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    Clinical Trial Results:
    A phase IIIa single-blind, controlled multicentre study to assess the safety, reactogenicity and immunogenicity of GSK Biologicals 10-valent pneumococcal conjugate vaccine or Prevenar when given as a fourth dose between 12-18 months of age in children previously vaccinated in infancy in the primary study 10PN-PD-DIT-001 (105553) with either GSK Biologicals 10-valent pneumococcal conjugate vaccine or Prevenar.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2006-001628-38
    Trial protocol
    		 FI   FR  
    Global end of trial date
    06 Nov 2007

    Results information
    Results version number
    		 v2
    This version publication date
    19 Mar 2016
    First version publication date
    29 Apr 2015
    Other versions
    		 v1 (removed from public view) , v3
    Version creation reason
    • Correction of full data set
    Data correction due to a system error in EudraCT – Results Correction of errors detected in immunogenicity data

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    107046
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00370396
    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
    13 Jun 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Nov 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine is non-inferior to Prevenar, both co-administered with DTPa-HBV-IPV/Hib vaccine, in terms of post-immunization febrile reactions with rectal fever > 39.0°C. Criteria for safety: Non-inferiority will be demonstrated if the upper limit of the 95% CI of the difference (10Pn-10Pn group minus 7Pn-7Pn group), in terms of percentage of subjects with rectal fever >39.0°C, is lower than 10%.
    Protection of trial subjects
    All subjects were supervised after vaccination/product administration with appropriate medical treatment readily available. Vaccines/products were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines/products. Towards ensuring the safety of subjects, the study design included an Active Primary Phase (Months 0-1) followed by an additional 5-months Extended Safety Follow-up Phase (ESFU (up to 6 months after the last vaccination/product administration during an). Prior to vaccination, subjects’ pre-vaccination body temperature was also evaluated.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Sep 2006
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 5 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 398
    Country: Number of subjects enrolled
    France: 142
    Country: Number of subjects enrolled
    Poland: 572
    Worldwide total number of subjects
    1112
    EEA total number of subjects
    1112
    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)
    1112
    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 study consisted of approximately 1200 subjects who were previously enrolled and had been vaccinated with either the 10Pn or 7Pn vaccine as part of the 10PN-PD-DIT-001 (105553) study (EudraCTnumber: 2005-003300-11).

    Pre-assignment
    Screening details
    		 During the screening the following was performed: informed consent was obtained and signed from parents or guardians of subjects, check for inclusion/exclusion criteria and contraindications/precautions was performed, and medical history of subjects was collected. Prior to vaccination, subjects’ pre-vaccination body temperature was evaluated.

    Period 1
    Period 1 title
    Overall Study Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 10Pn-10Pn Group
    Arm description
    		 This group consisted of subjects previously vaccinated with the 10Pn-PD-DiT vaccine (also referred as 10Pn vaccine or Synflorix™) as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of 10Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the second dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of 10Pn vaccine, injected IM in the right thigh or deltoid, co-administered with DTPa-HBV-IPV/Hib vaccine, injected IM in the left thigh or deltoid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    10 valent streptococcus pneumoniae conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT, Synflorix™ (by GSK Biologicals)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered at 12-18 months of age in the left thigh or deltoid

    Investigational medicinal product name
    DTPa-HBV-IPV/Hib
    Investigational medicinal product code
    Other name
    Infanrix hexa™ (by GSK Biologicals)
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered at at 12-18 months of age in the right thigh or deltoid

    Arm title
    		 7Pn-7Pn Group
    Arm description
    		 This group consisted of subjects previously vaccinated with the 7Pn vaccine (also referred as Prevenar™) as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of 7Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the second dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of 7Pn vaccine, injected IM in the right thigh or deltoid, co-administered with DTPa-HBV-IPV/Hib vaccine, injected IM in the left thigh or deltoid.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    7Pn
    Investigational medicinal product code
    Other name
    Prevenar™ by Wyeth Lederle Vaccines S.A.
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered at 12-18 months of age in the left thigh or deltoid

    Investigational medicinal product name
    DTPa-HBV-IPV/Hib
    Investigational medicinal product code
    Other name
    Infanrix hexa™ (by GSK Biologicals)
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered at at 12-18 months of age in the right thigh or deltoid

    Arm title
    		 7Pn-10Pn Group
    Arm description
    		 This group consisted of subjects previously vaccinated with the 7Pn vaccine (also referred as Prevenar™) as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of 7Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the second dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of 10Pn-PD-DiT vaccine (also referred as 10Pn vaccine or Synflorix™), injected IM in the right thigh or deltoid, co-administered with DTPa-HBV-IPV/Hib vaccine, injected IM in the left thigh or deltoid.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    10 valent streptococcus pneumoniae conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT, Synflorix™ (by GSK Biologicals)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered at 12-18 months of age in the left thigh or deltoid

    Investigational medicinal product name
    DTPa-HBV-IPV/Hib
    Investigational medicinal product code
    Other name
    Infanrix hexa™ (by GSK Biologicals)
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered at at 12-18 months of age in the right thigh or deltoid

    Number of subjects in period 1
    		10Pn-10Pn Group 7Pn-7Pn Group 7Pn-10Pn Group
    Started
    737
    92
    283
    Overall Study Period
    737
    92
    283
    Completed
    726
    91
    282
    Not completed
    11
    1
    1
         Consent withdrawn by subject
    -
    -
    1
         Lost to follow-up
    11
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    10Pn-10Pn Group
    Reporting group description
    		 This group consisted of subjects previously vaccinated with the 10Pn-PD-DiT vaccine (also referred as 10Pn vaccine or Synflorix™) as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of 10Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the second dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of 10Pn vaccine, injected IM in the right thigh or deltoid, co-administered with DTPa-HBV-IPV/Hib vaccine, injected IM in the left thigh or deltoid.

