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    Clinical Trial Results:
    A phase III, open, single centre study to assess the safety, reac-togenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate (10Pn-PD-DiT) vaccine (GSK 1024850A), when either given as a booster dose (at 15-21 months of age) in children previously primed with three doses of 10Pn-PD-DiT vaccine, or when given as a two-dose catch-up immunization (at 15-21 and 17-23 months of age) in unprimed children, all previously enrolled in the 10PN-PD-DIT-032 primary vaccination study in Nigeria.

    Summary
    EudraCT number
    		 2012-000826-23
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    16 Feb 2011

    Results information
    Results version number
    		 v3(current)
    This version publication date
    01 Mar 2023
    First version publication date
    25 Jun 2015
    Other versions
    		 v1 , v2
    Version creation reason
    • Correction of full data set
    Correction of full data set and alignment between registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    113199
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01153893
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Dec 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Feb 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Feb 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and reactogenicity of the 10Pn-PD-DiT vaccine in terms of occurrence of adverse events with grade 3 intensity after booster vaccination.
    Protection of trial subjects
    The vaccine recipients were observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of a rare anaphylactic reaction following the administration of vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Oct 2010
    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
    Nigeria: 107
    Worldwide total number of subjects
    107
    EEA total number of subjects
    0
    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)
    107
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The duration of the study per subject can vary from 1 month (Synflorix/Infanrix primed Group) to 3 months (Synflorix/Infanrix unprimed Group), depending on the group allocation. Out of the 107 subjects enrolled in the study, 3 did not start (2 due to the vaccine dose not being administered and 1 due to the non-allocation of a vaccine number).

    Pre-assignment
    Screening details
    		 Because of an issue with the informed consent of a child, the data of the child, who had a non-related to study medication serious adverse event, are not detailed in this analysis. Data were reanalyzed for the 104 subjects with data available.

    Pre-assignment period milestones
    Number of subjects started
    		 107
    Number of subjects completed
    		 104

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Vaccine dose not administrated: 2
    Reason: Number of subjects
    		 Vaccine number not allocated: 1
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Synflorix/Infanrix primed Group
    Arm description
    		 Subjects previously primed with the Synflorix vaccine in the primary study NCT00678301 received a booster dose of the Synflorix vaccine co-administered with a booster dose of the Infanrix vaccine at 15-21 months of age. Synflorix vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pneumococcal vaccine GSK1024850A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose, administered intramuscularly in the right thigh or deltoid muscle of the arm.

    Investigational medicinal product name
    Infanrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered intramuscularly in the left thigh or deltoid muscle of the arm.

    Arm title
    		 Synflorix/Infanrix unprimed Group
    Arm description
    		 Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix vaccine co-administered with the first dose of Synflorix vaccine at 15-21 months of age. Synflorix vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pneumococcal vaccine GSK1024850A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses, administered intramuscularly in the right thigh or deltoid muscle of the arm.

    Investigational medicinal product name
    Infanrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered intramuscularly in the left thigh or deltoid muscle of the arm.

    Number of subjects in period 1 [1]
    		Synflorix/Infanrix primed Group Synflorix/Infanrix unprimed Group
    Started
    68
    36
    Completed
    67
    36
    Not completed
    1
    0
         Adverse event, serious fatal
    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 the 107 subjects enrolled in the study, 3 did not start (2 due to the vaccine dose not being administered and 1 due to the non-allocation of a vaccine number).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Synflorix/Infanrix primed Group
    Reporting group description
    		 Subjects previously primed with the Synflorix vaccine in the primary study NCT00678301 received a booster dose of the Synflorix vaccine co-administered with a booster dose of the Infanrix vaccine at 15-21 months of age. Synflorix vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.

    Reporting group title
    Synflorix/Infanrix unprimed Group
    Reporting group description
    		 Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix vaccine co-administered with the first dose of Synflorix vaccine at 15-21 months of age. Synflorix vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.

