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    Clinical Trial Results:
    A phase III, multi-centre, open study to assess antibody persistence after completion of the 3-dose primary vaccination course with GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine in study 10PN-PD-DIT-048 (111654) in Singapore as well as the safety, reactogenicity and immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine when given as a booster dose at 18-21 months of age

    Summary
    EudraCT number
    		 2012-000819-82
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    17 Feb 2011

    Results information
    Results version number
    		 v2(current)
    This version publication date
    19 Nov 2022
    First version publication date
    28 Jun 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of full data set and alingment between registry.

    Trial information

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    Trial identification
    Sponsor protocol code
    113266
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01119625
    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, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center , GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Dec 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Feb 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the antibody persistence induced by the GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (commercial lot versus phase III clinical lot), when co-administered with DTPa-IPV/Hib 13-16 months after completion of the 3-dose primary vaccination course in study 10PN-PD-DIT-048 (111654).
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Jul 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
    Singapore: 238
    Worldwide total number of subjects
    238
    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)
    238
    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
    		 This booster study was conducted in Singapore only whereas the primary vaccination phase (NCT00808444) was conducted in Singapore and Malaysia.

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

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group
    Arm description
    		 Children primed with 3 doses of clinical lot of Synflorix + Rotarix co-administered with Infanrix-hexa in the primary phase of the study (NCT00808444) and boosted, with commercial lot of Synflorix coadministered with Infanrix-IPV/Hib. The Synflorix vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
    Arm type
    		 Active comparator

    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
    One dose, administered intramuscularly in the right deltoid or anterolateral thigh.

    Investigational medicinal product name
    Infanrix-IPV/Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose, administered intramuscularly in the left deltoid or anterolateral thigh.

    Arm title
    		 Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Arm description
    		 Children primed with 3 doses of commercial lot of Synflorix co-administered with Rotarix and Infanrix-hexa in the primary phase of the study (NCT00808444) and boosted, with commercial lot of Synflorix co-administered with Infanrix-IPV/Hib. The Synflorix vaccine (commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
    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
    One dose, administered intramuscularly in the right deltoid or anterolateral thigh.

    Investigational medicinal product name
    Infanrix-IPV/Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose, administered intramuscularly in the left deltoid or anterolateral thigh.

    Number of subjects in period 1
    		Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Started
    118
    120
    Completed
    115
    116
    Not completed
    3
    4
         Consent withdrawn by subject
    2
    1
         out of window period
    -
    1
         Lost to follow-up
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group
    Reporting group description
    		 Children primed with 3 doses of clinical lot of Synflorix + Rotarix co-administered with Infanrix-hexa in the primary phase of the study (NCT00808444) and boosted, with commercial lot of Synflorix coadministered with Infanrix-IPV/Hib. The Synflorix vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.

    Reporting group title
    Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Reporting group description
    		 Children primed with 3 doses of commercial lot of Synflorix co-administered with Rotarix and Infanrix-hexa in the primary phase of the study (NCT00808444) and boosted, with commercial lot of Synflorix co-administered with Infanrix-IPV/Hib. The Synflorix vaccine (commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.

    Reporting group values
    		 Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group Total
    Number of subjects
    		 118 120 238
    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)
    		 118 120 238
        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)
    		 18.8 ( 0.84 ) 18.9 ( 0.87 ) -
    Gender categorical
    Units: Subjects
        Female
    		 62 49 111
        Male
    		 56 71 127

    End points

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    End points reporting groups
    Reporting group title
    Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group
    Reporting group description
    		 Children primed with 3 doses of clinical lot of Synflorix + Rotarix co-administered with Infanrix-hexa in the primary phase of the study (NCT00808444) and boosted, with commercial lot of Synflorix coadministered with Infanrix-IPV/Hib. The Synflorix vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.

    Reporting group title
    Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Reporting group description
    		 Children primed with 3 doses of commercial lot of Synflorix co-administered with Rotarix and Infanrix-hexa in the primary phase of the study (NCT00808444) and boosted, with commercial lot of Synflorix co-administered with Infanrix-IPV/Hib. The Synflorix vaccine (commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.

