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    Clinical Trial Results:
    A phase III, open, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar when given as a booster dose between 11-18 months of age in children previously vaccinated in the primary study 10PN-PD-DIT-011 (107005) with either GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar.

    Summary
    EudraCT number
    		 2006-005733-38
    Trial protocol
    		 DE   ES   PL  
    Global end of trial date
    14 Jun 2008

    Results information
    Results version number
    		 v1
    This version publication date
    22 Mar 2016
    First version publication date
    05 Dec 2014
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    109507
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00463437
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium,
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Dec 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jun 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study is to demonstrate that a booster dose GSK Biologicals’ 10-valent pneumococcal conjugate vaccine is non-inferior to Prevenar, both co-administered with DTPa-HBV-IPV and Hib-MenC vaccines, in terms of post-immunization febrile reactions with rectal fever > 39.0°C in children at 11 to 18 months of age. Criteria for safety: Non-inferiority will be demonstrated if one can rule out an increase, in terms of percentage of subjects with rectal fever >39.0°C (10Pn+Hib-MenC group as compared to Prevenar group) above 5% + half the incidence in the control group (= null hypothesis) as shown by an one-sided P-value < 2.5%.
    Protection of trial subjects
    During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms. Thereafter, the safety follow-up phase of the study aimed at ensuring continued assessment of the safety of the subjects participating to the study for a duration of about 6 months (minimum 180 days) after the administration of the booster dose of the study vaccines to each subject. Towards this, subjects were followed up for 6 months via contacts with the parents/guardians by phone to determine if the subject had experienced a serious adverse event during this time period.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Apr 2007
    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
    Germany: 341
    Country: Number of subjects enrolled
    Spain: 463
    Country: Number of subjects enrolled
    Poland: 633
    Worldwide total number of subjects
    1437
    EEA total number of subjects
    1437
    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)
    1437
    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
    		 Activities performed pre vaccination during the screening phase included the following: check for inclusion criteria, exclusion criteria, contraindications/precautions, elimination criteria and medical history of subjects. Thereafter, informed consents were signed by the parent(s)/guardian(s) of the subjects.

    Period 1
    Period 1 title
    Overall Trial (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
    		 GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™
    Arm description
    		 Subjects previously vaccinated with a 3-dose course of GSK Biologicals’ pneumococcal conjugate vaccine GSK1024850A (10Pn) co-administered with Infanrix™ IPV Hib and Wyeth’s Men-C conjugate vaccine (Meningitec™) received a booster dose of the 10Pn vaccine co-administered with GSK Biologicals’ DTPa-combined vaccine (either Infanrix™ hexa in Germany and Poland or Infanrix™ IPV Hib in Spain) and Meningitec™ at 11-18 months of age. All vaccines were administered intramuscularly in the thigh for children aged <12 months or in the thigh or deltoid for children aged ≥ 12 months. The 10Pn vaccine was administered in the right thigh or deltoid; the Infanrix™ hexa and Infanrix™ IPV Hib vaccines were administered in the upper left thigh or deltoid; and Meningitec™ was administered in the lower left thigh or deltoid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    10-valent Streptococcus pneumoniae conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn, 10Pn-PD-DiT, GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine, Synflorix™, GSK1024850A
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of the vaccine was administered in the right thigh or deltoid.

    Investigational medicinal product name
    Infanrix IPV + Hib
    Investigational medicinal product code
    Other name
    DTPa- IPV/Hib, Infanrix IPV Hib, GSK Biologicals’ diphtheria-tetanus-acellular pertussis-inactivated poliovirus and Haemophilus influenzae type b vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of the vaccine was administered in the upper left thigh or deltoid.

    Investigational medicinal product name
    Meningitec
    Investigational medicinal product code
    Other name
    Wyeth’s conjugated meningococcal C vaccine, Meningitec™
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of the vaccine was administered, in the lower left thigh or deltoid.

    Investigational medicinal product name
    Infanrix Hexa
    Investigational medicinal product code
    Other name
    DTPa-IPV-HBV / Hib, GSK Biologicals’ diphtheria-tetanus-acellular pertussis, hepatitis B virus-inactivated poliovirus and Haemophilus influenzae type b vaccine
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of the vaccine was administered in the upper left thigh or deltoid.

