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    Clinical Trial Results:
    A phase III open study to assess the safety, reactogenicity and immunogenicity following booster administration of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine, co-administered with a booster dose of DTPa-IPV/Hib (Infanrix-IPV/Hib) vaccine in preterm born children at 16-18 months of age following primary immunisation in study 10PN-PD-DIT-015 (107737).

    Summary
    EudraCT number
    		 2007-000596-42
    Trial protocol
    		 GR   ES  
    Global end of trial date
    30 Mar 2009

    Results information
    Results version number
    		 v2(current)
    This version publication date
    19 Apr 2023
    First version publication date
    14 Jun 2015
    Other versions
    		 v1
    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
    109621
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00609492
    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 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Apr 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Mar 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and reactogenicity of a booster dose of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine co-administered with a booster dose of DTPa-IPV/Hib vaccine in preterm born children at 16-18 months of age.
    Protection of trial subjects
    In the purely scientific application of medical research carried out on a human being, it was the duty of the physician to remain the protector of the life and health of that person on whom biomedical research is being carried out. 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
    03 Jan 2008
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 167
    Country: Number of subjects enrolled
    Greece: 78
    Worldwide total number of subjects
    245
    EEA total number of subjects
    245
    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)
    245
    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
    		 -

    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
    Active Phase (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
    		 Preterm I Group
    Arm description
    		 Children born after a gestation period of 27-30 weeks (189-216 days) who were previously primed with three doses of 10Pn-PD-DiT (Synflorix) co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) in the primary vaccination study 10PN-PD-DIT-015.
    Arm type
    		 Experimental

    Investigational medicinal product name
    10-valent streptococcus pneumoniae conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT vaccine, Synflorix
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single booster dose, administered intramuscularly in the right thigh or right deltoid, at 16-18 months of age, following the primary vaccination administered in the study 10PN-PD-DIT-015(107737).

    Investigational medicinal product name
    Infanrix IPV/Hib
    Investigational medicinal product code
    Other name
    DTPa –IPV/Hib
    Pharmaceutical forms
    Powder and solvent for suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose, administered intramuscularly in the left thigh or left deltoid.

    Arm title
    		 Preterm II Group
    Arm description
    		 Children born after a gestation period of 31-36 weeks (217-258 days) who were previously primed with three doses of Synflorix co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) in the primary vaccination study 10PN-PD-DIT-015.
    Arm type
    		 Experimental

    Investigational medicinal product name
    10-valent streptococcus pneumoniae conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single booster dose, administered intramuscularly in the right thigh or right deltoid, at 16-18 months of age, following the primary vaccination administered in the study 10PN-PD-DIT-015(107737).

    Investigational medicinal product name
    Infanrix IPV/Hib
    Investigational medicinal product code
    Other name
    DTPa –IPV/Hib
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose, administered intramuscularly in the left thigh or left deltoid.

    Arm title
    		 Full term Group
    Arm description
    		 Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously primed with three doses of Synflorix co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) in the primary vaccination study 10PN-PD-DIT-015.
    Arm type
    		 Experimental

    Investigational medicinal product name
    10-valent streptococcus pneumoniae conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single booster dose, administered intramuscularly in the right thigh or right deltoid, at 16-18 months of age, following the primary vaccination administered in the study 10PN-PD-DIT-015(107737).

    Investigational medicinal product name
    Infanrix IPV/Hib
    Investigational medicinal product code
    Other name
    DTPa –IPV/Hib
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose, administered intramuscularly in the left thigh or left deltoid.

    Number of subjects in period 1
    		Preterm I Group Preterm II Group Full term Group
    Started
    44
    72
    129
    Completed
    43
    69
    122
    Not completed
    1
    3
    7
         Consent withdrawn by subject
    -
    2
    3
         Lost to follow-up
    1
    1
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Preterm I Group
    Reporting group description
    		 Children born after a gestation period of 27-30 weeks (189-216 days) who were previously primed with three doses of 10Pn-PD-DiT (Synflorix) co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) in the primary vaccination study 10PN-PD-DIT-015.

    Reporting group title
    Preterm II Group
    Reporting group description
    		 Children born after a gestation period of 31-36 weeks (217-258 days) who were previously primed with three doses of Synflorix co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) in the primary vaccination study 10PN-PD-DIT-015.

    Reporting group title
    Full term Group
    Reporting group description
    		 Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously primed with three doses of Synflorix co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) in the primary vaccination study 10PN-PD-DIT-015.

    Reporting group values
    		 Preterm I Group Preterm II Group Full term Group Total
    Number of subjects
    		 44 72 129 245
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 44 72 129 245
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 16.8 ± 0.63 17.2 ± 0.68 16.6 ± 0.73 -
    Gender categorical
    Units: Subjects
        Female
    		 16 29 50 95
        Male
    		 28 43 79 150

    End points

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    End points reporting groups
    Reporting group title
    Preterm I Group
    Reporting group description
    		 Children born after a gestation period of 27-30 weeks (189-216 days) who were previously primed with three doses of 10Pn-PD-DiT (Synflorix) co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) in the primary vaccination study 10PN-PD-DIT-015.

