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    Clinical Trial Results:
    Persistence of antibodies after full vaccination course with GSK Biologicals’ Menitorix or MenC conjugate vaccine, co-administered with DTPa or DTPa/Hib containing vaccine and pneumococcal conjugate vaccine, in children up to 6 years of age

    Summary
    EudraCT number
    		 2008-007846-69
    Trial protocol
    		 DE   ES  
    Global end of trial date
    21 Nov 2012

    Results information
    Results version number
    		 v2(current)
    This version publication date
    05 Aug 2016
    First version publication date
    23 Apr 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Data (typos) were corrected.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    112830
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00891176
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Jun 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Nov 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Nov 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    At approximately 3, 4 and 6 years of age, in subjects who previously received a full vaccination course with Hib-MenC conjugate vaccine co-administrated with DTPa-containing and pneumococcal conjugate vaccines or with MenC conjugate vaccines co-administered with DTPa/Hib containing and GSK Biologicals’ 10Pn-PD-DiT conjugate vaccines, and who participated in the blood sampling subset of study 10PN-PD-DIT-017: •To evaluate the antibody persistence with respect to the MenC component of the Hib-MenC conjugate vaccine in terms of percentage of subjects with rSBA-MenC titres >= 1:8
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 May 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 72 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 108
    Country: Number of subjects enrolled
    Spain: 186
    Country: Number of subjects enrolled
    Poland: 306
    Worldwide total number of subjects
    600
    EEA total number of subjects
    600
    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)
    0
    Children (2-11 years)
    600
    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
    		 All subjects who received the full vaccination course corresponding to their group in the primary vaccination study 107005 and in the booster vaccination study 109507 and who were part of the blood sampling subset were asked to participate in this long-term follow up study comprising 3 time points. No vaccine was given.

    Pre-assignment period milestones
    Number of subjects started
    		 600
    Number of subjects completed
    		 581

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 No vaccination received: 19
    Period 1
    Period 1 title
    Long term Persistence (Visit 1)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Synflorix-Meningitec 1 Group
    Arm description
    		 Subjects who received concomitantly in the primary study 107005: 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland, subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Menitorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.

    Investigational medicinal product name
    Pneumoccoccal conjugate vaccine GSK1024850A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.

    Investigational medicinal product name
    Infanrix Penta
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study

    Investigational medicinal product name
    Infanrix IPV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as booster dose at 11-18 months of age (Spain) No vaccine was administered during this long-term follow up study

    Arm title
    		 Synflorix-NeisVac-C 1 Group
    Arm description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland, subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menitorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study

    Investigational medicinal product name
    Pneumococcal conjugate vaccine GSK1024850A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study

    Investigational medicinal product name
    Prevenar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.

    Arm title
    		 Synflorix-Menitorix 1 Group
    Arm description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age. 3 primary doses of Pediarix intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Pediarix
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pneumococcal conjugate vaccine GSK1024850A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.

    Investigational medicinal product name
    Meningitec
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study

    Arm title
    		 Prevenar-Menitorix 1 Group
    Arm description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age. 3 primary doses of Pediarix intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Pediarix
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pneumococcal conjugate vaccine GSK1024850A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.

    Number of subjects in period 1 [1]
    		Synflorix-Meningitec 1 Group Synflorix-NeisVac-C 1 Group Synflorix-Menitorix 1 Group Prevenar-Menitorix 1 Group
    Started
    144
    147
    149
    141
    Completed
    144
    147
    149
    141
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Some subjects were enrolled but did not start the trial.
    Period 2
    Period 2 title
    Long term Persistence (Visit 2)
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Synflorix-Meningitec 2 Group
    Arm description
    		 Subjects who received concomitantly in the primary study 107005: 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland, subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Menitorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.

    Arm title
    		 Synflorix-NeisVac-C 2 Group
    Arm description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland, subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menitorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.

    Arm title
    		 Synflorix-Menitorix 2 Group
    Arm description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age. 3 primary doses of Pediarix intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Pediarix
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pneumococcal conjugate vaccine GSK1024850A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.

    Arm title
    		 Prevenar-Menitorix 2 Group
    Arm description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age. 3 primary doses of Pediarix intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Pediarix
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pneumococcal conjugate vaccine GSK1024850A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.

    Number of subjects in period 2 [2]
    		Synflorix-Meningitec 2 Group Synflorix-NeisVac-C 2 Group Synflorix-Menitorix 2 Group Prevenar-Menitorix 2 Group
    Started
    140
    142
    142
    137
    Completed
    140
    142
    142
    137
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Some subjects did not come back for the subsequent visits.
    Period 3
    Period 3 title
    Long term Persistence (Visit 3)
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Synflorix-Meningitec 3 Group
    Arm description
    		 Subjects who received concomitantly in the primary study 107005: 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland, subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Menitorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.