    Arm title
    		 GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
    Arm description
    		 Subjects previously vaccinated with a 3-dose course of GSK Biologicals’ pneumococcal conjugate vaccine GSK1024850A co-administered with Infanrix™ IPV Hib and Baxter’s Men-C conjugate vaccine (NeisVac-C™) received a booster dose of the GSK1024850A vaccine co-administered with GSK Biologicals’ DTPa-combined vaccine (either Infanrix™ hexa in Germany and Poland or Infanrix™ IPV Hib in Spain) Hib and NeisVac-C™ at 11-18 months of age. The 10Pn vaccine was administered in the right thigh or deltoid; the Infanrix™ hexa and Infanrix™ IPV Hib vaccines were administered in the upper left thigh or deltoid; and NeisVac-C™ was administered in the lower left thigh or deltoid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    10-valent Streptococcus pneumoniae conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn, 10Pn-PD-DiT, GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine, Synflorix™, GSK1024850A
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of the vaccine was administered in the right thigh or deltoid.

    Investigational medicinal product name
    Infanrix IPV + Hib
    Investigational medicinal product code
    Other name
    DTPa- IPV/Hib, Infanrix IPV Hib, GSK Biologicals’ diphtheria-tetanus-acellular pertussis-inactivated poliovirus and Haemophilus influenzae type b vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of the vaccine was administered in the upper left thigh or deltoid.

    Investigational medicinal product name
    NeisVac-C
    Investigational medicinal product code
    Other name
    Baxter's meningococcal C conjugate vaccine, NeisVac-C™
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of the vaccine was administered, in the lower left thigh or deltoid.

    Investigational medicinal product name
    Infanrix Hexa
    Investigational medicinal product code
    Other name
    DTPa-IPV-HBV / Hib, GSK Biologicals’ diphtheria-tetanus-acellular pertussis, hepatitis B virus-inactivated poliovirus and Haemophilus influenzae type b vaccine
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of the vaccine was administered in the upper left thigh or deltoid.

    Arm title
    		 GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
    Arm description
    		 This group is also referred to as the Group 10Pn + Hib-MenC in this record. Subjects previously vaccinated with a 3-dose course of GSK Biologicals’ pneumococcal conjugate vaccine GSK1024850A co-administered with Infanrix™ penta and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) received a booster dose of the GSK1024850A vaccine co-administered with DTPa-combined vaccine (either Infanrix™ penta in Germany and Poland or Infanrix™ IPV in Spain) and Menitorix™ at 11-18 months of age. The 10Pn vaccine was administered in the right thigh or deltoid; the Infanrix™ penta and Infanrix™ IPV vaccines were administered in the upper left thigh or deltoid; and Menitorix™ was administered in the lower left thigh or deltoid.
    Arm type
    		 Experimental

    Investigational medicinal product name
    10-valent Streptococcus pneumoniae conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn, 10Pn-PD-DiT, GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine, Synflorix™, GSK1024850A
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of the vaccine was administered in the right thigh or deltoid.

    Investigational medicinal product name
    Infanrix penta
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV, Infanrix™ penta
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of the vaccine was administered, in the upper left thigh or deltoid.

    Investigational medicinal product name
    Menitorix
    Investigational medicinal product code
    Other name
    GSK Biologicals’ combined Haemophilus influenzae type b - meningococcal serogroup vaccine, Hib-MenC, Menitorix™
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of the vaccine was administered, in the lower left thigh or deltoid.

    Investigational medicinal product name
    Infanrix IPV
    Investigational medicinal product code
    Other name
    DTPa- IPV, Infanrix™ IPV, GSK Biologicals’ diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of the vaccine was administered in the upper left thigh or deltoid.

    Arm title
    		 Prevenar™ + Menitorix™
    Arm description
    		 This group is also referred to as the Group Prevenar in this record. Subjects previously vaccinated with a 3-dose course of Wyeth’s 7-valent pneumococcal conjugate vaccine (Prevenar™ or 7Pn) co-administered with Infanrix™ penta and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) received a booster dose of Prevenar™ co-administered with DTPa-combined vaccine (either Infanrix™ penta in Germany and Poland or Infanrix™ IPV in Spain) and Menitorix™ at 11-18 months of age. The 7Pn vaccine was administered in the right thigh or deltoid; the Infanrix™ penta and Infanrix™ IPV vaccines were administered in the upper left thigh or deltoid; and Menitorix™ was administered in the lower left thigh or deltoid.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevenar
    Investigational medicinal product code
    Other name
    Wyeth Lederle's 7-valent pneumococcal conjugate vaccine, 7Pn, Prevenar™
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of the vaccine was administered in the right thigh or deltoid.

