 / 463 (0.00%)
    2 / 449 (0.45%)
         occurrences all number
    0
    2
    Pain
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 463 (0.00%)
    2 / 449 (0.45%)
         occurrences all number
    0
    2
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    0 / 463 (0.00%)
    2 / 449 (0.45%)
         occurrences all number
    0
    2
    Pyrexia
         subjects affected / exposed
    29 / 463 (6.26%)
    23 / 449 (5.12%)
         occurrences all number
    32
    26
    Sensation of foreign body
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 463 (0.00%)
    2 / 449 (0.45%)
         occurrences all number
    0
    2
    Seasonal allergy
         subjects affected / exposed
    1 / 463 (0.22%)
    1 / 449 (0.22%)
         occurrences all number
    1
    1
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Breast pain
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 463 (0.22%)
    1 / 449 (0.22%)
         occurrences all number
    1
    1
    Bronchospasm
         subjects affected / exposed
    0 / 463 (0.00%)
    2 / 449 (0.45%)
         occurrences all number
    0
    2
    Dyspnoea
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Dysphonia
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Dry throat
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    2 / 463 (0.43%)
    2 / 449 (0.45%)
         occurrences all number
    2
    3
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 463 (0.00%)
    2 / 449 (0.45%)
         occurrences all number
    0
    2
    Epistaxis
         subjects affected / exposed
    1 / 463 (0.22%)
    1 / 449 (0.22%)
         occurrences all number
    1
    1
    Lower respiratory tract congestion
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Haemoptysis
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    2
    Nasal congestion
         subjects affected / exposed
    2 / 463 (0.43%)
    0 / 449 (0.00%)
         occurrences all number
    2
    0
    Nasal discomfort
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 463 (0.22%)
    3 / 449 (0.67%)
         occurrences all number
    1
    3
    Pulmonary arterial hypertension
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Throat irritation
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Acute stress disorder
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Depression
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    1 / 463 (0.22%)
    1 / 449 (0.22%)
         occurrences all number
    1
    1
    Restlessness
         subjects affected / exposed
    1 / 463 (0.22%)
    1 / 449 (0.22%)
         occurrences all number
    1
    1
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    2 / 463 (0.43%)
    0 / 449 (0.00%)
         occurrences all number
    2
    0
    Arthropod bite
         subjects affected / exposed
    2 / 463 (0.43%)
    0 / 449 (0.00%)
         occurrences all number
    2
    0
    Mallet finger
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Limb injury
         subjects affected / exposed
    1 / 463 (0.22%)
    1 / 449 (0.22%)
         occurrences all number
    1
    1
    Joint dislocation
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Head injury
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Contusion
         subjects affected / exposed
    1 / 463 (0.22%)
    1 / 449 (0.22%)
         occurrences all number
    1
    1
    Procedural pain
         subjects affected / exposed
    2 / 463 (0.43%)
    0 / 449 (0.00%)
         occurrences all number
    2
    0
    Road traffic accident
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Burning sensation
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    2 / 463 (0.43%)
    3 / 449 (0.67%)
         occurrences all number
    2
    3
    Hypoaesthesia
         subjects affected / exposed
    1 / 463 (0.22%)
    1 / 449 (0.22%)
         occurrences all number
    1
    1
    Headache
         subjects affected / exposed
    241 / 463 (52.05%)
    206 / 449 (45.88%)
         occurrences all number
    376
    287
    Dysgeusia
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    3
    0
    Neuralgia
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    VIth nerve paresis
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Trigeminal neuralgia
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Sciatica
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Paraesthesia
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Neuromuscular blockade
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Pseudolymphoma
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Presbyacusis
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Vertigo
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Ocular hyperaemia
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Retinal detachment
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Aphthous ulcer
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 463 (0.00%)
    3 / 449 (0.67%)
         occurrences all number
    0
    3
    Diarrhoea
         subjects affected / exposed
    1 / 463 (0.22%)
    1 / 449 (0.22%)
         occurrences all number
    1
    1
    Dental caries
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Hypoaesthesia oral
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 463 (0.22%)
    1 / 449 (0.22%)
         occurrences all number
    1
    1
    Gastrointestinal disorder
         subjects affected / exposed
    119 / 463 (25.70%)
    102 / 449 (22.72%)
         occurrences all number
    153
    118
    Food poisoning
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Mouth haemorrhage
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Enteritis
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Rectal fissure