    Arm title
    		 Synflorix-NeisVac-C 3 Group
    Arm description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland, subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menitorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.

    Arm title
    		 Synflorix-Menitorix 3 Group
    Arm description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age. 3 primary doses of Pediarix intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Pediarix
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pneumococcal conjugate vaccine GSK1024850A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.

    Arm title
    		 Prevenar-Menitorix 3 Group
    Arm description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age. 3 primary doses of Pediarix intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Pediarix
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pneumococcal conjugate vaccine GSK1024850A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.

    Number of subjects in period 3 [3]
    		Synflorix-Meningitec 3 Group Synflorix-NeisVac-C 3 Group Synflorix-Menitorix 3 Group Prevenar-Menitorix 3 Group
    Started
    131
    138
    135
    135
    Completed
    131
    138
    135
    135
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Some subjects did not come back for the subsequent visits.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Synflorix-Meningitec 1 Group
    Reporting group description
    		 Subjects who received concomitantly in the primary study 107005: 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland, subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.

    Reporting group title
    Synflorix-NeisVac-C 1 Group
    Reporting group description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland, subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.

    Reporting group title
    Synflorix-Menitorix 1 Group
    Reporting group description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age. 3 primary doses of Pediarix intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Pediarix

    Reporting group title
    Prevenar-Menitorix 1 Group
    Reporting group description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age. 3 primary doses of Pediarix intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Pediarix

    Reporting group values
    		 Synflorix-Meningitec 1 Group Synflorix-NeisVac-C 1 Group Synflorix-Menitorix 1 Group Prevenar-Menitorix 1 Group Total
    Number of subjects
    		 144 147 149 141 581
    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
        arithmetic mean (standard deviation)
    		 37.1 ± 1.17 37.2 ± 1.2 37.3 ± 1.18 37.3 ± 1.28 -
    Gender categorical
    Units: Subjects
        Female
    		 71 65 86 71 293
        Male
    		 73 82 63 70 288

    End points

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    End points reporting groups
    Reporting group title
    Synflorix-Meningitec 1 Group
    Reporting group description
    		 Subjects who received concomitantly in the primary study 107005: 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland, subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.

    Reporting group title
    Synflorix-NeisVac-C 1 Group
    Reporting group description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland, subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.

    Reporting group title
    Synflorix-Menitorix 1 Group
    Reporting group description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age. 3 primary doses of Pediarix intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Pediarix

    Reporting group title
    Prevenar-Menitorix 1 Group
    Reporting group description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age. 3 primary doses of Pediarix intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Pediarix
    Reporting group title
    Synflorix-Meningitec 2 Group
    Reporting group description
    		 Subjects who received concomitantly in the primary study 107005: 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland, subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.

    Reporting group title
    Synflorix-NeisVac-C 2 Group
    Reporting group description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland, subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.

    Reporting group title
    Synflorix-Menitorix 2 Group
    Reporting group description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age. 3 primary doses of Pediarix intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Pediarix

    Reporting group title
    Prevenar-Menitorix 2 Group
    Reporting group description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age. 3 primary doses of Pediarix intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Pediarix
    Reporting group title
    Synflorix-Meningitec 3 Group
    Reporting group description
    		 Subjects who received concomitantly in the primary study 107005: 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland, subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.

    Reporting group title
    Synflorix-NeisVac-C 3 Group
    Reporting group description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland, subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.

    Reporting group title
    Synflorix-Menitorix 3 Group
    Reporting group description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age. 3 primary doses of Pediarix intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Pediarix

    Reporting group title
    Prevenar-Menitorix 3 Group
    Reporting group description
    		 Subjects who received concomitantly in the primary study (107005): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age. 3 primary doses of Pediarix intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (109507), subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Pediarix

    Primary: Number of subjects with Meningoccoccal serogroup C serum bactericidal titers using rabitt complement (rSBA-MenC) equal to or above the cut-off value 1:8