    Reporting group title
    7Pn-7Pn Group
    Reporting group description
    		 This group consisted of subjects previously vaccinated with the 7Pn vaccine (also referred as Prevenar™) as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of 7Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the second dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of 7Pn vaccine, injected IM in the right thigh or deltoid, co-administered with DTPa-HBV-IPV/Hib vaccine, injected IM in the left thigh or deltoid.

    Reporting group title
    7Pn-10Pn Group
    Reporting group description
    		 This group consisted of subjects previously vaccinated with the 7Pn vaccine (also referred as Prevenar™) as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of 7Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the second dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of 10Pn-PD-DiT vaccine (also referred as 10Pn vaccine or Synflorix™), injected IM in the right thigh or deltoid, co-administered with DTPa-HBV-IPV/Hib vaccine, injected IM in the left thigh or deltoid.

    Reporting group values
    		 10Pn-10Pn Group 7Pn-7Pn Group 7Pn-10Pn Group Total
    Number of subjects
    		 737 92 283 1112
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: months
        geometric mean (standard deviation)
    		 15.3 ± 2.08 14.2 ± 2.26 14.2 ± 2.23 -
    Gender categorical
    Units: Subjects
        Female
    		 360 50 134 544
        Male
    		 377 42 149 568

    End points

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    End points reporting groups
    Reporting group title
    10Pn-10Pn Group
    Reporting group description
    		 This group consisted of subjects previously vaccinated with the 10Pn-PD-DiT vaccine (also referred as 10Pn vaccine or Synflorix™) as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of 10Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the second dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of 10Pn vaccine, injected IM in the right thigh or deltoid, co-administered with DTPa-HBV-IPV/Hib vaccine, injected IM in the left thigh or deltoid.

    Reporting group title
    7Pn-7Pn Group
    Reporting group description
    		 This group consisted of subjects previously vaccinated with the 7Pn vaccine (also referred as Prevenar™) as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of 7Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the second dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of 7Pn vaccine, injected IM in the right thigh or deltoid, co-administered with DTPa-HBV-IPV/Hib vaccine, injected IM in the left thigh or deltoid.

    Reporting group title
    7Pn-10Pn Group
    Reporting group description
    		 This group consisted of subjects previously vaccinated with the 7Pn vaccine (also referred as Prevenar™) as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of 7Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the second dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of 10Pn-PD-DiT vaccine (also referred as 10Pn vaccine or Synflorix™), injected IM in the right thigh or deltoid, co-administered with DTPa-HBV-IPV/Hib vaccine, injected IM in the left thigh or deltoid.

    Primary: Number of subjects with rectal temperature above (>) 39.0 degrees Celsius (°C) post booster between the 10Pn-10Pn and 7Pn-7Pn groups

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    End point title
    		 Number of subjects with rectal temperature above (>) 39.0 degrees Celsius (°C) post booster between the 10Pn-10Pn and 7Pn-7Pn groups [1]
    End point description
    Fever was measured as rectal temperature. Assessment of occurrences of rectal temperature > 39.0 °C was performed post administration of the booster dose of pneumococcal vaccine (10PN or 7Pn vaccine) in this study. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available.
    End point type
    Primary
    End point timeframe
    Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007
    Notes
    [1] - 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 was not assessed in the 7Pn-10Pn Group.
    End point values
    		 10Pn-10Pn Group 7Pn-7Pn Group
    Number of subjects analysed
    735
    91
    Units: Subjects
        Subjects with rectal temperature >39°C
    24
    7
    Statistical analysis title
    		 Non-inferiority of 10Pn vs 7Pn vaccine
    Statistical analysis description
    Analysis aimed at demonstrating the non-inferiority of 10Pn vs 7Pn vaccine, both co-administered with DTPa-HBV-IPV/Hib vaccine, in terms of post-immunization febrile reactions with rectal fever > 39.0°C.Towards this, standardized asymptotic 95% confidence interval (CI) for the difference [10Pn-10Pn minus 7Pn-7Pn] in terms of percentages of subjects reporting rectal fever >39.0°C was computed.
    Comparison groups
    7Pn-7Pn Group v 10Pn-10Pn Group
    Number of subjects included in analysis
    826
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -4.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.85
         upper limit
    		 -0.21
    Notes
    [2] - Non-inferiority was demonstrated if the upper limit of the computed standardized asymptotic 95% CI was lower than the pre-defined limit of 10%.