    Investigational medicinal product name
    Infanrix penta
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV, Infanrix™ penta
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of the vaccine was administered, in the upper left thigh or deltoid.

    Investigational medicinal product name
    Menitorix
    Investigational medicinal product code
    Other name
    GSK Biologicals’ combined Haemophilus influenzae type b - meningococcal serogroup vaccine, Hib-MenC, Menitorix™
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of the vaccine was administered, in the lower left thigh or deltoid.

    Investigational medicinal product name
    Infanrix IPV
    Investigational medicinal product code
    Other name
    DTPa- IPV, GSK Biologicals’ diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of the vaccine was administered in the upper left thigh or deltoid.

    Number of subjects in period 1
    		GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™ GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ Prevenar™ + Menitorix™
    Started
    359
    363
    358
    357
    Completed
    355
    352
    352
    350
    Not completed
    4
    11
    6
    7
         Consent withdrawn by subject
    -
    -
    -
    1
         Lost to follow-up
    4
    11
    6
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™
    Reporting group description
    		 Subjects previously vaccinated with a 3-dose course of GSK Biologicals’ pneumococcal conjugate vaccine GSK1024850A (10Pn) co-administered with Infanrix™ IPV Hib and Wyeth’s Men-C conjugate vaccine (Meningitec™) received a booster dose of the 10Pn vaccine co-administered with GSK Biologicals’ DTPa-combined vaccine (either Infanrix™ hexa in Germany and Poland or Infanrix™ IPV Hib in Spain) and Meningitec™ at 11-18 months of age. All vaccines were administered intramuscularly in the thigh for children aged <12 months or in the thigh or deltoid for children aged ≥ 12 months. The 10Pn vaccine was administered in the right thigh or deltoid; the Infanrix™ hexa and Infanrix™ IPV Hib vaccines were administered in the upper left thigh or deltoid; and Meningitec™ was administered in the lower left thigh or deltoid.

    Reporting group title
    GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
    Reporting group description
    		 Subjects previously vaccinated with a 3-dose course of GSK Biologicals’ pneumococcal conjugate vaccine GSK1024850A co-administered with Infanrix™ IPV Hib and Baxter’s Men-C conjugate vaccine (NeisVac-C™) received a booster dose of the GSK1024850A vaccine co-administered with GSK Biologicals’ DTPa-combined vaccine (either Infanrix™ hexa in Germany and Poland or Infanrix™ IPV Hib in Spain) Hib and NeisVac-C™ at 11-18 months of age. The 10Pn vaccine was administered in the right thigh or deltoid; the Infanrix™ hexa and Infanrix™ IPV Hib vaccines were administered in the upper left thigh or deltoid; and NeisVac-C™ was administered in the lower left thigh or deltoid.

    Reporting group title
    GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
    Reporting group description
    		 This group is also referred to as the Group 10Pn + Hib-MenC in this record. Subjects previously vaccinated with a 3-dose course of GSK Biologicals’ pneumococcal conjugate vaccine GSK1024850A co-administered with Infanrix™ penta and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) received a booster dose of the GSK1024850A vaccine co-administered with DTPa-combined vaccine (either Infanrix™ penta in Germany and Poland or Infanrix™ IPV in Spain) and Menitorix™ at 11-18 months of age. The 10Pn vaccine was administered in the right thigh or deltoid; the Infanrix™ penta and Infanrix™ IPV vaccines were administered in the upper left thigh or deltoid; and Menitorix™ was administered in the lower left thigh or deltoid.

    Reporting group title
    Prevenar™ + Menitorix™
    Reporting group description
    		 This group is also referred to as the Group Prevenar in this record. Subjects previously vaccinated with a 3-dose course of Wyeth’s 7-valent pneumococcal conjugate vaccine (Prevenar™ or 7Pn) co-administered with Infanrix™ penta and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) received a booster dose of Prevenar™ co-administered with DTPa-combined vaccine (either Infanrix™ penta in Germany and Poland or Infanrix™ IPV in Spain) and Menitorix™ at 11-18 months of age. The 7Pn vaccine was administered in the right thigh or deltoid; the Infanrix™ penta and Infanrix™ IPV vaccines were administered in the upper left thigh or deltoid; and Menitorix™ was administered in the lower left thigh or deltoid.