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    End point title
    		 Number of subjects with Meningoccoccal serogroup C serum bactericidal titers using rabitt complement (rSBA-MenC) equal to or above the cut-off value 1:8 [1]
    End point description
    End point type
    Primary
    End point timeframe
    At 3, 4 and 6 years of age
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Synflorix-Meningitec 1 Group Synflorix-Meningitec 2 Group Synflorix-Meningitec 3 Group Synflorix-NeisVac-C 1 Group Synflorix-NeisVac-C 2 Group Synflorix-NeisVac-C 3 Group Synflorix-Menitorix 1 Group Synflorix-Menitorix 2 Group Synflorix-Menitorix 3 Group Prevenar-Menitorix 1 Group Prevenar-Menitorix 2 Group Prevenar-Menitorix 3 Group
    Number of subjects analysed
    139
    134
    128
    146
    137
    137
    143
    128
    130
    137
    128
    134
    Units: Subjects
        rSBA-MenC
    120
    97
    31
    144
    132
    55
    127
    108
    50
    113
    98
    34
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-polyribosyl -ribitol phosphate (Anti-PRP) and antibody concentration equal to or above cut-off

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    End point title
    		 Number of subjects with anti-polyribosyl -ribitol phosphate (Anti-PRP) and antibody concentration equal to or above cut-off
    End point description
    End point type
    Secondary
    End point timeframe
    At 3, 4 and 6 years of age. The cut-off were 0.15 ug/mL and 1.0 ug/mL
    End point values
    		 Synflorix-Meningitec 1 Group Synflorix-Meningitec 2 Group Synflorix-Meningitec 3 Group Synflorix-NeisVac-C 1 Group Synflorix-NeisVac-C 2 Group Synflorix-NeisVac-C 3 Group Synflorix-Menitorix 1 Group Synflorix-Menitorix 2 Group Synflorix-Menitorix 3 Group Prevenar-Menitorix 1 Group Prevenar-Menitorix 2 Group Prevenar-Menitorix 3 Group
    Number of subjects analysed
    132
    134
    127
    139
    136
    134
    137
    130
    130
    138
    133
    132
    Units: Subjects
        ≥ 0.15 µg/mL
    132
    133
    126
    139
    134
    132
    137
    130
    130
    138
    132
    132
        ≥ 1.0 µg/mL
    101
    88
    85
    105
    85
    77
    127
    117
    110
    115
    106
    100
    No statistical analyses for this end point

    Secondary: Number of subjects with pneumoccoccal serotypes concentration equal to and above the cut-off values

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    End point title
    		 Number of subjects with pneumoccoccal serotypes concentration equal to and above the cut-off values
    End point description
    End point type
    Secondary
    End point timeframe
    At 3, 4 and 6 years of age
    End point values
    		 Synflorix-Meningitec 1 Group Synflorix-Meningitec 2 Group Synflorix-Meningitec 3 Group Synflorix-NeisVac-C 1 Group Synflorix-NeisVac-C 2 Group Synflorix-NeisVac-C 3 Group Synflorix-Menitorix 1 Group Synflorix-Menitorix 2 Group Synflorix-Menitorix 3 Group Prevenar-Menitorix 1 Group Prevenar-Menitorix 2 Group Prevenar-Menitorix 3 Group
    Number of subjects analysed
    141
    136
    128
    146
    138
    137
    144
    133
    130
    140
    136
    133
    Units: Subjects
        Anti-1
    138
    130
    121
    143
    135
    129
    135
    124
    114
    83
    100
    101
        Anti-4
    138
    130
    108
    141
    133
    123
    140
    127
    106
    133
    132
    126
        Anti-5
    140
    136
    125
    144
    137
    131
    142
    131
    124
    101
    115
    112
        Anti-6B
    137
    131
    125
    143
    134
    133
    139
    125
    128
    137
    132
    130
        Anti-7F
    141
    135
    125
    146
    138
    134
    141
    130
    129
    68
    85
    113
        Anti-9V
    138
    135
    125
    144
    135
    133
    141
    128
    126
    139
    135
    131
        Anti14
    141
    136
    128
    146
    138
    137
    144
    132
    130
    140
    136
    133
        Anti-18 C
    141
    136
    127
    146
    138
    136
    140
    130
    125
    139
    136
    128
        Anti-19F
    141
    135
    128
    146
    136
    137
    144
    133
    130
    137
    136
    133
        Anti-23
    140
    133
    127
    145
    137
    136
    140
    126
    128
    139
    134
    133
    No statistical analyses for this end point