    Reporting group values
    		 Synflorix/Infanrix primed Group Synflorix/Infanrix unprimed Group Total
    Number of subjects
    		 68 36 104
    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)
    		 68 36 104
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 16.7 ( 1 ) 16.4 ( 0.91 ) -
    Gender categorical
    Units: Subjects
        Female
    		 29 17 46
        Male
    		 39 19 58

    End points

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    End points reporting groups
    Reporting group title
    Synflorix/Infanrix primed Group
    Reporting group description
    		 Subjects previously primed with the Synflorix vaccine in the primary study NCT00678301 received a booster dose of the Synflorix vaccine co-administered with a booster dose of the Infanrix vaccine at 15-21 months of age. Synflorix vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.

    Reporting group title
    Synflorix/Infanrix unprimed Group
    Reporting group description
    		 Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix vaccine co-administered with the first dose of Synflorix vaccine at 15-21 months of age. Synflorix vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.

    Primary: Number of subjects reporting Grade 3 symptoms (solicited and unsolicited)

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    End point title
    		 Number of subjects reporting Grade 3 symptoms (solicited and unsolicited) [1] [2]
    End point description
    Grade 3 symptom = severe symptom that prevented normal activity. Solicited local symptoms assessed were pain, redness and swelling. Solicited general symptoms assessed were drowsiness, fever, irritability and loss of appetite. Unsolicited AEs = Any AE reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. The Total Vaccinated cohort included all vaccinated subjects.
    End point type
    Primary
    End point timeframe
    Within 31 days (Day 0 to Day 30) after administration of a booster dose of Synflorix vaccine in the Synflorix/Infanrix primed Group
    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 analysis of the primary endpoint was descriptive i.e. 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: These results were only assessed in the Synflorix/Infanrix primed Group.
    End point values
    		 Synflorix/Infanrix primed Group
    Number of subjects analysed
    68
    Units: Subjects
        Any symptom
    3
        General symptoms
    1
        Local symptoms
    2
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against vaccine pneumococcal serotypes

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    End point title
    		 Concentrations of antibodies against vaccine pneumococcal serotypes
    End point description
    Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL. The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group
    End point values
    		 Synflorix/Infanrix primed Group Synflorix/Infanrix unprimed Group
    Number of subjects analysed
    68
    35
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-1 [pre-booster;pre-vacc] (N=68,35)
    0.29 (0.22 to 0.4)
    0.03 (0.03 to 0.04)
        Anti-1 [post-booster;post-dose 2] (N=67,35)
    8.72 (6.37 to 11.93)
    3.17 (2.58 to 3.89)
        Anti-4 [pre-booster;pre-vacc] (N=68,35)
    0.4 (0.31 to 0.5)
    0.06 (0.04 to 0.09)
        Anti-4 [post-booster;post-dose 2] (N=67,35)
    11.03 (9.06 to 13.42)
    8.22 (6.75 to 10.02)
        Anti-5 [pre-booster;pre-vacc] (N=68,35)
    0.49 (0.4 to 0.61)
    0.05 (0.04 to 0.07)
        Anti-5 [post-booster;post-dose 2] (N=67,35)
    10.34 (8.32 to 12.85)
    2.87 (2.22 to 3.71)
        Anti-6B [pre-booster;pre-vacc] (N=68,35)
    0.63 (0.48 to 0.83)
    0.05 (0.03 to 0.08)
        Anti-6B [post-booster;post-dose 2] (N=67,35)
    4.31 (3.37 to 5.52)
    0.85 (0.52 to 1.38)
        Anti-7F [pre-booster;pre-vacc] (N=68,35)
    0.73 (0.57 to 0.92)
    0.05 (0.04 to 0.08)
        Anti-7F [post-booster;post-dose 2] (N=67,35)
    10.3 (8.57 to 12.38)
    6.07 (4.89 to 7.52)
        Anti-9V [pre-booster;pre-vacc] (N=67,35)
    1.04 (0.78 to 1.39)
    0.06 (0.04 to 0.1)
        Anti-9V [post-booster;post-dose 2] (N=67,35)
    11.49 (9.02 to 14.65)
    2.7 (2.05 to 3.55)
        Anti-14 [pre-booster;pre-vacc] (N=68,35)
    1.13 (0.87 to 1.46)
    0.14 (0.08 to 0.23)
        Anti-14 [post-booster;post-dose 2] (N=67,35)
    14.14 (11.74 to 17.04)
    10.59 (8.7 to 12.89)
        Anti-18C [pre-booster;pre-vacc] (N=68,35)
    1.62 (1.3 to 2.04)
    0.05 (0.03 to 0.09)
        Anti-18C [post-booster;post-dose 2] (N=67,35)
    35.33 (27.73 to 45.02)
    25.61 (19.7 to 33.3)
        Anti-19F [pre-booster;pre-vacc] (N=67,35)
    1.2 (0.85 to 1.71)
    0.14 (0.08 to 0.24)
        Anti-19F [post-booster;post-dose 2] (N=67,35)
    9.26 (7.2 to 11.91)
    7.16 (4.27 to 12.02)
        Anti-23F [pre-booster;pre-vacc] (N=68,35)
    0.46 (0.32 to 0.68)
    0.03 (0.02 to 0.04)
        Anti-23F [post-booster;post-dose 2] (N=67,35)
    6.99 (5.21 to 9.39)
    1.06 (0.66 to 1.7)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against cross-reactive pneumococcal serotypes