    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
    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. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available.
    End point type
    Secondary
    End point timeframe
    Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007
    End point values
    		 10Pn-10Pn Group 7Pn-7Pn Group 7Pn-10Pn Group
    Number of subjects analysed
    735
    91
    282
    Units: Subjects
        Any Pain
    452
    48
    150
        Grade 3 Pain
    47
    3
    18
        Any Swelling
    338
    42
    112
        Grade 3 Swelling
    67
    7
    20
        Any Redness
    451
    59
    153
        Grade 3 Redness
    96
    7
    19
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any and any Grade 3 solicited general symptoms
    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 was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal everyday activities. Grade 3 loss of appetite was defined as the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available.
    End point type
    Secondary
    End point timeframe
    Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007
    End point values
    		 10Pn-10Pn Group 7Pn-7Pn Group 7Pn-10Pn Group
    Number of subjects analysed
    735
    91
    282
    Units: Subjects
        Any drowsiness
    303
    48
    130
        Grade 3 drowsiness
    5
    0
    5
        Any fever
    245
    33
    112
        Grade 3 fever
    1
    2
    3
        Any irritability
    438
    55
    176
        Grade 3 irritability
    15
    2
    12
        Any loss of appetite
    230
    31
    92
        Grade 3 loss of appetite
    4
    0
    3
    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)
    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 an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007.
    End point type
    Secondary
    End point timeframe
    Within 31 days (Day 0-30) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007
    End point values
    		 10Pn-10Pn Group 7Pn-7Pn Group 7Pn-10Pn Group
    Number of subjects analysed
    737
    92
    283
    Units: Subjects
        Subject(s) with unsolicited AE(s)
    188
    32
    99
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs) during the Active Phase of the study

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    End point title
    		 Number of subjects with serious adverse events (SAEs) during the Active Phase of the study
    End point description
    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. “Any” is defined an incidence of a SAE regardless of intensity/severity . The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007.
    End point type
    Secondary
    End point timeframe
    Throughout the Active Phase of the study, that is, within 31 days (Day 0-30) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007
    End point values
    		 10Pn-10Pn Group 7Pn-7Pn Group 7Pn-10Pn Group
    Number of subjects analysed
    737
    92
    283
    Units: Subjects
        Subject(s) with SAEs
    12
    1
    4
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs) during the entire study

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    End point title
    		 Number of subjects with serious adverse events (SAEs) during the entire study
    End point description
    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. “Any” is defined an incidence of a SAE regardless of intensity/severity. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects enrolled in the ESFU Phase of the study.
    End point type
    Secondary
    End point timeframe
    Throughout the study period, from Month 0 prior to booster vaccination up to Month 6, end of the ESFU in this study 10PN-PD-DIT-007
    End point values
    		 10Pn-10Pn Group 7Pn-7Pn Group 7Pn-10Pn Group
    Number of subjects analysed
    726
    92
    282
    Units: Subjects
        Subject(s) with SAEs
    33
    6
    8
    No statistical analyses for this end point

    Secondary: Number of subjects seroprotected as regards anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antigens – by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA)

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    End point title
    		 Number of subjects seroprotected as regards anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antigens – by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA)
    End point description
    A seroprotected subject as regards anti-pneumococcal serotype antibody was defined as a subject with anti-pneumococcal serotype antibody concentration above than or equal to (≥) 0.20 microgram per millilitre (μg/mL). Anti-pneumococcal serotypes antibodies assessed were antibodies against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F). Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using ≥ 0.05 μg/mL as seropositivity cut off. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after (Month 1) booster vaccination
    End point values
    		 10Pn-10Pn Group 7Pn-7Pn Group 7Pn-10Pn Group
    Number of subjects analysed
    347
    89
    134
    Units: Subjects
        Anti-1 PRE (N=338;82;133)
    123
    3
    3
        Anti-1 Month 1 (N=342;81;133)
    340
    4
    113
        Anti-4 PRE (N=342;78;131)
    196
    53
    99
        Anti-4 Month 1 (N=343;88;133)
    342
    88
    133
        Anti-5 PRE (N=344;84;134)
    231
    5
    14
        Anti-5 Month 1 (N=342;82;133)
    340
    5
    114
        Anti-6B PRE (N=333;75;131)
    223
    23
    69
        Anti-6B Month 1 (N=341 ;87;133 )
    329
    85
    131
        Anti-7F PRE (N=340;85;133)
    308
    4
    3
        Anti-7F Month 1 (N=342;85;133)
    342
    6
    127
        Anti-9V PRE (N=344;77;130)
    291
    70
    123
        Anti-9V Month 1 (N=340;89;133)
    340
    89
    133
        Anti-14 PRE (N=336;75;130)
    268
    70
    125
        Anti-14 Month 1 (N=339;86;133)
    336
    86
    133
        Anti-18C PRE (N=341;83;131)
    240
    60
    107
        Anti-18C Month 1 (N=343;87;134)
    343
    87
    133
        Anti-19F PRE (N=347;85;134)
    272
    38
    76
        Anti-19F Month 1 (N=343;87;134)
    341
    87
    131
        Anti-23F PRE (N=338;77;130)
    206
    43
    98
        Anti-23F Month 1 (N=341;88;132)
    332
    87
    128
    No statistical analyses for this end point