    Secondary: Number of subjects with opsonophagocytic activity

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    End point title
    		 Number of subjects with opsonophagocytic activity
    End point description
    End point type
    Secondary
    End point timeframe
    At 3 years of age
    End point values
    		 Synflorix-Meningitec 1 Group Synflorix-NeisVac-C 1 Group Synflorix-Menitorix 1 Group Prevenar-Menitorix 1 Group
    Number of subjects analysed
    131
    131
    131
    132
    Units: Subjects
        Opsono-1 [N=131;131;131;131]
    30
    32
    29
    14
        Opsono-4 [N=126;127;129;128]
    54
    48
    43
    77
        Opsono-5 [N=130;130;129;132]
    73
    47
    55
    5
        Opsono-6B [N=128;127;124;131]
    84
    81
    78
    115
        Opsono-7F [N=131;130;131;130]
    128
    130
    131
    126
        Opsono-9V [N=131;131;129;132]
    127
    131
    127
    124
        Opsono-14 [N=129;128;128;131]
    110
    118
    106
    112
        Opsono-18C [N=126;121;123;122]
    51
    68
    44
    48
        Opsono-19F [N=130;130;131;132]
    105
    108
    89
    91
        Opsono-23F [N=125;124;125;132]
    106
    112
    113
    129
    No statistical analyses for this end point

    Secondary: Antibody concentrations against vaccine pneumococcal serotypes

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    End point title
    		 Antibody concentrations against vaccine pneumococcal serotypes
    End point description
    End point type
    Secondary
    End point timeframe
    At 3, 4 and 6 years of age
    End point values
    		 Synflorix-Meningitec 1 Group Synflorix-Meningitec 2 Group Synflorix-Meningitec 3 Group Synflorix-NeisVac-C 1 Group Synflorix-NeisVac-C 2 Group Synflorix-NeisVac-C 3 Group Synflorix-Menitorix 1 Group Synflorix-Menitorix 2 Group Synflorix-Menitorix 3 Group Prevenar-Menitorix 1 Group Prevenar-Menitorix 2 Group Prevenar-Menitorix 3 Group
    Number of subjects analysed
    141
    136
    128
    146
    138
    137
    144
    133
    131
    140
    136
    134
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-1
    0.26 (0.22 to 0.3)
    0.22 (0.19 to 0.27)
    0.19 (0.16 to 0.23)
    0.23 (0.19 to 0.26)
    0.21 (0.17 to 0.26)
    0.22 (0.17 to 0.27)
    0.21 (0.18 to 0.25)
    0.18 (0.15 to 0.21)
    0.2 (0.15 to 0.26)
    0.07 (0.06 to 0.09)
    0.08 (0.07 to 0.1)
    0.11 (0.09 to 0.13)
        Anti-4
    0.27 (0.23 to 0.32)
    0.22 (0.19 to 0.26)
    0.14 (0.11 to 0.17)
    0.23 (0.2 to 0.27)
    0.21 (0.18 to 0.25)
    0.14 (0.11 to 0.17)
    0.23 (0.2 to 0.27)
    0.2 (0.17 to 0.24)
    0.12 (0.1 to 0.15)
    0.35 (0.29 to 0.42)
    0.32 (0.27 to 0.39)
    0.24 (0.19 to 0.29)
        Anti-5
    0.46 (0.39 to 0.54)
    0.47 (0.37 to 0.59)
    0.37 (0.3 to 0.45)
    0.39 (0.33 to 0.46)
    0.36 (0.3 to 0.42)
    0.31 (0.26 to 0.37)
    0.41 (0.35 to 0.5)
    0.34 (0.28 to 0.42)
    0.3 (0.25 to 0.37)
    0.09 (0.07 to 0.1)
    0.1 (0.08 to 0.11)
    0.13 (0.11 to 0.15)
        Anti-6B
    0.59 (0.45 to 0.76)
    0.74 (0.53 to 1.01)
    1.71 (1.32 to 2.23)
    0.56 (0.45 to 0.71)
    0.65 (0.49 to 0.86)
    1.13 (0.87 to 1.48)
    0.63 (0.47 to 0.84)
    0.78 (0.57 to 1.06)
    1.28 (1 to 1.64)
    0.95 (0.77 to 1.18)
    0.99 (0.76 to 1.29)
    1.73 (1.38 to 2.16)
        Anti-7F
    0.58 (0.5 to 0.67)
    0.51 (0.41 to 0.63)
    0.61 (0.49 to 0.78)
    0.51 (0.43 to 0.59)
    0.44 (0.37 to 0.52)
    0.59 (0.46 to 0.74)
    0.54 (0.45 to 0.66)
    0.46 (0.37 to 0.58)
    0.64 (0.5 to 0.82)
    0.07 (0.05 to 0.09)
    0.09 (0.07 to 0.12)
    0.24 (0.18 to 0.32)
        Anti-9V
    0.6 (0.49 to 0.73)
    0.52 (0.42 to 0.65)
    0.76 (0.56 to 1.01)
    0.54 (0.44 to 0.66)
    0.61 (0.46 to 0.81)
    0.67 (0.51 to 0.88)
    0.47 (0.39 to 0.57)
    0.54 (0.4 to 0.72)
    0.57 (0.42 to 0.79)
    0.7 (0.57 to 0.85)
    0.72 (0.57 to 0.91)
    0.65 (0.51 to 0.83)
        Anti-14
    1.33 (1.04 to 1.7)
    1.51 (1.18 to 1.92)
    2.84 (2.17 to 3.73)
    1.09 (0.88 to 1.35)
    1.57 (1.25 to 1.97)
    2.22 (1.72 to 2.86)
    1 (0.8 to 1.25)
    1.41 (1.1 to 1.82)
    2.81 (2.07 to 3.81)
    1.48 (1.23 to 1.78)
    1.71 (1.38 to 2.12)
    2.59 (2.08 to 3.23)
        Anti-18C
    0.6 (0.5 to 0.71)
    0.49 (0.41 to 0.59)
    0.52 (0.41 to 0.66)
    0.84 (0.73 to 0.97)
    0.81 (0.67 to 0.98)
    0.75 (0.6 to 0.94)
    0.59 (0.48 to 0.71)
    0.6 (0.48 to 0.75)
    0.56 (0.43 to 0.74)
    0.59 (0.5 to 0.7)
    0.49 (0.4 to 0.59)
    0.49 (0.39 to 0.62)
        Anti-19F
    2.06 (1.58 to 2.69)
    2.66 (1.92 to 3.67)
    3.91 (3.01 to 5.1)
    1.63 (1.27 to 2.09)
    2.36 (1.7 to 3.29)
    3.94 (2.99 to 5.2)
    1.35 (1.05 to 1.72)
    2.5 (1.8 to 3.48)
    4.24 (3.3 to 5.45)
    1.48 (1.07 to 2.05)
    2.41 (1.78 to 3.25)
    3.11 (2.48 to 3.91)
        Anti-23F
    0.73 (0.58 to 0.92)
    0.98 (0.71 to 1.35)
    1.71 (1.26 to 2.3)
    0.69 (0.55 to 0.88)
    0.84 (0.65 to 1.1)
    1.7 (1.27 to 2.26)
    0.62 (0.46 to 0.82)
    0.98 (0.69 to 1.39)
    1.41 (1.06 to 1.87)
    1.36 (1.07 to 1.73)
    1.56 (1.16 to 2.09)
    2.99 (2.32 to 3.86)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-protein D (anti-PD) antibody concentrations equal or above cut off values