    Reporting group values
    		 GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™ GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ Prevenar™ + Menitorix™ Total
    Number of subjects
    		 359 363 358 357 1437
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 359 363 358 357 1437
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 14.3 ± 1.81 14.3 ± 1.74 14.3 ± 1.78 14.3 ± 1.78 -
    Gender categorical
    Units: Subjects
        Female
    		 182 176 195 171 724
        Male
    		 177 187 163 186 713

    End points

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    End points reporting groups
    Reporting group title
    GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™
    Reporting group description
    		 Subjects previously vaccinated with a 3-dose course of GSK Biologicals’ pneumococcal conjugate vaccine GSK1024850A (10Pn) co-administered with Infanrix™ IPV Hib and Wyeth’s Men-C conjugate vaccine (Meningitec™) received a booster dose of the 10Pn vaccine co-administered with GSK Biologicals’ DTPa-combined vaccine (either Infanrix™ hexa in Germany and Poland or Infanrix™ IPV Hib in Spain) and Meningitec™ at 11-18 months of age. All vaccines were administered intramuscularly in the thigh for children aged <12 months or in the thigh or deltoid for children aged ≥ 12 months. The 10Pn vaccine was administered in the right thigh or deltoid; the Infanrix™ hexa and Infanrix™ IPV Hib vaccines were administered in the upper left thigh or deltoid; and Meningitec™ was administered in the lower left thigh or deltoid.

    Reporting group title
    GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
    Reporting group description
    		 Subjects previously vaccinated with a 3-dose course of GSK Biologicals’ pneumococcal conjugate vaccine GSK1024850A co-administered with Infanrix™ IPV Hib and Baxter’s Men-C conjugate vaccine (NeisVac-C™) received a booster dose of the GSK1024850A vaccine co-administered with GSK Biologicals’ DTPa-combined vaccine (either Infanrix™ hexa in Germany and Poland or Infanrix™ IPV Hib in Spain) Hib and NeisVac-C™ at 11-18 months of age. The 10Pn vaccine was administered in the right thigh or deltoid; the Infanrix™ hexa and Infanrix™ IPV Hib vaccines were administered in the upper left thigh or deltoid; and NeisVac-C™ was administered in the lower left thigh or deltoid.

    Reporting group title
    GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
    Reporting group description
    		 This group is also referred to as the Group 10Pn + Hib-MenC in this record. Subjects previously vaccinated with a 3-dose course of GSK Biologicals’ pneumococcal conjugate vaccine GSK1024850A co-administered with Infanrix™ penta and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) received a booster dose of the GSK1024850A vaccine co-administered with DTPa-combined vaccine (either Infanrix™ penta in Germany and Poland or Infanrix™ IPV in Spain) and Menitorix™ at 11-18 months of age. The 10Pn vaccine was administered in the right thigh or deltoid; the Infanrix™ penta and Infanrix™ IPV vaccines were administered in the upper left thigh or deltoid; and Menitorix™ was administered in the lower left thigh or deltoid.

    Reporting group title
    Prevenar™ + Menitorix™
    Reporting group description
    		 This group is also referred to as the Group Prevenar in this record. Subjects previously vaccinated with a 3-dose course of Wyeth’s 7-valent pneumococcal conjugate vaccine (Prevenar™ or 7Pn) co-administered with Infanrix™ penta and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) received a booster dose of Prevenar™ co-administered with DTPa-combined vaccine (either Infanrix™ penta in Germany and Poland or Infanrix™ IPV in Spain) and Menitorix™ at 11-18 months of age. The 7Pn vaccine was administered in the right thigh or deltoid; the Infanrix™ penta and Infanrix™ IPV vaccines were administered in the upper left thigh or deltoid; and Menitorix™ was administered in the lower left thigh or deltoid.