    Secondary: Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) – by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA)

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    End point title
    		 Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) – by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA)
    End point description
    Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean concentrations (GMCs), in microgram per millilitre (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 µg/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month (Month 1) post booster vaccination
    End point values
    		 10Pn-10Pn Group 7Pn-7Pn Group 7Pn-10Pn Group
    Number of subjects analysed
    347
    89
    134
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-1 PRE (N=338;82;133)
    0.14 (0.13 to 0.16)
    0.03 (0.03 to 0.04)
    0.03 (0.03 to 0.04)
        Anti-1 Month 1 (N=342;81;133)
    1.53 (1.4 to 1.68)
    0.04 (0.03 to 0.05)
    0.67 (0.56 to 0.8)
        Anti-4 PRE (N=342;78;131)
    0.23 (0.21 to 0.26)
    0.3 (0.25 to 0.37)
    0.35 (0.3 to 0.41)
        Anti-4 Month 1 (N=343;88;133)
    3.35 (3.06 to 3.67)
    4.4 (3.75 to 5.15)
    4.47 (3.85 to 5.19)
        Anti-5 PRE (N=344;84;134)
    0.27 (0.25 to 0.3)
    0.04 (0.04 to 0.05)
    0.05 (0.04 to 0.05)
        Anti-5 Month 1 (N=342;82;133)
    2.2 (2 to 2.42)
    0.05 (0.04 to 0.07)
    0.74 (0.6 to 0.9)
        Anti-6B PRE (N=333;75;131)
    0.31 (0.27 to 0.35)
    0.14 (0.11 to 0.19)
    0.26 (0.2 to 0.33)
        Anti-6B Month 1 (N=341 ;87;133)
    1.94 (1.74 to 2.17)
    3.53 (2.83 to 4.41)
    1.74 (1.48 to 2.05)
        Anti-7F PRE (N=340;85;133)
    0.57 (0.52 to 0.62)
    0.03 (0.03 to 0.04)
    0.03 (0.03 to 0.03)
        Anti-7F Month 1 (N=342;85;133)
    3.5 (3.25 to 3.76)
    0.04 (0.03 to 0.05)
    1.83 (1.49 to 2.24)
        Anti-9V PRE (N=344;77;130)
    0.54 (0.48 to 0.6)
    0.62 (0.51 to 0.76)
    0.78 (0.68 to 0.89)
        Anti-9V Month 1 (N=340;89;133)
    3.25 (2.99 to 3.53)
    6.09 (5.19 to 7.15)
    1.94 (1.73 to 2.19)
        Anti-14 PRE (N=336;75;130)
    0.66 (0.56 to 0.76)
    1.06 (0.82 to 1.38)
    1.69 (1.4 to 2.03)
        Anti-14 Month 1 (N=339;86;133)
    5.56 (5.01 to 6.18)
    9.29 (7.85 to 10.99)
    4.76 (4.12 to 5.49)
        Anti-18C PRE (N=341;83;131)
    0.3 (0.28 to 0.34)
    0.32 (0.26 to 0.39)
    0.37 (0.32 to 0.43)
        Anti-18C Month 1 (N=343;87;134)
    5.01 (4.6 to 5.46)
    5.21 (4.44 to 6.11)
    4.98 (4.17 to 5.93)
        Anti-19F PRE (N=347;85 ;134)
    0.53 (0.46 to 0.61)
    0.23 (0.17 to 0.31)
    0.31 (0.24 to 0.41)
        Anti-19F Month 1 (N=343;87;134)
    6.05 (5.46 to 6.71)
    3.35 (2.83 to 3.97)
    5.06 (4.24 to 6.04)
        Anti-23F PRE (N=338;77;130)
    0.27 (0.23 to 0.31)
    0.24 (0.19 to 0.31)
    0.4 (0.32 to 0.5)
        Anti-23F Month 1 (N=341;88;132)
    2.38 (2.13 to 2.66)
    6.67 (5.38 to 8.26)
    2.42 (1.99 to 2.95)
    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
    OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMT calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month (Month 1) post booster vaccination
    End point values
    		 10Pn-10Pn Group 7Pn-7Pn Group 7Pn-10Pn Group
    Number of subjects analysed
    326
    83
    126
    Units: Titer
    geometric mean (confidence interval 95%)
        Opsono-1 PRE (N=326;83;126)
    6.1 (5.4 to 6.9)
    5 (4.1 to 6)
    4.9 (4.2 to 5.8)
        Opsono-1 Month 1 (N=301;83;121)
    192.2 (157.5 to 234.6)
    4.3 (3.9 to 4.7)
    8.3 (6.7 to 10.4)
        Opsono-4 PRE (N=295;79;112)
    20.3 (16.2 to 25.5)
    24.5 (15.4 to 38.8)
    37.8 (24.8 to 57.7)
        Opsono-4 Month 1 (N=297;81;123)
    1856.3 (1666.1 to 2068)
    2812.6 (2282.5 to 3465.9)
    1528.9 (1286.5 to 1817)
        Opsono-5 PRE (N=305;79;124)
    8.2 (7.2 to 9.4)
    4.4 (3.9 to 4.9)
    4.1 (3.9 to 4.3)
        Opsono-5 Month 1 (N=299;83;122)
    144.1 (122.1 to 170)
    4.1 (3.9 to 4.4)
    9.5 (7.5 to 11.9)
        Opsono-6B PRE (N=284;75;120)
    60.3 (44.6 to 81.7)
    51.4 (27.1 to 97.5)
    36.7 (23.3 to 57.7)
        Opsono-6B Month 1 (N=295;79;118)
    981.2 (830.7 to 1159.1)
    3459.6 (2535.7 to 4720.3)
    640.2 (480.7 to 852.7)
        Opsono-7F PRE (N=294;76;117)
    377.7 (279.8 to 509.9)
    34.8 (17.5 to 69.3)
    25.3 (15.4 to 41.6)
        Opsono-7F Month 1 (N=296;74;118)
    4330.3 (3836 to 4888.3)
    25.2 (13.1 to 48.7)
    2397.2 (1929.2 to 2978.7)
        Opsono-9V PRE (N=309;81;122)
    296.9 (259.3 to 339.9)
    305.5 (227.1 to 411)
    305.1 (248.7 to 374.4)
        Opsono-9V Month 1 (N=297;79;120)
    2343.5 (2097.1 to 2618.7)
    5357.4 (4212.5 to 6813.6)
    886.8 (747.7 to 1051.8)
        Opsono-14 PRE (N=299;79;118)
    188.1 (149.9 to 235.9)
    201.6 (129.4 to 314.2)
    391.1 (303.1 to 504.6)
        Opsono-14 Month 1 (N=304;82;123)
    2085.9 (1868 to 2329.1)
    2134.2 (1689.1 to 2696.6)
    977.8 (828.9 to 1153.5)
        Opsono-18C PRE (N=309;82;121)
    8.7 (7.4 to 10.3)
    10.4 (7.4 to 14.7)
    8.5 (6.6 to 10.9)
        Opsono-18C Month 1 (N=299;76;121)
    810.3 (712.4 to 921.7)
    968.7 (724.1 to 1295.8)
    610.7 (480.3 to 776.4)
        Opsono-19F PRE (N=317;81;123)
    10.5 (8.9 to 12.3)
    5.9 (4.5 to 7.8)
    7.3 (5.5 to 9.6)
        Opsono-19F Month 1 (N=293;80;120)
    624.3 (509.7 to 764.7)
    287.8 (190.8 to 434.3)
    530.1 (393 to 715.2)
        Opsono-23F PRE (N=305;77;120)
    171.5 (126.3 to 232.8)
    205.8 (110.1 to 384.6)
    532.9 (344.4 to 824.7)
        Opsono-23F Month 1 (N=301;80;122)
    2830.1 (2487.2 to 3220.3)
    13900.7 (10177.4 to 18986.1)
    2828.8 (2234.3 to 3581.6)
    No statistical analyses for this end point