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    End point title
    		 Number of subjects with anti-protein D (anti-PD) antibody concentrations equal or above cut off values
    End point description
    End point type
    Secondary
    End point timeframe
    At 3, 4 and 6 years of age
    End point values
    		 Synflorix-Meningitec 1 Group Synflorix-Meningitec 2 Group Synflorix-Meningitec 3 Group Synflorix-NeisVac-C 1 Group Synflorix-NeisVac-C 2 Group Synflorix-NeisVac-C 3 Group Synflorix-Menitorix 1 Group Synflorix-Menitorix 2 Group Synflorix-Menitorix 3 Group Prevenar-Menitorix 1 Group Prevenar-Menitorix 2 Group Prevenar-Menitorix 3 Group
    Number of subjects analysed
    140
    136
    128
    145
    138
    137
    144
    129
    131
    139
    132
    133
    Units: Subjects
        Anti-PD
    132
    127
    113
    137
    128
    119
    136
    115
    113
    69
    75
    74
    No statistical analyses for this end point

    Secondary: Concentration of antibodies against protein D

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    End point title
    		 Concentration of antibodies against protein D
    End point description
    End point type
    Secondary
    End point timeframe
    At 3, 4 and 6 years of age
    End point values
    		 Synflorix-Meningitec 1 Group Synflorix-Meningitec 2 Group Synflorix-Meningitec 3 Group Synflorix-NeisVac-C 1 Group Synflorix-NeisVac-C 2 Group Synflorix-NeisVac-C 3 Group Synflorix-Menitorix 1 Group Synflorix-Menitorix 2 Group Synflorix-Menitorix 3 Group Prevenar-Menitorix 1 Group Prevenar-Menitorix 2 Group Prevenar-Menitorix 3 Group
    Number of subjects analysed
    140
    136
    128
    145
    138
    137
    144
    129
    131
    139
    132
    133
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PD
    494.6 (414 to 591)
    401.1 (338.3 to 475.6)
    284.7 (239.5 to 338.4)
    444.8 (373.2 to 530.1)
    387.2 (326.7 to 458.9)
    278 (236.3 to 327.1)
    439.8 (366.4 to 527.9)
    334.8 (277.7 to 403.7)
    266.1 (222.2 to 318.8)
    100.3 (87.6 to 114.9)
    107.9 (94.6 to 123.1)
    105.2 (92.4 to 119.8)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody concentrations equal to or above cut-off values