    Primary: Number of subjects reporting fever above 39.0 degree Celsius (°C)

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    End point title
    		 Number of subjects reporting fever above 39.0 degree Celsius (°C) [1]
    End point description
    Fever was measured as rectal temperature.
    End point type
    Primary
    End point timeframe
    During the 4-day (Day 0-3) period after the booster vaccination
    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 is related to assess solely the difference between the GSK’s 10-valent Pneumococcal vaccine 1024850A + Menitorix™ and Prevenar™ + Menitorix™ groups as regards incidence of Grade 3 fever.
    End point values
    		 GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ Prevenar™ + Menitorix™
    Number of subjects analysed
    355
    355
    Units: subjects
        > 39.0 degrees Celsius
    11
    8
    Statistical analysis title
    		 Non-inferiority of 10Pn vs 7Pn vaccine
    Statistical analysis description
    Analysis assessed the difference in percentage of subjects reporting Grade 3 fever (rectal temperature > 39.0°C). Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects with Grade 3 fever (GSK’s 10-valent Pneumococcal vaccine 1024850A + Menitorix™ group minus Prevenar™ + Menitorix™ control group) above the clinically acceptable limit of 5% + half the incidence in control (= null hypothesis) as shown by an one-sided P-value < 2.5%.
    Comparison groups
    GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ v Prevenar™ + Menitorix™
    Number of subjects included in analysis
    710
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [2]
    Method
    		 Kem Phillip's statistical test
    Parameter type
    		 Difference in percentage
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.67
         upper limit
    		 3.48
    Notes
    [2] - Non-inferiority was evaluated via the calculation of p-value using Kem Phillip's statistical test method, an extension of Farrington and Manning’s methods. This allowed the inferiority limit to vary taking into account the underlying failure rates.

    Secondary: Number of subjects reporting solicited local symptoms

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    End point title
    		 Number of subjects reporting solicited local symptoms
    End point description
    Solicited local symptoms assessed include pain, redness and swelling.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0-3) period after the booster vaccination
    End point values
    		 GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™ GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ Prevenar™ + Menitorix™
    Number of subjects analysed
    356
    357
    355
    355
    Units: subjects
        Pain
    196
    195
    193
    165
        Redness
    194
    183
    186
    173
        Swelling
    162
    148
    150
    134
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited general symptoms

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    End point title
    		 Number of subjects reporting solicited general symptoms
    End point description
    Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0-3) period after the booster vaccination
    End point values
    		 GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™ GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ Prevenar™ + Menitorix™
    Number of subjects analysed
    356
    357
    355
    355
    Units: subjects
        Drowsiness
    124
    142
    139
    105
        Fever (≥ 38.0 °C)
    109
    122
    105
    108
        Irritability
    170
    190
    191
    157
        Loss of appetite
    101
    99
    112
    93
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting unsolicited adverse events (AE)
    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.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Day 0-30) period after the booster vaccination
    End point values
    		 GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™ GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ Prevenar™ + Menitorix™
    Number of subjects analysed
    359
    363
    358
    357
    Units: subjects
        Number of subjects reporting unsolicited AEs
    59
    74
    59
    76
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting serious adverse events (SAE)
    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, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Day 0-30) period after the booster vaccination
    End point values
    		 GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™ GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ Prevenar™ + Menitorix™
    Number of subjects analysed
    359
    363
    358
    357
    Units: subjects
        Number of subjects reporting SAEs
    3
    5
    3
    2
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting serious adverse events (SAE)
    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, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
    End point type
    Secondary
    End point timeframe
    From the beginning of the study up to the end of the extended 6-month safety follow-up period
    End point values
    		 GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™ GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ Prevenar™ + Menitorix™
    Number of subjects analysed
    359
    363
    358
    357
    Units: subjects
        Number of subjects reporting SAEs
    15
    9
    13
    13
    No statistical analyses for this end point

    Secondary: Number of subjects with vaccine pneumococcal serotype antibody concentrations above the cut-off value