    Secondary: Antibody concentrations to protein D (Anti-PD) - by Enzyme-Linked Immunosorbent Assay (ELISA)

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    End point title
    		 Antibody concentrations to protein D (Anti-PD) - by Enzyme-Linked Immunosorbent Assay (ELISA)
    End point description
    Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month (Month 1) post booster vaccination
    End point values
    		 10Pn-10Pn Group 7Pn-7Pn Group 7Pn-10Pn Group
    Number of subjects analysed
    340
    86
    134
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PD, PRE (N=338;73;127)
    556.4 (494.7 to 625.7)
    72.3 (59.3 to 88)
    78.1 (67.8 to 89.9)
        Anti-PD, Month 1 (N=340;86;134)
    2887.6 (2573.7 to 3239.8)
    75.3 (60 to 94.4)
    125.5 (103.4 to 152.4)
    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
    Anti-PRP antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in microgram per milliliter (µg/mL), and tabulated. The seroprotection cut-off for the assay for the purpose of this endpoint was ≥ 0.15 µg/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month (Month 1) post booster vaccination
    End point values
    		 10Pn-10Pn Group 7Pn-7Pn Group 7Pn-10Pn Group
    Number of subjects analysed
    344
    46
    136
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP, PRE (N=344;39;136)
    0.308 (0.272 to 0.348)
    0.231 (0.151 to 0.353)
    0.246 (0.2 to 0.304)
        Anti-PRP, Month 1 (N=343;46;136)
    36.634 (31.897 to 42.074)
    25.731 (15.87 to 41.719)
    29.851 (23.563 to 37.816)
    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
    Anti-PT, Anti-FHA and Anti-PRN concentrations measured by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 5 EL.U/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month (Month 1) post booster vaccination
    End point values
    		 10Pn-10Pn Group 7Pn-7Pn Group 7Pn-10Pn Group
    Number of subjects analysed
    344
    46
    136
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT, PRE (N=332;34;133)
    5.5 (5.1 to 6.1)
    7.3 (5.2 to 10.3)
    7 (6.1 to 8.1)
        Anti-PT, Month 1 (N=338;46;135)
    79.6 (73.8 to 85.9)
    76 (60.4 to 95.7)
    85.8 (76.9 to 95.7)
        Anti-FHA, PRE (N=343;36;135)
    27.1 (24.4 to 30.1)
    29 (20.5 to 40.8)
    35.5 (29.7 to 42.3)
        Anti-FHA, Month 1 (N=343;46;136)
    357.7 (332.6 to 384.7)
    334.5 (278.1 to 402.2)
    400.2 (356.4 to 449.5)
        Anti-PRN, PRE (N=344;34;136)
    9.1 (8.2 to 10.1)
    11.1 (7.6 to 16.2)
    12.1 (10.1 to 14.6)
        Anti-PRN, Month 1 (N=342;45;135)
    248.9 (226.5 to 273.4)
    204.6 (155.8 to 268.7)
    276.5 (239.1 to 319.7)
    No statistical analyses for this end point