    Reporting group title
    Preterm II Group
    Reporting group description
    		 Children born after a gestation period of 31-36 weeks (217-258 days) who were previously primed with three doses of Synflorix co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) in the primary vaccination study 10PN-PD-DIT-015.

    Reporting group title
    Full term Group
    Reporting group description
    		 Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously primed with three doses of Synflorix co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) in the primary vaccination study 10PN-PD-DIT-015.

    Subject analysis set title
    Preterm Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Pooled group with subjects of the Preterm I Group and the Preterm II Group.

    Primary: Number of subjects reporting fever with rectal temperature above (>) 39.0 degrees Celsius (°C)

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    End point title
    		 Number of subjects reporting fever with rectal temperature above (>) 39.0 degrees Celsius (°C) [1] [2]
    End point description
    Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed within 4-days (Days 0-3) after booster vaccination of Synflorix and Infanrix-IPV/Hib vaccine.
    End point type
    Primary
    End point timeframe
    Within 4-days (Days 0-3) after booster vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: 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: This endpoint is only reporting values for the Full term Group and the Preterm Group.
    End point values
    		 Full term Group Preterm Group
    Number of subjects analysed
    122
    112
    Units: Subjects
        Fever>39°C
    6
    8
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any and Grade 3 solicited local symptoms [3]
    End point description
    Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity.
    End point type
    Secondary
    End point timeframe
    Within 4-days (Days 0-3) after booster vaccination
    Notes
    [3] - 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 is only reporting values for the Full term Group and the Preterm Group.
    End point values
    		 Full term Group Preterm Group
    Number of subjects analysed
    122
    112
    Units: Subjects
        Any Pain
    67
    47
        Grade 3 Pain
    4
    5
        Any Redness
    65
    35
        Grade 3 Redness
    19
    3
        Any Swelling
    55
    27
        Grade 3 Swelling
    14
    1
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any and Grade 3 solicited general symptoms [4]
    End point description
    Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥38.0°C), irritability, and loss of appetite. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 fever = fever above (>) 40.0 degree Celsius (°C). Grade 3 irritability = crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite = the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.
    End point type
    Secondary
    End point timeframe
    Within 4-days (Days 0-3) after booster vaccination
    Notes
    [4] - 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 is only reporting values for the Full term Group and the Preterm Group.
    End point values
    		 Full term Group Preterm Group
    Number of subjects analysed
    122
    112
    Units: Subjects
        Any Drowsiness
    33
    21
        Grade 3 Drowsiness
    1
    1
        Any Fever
    39
    34
        Grade 3 Fever
    1
    0
        Any Irritability
    49
    36
        Grade 3 Irritability
    2
    2
        Any Loss of appetite
    35
    26
        Grade 3 Loss of appetite
    1
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs) [5]
    End point description
    An AE is 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. “Any” is defined as incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
    End point type
    Secondary
    End point timeframe
    Within 31-days (Days 0-30) after booster vaccination
    Notes
    [5] - 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 is only reporting values for the Full term Group and the Preterm Group.
    End point values
    		 Full term Group Preterm Group
    Number of subjects analysed
    129
    116
    Units: Subjects
        Any AE(s)
    24
    17
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with serious adverse events (SAEs) [6]
    End point description
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    Throughout the active phase of the study (Month 0 to Month 1)
    Notes
    [6] - 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 is only reporting values for the Full term Group and the Preterm Group.
    End point values
    		 Full term Group Preterm Group
    Number of subjects analysed
    129
    116
    Units: Subjects
        Any SAE(s)
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with serious adverse events (SAEs) [7]
    End point description
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    Throughout the entire study period starting from Month 0 up to the end of the extended safety follow-up (Month 6)
    Notes
    [7] - 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 is only reporting values for the Full term Group and the Preterm Group.
    End point values
    		 Full term Group Preterm Group
    Number of subjects analysed
    129
    116
    Units: Subjects
        Any SAE(s)
    1
    3
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations above or equal to (≥) 0.20 microgram per millilitre (µg/mL)