    Primary: Concentrations of antibodies against vaccine pneumococcal serotypes

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    End point title
    		 Concentrations of antibodies against vaccine pneumococcal serotypes [1]
    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 millilitre (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.
    End point type
    Primary
    End point timeframe
    Before booster vaccination at Month 0
    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.
    End point values
    		 Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Number of subjects analysed
    111
    112
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-1 [Pre-booster] (N=111;112)
    0.48 (0.4 to 0.57)
    0.35 (0.3 to 0.41)
        Anti-4 [Pre-booster] (N=107;106)
    0.56 (0.48 to 0.67)
    0.48 (0.4 to 0.58)
        Anti-5 [Pre-booster] (N=103;103)
    0.76 (0.65 to 0.89)
    0.54 (0.47 to 0.63)
        Anti-6B [Pre-booster] (N=103;102)
    0.34 (0.29 to 0.4)
    0.32 (0.25 to 0.41)
        Anti-7F [Pre-booster] (N=104;105)
    0.88 (0.75 to 1.03)
    0.91 (0.78 to 1.07)
        Anti-9V [Pre-booster] (N=105;102)
    0.9 (0.77 to 1.06)
    0.73 (0.62 to 0.85)
        Anti-14 [Pre-booster] (N=105;100)
    1.06 (0.86 to 1.31)
    0.91 (0.75 to 1.11)
        Anti-18C [Pre-booster] (N=109;108)
    0.83 (0.69 to 1.01)
    0.78 (0.65 to 0.93)
        Anti-19F [Pre-booster] (N=103;103)
    1.1 (0.87 to 1.4)
    0.96 (0.82 to 1.13)
        Anti-23F [Pre-booster] (N=108;106)
    0.66 (0.51 to 0.84)
    0.47 (0.38 to 0.58)
    No statistical analyses for this end point

    Primary: Concentrations of antibodies against protein D (PD)

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    End point title
    		 Concentrations of antibodies against protein D (PD) [2]
    End point description
    Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL).
    End point type
    Primary
    End point timeframe
    Before booster vaccination at Month 0
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Number of subjects analysed
    116
    118
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Anti-PD [pre-booster]
    801.6 (693.1 to 927.1)
    619.7 (530.1 to 724.3)
    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 is 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 above 30 millimetre (mm).
    End point type
    Secondary
    End point timeframe
    Within 4 days (Days 0-3) after booster vaccination
    End point values
    		 Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Number of subjects analysed
    117
    117
    Units: Subjects
        Any pain
    61
    70
        Grade 3 pain
    8
    13
        Any redness
    66
    61
        Grade 3 redness
    0
    0
        Any swelling
    45
    49
        Grade 3 swelling
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related solicited general adverse events (AEs)

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    End point title
    		 Number of subjects reporting any, grade 3 and related solicited general adverse events (AEs)
    End point description
    Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (= axillary temperature equal to or above 37.5 degrees Celsius (°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 greater than (>) 39.5°C. Related = solicited symptom assessed by the investigator as causally related to study vaccination.
    End point type
    Secondary
    End point timeframe
    Within 4 days (Days 0-3) after booster vaccination
    End point values
    		 Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Number of subjects analysed
    117
    117
    Units: Subjects
        Any drowsiness
    38
    49
        Grade 3 drowsiness
    2
    2
        Related drowsiness
    38
    48
        Fever >= 37.5°C
    56
    75
        Fever > 39.5°C
    1
    1
        Related fever
    55
    72
        Any irritability
    51
    67
        Grade 3 irritability
    3
    5
        Related irritability
    50
    67
        Any loss of appetite
    42
    49
        Grade 3 loss of appetite
    1
    1
        Related loss of appetite
    41
    47
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting unsolicited adverse events (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.
    End point type
    Secondary
    End point timeframe
    Within 31 days (Days 0-30) after booster vaccination
    End point values
    		 Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Number of subjects analysed
    118
    120
    Units: Subjects
        Unsolicited AEs
    18
    25
    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 subjects.
    End point type
    Secondary
    End point timeframe
    During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1
    End point values
    		 Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Number of subjects analysed
    118
    120
    Units: Subjects
        SAEs
    0
    4
    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.
    End point type
    Secondary
    End point timeframe
    Before booster vaccination at Month 0
    End point values
    		 Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Number of subjects analysed
    112
    111
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-6A [pre-booster] (N=109;111)
    0.23 (0.18 to 0.28)
    0.21 (0.16 to 0.26)
        Anti-19A [pre-booster] (N=112;109)
    0.18 (0.14 to 0.22)
    0.19 (0.15 to 0.24)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against diphtheria and tetanus