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Tongue eruption
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 463 (0.22%)
    1 / 449 (0.22%)
         occurrences all number
    1
    1
    Dermatitis
         subjects affected / exposed
    1 / 463 (0.22%)
    1 / 449 (0.22%)
         occurrences all number
    1
    1
    Alopecia
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Night sweats
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 463 (0.00%)
    2 / 449 (0.45%)
         occurrences all number
    0
    2
    Erythema
         subjects affected / exposed
    4 / 463 (0.86%)
    6 / 449 (1.34%)
         occurrences all number
    6
    7
    Peau d'orange
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    2 / 463 (0.43%)
    2 / 449 (0.45%)
         occurrences all number
    2
    3
    Rash
         subjects affected / exposed
    2 / 463 (0.43%)
    1 / 449 (0.22%)
         occurrences all number
    2
    1
    Rash erythematous
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Haematuria
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Urinary retention
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Autoimmune thyroiditis
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    8 / 463 (1.73%)
    5 / 449 (1.11%)
         occurrences all number
    10
    6
    Flank pain
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Bursitis
         subjects affected / exposed
    2 / 463 (0.43%)
    0 / 449 (0.00%)
         occurrences all number
    2
    0
    Back pain
         subjects affected / exposed
    1 / 463 (0.22%)
    1 / 449 (0.22%)
         occurrences all number
    1
    1
    Axillary mass
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Arthritis
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Limb discomfort
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Joint swelling
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 463 (0.00%)
    2 / 449 (0.45%)
         occurrences all number
    0
    2
    Myalgia
         subjects affected / exposed
    284 / 463 (61.34%)
    260 / 449 (57.91%)
         occurrences all number
    501
    373
    Neck pain
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Osteoarthritis
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Plantar fasciitis
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    3 / 463 (0.65%)
    4 / 449 (0.89%)
         occurrences all number
    3
    5
    Synovial cyst
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Tendon disorder
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 463 (0.22%)
    5 / 449 (1.11%)
         occurrences all number
    1
    5
    Cystitis
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Ear infection
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Erysipelas
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Fungal infection
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Fungal skin infection
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    3 / 463 (0.65%)
    0 / 449 (0.00%)
         occurrences all number
    3
    0
    Herpes simplex
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Genital infection fungal
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Impetigo
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Injection site cellulitis
         subjects affected / exposed
    0 / 463 (0.00%)
    2 / 449 (0.45%)
         occurrences all number
    0
    2
    Influenza
         subjects affected / exposed
    3 / 463 (0.65%)
    2 / 449 (0.45%)
         occurrences all number
    3
    2
    Infection
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Otitis externa
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Oral herpes
         subjects affected / exposed
    2 / 463 (0.43%)
    1 / 449 (0.22%)
         occurrences all number
    2
    1
    Nasopharyngitis
         subjects affected / exposed
    7 / 463 (1.51%)
    3 / 449 (0.67%)
         occurrences all number
    7
    3
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Laryngitis
         subjects affected / exposed
    1 / 463 (0.22%)
    1 / 449 (0.22%)
         occurrences all number
    1
    1
    Pneumonia
         subjects affected / exposed
    0 / 463 (0.00%)
    2 / 449 (0.45%)
         occurrences all number
    0
    2
    Pulpitis dental
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Rash pustular
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    4 / 463 (0.86%)
    0 / 449 (0.00%)
         occurrences all number
    4
    0
    Otitis media
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 463 (1.51%)
    4 / 449 (0.89%)
         occurrences all number
    7
    4
    Urinary tract infection
         subjects affected / exposed
    2 / 463 (0.43%)
    0 / 449 (0.00%)
         occurrences all number
    2
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    4 / 463 (0.86%)
    1 / 449 (0.22%)
         occurrences all number
    4
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 463 (0.22%)
    0 / 449 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1
    Dyslipidaemia
         subjects affected / exposed
    0 / 463 (0.00%)
    2 / 449 (0.45%)
         occurrences all number
    0
    2
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 463 (0.00%)
    1 / 449 (0.22%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Oct 2017
    • Following the initial approval of the GlaxoSmithKline (GSK) Biologicals’ HZ/su vaccine, this protocol was amended to indicate that the Trademark is Shingrix. In addition, the term “candidate” vaccine has been replaced by “study” vaccine throughout the protocol and the term “investigational” vaccine has been replaced by “study” vaccine.

    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.

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