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    End point title
    		 Number of subjects with anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations above or equal to (≥) 0.20 microgram per millilitre (µg/mL)
    End point description
    A seroprotected subject was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The anti-pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
    End point type
    Secondary
    End point timeframe
    Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix vaccine co-administered with the booster dose of Infanrix-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    43
    69
    125
    Units: Subjects
        Anti-1, Pre-booster [N=43;66;121]
    16
    28
    53
        Anti-1, Post-booster [N=43;66;119]
    43
    66
    118
        Anti-4, Pre-booster [N=43;69;123]
    23
    40
    82
        Anti-4, Post-booster [N=43;66;119]
    43
    66
    119
        Anti-5, Pre-booster [N=43;68;124]
    27
    43
    105
        Anti-5, Post-booster [N=43;66;119]
    43
    66
    119
        Anti-6B, Pre-booster [N=43;67;124]
    28
    41
    99
        Anti-6B, Post-booster [N=42;66;119]
    42
    65
    119
        Anti-7F, Pre-booster [N=43;65;123]
    34
    56
    115
        Anti-7F, Post-booster [N=43;66;118]
    43
    66
    118
        Anti-9V, Pre-booster [N=43;69;123]
    39
    59
    115
        Anti-9V, Post-booster [N=43;66;119]
    43
    66
    119
        Anti-14, Pre-booster [N=43;68;124]
    41
    55
    105
        Anti-14, P-booster [N=43;66;119]
    43
    66
    119
        Anti-18C, Pre-booster [N=43;68;125]
    36
    60
    106
        Anti-18C, Post-booster [N=43;66;119]
    43
    66
    118
        Anti-19F, Pre-booster [N=43;68;125]
    38
    66
    120
        Anti-19F, Post-booster [N=43;66;119]
    43
    66
    119
        Anti-23F, Pre-booster [N=43;69;123]
    30
    45
    99
        Anti-23F, Post-booster [N=42;66;119]
    41
    66
    118
    No statistical analyses for this end point

    Secondary: Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations

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    End point title
    		 Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations
    End point description
    Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.05 microgram per millilitre (µg/mL). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).
    End point type
    Secondary
    End point timeframe
    Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix vaccine co-administered with the booster dose of Infanrix-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    43
    69
    125
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-1, Pre-booster [N=43;66;121]
    0.15 (0.11 to 0.2)
    0.14 (0.11 to 0.18)
    0.17 (0.15 to 0.21)
        Anti-1, Post-booster [N=43;66;119]
    1.57 (1.2 to 2.05)
    1.74 (1.41 to 2.15)
    1.98 (1.66 to 2.37)
        Anti-4, Pre-booster [N=43;69;123]
    0.25 (0.18 to 0.35)
    0.24 (0.2 to 0.3)
    0.3 (0.25 to 0.35)
        Anti-4, Post-booster [N=43;66;119]
    2.98 (2.31 to 3.85)
    3.67 (3.07 to 4.39)
    4.23 (3.67 to 4.88)
        Anti-5, Pre-booster [N=43;68;124]
    0.24 (0.18 to 0.33)
    0.27 (0.21 to 0.34)
    0.4 (0.34 to 0.48)
        Anti-5, Post-booster [N=43;66;119]
    1.84 (1.43 to 2.38)
    2.38 (1.93 to 2.94)
    2.58 (2.2 to 3.02)
        Anti-6B, Pre-booster [N=43;67;124]
    0.28 (0.21 to 0.38)
    0.3 (0.23 to 0.37)
    0.37 (0.31 to 0.45)
        Anti-6B, Post-booster [N=42;66;119]
    2.44 (1.87 to 3.17)
    2.46 (1.97 to 3.06)
    2.67 (2.27 to 3.13)
        Anti-7F, Pre-booster [N=43;65;123]
    0.42 (0.31 to 0.56)
    0.46 (0.37 to 0.58)
    0.66 (0.57 to 0.77)
        Anti-7F, Post-booster [N=43;66;118]
    3.11 (2.48 to 3.9)
    4.16 (3.52 to 4.9)
    3.93 (3.45 to 4.47)
        Anti-9V, Pre-booster [N=43;69;123]
    0.51 (0.39 to 0.67)
    0.42 (0.35 to 0.52)
    0.59 (0.51 to 0.69)
        Anti-9V, Post-booster [N=43;66;119]
    2.87 (2.23 to 3.7)
    3.47 (2.86 to 4.2)
    4.17 (3.6 to 4.83)
        Anti-14, Pre-booster [N=43;68;124]
    0.78 (0.54 to 1.11)
    0.48 (0.37 to 0.61)
    0.68 (0.55 to 0.84)
        Anti-14, P-booster [N=43;66;119]
    4.88 (3.42 to 6.98)
    5.14 (4.22 to 6.25)
    5.98 (5.1 to 7.02)
        Anti-18C, Pre-booster [N=43;68;125]
    0.58 (0.42 to 0.8)
    0.56 (0.45 to 0.7)
    0.6 (0.49 to 0.73)
        Anti-18C, Post-booster [N=43;66;119]
    9.51 (7.36 to 12.29)
    13.2 (10.97 to 15.89)
    12.38 (10.21 to 15)
        Anti-19F, Pre-booster [N=43;68;125]
    0.86 (0.58 to 1.3)
    1.07 (0.78 to 1.46)
    1.27 (1.02 to 1.59)
        Anti-19F, Post-booster [N=43;66;119]
    6.83 (5.24 to 8.89)
    9.78 (8.19 to 11.68)
    9.72 (8.38 to 11.29)
        Anti-23F, Pre-booster [N=43;69;123]
    0.27 (0.2 to 0.36)
    0.3 (0.24 to 0.38)
    0.42 (0.35 to 0.51)
        Anti-23F, Post-booster [N=42;66;119]
    2.7 (1.91 to 3.81)
    3.45 (2.93 to 4.06)
    3.3 (2.74 to 3.99)
    No statistical analyses for this end point