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    End point title
    		 Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody concentrations equal to or above cut-off values
    End point description
    End point type
    Secondary
    End point timeframe
    At 3 years of age
    End point values
    		 Synflorix-Meningitec 1 Group Synflorix-NeisVac-C 1 Group Synflorix-Menitorix 1 Group Prevenar-Menitorix 1 Group
    Number of subjects analysed
    107
    102
    105
    102
    Units: Subjects
        ≥ 10 mIU/mL
    105
    96
    102
    99
        ≥ 100 mIU/mL
    77
    81
    74
    74
    No statistical analyses for this end point

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

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    End point title
    		 Anti-hepatitis B surface antigen (anti-HBs) antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    At 3 years of age
    End point values
    		 Synflorix-Meningitec 1 Group Synflorix-NeisVac-C 1 Group Synflorix-Menitorix 1 Group Prevenar-Menitorix 1 Group
    Number of subjects analysed
    107
    102
    105
    102
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs antibody concentrations
    367.5 (256.8 to 525.9)
    325.7 (228.3 to 464.7)
    288.1 (198.7 to 417.9)
    371.4 (254.1 to 542.8)
    No statistical analyses for this end point

    Secondary: Number of subjects with Meningoccoccal serogroup C serum bactericidal titers using rabitt complement (rSBA-MenC) equal to or above cut-off value 1:128

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    End point title
    		 Number of subjects with Meningoccoccal serogroup C serum bactericidal titers using rabitt complement (rSBA-MenC) equal to or above cut-off value 1:128
    End point description
    End point type
    Secondary
    End point timeframe
    At 3, 4 and 6 years of age
    End point values
    		 Synflorix-Meningitec 1 Group Synflorix-Meningitec 2 Group Synflorix-Meningitec 3 Group Synflorix-NeisVac-C 1 Group Synflorix-NeisVac-C 2 Group Synflorix-NeisVac-C 3 Group Synflorix-Menitorix 1 Group Synflorix-Menitorix 2 Group Synflorix-Menitorix 3 Group Prevenar-Menitorix 1 Group Prevenar-Menitorix 2 Group Prevenar-Menitorix 3 Group
    Number of subjects analysed
    139
    134
    128
    146
    137
    137
    143
    128
    130
    137
    128
    134
    Units: Subjects
        rSBA-MenC
    69
    49
    11
    109
    79
    19
    98
    75
    15
    68
    58
    14
    No statistical analyses for this end point

    Secondary: Meningoccoccal serogroup C serum bactericidal (rSBA-MenC) titers

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    End point title
    		 Meningoccoccal serogroup C serum bactericidal (rSBA-MenC) titers
    End point description
    End point type
    Secondary
    End point timeframe
    At 3, 4 and 6 years of age
    End point values
    		 Synflorix-Meningitec 1 Group Synflorix-Meningitec 2 Group Synflorix-Meningitec 3 Group Synflorix-NeisVac-C 1 Group Synflorix-NeisVac-C 2 Group Synflorix-NeisVac-C 3 Group Synflorix-Menitorix 1 Group Synflorix-Menitorix 2 Group Synflorix-Menitorix 3 Group Prevenar-Menitorix 1 Group Prevenar-Menitorix 2 Group Prevenar-Menitorix 3 Group
    Number of subjects analysed
    139
    134
    128
    146
    137
    137
    143
    128
    130
    137
    128
    134
    Units: Titer
    geometric mean (confidence interval 95%)
        rSBA-MenC titers
    100.5 (75.6 to 133.8)
    45.3 (33.2 to 61.8)
    7.2 (5.8 to 8.9)
    235.3 (189.1 to 292.7)
    146.8 (116.2 to 185.4)
    11.9 (8.9 to 16)
    167.5 (126 to 222.7)
    112.4 (81.8 to 154.6)
    10.1 (7.9 to 12.9)
    84 (61.6 to 114.6)
    68.1 (48.4 to 95.9)
    8.5 (6.6 to 11.1)
    No statistical analyses for this end point