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    End point title
    		 Concentrations of antibodies against cross-reactive pneumococcal serotypes
    End point description
    Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL. The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group
    End point values
    		 Synflorix/Infanrix primed Group Synflorix/Infanrix unprimed Group
    Number of subjects analysed
    68
    35
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-6A [pre-booster;pre-vacc] (N=68,35)
    0.19 (0.13 to 0.27)
    0.05 (0.03 to 0.07)
        Anti-6A [post-booster;post-dose 2] (N=67,35)
    0.81 (0.56 to 1.18)
    0.24 (0.15 to 0.4)
        Anti-19A [pre-booster;pre-vacc] (N=68,35)
    0.24 (0.17 to 0.36)
    0.09 (0.05 to 0.17)
        Anti-19A [post-booster;post-dose 2] (N=67,35)
    1.33 (0.88 to 2)
    1.94 (1.13 to 3.33)
    No statistical analyses for this end point

    Secondary: Opsonophagocytic activity against vaccine pneumococcal serotypes

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    End point title
    		 Opsonophagocytic activity against vaccine pneumococcal serotypes
    End point description
    Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results were presented as the dilution of serum (opsonic titre) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titre of 8. The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.
    End point type
    Secondary
    End point timeframe
    One month after the booster immunisation for the Synflorix/Infanrix primed Group and one month after Dose 2 in the Synflorix/Infanrix unprimed Group
    End point values
    		 Synflorix/Infanrix primed Group Synflorix/Infanrix unprimed Group
    Number of subjects analysed
    67
    35
    Units: Titres
    geometric mean (confidence interval 95%)
        Opsono-1 [post-booster;post-dose 2] (N=66,35)
    1667.8 (1210.9 to 2297)
    103.4 (67.7 to 157.9)
        Opsono-4 [post-booster;post-dose 2] (N=65,35)
    3869.1 (3122.8 to 4793.9)
    1482.9 (1211 to 1815.8)
        Opsono-5 [post-booster;post-dose 2] (N=67,35)
    679.9 (515.9 to 895.9)
    58.7 (38.6 to 89.4)
        Opsono-6B [post-booster;post-dose 2] (N=66,31)
    1687.6 (1138.7 to 2501)
    325.7 (118.1 to 898.6)
        Opsono-7F [post-booster;post-dose 2] (N=67,35)
    11045.3 (8456.8 to 14426.3)
    7980.2 (6287.8 to 10128.1)
        Opsono-9V [post-booster;post-dose 2] (N=66,35)
    5300.1 (4329.3 to 6488.5)
    6375.3 (4779.4 to 8504.1)
        Opsono-14 [post-booster;post-dose 2] (N=66,35)
    2472 (1767.3 to 3457.8)
    1797.8 (1241.4 to 2603.6)
        Opsono-18C [post-booster;post-dose 2] (N=67,35)
    2323 (1403.1 to 3846.1)
    4104.2 (2954.5 to 5701.2)
        Opsono-19F [post-booster;post-dose 2] (N=65,34)
    683.5 (440 to 1062)
    443.5 (203 to 968.8)
        Opsono-23F [post-booster;post-dose 2] (N=67,35)
    5144.5 (3657.4 to 7236.3)
    3081.7 (1389.3 to 6836.1)
    No statistical analyses for this end point