    Secondary: Antibody concentrations against pneumococcal cross-reactive serotypes 6A and 19A

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    End point title
    		 Antibody concentrations against pneumococcal cross-reactive serotypes 6A and 19A
    End point description
    Seropositivity status, defined as anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥0.05 microgram per millilitre (µg/mL).
    End point type
    Secondary
    End point timeframe
    Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix vaccine co-administered with the booster dose of Infanrix-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    43
    67
    122
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-6A, Pre-booster [N=42;67;122]
    0.12 (0.08 to 0.17)
    0.12 (0.09 to 0.16)
    0.14 (0.12 to 0.18)
        Anti-6A, Post-booster [N=42;66;118]
    0.7 (0.47 to 1.05)
    0.77 (0.55 to 1.07)
    0.79 (0.61 to 1.02)
        Anti-19A, Pre-booster [N=43;67;121]
    0.14 (0.08 to 0.24)
    0.15 (0.1 to 0.22)
    0.16 (0.12 to 0.22)
        Anti-19A, Post-booster [N=42;66;118]
    0.65 (0.4 to 1.04)
    0.93 (0.64 to 1.37)
    1.1 (0.82 to 1.47)
    No statistical analyses for this end point

    Secondary: Antibody concentrations to protein D (Anti-PD)

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    End point title
    		 Antibody concentrations to protein D (Anti-PD)
    End point description
    Seropositivity status, defined as anti-PD antibody concentrations ≥ 100 ELISA units per millilitre (EL.U/mL). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).
    End point type
    Secondary
    End point timeframe
    Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of 10Pn-PD-DiT vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    43
    67
    123
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PD Pre-booster [N=42;67;123]
    478.3 (361.4 to 633.1)
    340 (258.1 to 447.9)
    383.7 (317.6 to 463.5)
        Anti-PD Post-booster [N=43;66;118]
    1892.9 (1415.1 to 2532.2)
    1576.5 (1232.7 to 2016.1)
    1533.6 (1278.2 to 1840.1)
    No statistical analyses for this end point

    Secondary: Anti-diphtheria (Anti-DT) and anti-tetanus toxoids (Anti-TT) antibody concentrations

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    End point title
    		 Anti-diphtheria (Anti-DT) and anti-tetanus toxoids (Anti-TT) antibody concentrations
    End point description
    Seroprotection status, defined as anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥0.1 IU/mL. Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).
    End point type
    Secondary
    End point timeframe
    Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of 10Pn-PD-DiT vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    23
    34
    60
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-DT Pre-booster [N=23;31;59]
    0.381 (0.21 to 0.689)
    0.674 (0.38 to 1.196)
    0.481 (0.324 to 0.716)
        Anti-DT Post-booster [N=21;34;60]
    6.252 (4.572 to 8.551)
    9.982 (7.392 to 13.478)
    6.73 (5.254 to 8.62)
        Anti-TT Pre-booster [N=23;32;59]
    0.821 (0.591 to 1.141)
    0.726 (0.601 to 0.877)
    0.918 (0.711 to 1.184)
        Anti-TT Post-booster [N=21;34;60]
    12.374 (9.629 to 15.903)
    14.392 (11.717 to 17.676)
    13.026 (11.176 to 15.183)
    No statistical analyses for this end point

    Secondary: Anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations

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    End point title
    		 Anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations
    End point description
    Seroprotection status, defined as anti-PRP antibody concentrations ≥0.15 µg/mL and ≥1.0 µg/mL. Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).
    End point type
    Secondary
    End point timeframe
    Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of 10Pn-PD-DiT vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    23
    34
    59
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP Pre-booster [N=23;32;59]
    0.376 (0.196 to 0.719)
    0.509 (0.312 to 0.832)
    0.577 (0.372 to 0.896)
        Anti-PRP Post-booster [N=20;34;59]
    33.731 (17.907 to 63.54)
    36.902 (25.148 to 54.148)
    38.713 (27.736 to 54.034)
    No statistical analyses for this end point

    Secondary: Anti-pertussis toxoid (Anti-PT), anti- filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations

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    End point title
    		 Anti-pertussis toxoid (Anti-PT), anti- filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations
    End point description
    Seropositivity status, defined as anti-PT, anti-FHA, anti-PRN antibody concentrations ≥5 EL.U/mL. Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).
    End point type
    Secondary
    End point timeframe
    Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of 10Pn-PD-DiT vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    23
    34
    60
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT Pre-booster [N=22;32;58]
    5.7 (3.3 to 9.8)
    3.8 (3 to 4.7)
    5.5 (4.4 to 6.9)
        Anti-PT Post-booster [N=21;34;59]
    38.4 (29.8 to 49.5)
    32.7 (24.2 to 44.2)
    45.1 (37 to 54.9)
        Anti-FHA Pre-booster [N=20;27;47]
    39.4 (18.4 to 84.2)
    13.7 (9.3 to 20.1)
    17 (12.4 to 23.3)
        Anti-FHA Post-booster [N=21;34;59]
    250.3 (162.4 to 385.8)
    275.3 (207 to 366.1)
    229 (188.1 to 278.9)
        Anti-PRN Pre-booster [N=23;32;59]
    16.7 (9.4 to 29.9)
    10.3 (7.4 to 14.2)
    11.3 (8.7 to 14.8)
        Anti-PRN Post-booster [N=21;34;60]
    259.7 (151.5 to 445.2)
    286.5 (192.6 to 426)
    264.5 (200.2 to 349.5)
    No statistical analyses for this end point

    Secondary: Anti-polio type 1, 2 and 3 antibody titers

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    End point title
    		 Anti-polio type 1, 2 and 3 antibody titers
    End point description
    Seroprotection status, defined as Anti-polio type 1, Anti-polio type 2 and Anti-polio type 3 antibody titers ≥ 8 presented as geometric mean titers (GMTs).
    End point type
    Secondary
    End point timeframe
    Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of 10Pn-PD-DiT vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    17
    29
    53
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Polio 1 Pre-booster [N=17;29;53]
    52.3 (31.2 to 87.6)
    34.8 (19.4 to 62.7)
    54.7 (37.7 to 79.3)
        Anti-Polio 1 Post-booster [N=3;8;20]
    512 (115.3 to 2274)
    1386.7 (456.6 to 4210.9)
    1327.9 (795.4 to 2217.1)
        Anti-Polio 2 Pre-booster [N=17;29;53]
    65.2 (37.4 to 113.7)
    47.3 (26.2 to 85.3)
    50.9 (33.7 to 76.6)
        Anti-Polio 2 Post-booster [N=3;8;20]
    1290.1 (147.8 to 11259.3)
    2048 (759.7 to 5520.9)
    1116.9 (600.9 to 2076.1)
        Anti-Polio 3 Pre-booster [N=17;29;53]
    23 (10 to 53.2)
    31.3 (16.8 to 58.4)
    84.3 (59 to 120.4)
        Anti-Polio 3 Post-booster [N=3;8;20]
    574.7 (36.1 to 9148.9)
    1448.1 (464 to 4519.2)
    1692.5 (1147.7 to 2495.9)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 µg/mL

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    End point title
    		 Number of subjects with anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 µg/mL
    End point description
    A seropositive subject was defined as a subject who had the anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C , 19F and 23F concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (μg/mL).
    End point type
    Secondary
    End point timeframe
    Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of 10Pn-PD-DiT vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    43
    69
    125
    Units: Subjects
        Anti-1, Pre-booster [N=43;66;121]
    39
    56
    111
        Anti-1, Post-booster [N=43;66;119]
    43
    66
    119
        Anti-4, Pre-booster [N=43;69;123]
    40
    68
    120
        Anti-4, Post-booster [N=43;66;119]
    43
    66
    119
        Anti-5, Pre-booster [N=43;68;124]
    41
    66
    122
        Anti-5, Post-booster [N=43;66;119]
    43
    66
    119
        Anti-6B, Pre-booster [N=43;67;124]
    41
    66
    119
        Anti-6B, Post-booster [N=42;66;119]
    42
    65
    119
        Anti-7F, Pre-booster [N=43;65;123]
    42
    65
    123
        Anti-7F, Post-booster [N=43;66;118]
    43
    66
    118
        Anti-9V, Pre-booster [N=43;69;123]
    43
    69
    123
        Anti-9V, Post-booster [N=43;66;119]
    43
    66
    119
        Anti-14, Pre-booster [N=43;68;124]
    43
    68
    121
        Anti-14, P-booster [N=43;66;119]
    43
    66
    119
        Anti-18C, Pre-booster [N=43;68;125]
    43
    68
    123
        Anti-18C, Post-booster [N=43;66;119]
    43
    66
    118
        Anti-19F, Pre-booster [N=43;68;125]
    43
    68
    125
        Anti-19F, Post-booster [N=43;66;119]
    43
    66
    119
        Anti-23F, Pre-booster [N=43;69;123]
    41
    68
    122
        Anti-23F, Post-booster [N=42;66;119]
    41
    66
    118
    No statistical analyses for this end point

    Secondary: Number of subjects with concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A ≥ 0.05 μg/mL