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

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    End point title
    		 Anti-diphtheria (Anti-D) and anti-tetanus toxoids (Anti-TT) antibody concentrations
    End point description
    Anti-D and Anti-TT antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in International units per milliliter (IU/mL), and tabulated. The seropositivity cut-off for the assay was ≥ 0.1 IU/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month (Month 1) post booster vaccination
    End point values
    		 10Pn-10Pn Group 7Pn-7Pn Group 7Pn-10Pn Group
    Number of subjects analysed
    344
    46
    136
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-D, PRE (N=344;34;136)
    0.179 (0.161 to 0.199)
    0.291 (0.2 to 0.424)
    0.29 (0.25 to 0.336)
        Anti-D, Month 1 (N=343;45;136)
    5.809 (5.352 to 6.305)
    6.272 (4.883 to 8.055)
    9.337 (8.419 to 10.356)
        Anti-TT, PRE (N=344;35;136)
    0.417 (0.382 to 0.456)
    0.261 (0.187 to 0.364)
    0.265 (0.225 to 0.313)
        Anti-TT, Month 1 (N=343;46;136)
    9.983 (9.293 to 10.724)
    4.28 (3.294 to 5.562)
    5.677 (5.038 to 6.397)
    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
    Anti-HBs antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in milli-International unit per milliliter (IU/mL), and tabulated. The seropositivity cut-off for the assay was ≥ 10 mIU/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month (Month 1) post booster vaccination
    End point values
    		 10Pn-10Pn Group 7Pn-7Pn Group 7Pn-10Pn Group
    Number of subjects analysed
    329
    48
    134
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs, PRE (N=329;48;134)
    147.2 (124.7 to 173.7)
    148.9 (100.4 to 220.8)
    156.6 (125.5 to 195.5)
        Anti-HBs, Month 1 (N=325;47;132)
    3869.1 (3218.1 to 4651.8)
    3132.2 (1906.3 to 5146.5)
    4358.6 (3495.5 to 5434.8)
    No statistical analyses for this end point

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

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    End point title
    		 Anti-polio type 1, 2 and 3 (Anti-Polio 1, 2 and 3) antibody titers
    End point description
    Anti-Polio 1, 2 and 3 antibody titers were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seroprotection cut-off for the assay was ≥ 8. Antibody titers below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMT calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month (Month 1) post booster vaccination
    End point values
    		 10Pn-10Pn Group 7Pn-7Pn Group 7Pn-10Pn Group
    Number of subjects analysed
    318
    48
    131
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Polio 1, PRE (N=318;48;131)
    25.3 (21.9 to 29.3)
    21.2 (15 to 30)
    27.1 (20.7 to 35.4)
        Anti-Polio 1, Month 1 (N=279;42;121)
    904.4 (779.7 to 1049.1)
    819.3 (552.9 to 1214.2)
    1003.7 (817.5 to 1232.3)
        Anti-Polio 2, PRE (N=317;46;130)
    20.8 (18.1 to 24)
    12.9 (8.8 to 18.9)
    17.9 (14.1 to 22.8)
        Anti-Polio 2 , Month 1 (N=280;43;122)
    793.5 (679.7 to 926.3)
    495.7 (300.2 to 818.5)
    661.2 (496.7 to 880.3)
        Anti-Polio 3, PRE (N=262;39;113)
    33.7 (28.5 to 39.8)
    25.8 (16.7 to 39.8)
    28.2 (21.6 to 36.8)
        Anti-Polio 3, Month 1 (N=270;41;116)
    1465 (1257.1 to 1707.3)
    1191.7 (743.1 to 1911.3)
    1646.5 (1294.4 to 2094.5)
    No statistical analyses for this end point

    Secondary: Number of subjects booster (BST) responder to pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin antigens