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    End point title
    		 Concentrations of antibodies against diphtheria and tetanus
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL.
    End point type
    Secondary
    End point timeframe
    Before booster vaccination at Month 0
    End point values
    		 Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Number of subjects analysed
    43
    49
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-diphtheria [pre-booster] (N=42;49)
    0.32 (0.25 to 0.39)
    0.3 (0.24 to 0.39)
        Anti-tetanus [pre-booster] (N=43;48)
    0.51 (0.43 to 0.61)
    0.47 (0.38 to 0.59)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN)

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    End point title
    		 Concentrations of antibodies against pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN)
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL.
    End point type
    Secondary
    End point timeframe
    Before booster vaccination at Month 0
    End point values
    		 Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Number of subjects analysed
    42
    47
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Anti-PT [pre-booster] (N=41;45)
    5.7 (4.5 to 7.2)
    6.5 (4.7 to 8.9)
        Anti-FHA [pre-booster] (N=40;46)
    19.5 (15.1 to 25.3)
    29.2 (21.5 to 39.6)
        Anti-PRN [pre-booster] (N=42;47)
    14.8 (10.7 to 20.6)
    15.1 (11.1 to 20.5)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against polyribosyl-ribitol phosphate (PRP)

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    End point title
    		 Concentrations of antibodies against polyribosyl-ribitol phosphate (PRP)
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL.
    End point type
    Secondary
    End point timeframe
    Before booster vaccination at Month 0
    End point values
    		 Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Number of subjects analysed
    52
    57
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP [pre-booster]
    0.68 (0.5 to 0.92)
    0.85 (0.65 to 1.11)
    No statistical analyses for this end point

    Secondary: Titers of antibodies against poliovirus types 1, 2 and 3

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    End point title
    		 Titers of antibodies against poliovirus types 1, 2 and 3
    End point description
    Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8.
    End point type
    Secondary
    End point timeframe
    Before booster vaccination at Month 0
    End point values
    		 Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Number of subjects analysed
    29
    25
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-polio 1 [pre-booster]
    40.7 (23.2 to 71.3)
    32.8 (19.1 to 56.3)
        Anti-polio 2 [pre-booster]
    38.7 (26.5 to 56.7)
    34.9 (18.8 to 64.7)
        Anti-polio 3 [pre-booster]
    40.7 (24.4 to 67.8)
    43.3 (24 to 78)
    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 millilitre (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.
    End point type
    Secondary
    End point timeframe
    Before and one month after booster vaccination (at Month 0 and Month 1)
    End point values
    		 Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Number of subjects analysed
    109
    111
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-1 [pre-booster] (N=109;109)
    0.48 (0.4 to 0.57)
    0.35 (0.3 to 0.41)
        Anti-1 [post-booster] (N=107;111)
    7.14 (6.12 to 8.32)
    6.29 (5.38 to 7.35)
        Anti-4 [pre-booster] (N=105;103)
    0.56 (0.47 to 0.67)
    0.48 (0.4 to 0.58)
        Anti-4 [post-booster] (N=106;109)
    7.53 (6.44 to 8.8)
    7.43 (6.33 to 8.71)
        Anti-5 [pre-booster] (N=101;100)
    0.77 (0.65 to 0.9)
    0.54 (0.46 to 0.62)
        Anti-5 [post-booster] (N=106;108)
    7.91 (6.91 to 9.06)
    7.16 (6.25 to 8.2)
        Anti-6B [pre-booster] (N=101;99)
    0.34 (0.29 to 0.4)
    0.32 (0.25 to 0.41)
        Anti-6B [post-booster] (N=106;109)
    3.3 (2.85 to 3.81)
    3.12 (2.59 to 3.76)
        Anti-7F [pre-booster] (N=102;102)
    0.88 (0.75 to 1.04)
    0.93 (0.8 to 1.08)
        Anti-7F [post-booster] (N=106;109)
    9.02 (7.77 to 10.47)
    9.25 (8.04 to 10.64)
        Anti-9V [pre-booster] (N=103;99)
    0.9 (0.77 to 1.06)
    0.72 (0.62 to 0.84)
        Anti-9V [post-booster] (N=107;109)
    9.36 (8.15 to 10.75)
    10.42 (8.94 to 12.14)
        Anti-14 [pre-booster] (N=103;97)
    1.05 (0.85 to 1.31)
    0.93 (0.76 to 1.14)
        Anti-14 [post-booster] (N=106;106)
    13.03 (10.95 to 15.5)
    13.28 (11.06 to 15.95)
        Anti-18C [pre-booster] (N=107;105)
    0.83 (0.69 to 1.01)
    0.78 (0.66 to 0.94)
        Anti-18C [post-booster] (N=106;108)
    19.8 (17.02 to 23.03)
    24.19 (20.66 to 28.33)
        Anti-19F [pre-booster] (N=101;100)
    1.11 (0.87 to 1.41)
    0.97 (0.82 to 1.14)
        Anti-19F [post-booster] (N=106;108)
    19.68 (17.22 to 22.51)
    20.55 (17.62 to 23.98)
        Anti-23F [pre-booster] (N=106;103)
    0.65 (0.5 to 0.83)
    0.47 (0.38 to 0.59)
        Anti-23F [post-booster] (N=107;109)
    7.19 (5.94 to 8.71)
    6.83 (5.77 to 8.07)
    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.
    End point type
    Secondary
    End point timeframe
    Before and one month after booster vaccination (at Month 0 and Month 1)
    End point values
    		 Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Number of subjects analysed
    110
    109
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-6A [pre-booster] (N=107;108)
    0.23 (0.18 to 0.28)
    0.21 (0.16 to 0.26)
        Anti-6A [post-booster] (N=106;108)
    2.13 (1.7 to 2.66)
    1.99 (1.6 to 2.49)
        Anti-19A [pre-booster] (N=110;106)
    0.18 (0.14 to 0.22)
    0.2 (0.15 to 0.25)
        Anti-19A [post-booster] (N=106;109)
    2.13 (1.65 to 2.76)
    2.96 (2.26 to 3.87)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against protein D (PD)