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    End point title
    		 Number of subjects with concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A ≥ 0.05 μg/mL
    End point description
    A seropositive subject was defined as a subject who had the anti-pneumococcal serotypes 6A and 19A concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (μg/mL).
    End point type
    Secondary
    End point timeframe
    Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of 10Pn-PD-DiT vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    43
    67
    122
    Units: Subjects
        Anti-6A, Pre-booster [N=42;67;122]
    34
    51
    98
        Anti-6A, Post-booster [N=42;66;118]
    41
    63
    115
        Anti-19A, Pre-booster [N=43;67;121]
    28
    49
    95
        Anti-19A, Post-booster [N=42;66;118]
    40
    63
    113
    No statistical analyses for this end point

    Secondary: Number of subjects with antibody concentrations against protein D (Anti-PD) ≥ 100 EL.U/mL

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    End point title
    		 Number of subjects with antibody concentrations against protein D (Anti-PD) ≥ 100 EL.U/mL
    End point description
    A seropositive subject was defined as a subject who had anti-PD concentration greater than or equal to (≥) the value of 100 ELISA units per milliliter (EL.U/mL).
    End point type
    Secondary
    End point timeframe
    Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of 10Pn-PD-DiT vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    43
    67
    123
    Units: Subjects
        Anti-PD Pre-booster [N=42;67;123]
    39
    58
    114
        Anti-PD Post-booster [N=43;66;118]
    43
    66
    117
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-pertussis toxoid (Anti-PT), anti- filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations ≥ 5 ELISA units per millilitre (EL.U/mL)

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    End point title
    		 Number of subjects with anti-pertussis toxoid (Anti-PT), anti- filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations ≥ 5 ELISA units per millilitre (EL.U/mL)
    End point description
    A seropositive subject was defined as a subject who had anti-PT, anti-FHA and anti-PRN concentrations greater than or equal to (≥) the value of 5 ELISA units per milliliter (EL.U/mL).
    End point type
    Secondary
    End point timeframe
    Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of 10Pn-PD-DiT vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    23
    34
    60
    Units: Subjects
        Anti-PT Pre-booster [N=22;32;58]
    10
    11
    30
        Anti-PT Post-booster [N=21;34;59]
    21
    34
    59
        Anti-FHA Pre-booster [N=20;27;47]
    19
    24
    43
        Anti-FHA Post-booster [N=21;34;59]
    21
    34
    59
        Anti-PRN Pre-booster [N=23;32;59]
    20
    28
    47
        Anti-PRN Post-booster [N=21;34;60]
    21
    34
    60
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-diphtheria (Anti-DT) and anti-tetanus toxoids (Anti-TT) antibody concentrations ≥ 0.1 international units per mililitre (IU/mL)

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    End point title
    		 Number of subjects with anti-diphtheria (Anti-DT) and anti-tetanus toxoids (Anti-TT) antibody concentrations ≥ 0.1 international units per mililitre (IU/mL)
    End point description
    A seroprotected subject was defined as a subject who had anti-DT and anti-TT concentrations greater than or equal to (≥) the value of 0.1 international units per milliliter (IU/mL).
    End point type
    Secondary
    End point timeframe
    Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of 10Pn-PD-DiT vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    23
    34
    60
    Units: Subjects
        Anti-DT Pre-booster [N=23;31;59]
    20
    27
    51
        Anti-DT Post-booster [N=21;34;60]
    21
    34
    60
        Anti-TT Pre-booster [N=23;32;59]
    23
    32
    59
        Anti-TT Post-booster [N=21;34;60]
    21
    34
    60
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration ≥ 0.15 µg/mL

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    End point title
    		 Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration ≥ 0.15 µg/mL
    End point description
    A seroprotected subject was defined as a subject who had anti-PRP concentrations greater than or equal to (≥) the value of 0.15 micrograms per milliliter (µg /mL).
    End point type
    Secondary
    End point timeframe
    Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of 10Pn-PD-DiT vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    23
    34
    59
    Units: Subjects
        Anti-PRP Pre-booster [N=23;32;59]
    16
    26
    50
        Anti-PRP Post-booster [N=20;34;59]
    20
    34
    59
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration ≥ 1.0 µg/mL

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    End point title
    		 Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration ≥ 1.0 µg/mL
    End point description
    The concentration of anti-polyribosyl-ribitol phosphate (Anti-PRP) antibody assessed was greater than or equal to (≥) the value of 1.0 micrograms per milliliter (µg /mL).
    End point type
    Secondary
    End point timeframe
    Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of 10Pn-PD-DiT vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    23
    34
    59
    Units: Subjects
        Anti-PRP Pre-booster [N=23;32;59]
    6
    9
    20
        Anti-PRP Post-booster [N=20;34;59]
    20
    34
    59
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polio type 1, 2 and 3 (Anti-Polio 1, 2 and 3) antibody titers ≥ 8