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    End point title
    		 Number of subjects booster (BST) responder to pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin antigens
    End point description
    A BST responder to PT, FHA and PRN antigens was defined as a subject with the appearance of antibodies in subjects who were seronegative prior to the booster vaccination or at least 2-fold increase of pre-booster vaccination antibody concentrations in subjects who were seropositive prior to the booster vaccination. A seropositive/seronegative subject as regards Anti-PT/-FHA/ -PRN antibodies was defined as a subject with anti-PT/-FHA/ -PRN antibody concentrations ≥ 5 Enzyme-linked Immunosorbent assay (ELISA) unit per milli-liter (EL.U/mL)
    End point type
    Secondary
    End point timeframe
    One month (Month 1) post booster vaccination
    End point values
    		 10Pn-10Pn Group 7Pn-7Pn Group 7Pn-10Pn Group
    Number of subjects analysed
    340
    33
    135
    Units: Subjects
        BST responder to PT antigens (N=324;31;132)
    323
    31
    132
        BST responder to FHA antigens (N=340;33;135)
    332
    31
    129
        BST responder to PRN antigens (N=340;31;135)
    339
    30
    131
    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 post booster; Unsolicited AEs: During the 31 days post booster; SAEs: From Month 0 prior to booster vaccination up to Month 6, end of the extended safety follow-up in this study 10PN-PD-DIT-007
    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
    10.0
    Reporting groups
    Reporting group title
    10Pn-10Pn Group
    Reporting group description
    		 This group consisted of subjects previously vaccinated with the 10Pn-PD-DiT vaccine (also referred as 10Pn vaccine or Synflorix™) as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of 10Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the second dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of 10Pn vaccine, injected IM in the right thigh or deltoid, co-administered with DTPa-HBV-IPV/Hib vaccine, injected IM in the left thigh or deltoid.

    Reporting group title
    7Pn-10Pn Group
    Reporting group description
    		 This group consisted of subjects previously vaccinated with the 7Pn vaccine (also referred as Prevenar™) as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of 7Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the second dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of 10Pn-PD-DiT vaccine (also referred as 10Pn vaccine or Synflorix™), injected IM in the right thigh or deltoid, co-administered with DTPa-HBV-IPV/Hib vaccine, injected IM in the left thigh or deltoid.

    Reporting group title
    7Pn-7Pn Group
    Reporting group description
    		 This group consisted of subjects previously vaccinated with the 7Pn vaccine (also referred as Prevenar™) as part of a previous study by GSK Biologicals – the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of 7Pn vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with DTPa-HBV-IPV/Hib vaccine (or Infanrix hexa™), except for the second dose in France, which was co-administered with DTPa-IPV/Hib (or Infanrix™ IPV Hib), injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of 7Pn vaccine, injected IM in the right thigh or deltoid, co-administered with DTPa-HBV-IPV/Hib vaccine, injected IM in the left thigh or deltoid.