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    End point title
    		 Concentrations of antibodies against protein D (PD)
    End point description
    Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL).
    End point type
    Secondary
    End point timeframe
    Before and one month after booster vaccination (at Month 0 and Month 1)
    End point values
    		 Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Number of subjects analysed
    113
    115
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Anti-PD [pre-booster] (N=113;115)
    794.9 (686.3 to 920.7)
    618.4 (527.8 to 724.6)
        Anti-PD [post-booster] (N=107;111)
    3631.3 (3149.2 to 4187.2)
    3115.9 (2634.7 to 3685.1)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against diphtheria and tetanus

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    End point title
    		 Concentrations of antibodies against diphtheria and tetanus
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL.
    End point type
    Secondary
    End point timeframe
    Before and one month after booster vaccination (at Month 0 and Month 1)
    End point values
    		 Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Number of subjects analysed
    52
    55
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-diphtheria [pre-booster] (N=41;47)
    0.31 (0.25 to 0.39)
    0.29 (0.23 to 0.37)
        Anti-diphtheria [post-booster] (N=52;55)
    8.17 (6.72 to 9.94)
    10.89 (9.16 to 12.94)
        Anti-tetanus [pre-booster] (N=42;46)
    0.52 (0.43 to 0.62)
    0.46 (0.37 to 0.58)
        Anti-tetanus [post-booster] (N=52;55)
    14.35 (12.41 to 16.6)
    14.73 (12.75 to 17.01)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN)

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    End point title
    		 Concentrations of antibodies against pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN)
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL.
    End point type
    Secondary
    End point timeframe
    Before and one month after booster vaccination (at Month 0 and Month 1)
    End point values
    		 Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Number of subjects analysed
    52
    55
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Anti-PT [pre-booster] (N=40;43)
    5.8 (4.5 to 7.3)
    6.8 (4.9 to 9.3)
        Anti-PT [post-booster] (N=52;55)
    80.8 (65.6 to 99.4)
    86 (67.9 to 108.9)
        Anti-FHA [pre-booster] (N=39;44)
    19.3 (14.8 to 25.2)
    29.6 (21.5 to 40.7)
        Anti-FHA [post-booster] (N=52;54)
    358.3 (290.5 to 442)
    484.3 (418.9 to 559.9)
        Anti-PRN [pre-booster] (N=41;45)
    15 (10.7 to 20.9)
    15.4 (11.3 to 21)
        Anti-PRN [post-booster] (N=52;55)
    314.3 (229.6 to 430.2)
    509.5 (387 to 670.9)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against polyribosyl-ribitol phosphate (PRP)