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    End point title
    		 Number of subjects with vaccine pneumococcal serotype antibody concentrations above the cut-off value
    End point description
    Anti-pneumococcal antibody concentration cut-off value assessed was 0.05 microgram per milliliter (µg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
    End point type
    Secondary
    End point timeframe
    Before (pre) and one month after (post) the booster administration
    End point values
    		 GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™ GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ Prevenar™ + Menitorix™
    Number of subjects analysed
    158
    158
    160
    153
    Units: subjects
        Anti-1 pre (N=150,152,149, 151)
    146
    146
    140
    21
        Anti-1 post (N=158,152,160,151)
    158
    152
    160
    28
        Anti-4 pre (N=153,156,150,153)
    152
    156
    147
    150
        Anti-4 post (N=158,153,160,152)
    158
    153
    160
    152
        Anti-5 pre (N=149,146,146,148)
    149
    146
    144
    37
        Anti-5 post (N=157,153,160,150)
    157
    153
    160
    64
        Anti-6B pre (N=151,155,150,151)
    149
    153
    144
    137
        Anti-6B post (N=158,153,160,153)
    157
    151
    158
    153
        Anti-7F pre (N=149,153,148,151)
    149
    153
    147
    18
        Anti-7F post (N=158,152,160,151)
    158
    152
    160
    25
        Anti-9V pre (N=149,155,149,152)
    149
    154
    149
    152
        Anti-9V post (N=158,153,160,153)
    158
    152
    160
    153
        Anti-14 pre (N=153,158,152,153)
    151
    157
    152
    151
        Anti-14 post (N=158,153,160,153)
    158
    153
    160
    153
        Anti-18C pre (N=151,153,145,151)
    149
    151
    145
    151
        Anti-18C post (N=157,152,160,152)
    157
    152
    160
    152
        Anti-19F pre (N=143,146,139,150)
    143
    146
    139
    143
        Anti-19F post (N=158,151,160,152)
    158
    151
    160
    152
        Anti-23F pre (N=152,156,150,153)
    149
    153
    144
    141
        Anti-23F post (N=158,153,160,153)
    158
    152
    158
    153
    No statistical analyses for this end point

    Secondary: Number of subjects with opsonophagocytic activity against vaccine pneumococcal serotypes above the cut-off value

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    End point title
    		 Number of subjects with opsonophagocytic activity against vaccine pneumococcal serotypes above the cut-off value
    End point description
    Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F.
    End point type
    Secondary
    End point timeframe
    Before (pre) and one month after (post) the booster administration
    End point values
    		 GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™ GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ Prevenar™ + Menitorix™
    Number of subjects analysed
    145
    145
    146
    143
    Units: subjects
        Opsono-1 pre (N=144,145,141,143)
    46
    39
    41
    8
        Opsono-1 post (N=140,139,140,137)
    132
    133
    127
    12
        Opsono-4 pre (N=104,121,112,109)
    61
    67
    61
    73
        Opsono-4 post (N=137,134,140,135)
    137
    134
    140
    135
        Opsono-5 pre (N=116,114,117,124)
    77
    71
    72
    3
        Opsono-5 post (N=124,130,136,127)
    121
    127
    131
    4
        Opsono-6B pre (N=133,132,133,137)
    75
    60
    75
    67
        Opsono-6B post (N=142,135,142,140)
    134
    127
    135
    138
        Opsono-7F pre (N=111,122,115,104)
    109
    117
    109
    42
        Opsono-7F post (N=140,137,139,112)
    140
    137
    139
    53
        Opsono-9V pre (N=133,133,130,130)
    131
    130
    122
    126
        Opsono-9V post (N=143,139,143,137)
    143
    139
    143
    137
        Opsono-14 pre (N=121,125,114,125)
    115
    116
    107
    124
        Opsono-14 post (N=137,138,138,134)
    137
    138
    138
    134
        Opsono-18C pre (N=126,118,123,123)
    45
    54
    34
    35
        Opsono-18C post (N=121,129,121,114)
    121
    127
    121
    110
        Opsono-19F pre (N=127,135,134,134)
    102
    110
    95
    29
        Opsono-19F post (N=137,137,139,133)
    133
    132
    139
    131
        Opsono-23F pre (N=132,136,128,137)
    121
    120
    105
    124
        Opsono-23F post (N=145,143,146,143)
    145
    143
    146
    143
    No statistical analyses for this end point

    Secondary: Number of subjects with cross-reactive pneumococcal serotype antibody concentrations above the cut-off value

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    End point title
    		 Number of subjects with cross-reactive pneumococcal serotype antibody concentrations above the cut-off value
    End point description
    Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL). The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
    End point type
    Secondary
    End point timeframe
    Before (pre) and one month after (post) the booster administration
    End point values
    		 GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™ GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ Prevenar™ + Menitorix™
    Number of subjects analysed
    157
    153
    160
    152
    Units: subjects
        Anti-6A pre (N=145,144,144,149)
    126
    120
    119
    110
        Anti-6A post (N=156,152,159,152)
    152
    145
    149
    148
        Anti-19A pre (N=145,153,145,151)
    130
    138
    121
    87
        Anti-19A post (N=157,153,160,152)
    154
    151
    155
    149
    No statistical analyses for this end point