    Secondary: Opsonophagocytic activity against cross-reactive pneumococcal serotypes

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    End point title
    		 Opsonophagocytic activity against cross-reactive pneumococcal serotypes
    End point description
    Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results were presented as the dilution of serum (opsonic titre) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titre of 8. The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.
    End point type
    Secondary
    End point timeframe
    One month after the booster immunisation for the Synflorix/Infanrix primed Group and one month after Dose 2 in the Synflorix/Infanrix unprimed Group
    End point values
    		 Synflorix/Infanrix primed Group Synflorix/Infanrix unprimed Group
    Number of subjects analysed
    66
    35
    Units: Titres
    geometric mean (confidence interval 95%)
        Opsono-6A [post-booster;post-dose 2] (N=61,34)
    213 (121.7 to 372.9)
    313.9 (147.6 to 667.4)
        Opsono-19A [post-booster;post-dose 2] (N=66,35)
    112.7 (66.7 to 190.5)
    341.2 (159 to 732.1)
    No statistical analyses for this end point

    Secondary: Concentration of antibodies against protein D (PD)

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    End point title
    		 Concentration of antibodies against protein D (PD)
    End point description
    Anti-PD antibodies were determined using an ELISA assay. Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EL.U/mL). Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per milliliter (EL.U/mL). The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster immunization for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group
    End point values
    		 Synflorix/Infanrix primed Group Synflorix/Infanrix unprimed Group
    Number of subjects analysed
    67
    35
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PD [pre-booster;pre-vacc] (N=66,35)
    270.4 (211.7 to 345.3)
    61.5 (52 to 72.7)
        Anti-PD [post-booster;post-dose 2] (N=67,35)
    2955.3 (2342 to 3729.2)
    501.1 (345 to 727.9)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and grade 3 solicited local Adverse Events (AEs)

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    End point title
    		 Number of subjects reporting any and grade 3 solicited local Adverse Events (AEs)
    End point description
    Solicited AEs = AEs to be recorded as endpoints in the clinical study. The presence/occurrence/intensity of these events was actively solicited from the subject or an observer during a specified post-vaccination follow-up period. Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling greather than (>) 30 millimeter (mm). The Total Vaccinated cohort included all vaccinated subjects.
    End point type
    Secondary
    End point timeframe
    Within 4 days (Days 0-3) after vaccination
    End point values
    		 Synflorix/Infanrix primed Group Synflorix/Infanrix unprimed Group
    Number of subjects analysed
    68
    36
    Units: Subjects
        Any pain
    27
    13
        Grade 3 pain
    0
    0
        Any redness
    1
    1
        Redness > 30 mm
    0
    1
        Any swelling
    4
    2
        Swelling > 30 mm
    2
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related solicited general AEs

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    End point title
    		 Number of subjects reporting any, grade 3 and related solicited general AEs
    End point description
    Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (= axillary temperature greater than or equal to [≥] 37.5 °C). Any= occurrence of any general symptom regardless of intensity grade or relationship to vaccination Grade 3 drowsiness = drowsiness which prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = temperature >39.5°C. Related = solicited symptom assessed by the investigator as causally related to study vaccination. The Total Vaccinated cohort included all vaccinated subjects.
    End point type
    Secondary
    End point timeframe
    Within 4 days (Days 0-3) after vaccination
    End point values
    		 Synflorix/Infanrix primed Group Synflorix/Infanrix unprimed Group
    Number of subjects analysed
    68
    36
    Units: Subjects
        Any drowsiness
    2
    0
        Grade 3 drowsiness
    0
    0
        Related drowsiness
    2
    0
        Fever > 39.5°C
    0
    1
        Related fever
    8
    3
        Any irritability
    2
    0
        Grade 3 irritability
    0
    0
        Related irritability
    2
    0
        Any loss of appetite
    1
    1
        Grade 3 loss of appetite
    0
    0
        Related loss of appetite
    1
    1
        Fever ≥ 37.5°C
    8
    3
    No statistical analyses for this end point