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    End point title
    		 Number of subjects with anti-polio type 1, 2 and 3 (Anti-Polio 1, 2 and 3) antibody titers ≥ 8
    End point description
    A seroprotected subject was defined as a subject who had anti-polio types 1, 2 and 3 titers greater than or equal to (≥) the value of 8.
    End point type
    Secondary
    End point timeframe
    Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of 10Pn-PD-DiT vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    17
    29
    53
    Units: Subjects
        Anti-Polio 1 Pre-booster [N=17;29;53]
    17
    22
    49
        Anti-Polio 1 Post-booster [N=3;8;20]
    3
    8
    20
        Anti-Polio 2 Pre-booster [N=17;29;53]
    17
    26
    47
        Anti-Polio 2 Post-booster [N=3;8;20]
    3
    8
    20
        Anti-Polio 3 Pre-booster [N=17;29;53]
    12
    23
    51
        Anti-Polio 3 Post-booster [N=3;8;20]
    3
    8
    20
    No statistical analyses for this end point

    Secondary: Number of subjects with vaccine response for anti-PT, anti-FHA and anti-PRN antibodies

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    End point title
    		 Number of subjects with vaccine response for anti-PT, anti-FHA and anti-PRN antibodies
    End point description
    Vaccine response defined as : For initially seronegative subjects(S-)( with concentrations < 5 EL.U/mL), antibody concentration ≥ 5 EL.U/mL at post-Booster For initially seropositive subjects (S+) (with concentrations ≥ 5 EL.U/mL): antibody concentration at post-Booster ≥ 2 fold the pre-vaccination antibody concentration
    End point type
    Secondary
    End point timeframe
    One month after (Post-booster) the administration of the booster dose of 10Pn-PD-DiT vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    19
    28
    45
    Units: Subjects
        Anti-PT, S- [N=11;21;27]
    11
    21
    27
        Anti-PT, S+ [N=9;11;27]
    9
    11
    24
        Anti-FHA, S- [N=1;3;4]
    1
    3
    4
        Anti-FHA, S+ [N=17;24;39]
    17
    24
    37
        Anti-PRN, S- [N=2;4;11]
    2
    4
    11
        Anti-PRN, S+ [N=19;28;45]
    19
    28
    44
    No statistical analyses for this end point

    Secondary: Anti-hepatitis B surface antigen (HBs) antibody concentrations

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    End point title
    		 Anti-hepatitis B surface antigen (HBs) antibody concentrations
    End point description
    Seroprotection status, defined as Anti-HBs antibody concentrations ≥ 10 mIU/mL.
    End point type
    Secondary
    End point timeframe
    Prior to the administration of the booster dose of 10Pn-PD-DiT vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    2
    1
    12
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs
    21.9 (1.9 to 246.8)
    117.2 (117.2 to 117.2)
    37.2 (15.6 to 88.8)
    No statistical analyses for this end point

    Secondary: Opsonophagocytic activity (OPA) titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F

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    End point title
    		 Opsonophagocytic activity (OPA) titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
    End point description
    Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8 presented as geometric mean titers (GMTs).
    End point type
    Secondary
    End point timeframe
    One month after the administration of the booster dose of 10Pn-PD-DiT vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    38
    55
    100
    Units: Titers
    geometric mean (confidence interval 95%)
        OPA Anti-1, [N=37;52;99]
    125 (74.1 to 210.8)
    143.6 (93.1 to 221.3)
    170.9 (124.6 to 234.3)
        OPA Anti-4 ,[N=36;55;100]
    971.8 (623.7 to 1514.1)
    1307.2 (1070 to 1596.9)
    1479.3 (1259.6 to 1737.3)
        OPA Anti-5,[N=34;50;93]
    69.2 (45 to 106.4)
    120 (81.2 to 177.1)
    176.9 (138.1 to 226.5)
        OPA Anti-6B, [N=35;51;98]
    659 (353.9 to 1227.3)
    459.1 (286.7 to 735.3)
    635 (437.3 to 922.1)
        OPA Anti-7F, [N=37;49;99]
    6008.9 (4318.7 to 8360.5)
    4851.1 (3954.4 to 5951.1)
    4372.6 (3658.8 to 5225.5)
        OPA Anti-9V,[N=38;47;100]
    1666.4 (1218.1 to 2279.6)
    2192.5 (1724.3 to 2787.8)
    1798.8 (1522.8 to 2124.7)
        OPA Anti-14,[N=36;52;99]
    1489.5 (980.7 to 2262.3)
    1895.3 (1477.3 to 2431.7)
    1342.7 (1095.4 to 1646)
        OPA Anti-18C, [N=37;50;100]
    1656 (1005.6 to 2727)
    1672.4 (1154.4 to 2422.9)
    1561.9 (1251.2 to 1949.8)
        OPA Anti-19F,[N=36;52;96]
    379.3 (241.3 to 596.2)
    486.3 (327.9 to 721.3)
    626.8 (473.1 to 830.3)
        OPA Anti-23F,[N=37;54;99]
    2881.8 (1956.7 to 4244.3)
    2510.2 (2076.2 to 3035)
    3208.6 (2667.3 to 3859.8)
    No statistical analyses for this end point