    Secondary: Number of subjects with opsonophagocytic activity against cross-reactive pneumococcal serotypes above the cut-off value

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    End point title
    		 Number of subjects with opsonophagocytic activity against cross-reactive pneumococcal serotypes above the cut-off value
    End point description
    Anti-pneumococcal antibody cut-off value assessed was ≥ 8. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
    End point type
    Secondary
    End point timeframe
    Before (pre) and one month after (post) the booster administration
    End point values
    		 GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™ GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ Prevenar™ + Menitorix™
    Number of subjects analysed
    133
    138
    136
    134
    Units: subjects
        Opsono-6A pre (N=108,110,106,110)
    68
    66
    73
    62
        Opsono-6A post (N=127,128,128,122)
    116
    119
    117
    119
        Opsono-19A pre (N=133,138,136,134)
    4
    11
    4
    2
        Opsono-19A post (N=124,132,130,123)
    77
    75
    50
    29
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-protein D antibody concentrations above the cut-off value

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    End point title
    		 Number of subjects with anti-protein D antibody concentrations above the cut-off value
    End point description
    Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
    End point type
    Secondary
    End point timeframe
    Before (pre) and one month after (post) the booster administration
    End point values
    		 GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™ GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ Prevenar™ + Menitorix™
    Number of subjects analysed
    158
    153
    160
    148
    Units: subjects
        Pre (N=147,153,147,146)
    144
    147
    138
    59
        Post (N=158,152,160,148)
    158
    151
    160
    66
    No statistical analyses for this end point

    Secondary: Number of subjects with meningococcal serogroup C serum bactericidal assay titer above the cut-off value

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    End point title
    		 Number of subjects with meningococcal serogroup C serum bactericidal assay titer above the cut-off value
    End point description
    Meningococcal serogroup C serum bactericidal assay titer cut-off value assessed was ≥ 8.
    End point type
    Secondary
    End point timeframe
    Before (pre) and one month after (post) the booster administration
    End point values
    		 GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™ GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ Prevenar™ + Menitorix™
    Number of subjects analysed
    89
    84
    79
    78
    Units: subjects
        Pre (N=68,65,66,78)
    57
    62
    62
    68
        Post (N=89,84,79,76)
    89
    84
    79
    76
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-meningococcal polysaccharide C antibody concentrations above the cut-off value

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    End point title
    		 Number of subjects with anti-meningococcal polysaccharide C antibody concentrations above the cut-off value
    End point description
    Anti-meningococcal polysaccharide C antibody cut-off value assessed was ≥ 0.3 µg/mL.
    End point type
    Secondary
    End point timeframe
    Before (pre) and one month after (post) the booster administration
    End point values
    		 GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™ GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ Prevenar™ + Menitorix™
    Number of subjects analysed
    156
    149
    159
    149
    Units: subjects
        Pre (N=126,124,125,135)
    95
    82
    105
    102
        Post (N=156,149,159,149)
    156
    149
    159
    149
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polyribosyl-ribitol phosphate antibody concentrations above the cut-off value

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    End point title
    		 Number of subjects with anti-polyribosyl-ribitol phosphate antibody concentrations above the cut-off value
    End point description
    Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was ≥ 0.15 µg/mL.
    End point type
    Secondary
    End point timeframe
    Before (pre) and one month after (post) the booster administration
    End point values
    		 GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™ GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ Prevenar™ + Menitorix™
    Number of subjects analysed
    157
    153
    160
    152
    Units: subjects
        Pre (N=147,144,150,148)
    122
    128
    145
    143
        Post (N=157,153,160,152)
    157
    153
    160
    152
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events were assessed during the entire study period. Systematically assessed frequent AEs were assessed during the 31-day post vaccination period. Solicited local/general symptoms were assessed during the 4-day post vaccination period.
    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
    9.0
    Reporting groups
    Reporting group title
    GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™
    Reporting group description
    		 Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.

    Reporting group title
    GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
    Reporting group description
    		 Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.

    Reporting group title
    GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
    Reporting group description
    		 Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.

    Reporting group title
    Prevenar™ + Menitorix™
    Reporting group description
    		 Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.