    Secondary: Number of subjects reporting unsolicited AEs

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    End point title
    		 Number of subjects reporting unsolicited AEs
    End point description
    Unsolicited AEs = Any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. The Total Vaccinated cohort included all vaccinated subjects.
    End point type
    Secondary
    End point timeframe
    Within 31 days (Days 0-30) after vaccination
    End point values
    		 Synflorix/Infanrix primed Group Synflorix/Infanrix unprimed Group
    Number of subjects analysed
    68
    36
    Units: Subjects
        Any AE(s)
    31
    18
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting serious adverse events (SAEs)
    End point description
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. The Total Vaccinated cohort included all vaccinated subjects.
    End point type
    Secondary
    End point timeframe
    During the entire study period, from the vaccination visit at Day 0 up to the end of the follow-up visit at Month 1 for the Synflorix/Infanrix primed Group and up to Month 3 for the Synflorix/Infanrix unprimed Group
    End point values
    		 Synflorix/Infanrix primed Group Synflorix/Infanrix unprimed Group
    Number of subjects analysed
    68
    36
    Units: Subjects
        Any SAE(s)
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs: Within 4 days (Days 0-3) after vaccination. Unsolicited AEs: Within 31 days (Days 0-30) after vaccination. SAEs: From Day 0 up to Month 1 for the Synflorix/Infanrix primed Group and up to Month 3 for the Synflorix/Infanrix unprimed Group.
    Adverse event reporting additional description
    Because of an issue discovered with the informed consent obtained for one child after the original statistical analysis. The data of the child, who also had an SAE that was not considered to be related to the study medication by the investigator, have been removed from the results tables.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Synflorix/Infanrix primed Group
    Reporting group description
    		 Subjects previously primed with the Synflorix vaccine in the primary study NCT00678301 received a booster dose of the Synflorix vaccine co-administered with a booster dose of the Infanrix vaccine at 15-21 months of age. Synflorix vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.

    Reporting group title
    Synflorix/Infanrix unprimed Group
    Reporting group description
    		 Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix vaccine co-administered with the first dose of Synflorix vaccine at 15-21 months of age. Synflorix vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.

    Serious adverse events
    		 Synflorix/Infanrix primed Group Synflorix/Infanrix unprimed Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 36 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    Drowning
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Synflorix/Infanrix primed Group Synflorix/Infanrix unprimed Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 68 (67.65%)
    25 / 36 (69.44%)
    General disorders and administration site conditions
    Fever
         subjects affected / exposed
    8 / 68 (11.76%)
    3 / 36 (8.33%)
         occurrences all number
    8
    3
    Pain
         subjects affected / exposed
    27 / 68 (39.71%)
    13 / 36 (36.11%)
         occurrences all number
    27
    13
    Swelling
         subjects affected / exposed
    4 / 68 (5.88%)
    2 / 36 (5.56%)
         occurrences all number
    4
    2
    Eye disorders
    Conjunctivitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 68 (4.41%)
    2 / 36 (5.56%)
         occurrences all number
    3
    2
    Gastrointestinal disorders
    Enteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 68 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Infections and infestations
    Respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    13 / 68 (19.12%)
    7 / 36 (19.44%)
         occurrences all number
    13
    7
    Malaria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 68 (11.76%)
    10 / 36 (27.78%)
         occurrences all number
    8
    10
    Furuncle
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 68 (5.88%)
    1 / 36 (2.78%)
         occurrences all number
    4
    1
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 68 (4.41%)
    2 / 36 (5.56%)
         occurrences all number
    3
    2

    More information

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

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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