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

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    End point title
    		 Anti-polyribosyl -ribitol phosphate (anti-PRP) concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    At 3, 4 and 6 years of age
    End point values
    		 Synflorix-Meningitec 1 Group Synflorix-Meningitec 2 Group Synflorix-Meningitec 3 Group Synflorix-NeisVac-C 1 Group Synflorix-NeisVac-C 2 Group Synflorix-NeisVac-C 3 Group Synflorix-Menitorix 1 Group Synflorix-Menitorix 2 Group Synflorix-Menitorix 3 Group Prevenar-Menitorix 1 Group Prevenar-Menitorix 2 Group Prevenar-Menitorix 3 Group
    Number of subjects analysed
    132
    134
    127
    139
    136
    134
    137
    130
    130
    138
    133
    132
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP concentrations
    2.293 (1.87 to 2.812)
    1.767 (1.454 to 2.146)
    1.655 (1.339 to 2.045)
    2.222 (1.794 to 2.752)
    1.738 (1.386 to 2.178)
    1.647 (1.298 to 2.09)
    4.177 (3.427 to 5.092)
    3.804 (3.092 to 4.679)
    2.947 (2.396 to 3.624)
    3.636 (2.957 to 4.471)
    2.805 (2.297 to 3.425)
    2.558 (2.065 to 3.168)
    No statistical analyses for this end point

    Secondary: Number of subjects with Serious Adverse Events (SAEs)

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    End point title
    		 Number of subjects with Serious Adverse Events (SAEs)
    End point description
    End point type
    Secondary
    End point timeframe
    At 3, 4 and 6 years of age
    End point values
    		 Synflorix-Meningitec 1 Group Synflorix-Meningitec 2 Group Synflorix-Meningitec 3 Group Synflorix-NeisVac-C 1 Group Synflorix-NeisVac-C 2 Group Synflorix-NeisVac-C 3 Group Synflorix-Menitorix 1 Group Synflorix-Menitorix 2 Group Synflorix-Menitorix 3 Group Prevenar-Menitorix 1 Group Prevenar-Menitorix 2 Group Prevenar-Menitorix 3 Group
    Number of subjects analysed
    144
    140
    131
    147
    142
    138
    149
    142
    135
    141
    137
    135
    Units: Subjects
        SAE(s)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Related SAE(s)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Anti-hepatitis B surface antigen (anti-HBs) antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    At 4 years of age
    End point values
    		 Synflorix-Meningitec 2 Group Synflorix-NeisVac-C 2 Group Synflorix-Menitorix 2 Group Prevenar-Menitorix 2 Group
    Number of subjects analysed
    95
    102
    98
    98
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs antibody concentrations
    273.5 (183.2 to 408.3)
    238.8 (165.6 to 344.3)
    174.6 (114.5 to 266.4)
    284.7 (190.7 to 425.1)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody concentrations equal to or above cut-off values

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    End point title
    		 Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody concentrations equal to or above cut-off values
    End point description
    Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.
    End point type
    Secondary
    End point timeframe
    At 4 years of age
    End point values
    		 Synflorix-Meningitec 2 Group Synflorix-NeisVac-C 2 Group Synflorix-Menitorix 2 Group Prevenar-Menitorix 2 Group
    Number of subjects analysed
    95
    102
    98
    98
    Units: Subjects
        ≥ 10 mIU/mL
    86
    93
    86
    90
        ≥ 100 mIU/mL
    67
    72
    62
    72
    No statistical analyses for this end point

    Secondary: Number of subjects with opsonophagocytic activity

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    End point title
    		 Number of subjects with opsonophagocytic activity
    End point description
    Opsonophagocytic activity was measured by a killing-assay. The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer of 8.
    End point type
    Secondary
    End point timeframe
    At 4 years of age
    End point values
    		 Synflorix-Meningitec 2 Group Synflorix-NeisVac-C 2 Group Synflorix-Menitorix 2 Group Prevenar-Menitorix 2 Group
    Number of subjects analysed
    131
    134
    123
    128
    Units: Subjects
        Opsono-1 (n=131;134;123;128)
    33
    32
    20
    12
        Opsono-4 (N=127;132;118;126)
    49
    50
    36
    72
        Opsono-5 (N=129;132;122;128)
    65
    46
    40
    5
        Opsono-6B (N=128;129;122;126)
    93
    97
    101
    111
        Opsono-7F (N=131;134;123;128)
    131
    134
    123
    126
        Opsono-9V (N=130;132;120;126)
    125
    130
    118
    122
        Opsono-14 (N=126;128;114;121)
    96
    105
    95
    110
        Opsono-18C (N=113;118;113;118)
    34
    56
    46
    45
        Opsono-19F (N=131;133;123;128)
    87
    88
    80
    89
        Opsono-23F (N=129133;119;121)
    98
    108
    86
    111
    No statistical analyses for this end point