    Serious adverse events
    		 10Pn-10Pn Group 7Pn-10Pn Group 7Pn-7Pn Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    33 / 737 (4.48%)
    8 / 283 (2.83%)
    6 / 92 (6.52%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Drug toxicity (post booster)
    Additional description: SAE reported within the 31 days after the booster
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 283 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Concussion (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [1]
    1 / 726 (0.14%)
    0 / 282 (0.00%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug toxicity (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [2]
    1 / 726 (0.14%)
    0 / 282 (0.00%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Limb injury (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [3]
    1 / 726 (0.14%)
    0 / 282 (0.00%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thermal burn (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [4]
    0 / 726 (0.00%)
    0 / 282 (0.00%)
    1 / 91 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion (post booster)
    Additional description: SAE reported within the 31 days after the booster
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 283 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile convulsion (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [5]
    2 / 726 (0.28%)
    0 / 282 (0.00%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Microcytic anaemia (post booster)
    Additional description: SAE reported within the 31 days after the booster
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 283 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Microcytic anaemia(til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [6]
    1 / 726 (0.14%)
    0 / 282 (0.00%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Oedema peripheral (post booster)
    Additional description: SAE reported within the 31 days after the booster
         subjects affected / exposed
    0 / 737 (0.00%)
    1 / 283 (0.35%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [7]
    0 / 726 (0.00%)
    1 / 282 (0.35%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis (post booster)
    Additional description: SAE reported within the 31 days after the booster
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 283 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [8]
    1 / 726 (0.14%)
    0 / 282 (0.00%)
    1 / 91 (1.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [9]
    1 / 726 (0.14%)
    0 / 282 (0.00%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stomatitis (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [10]
    1 / 726 (0.14%)
    0 / 282 (0.00%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma (post booster)
    Additional description: SAE reported within the 31 days after the booster
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 283 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis chronic (post booster)
    Additional description: SAE reported within the 31 days after the booster
         subjects affected / exposed
    0 / 737 (0.00%)
    2 / 283 (0.71%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthma (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [11]
    1 / 726 (0.14%)
    0 / 282 (0.00%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis chronic (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [12]
    6 / 726 (0.83%)
    4 / 282 (1.42%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic (post booster)
    Additional description: SAE reported within the 31 days after the booster
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 283 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dermatitis atopic (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [13]
    1 / 726 (0.14%)
    0 / 282 (0.00%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Purpura (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [14]
    1 / 726 (0.14%)
    0 / 282 (0.00%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis (post booster)
    Additional description: SAE reported within the 31 days after the booster
         subjects affected / exposed
    1 / 737 (0.14%)
    1 / 283 (0.35%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear infection (post booster)
    Additional description: SAE reported within the 31 days after the booster
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 283 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis (post booster)
    Additional description: SAE reported within the 31 days after the booster
         subjects affected / exposed
    3 / 737 (0.41%)
    1 / 283 (0.35%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus (post booster)
    Additional description: SAE reported within the 31 days after the booster
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 283 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngitis (post booster)
    Additional description: SAE reported within the 31 days after the booster
         subjects affected / exposed
    0 / 737 (0.00%)
    0 / 283 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis (post booster)
    Additional description: SAE reported within the 31 days after the booster
         subjects affected / exposed
    0 / 737 (0.00%)
    1 / 283 (0.35%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis (post booster)
    Additional description: SAE reported within the 31 days after the booster
         subjects affected / exposed
    2 / 737 (0.27%)
    0 / 283 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia (post booster)
    Additional description: SAE reported within the 31 days after the booster
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 283 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection (post booster)
    Additional description: SAE reported within the 31 days after the booster
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 283 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection (post booster)
    Additional description: SAE reported within the 31 days after the booster
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 283 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenovirus infection (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [15]
    1 / 726 (0.14%)
    0 / 282 (0.00%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [16]
    0 / 726 (0.00%)
    0 / 282 (0.00%)
    1 / 91 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [17]
    2 / 726 (0.28%)
    2 / 282 (0.71%)
    1 / 91 (1.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear infection (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [18]
    0 / 726 (0.00%)
    0 / 282 (0.00%)
    1 / 91 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [19]
    1 / 726 (0.14%)
    1 / 282 (0.35%)
    1 / 91 (1.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngitis (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [20]
    1 / 726 (0.14%)
    0 / 282 (0.00%)
    2 / 91 (2.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [21]
    1 / 726 (0.14%)
    1 / 282 (0.35%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [22]
    0 / 726 (0.00%)
    1 / 282 (0.35%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [23]
    2 / 726 (0.28%)
    0 / 282 (0.00%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [24]
    2 / 726 (0.28%)
    0 / 282 (0.00%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [25]
    1 / 726 (0.14%)
    0 / 282 (0.00%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [26]
    1 / 726 (0.14%)
    1 / 282 (0.35%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection (til study end)
    Additional description: : SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [27]
    1 / 726 (0.14%)
    0 / 282 (0.00%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis (til study end)
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [28]
    9 / 726 (1.24%)
    1 / 282 (0.35%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration (post booster)
    Additional description: SAE reported within the 31 days after the booster
         subjects affected / exposed
    1 / 737 (0.14%)
    0 / 283 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [29]
    1 / 726 (0.14%)
    0 / 282 (0.00%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Weight gain poor (til study end)
    Additional description: SAE reported within the 31 days after the booster and during the ESFU, based on subjects participating for the ESFU phase
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed [30]
    1 / 726 (0.14%)
    0 / 282 (0.00%)
    0 / 91 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    [30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Analysis for this event was performed on subjects analysed and/or available results.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 10Pn-10Pn Group 7Pn-10Pn Group 7Pn-7Pn Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    452 / 737 (61.33%)
    176 / 283 (62.19%)
    59 / 92 (64.13%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed [31]
    452 / 735 (61.50%)
    150 / 282 (53.19%)
    48 / 91 (52.75%)
         occurrences all number
    452
    150
    48
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed [32]
    451 / 735 (61.36%)
    153 / 282 (54.26%)
    59 / 91 (64.84%)
         occurrences all number
    451
    153
    59
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [33]
    338 / 735 (45.99%)
    112 / 282 (39.72%)
    42 / 91 (46.15%)
         occurrences all number
    338
    112
    42
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [34]
    303 / 735 (41.22%)
    130 / 282 (46.10%)
    48 / 91 (52.75%)
         occurrences all number
    303
    130
    48
    Fever (rectal temperature ≥ 38°C)
    alternative assessment type: Systematic
         subjects affected / exposed [35]
    245 / 735 (33.33%)
    112 / 282 (39.72%)
    33 / 91 (36.26%)
         occurrences all number
    245
    112
    33
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [36]
    438 / 735 (59.59%)
    176 / 282 (62.41%)
    55 / 91 (60.44%)
         occurrences all number
    438
    176
    55
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed [37]
    230 / 735 (31.29%)
    92 / 282 (32.62%)
    31 / 91 (34.07%)
         occurrences all number
    230
    92
    31
    Injection site induration
         subjects affected / exposed
    1 / 737 (0.14%)
    7 / 283 (2.47%)
    7 / 92 (7.61%)
         occurrences all number
    1
    7
    7
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    28 / 737 (3.80%)
    19 / 283 (6.71%)
    4 / 92 (4.35%)
         occurrences all number
    28
    19
    4
    Upper respiratory tract infection
         subjects affected / exposed
    25 / 737 (3.39%)
    13 / 283 (4.59%)
    5 / 92 (5.43%)
         occurrences all number
    25
    13
    5
    Notes
    [31] - 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: Analysis for this event was performed on subjects analysed and/or available results.
    [32] - 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: Analysis for this event was performed on subjects analysed and/or available results.
    [33] - 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: Analysis for this event was performed on subjects analysed and/or available results.
    [34] - 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: Analysis for this event was performed on subjects analysed and/or available results.
    [35] - 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: Analysis for this event was performed on subjects analysed and/or available results.
    [36] - 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: Analysis for this event was performed on subjects analysed and/or available results.
    [37] - 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: Analysis for this event was performed on subjects analysed and/or available results.

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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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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