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    End point title
    		 Concentrations of antibodies against polyribosyl-ribitol phosphate (PRP)
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL.
    End point type
    Secondary
    End point timeframe
    Before and one month after booster vaccination (at Month 0 and Month 1)
    End point values
    		 Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Number of subjects analysed
    53
    55
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP [pre-booster] (N=51;55)
    0.66 (0.48 to 0.9)
    0.84 (0.64 to 1.12)
        Anti-PRP [post-booster] (N=53;55)
    58.26 (43.71 to 77.66)
    49.36 (37.4 to 65.15)
    No statistical analyses for this end point

    Secondary: Titers of antibodies against poliovirus types 1, 2 and 3

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    End point title
    		 Titers of antibodies against poliovirus types 1, 2 and 3
    End point description
    Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8.
    End point type
    Secondary
    End point timeframe
    Before and one month after booster vaccination (at Month 0 and Month 1)
    End point values
    		 Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Number of subjects analysed
    28
    27
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-polio 1 [pre-booster] (N=28;25)
    44.2 (25.3 to 77.1)
    32.8 (19.1 to 56.3)
        Anti-polio 1 [post-booster] (N=25;27)
    982.2 (688 to 1402.3)
    985.2 (627.9 to 1546)
        Anti-polio 2 [pre-booster] (N=28;25)
    38 (25.7 to 56.4)
    34.9 (18.8 to 64.7)
        Anti-polio 2 [post-booster] (N=25;27)
    1144.1 (773.7 to 1691.7)
    823.4 (553.5 to 1224.8)
        Anti-polio 3 [pre-booster] (N=28;25)
    41 (24.2 to 69.7)
    43.3 (24 to 78)
        Anti-polio 3 [post-booster] (N=25;26)
    1350.8 (857.4 to 2128.2)
    1527.4 (1016.6 to 2294.7)
    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 booster vaccination. SAEs: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1. Unsolicited AEs:Within 31 days (Days 0-30) after booster vaccination.
    Adverse event reporting additional description
    The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected. Systematically assessed Other Adverse Events are reported only for those participants who completed their symptoms sheet.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group
    Reporting group description
    		 Children primed with 3 doses of commercial lot of Synflorix co-administered with Rotarix and Infanrix-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix co-administered with Infanrix-IPV/Hib. The Synflorix vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.

    Reporting group title
    Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group
    Reporting group description
    		 Children primed with 3 doses of clinical lot of Synflorix + Rotarix co-administered with Infanrix-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix co-administered with Infanrix-IPV/Hib. The Synflorix vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.

    Serious adverse events
    		 Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 120 (3.33%)
    0 / 118 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 118 (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
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 120 (1.67%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Synflorix Commercial-Commercial + Infanrix-IPV/Hib Group Synflorix Clinical-Commercial + Infanrix-IPV/Hib Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    108 / 120 (90.00%)
    98 / 118 (83.05%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    70 / 117 (59.83%)
    61 / 117 (52.14%)
         occurrences all number
    70
    61
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    61 / 117 (52.14%)
    66 / 117 (56.41%)
         occurrences all number
    61
    66
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    49 / 117 (41.88%)
    45 / 117 (38.46%)
         occurrences all number
    49
    45
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    49 / 117 (41.88%)
    38 / 117 (32.48%)
         occurrences all number
    49
    38
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    75 / 117 (64.10%)
    56 / 117 (47.86%)
         occurrences all number
    75
    56
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    67 / 117 (57.26%)
    51 / 117 (43.59%)
         occurrences all number
    67
    51
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    49 / 117 (41.88%)
    42 / 117 (35.90%)
         occurrences all number
    49
    42
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    5 / 120 (4.17%)
    7 / 118 (5.93%)
         occurrences all number
    5
    7
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 120 (5.00%)
    4 / 118 (3.39%)
         occurrences all number
    6
    4
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.

    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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