    Serious adverse events
    		 GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™ GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ Prevenar™ + Menitorix™
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 359 (4.18%)
    9 / 363 (2.48%)
    13 / 358 (3.63%)
    13 / 357 (3.64%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    2 / 359 (0.56%)
    0 / 363 (0.00%)
    1 / 358 (0.28%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 363 (0.00%)
    0 / 358 (0.00%)
    1 / 357 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Electric shock
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 363 (0.00%)
    0 / 358 (0.00%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 363 (0.28%)
    2 / 358 (0.56%)
    2 / 357 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 363 (0.00%)
    1 / 358 (0.28%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastroenteritis rotavirus
         subjects affected / exposed
    4 / 359 (1.11%)
    0 / 363 (0.00%)
    1 / 358 (0.28%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 363 (0.00%)
    0 / 358 (0.00%)
    2 / 357 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 359 (0.28%)
    1 / 363 (0.28%)
    0 / 358 (0.00%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchpneumopathy
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 363 (0.00%)
    1 / 358 (0.28%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 363 (0.00%)
    1 / 358 (0.28%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 363 (0.00%)
    1 / 358 (0.28%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wheezing
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 363 (0.28%)
    0 / 358 (0.00%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Breath holding
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 363 (0.00%)
    1 / 358 (0.28%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 363 (0.00%)
    1 / 358 (0.28%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    2 / 359 (0.56%)
    4 / 363 (1.10%)
    2 / 358 (0.56%)
    3 / 357 (0.84%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 359 (0.56%)
    1 / 363 (0.28%)
    0 / 358 (0.00%)
    3 / 357 (0.84%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 359 (0.28%)
    1 / 363 (0.28%)
    0 / 358 (0.00%)
    2 / 357 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 363 (0.00%)
    1 / 358 (0.28%)
    1 / 357 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 363 (0.28%)
    2 / 358 (0.56%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute tonsillitis
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 363 (0.00%)
    1 / 358 (0.28%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 363 (0.00%)
    0 / 358 (0.00%)
    1 / 357 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 359 (0.00%)
    0 / 363 (0.00%)
    0 / 358 (0.00%)
    1 / 357 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 363 (0.00%)
    0 / 358 (0.00%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheitis
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 363 (0.00%)
    0 / 358 (0.00%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 363 (0.28%)
    0 / 358 (0.00%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 359 (0.00%)
    1 / 363 (0.28%)
    0 / 358 (0.00%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 359 (0.28%)
    0 / 363 (0.00%)
    0 / 358 (0.00%)
    0 / 357 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GSK's 10-valent Pneumococcal vaccine 1024850A + Meningitec™ GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ Prevenar™ + Menitorix™
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    196 / 359 (54.60%)
    195 / 363 (53.72%)
    193 / 358 (53.91%)
    173 / 357 (48.46%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    196 / 359 (54.60%)
    195 / 363 (53.72%)
    193 / 358 (53.91%)
    165 / 357 (46.22%)
         occurrences all number
    196
    195
    193
    165
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    194 / 359 (54.04%)
    183 / 363 (50.41%)
    186 / 358 (51.96%)
    173 / 357 (48.46%)
         occurrences all number
    194
    183
    186
    173
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    162 / 359 (45.13%)
    148 / 363 (40.77%)
    150 / 358 (41.90%)
    134 / 357 (37.54%)
         occurrences all number
    162
    148
    150
    134
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    124 / 359 (34.54%)
    142 / 363 (39.12%)
    139 / 358 (38.83%)
    105 / 357 (29.41%)
         occurrences all number
    124
    142
    139
    105
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    109 / 359 (30.36%)
    122 / 363 (33.61%)
    105 / 358 (29.33%)
    108 / 357 (30.25%)
         occurrences all number
    109
    122
    105
    108
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    170 / 359 (47.35%)
    190 / 363 (52.34%)
    191 / 358 (53.35%)
    157 / 357 (43.98%)
         occurrences all number
    170
    190
    191
    157
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    101 / 359 (28.13%)
    99 / 363 (27.27%)
    112 / 358 (31.28%)
    93 / 357 (26.05%)
         occurrences all number
    101
    99
    112
    93
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 359 (1.67%)
    19 / 363 (5.23%)
    14 / 358 (3.91%)
    18 / 357 (5.04%)
         occurrences all number
    6
    19
    14
    18

    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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    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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