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

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    End point title
    		 Anti-hepatitis B surface antigen (anti-HBs) antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    At 6 years of age
    End point values
    		 Synflorix-Meningitec 3 Group Synflorix-NeisVac-C 3 Group Synflorix-Menitorix 3 Group Prevenar-Menitorix 3 Group
    Number of subjects analysed
    122
    129
    125
    128
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs antibody concentrations
    66.7 (47.2 to 94.1)
    64.7 (46.4 to 90.2)
    45.7 (32.2 to 64.8)
    85.4 (60.4 to 120.6)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-hepatitis B surface antigen (anti- HBs) antibody concentrations equal to or above cut-off values

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    End point title
    		 Number of subjects with anti-hepatitis B surface antigen (anti- HBs) antibody concentrations equal to or above cut-off values
    End point description
    Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.
    End point type
    Secondary
    End point timeframe
    At 6 years of age
    End point values
    		 Synflorix-Meningitec 3 Group Synflorix-NeisVac-C 3 Group Synflorix-Menitorix 3 Group Prevenar-Menitorix 3 Group
    Number of subjects analysed
    122
    129
    125
    128
    Units: Subjects
        ≥ 10 mIU/mL
    100
    103
    91
    108
        ≥ 100 mIU/mL
    57
    62
    45
    66
    No statistical analyses for this end point

    Secondary: Anti-hepatitis B surface antigen (anti-HBs) antibody concentrations as measured by ChemiLuminescence ImmunoAssay (CLIA)

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    End point title
    		 Anti-hepatitis B surface antigen (anti-HBs) antibody concentrations as measured by ChemiLuminescence ImmunoAssay (CLIA)
    End point description
    End point type
    Secondary
    End point timeframe
    At 6 years of age
    End point values
    		 Synflorix-Meningitec 3 Group Synflorix-NeisVac-C 3 Group Synflorix-Menitorix 3 Group Prevenar-Menitorix 3 Group
    Number of subjects analysed
    122
    129
    125
    128
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs antibody concentrations
    66.7 (47.2 to 94.1)
    64.7 (46.4 to 90.2)
    45.7 (32.2 to 64.8)
    85.4 (60.4 to 120.6)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody as measured by CLIA concentrations equal to or above cut-off values

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    End point title
    		 Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody as measured by CLIA concentrations equal to or above cut-off values
    End point description
    Cut-off values assessed were defined as equal to or above 6.2 milli-international units per milliliter (mIU/mL) or equal to or above 10 mIU/mL or equal to or above 100 mIU/mL.
    End point type
    Secondary
    End point timeframe
    At 6 years of age
    End point values
    		 Synflorix-Meningitec 3 Group Synflorix-NeisVac-C 3 Group Synflorix-Menitorix 3 Group Prevenar-Menitorix 3 Group
    Number of subjects analysed
    122
    129
    125
    128
    Units: Subjects
        ≥ 6.2 mIU/mL
    102
    108
    98
    112
        ≥ 10 mIU/mL
    100
    103
    91
    108
        ≥ 100 mIU/mL
    57
    62
    45
    66
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From last study contact of the booster study at 17-24 months of age (NCT00463437) until 6 years of age
    Adverse event reporting additional description
    Since no vaccine was administered during the study, other adverse events were not assessed.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Synflorix-Meningitec Group
    Reporting group description
    		 Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.

    Reporting group title
    Synflorix-NeisVac-C Group
    Reporting group description
    		 Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.

    Reporting group title
    Synflorix-Menitorix Group
    Reporting group description
    		 Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.

    Reporting group title
    Prevenar-Menitorix Group
    Reporting group description
    		 Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.

    Serious adverse events
    		 Synflorix-Meningitec Group Synflorix-NeisVac-C Group Synflorix-Menitorix Group Prevenar-Menitorix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 144 (0.00%)
    0 / 147 (0.00%)
    0 / 149 (0.00%)
    0 / 141 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Synflorix-Meningitec Group Synflorix-NeisVac-C Group Synflorix-Menitorix Group Prevenar-Menitorix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 144 (0.00%)
    0 / 147 (0.00%)
    0 / 149 (0.00%)
    0 / 141 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events were recorded in this study.

    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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