    Secondary: Opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A

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    End point title
    		 Opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A
    End point description
    Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8 presented as geometric mean titers (GMTs).
    End point type
    Secondary
    End point timeframe
    One month after the administration of the booster dose of 10Pn-PD-DiT vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    38
    52
    95
    Units: Titers
    geometric mean (confidence interval 95%)
        OPA Anti-6A [N=34;50;95]
    270.6 (152.9 to 478.6)
    218.2 (137.4 to 346.6)
    207.4 (136.8 to 314.4)
        OPA Anti-19A [N=38;52;95]
    31.9 (16 to 63.6)
    41.4 (22 to 77.8)
    51.7 (32.1 to 83.5)
    No statistical analyses for this end point

    Secondary: Number of subjects with opsonophagocytic activity (OPA) titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8

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    End point title
    		 Number of subjects with opsonophagocytic activity (OPA) titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8
    End point description
    A seropositive subject was defines as a subject with opsonophagocytic activity cut-off value greater than or equal to (≥) the value of 8. The vaccine pneumococcal serotypes investigated were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
    End point type
    Secondary
    End point timeframe
    One month after the administration of the booster dose of 10Pn-PD-DiT vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    38
    55
    100
    Units: Subjects
        OPA Anti-1,[N=37;52;99]
    34
    49
    93
        OPA Anti-4,[N=36;55;100]
    35
    55
    100
        OPA Anti-5,[N=34;50;93]
    32
    48
    92
        OPA Anti-6B,[N=35;51;98]
    33
    49
    92
        OPA Anti-7F,[N=37;49;99]
    37
    49
    99
        OPA Anti-9V,[N=38;47;100]
    38
    47
    100
        OPA Anti-14,[N=36;52;99]
    36
    52
    99
        OPA Anti-18C,[N=37;50;100]
    37
    50
    100
        OPA Anti-19F,[N=36;52;96]
    36
    51
    96
        OPA Anti-23F,[N=37;54;99]
    37
    54
    99
    No statistical analyses for this end point

    Secondary: Number of subjects with opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8

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    End point title
    		 Number of subjects with opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8
    End point description
    A seropositive subject was defined as a subject with opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A greater than or equal to (≥) the cut-off value of 8.
    End point type
    Secondary
    End point timeframe
    One month after the administration of the booster dose of 10Pn10Pn-PD-DiT vaccine co-administered with the booster dose of DTPa-IPV/Hib vaccine
    End point values
    		 Preterm I Group Preterm II Group Full term Group
    Number of subjects analysed
    38
    52
    95
    Units: Subjects
        OPA Anti-6A ,[N=34;50;95]
    31
    45
    79
        OPA Anti-19A,[N=38;52;95]
    23
    30
    56
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and general symptoms: during the 4- days (Days 0-3) after booster vaccination. Unsolicited AEs: within 31- days (Days 0-30) after booster vaccination; SAEs: throughout the entire study period starting from Month 0 up to the end of study
    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.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Preterm Group
    Reporting group description
    		 -

    Reporting group title
    Full term Group
    Reporting group description
    		 -

    Serious adverse events
    		 Preterm Group Full term Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 116 (2.59%)
    1 / 129 (0.78%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 129 (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
    Bronchospasm
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 129 (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
    Latent tuberculosis
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 129 (0.78%)
         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
    1 / 116 (0.86%)
    0 / 129 (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
    		 Preterm Group Full term Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    71 / 116 (61.21%)
    98 / 129 (75.97%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    47 / 112 (41.96%)
    67 / 122 (54.92%)
         occurrences all number
    47
    67
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    35 / 112 (31.25%)
    65 / 122 (53.28%)
         occurrences all number
    35
    65
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    27 / 112 (24.11%)
    55 / 122 (45.08%)
         occurrences all number
    27
    55
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    21 / 112 (18.75%)
    33 / 122 (27.05%)
         occurrences all number
    21
    33
    Fever (rectal temperature measurement)
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    34 / 112 (30.36%)
    39 / 122 (31.97%)
         occurrences all number
    34
    39
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    36 / 112 (32.14%)
    49 / 122 (40.16%)
         occurrences all number
    36
    49
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    26 / 112 (23.21%)
    35 / 122 (28.69%)
         occurrences all number
    26
    35
    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: Assessment for this event for this phase was performed solely 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: Assessment for this event for this phase was performed solely 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: Assessment for this event for this phase was performed solely 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: Assessment for this event for this phase was performed solely 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: Assessment for this event for this phase was performed solely 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: Assessment for this event for this phase was performed solely 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: Assessment for this event for this phase was performed solely 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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