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    Clinical Trial Results:
    A phase IIIb open, controlled study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine when given as a catch-up immunization in children older than 7 months of age or given as a 3-dose primary immunization in children before 6 months of age.

    Summary
    EudraCT number
    		 2006-001482-42
    Trial protocol
    		 FI  
    Global end of trial date
    15 Nov 2007

    Results information
    Results version number
    		 v1
    This version publication date
    09 Feb 2016
    First version publication date
    14 Jun 2015
    Other versions
    		 v2 , v3

    Trial information

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    Trial identification
    Sponsor protocol code
    107058
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00345358
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 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
    29 Apr 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Nov 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, when given as a catch-up immunization in children older than 7 months of age (three age-groups with different schedules).
    Protection of trial subjects
    All vaccines were observed closely for at least 30 minutes following the administration of vaccines, with appropriate medical treatment readily available in case of a rare anaphylactic reaction. Vaccines/products were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines/products. Subjects were followed-up for up to 31 days for adverse events after the last vaccination/product administration and during the entire study period for serious adverse events.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Sep 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 600
    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)
    450
    Children (2-11 years)
    150
    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
    		 The study included a primary (PRI) phase (all groups) and a booster (BST) phase (only 10Pn <6M and 10Pn 7-11M groups).

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

    Period 1
    Period 1 title
    Primary Vaccination Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 10Pn <6M Group
    Arm description
    		 This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of 10Pn-PD-DiT (or 10Pn) vaccine co-administered with InfanrixTM IPV/Hib (DTPa-IPV/Hib) at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (10Pn-PD-DiT) or the left (DTPa-IPV/Hib) thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
    Arm type
    		 Experimental

    Investigational medicinal product name
    10-valent streptococcus pneumoniae conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT, 10Pn
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 primary doses administered at 3, 4 and 5 months of age followed by a booster dose at 12-15 months of age, all injected intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Investigational medicinal product name
    Infanrix-Polio+Hib
    Investigational medicinal product code
    Other name
    InfanrixTM IPV/Hib, DTPa-IPV/Hib
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 primary doses administered at 3, 4 and 5 months of age followed by a booster dose at 12-15 months of age, all injected intramuscularly in the left right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Arm title
    		 10Pn 7-11M Group
    Arm description
    		 This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of 10Pn-PD-DiT (10Pn), one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The 10PN-PD-DiT vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
    Arm type
    		 Experimental

    Investigational medicinal product name
    10-valent streptococcus pneumoniae conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT, 10Pn
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses, one first dose at enrolment followed by a second dose one month later, followed by a booster dose at 12-15 months of age., injected intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Arm title
    		 10Pn 12-23M Group
    Arm description
    		 This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of 10Pn-PD-DiT (10Pn), one first dose at enrolment followed by a second dose 2 months later. The 10PN-PD-DiT vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
    Arm type
    		 Experimental

    Investigational medicinal product name
    IMP Name 10-valent streptococcus pneumoniae conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT, 10Pn
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses of 10Pn-PD-DiT (10Pn), one first dose at enrolment followed by a second dose 2 months later, injected intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Arm title
    		 10Pn >=24M Group
    Arm description
    		 This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of 10Pn-PD-DiT (10Pn). The 10PN-PD-DiT vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
    Arm type
    		 Experimental

    Investigational medicinal product name
    10-valent streptococcus pneumoniae conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT, 10Pn
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered when subject’s age was between 24 months (inclusive) to 5 years of age (inclusive) at vaccination, injected intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Number of subjects in period 1
    		10Pn <6M Group 10Pn 7-11M Group 10Pn 12-23M Group 10Pn >=24M Group
    Started
    150
    150
    150
    150
    Completed
    145
    146
    142
    148
    Not completed
    5
    4
    8
    2
         Consent withdrawn by subject
    1
    2
    4
    -
         Adverse event, non-fatal
    3
    1
    1
    -
         Other reason (unspecified)
    -
    1
    1
    -
         Lost to follow-up
    1
    -
    2
    2
    Period 2
    Period 2 title
    Booster Vaccination Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 10Pn <6M Group
    Arm description
    		 This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of 10Pn-PD-DiT (or 10Pn) vaccine co-administered with InfanrixTM IPV/Hib (DTPa-IPV/Hib) at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (10Pn-PD-DiT) or the left (DTPa-IPV/Hib) thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
    Arm type
    		 Experimental

    Investigational medicinal product name
    10-valent streptococcus pneumoniae conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT, 10Pn
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 primary doses administered at 3, 4 and 5 months of age followed by a booster dose at 12-15 months of age, all injected intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Investigational medicinal product name
    Infanrix-Polio+Hib
    Investigational medicinal product code
    Other name
    InfanrixTM IPV/Hib, DTPa-IPV/Hib
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 primary doses administered at 3, 4 and 5 months of age followed by a booster dose at 12-15 months of age, all injected intramuscularly in the left right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Arm title
    		 10Pn 7-11M Group
    Arm description
    		 This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of 10Pn-PD-DiT (10Pn), one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The 10PN-PD-DiT vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
    Arm type
    		 Experimental

    Investigational medicinal product name
    10-valent streptococcus pneumoniae conjugate vaccine
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT, 10Pn
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses, one first dose at enrolment followed by a second dose one month later, followed by a booster dose at 12-15 months of age., injected intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Number of subjects in period 2 [1]
    		10Pn <6M Group 10Pn 7-11M Group
    Started
    145
    145
    Completed
    141
    145
    Not completed
    4
    0
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    3
    -
    Notes
    [1] - 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: One subject from the 10Pn 7-11M Group was not included in the Booster Phase of the study for not having received the booster vaccination dose.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    10Pn <6M Group
    Reporting group description
    		 This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of 10Pn-PD-DiT (or 10Pn) vaccine co-administered with InfanrixTM IPV/Hib (DTPa-IPV/Hib) at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (10Pn-PD-DiT) or the left (DTPa-IPV/Hib) thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Reporting group title
    10Pn 7-11M Group
    Reporting group description
    		 This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of 10Pn-PD-DiT (10Pn), one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The 10PN-PD-DiT vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Reporting group title
    10Pn 12-23M Group
    Reporting group description
    		 This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of 10Pn-PD-DiT (10Pn), one first dose at enrolment followed by a second dose 2 months later. The 10PN-PD-DiT vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Reporting group title
    10Pn >=24M Group
    Reporting group description
    		 This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of 10Pn-PD-DiT (10Pn). The 10PN-PD-DiT vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Reporting group values
    		 10Pn <6M Group 10Pn 7-11M Group 10Pn 12-23M Group 10Pn >=24M Group Total
    Number of subjects
    		 150 150 150 150 600
    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)
    		 10.8 ( 1.09 ) 8.3 ( 1.2 ) 17.9 ( 3.19 ) 36.6 ( 11.87 ) -
    Gender categorical
    Units: Subjects
        Female
    		 66 68 76 72 282
        Male
    		 84 82 74 78 318

    End points

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    End points reporting groups
    Reporting group title
    10Pn <6M Group
    Reporting group description
    		 This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of 10Pn-PD-DiT (or 10Pn) vaccine co-administered with InfanrixTM IPV/Hib (DTPa-IPV/Hib) at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (10Pn-PD-DiT) or the left (DTPa-IPV/Hib) thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Reporting group title
    10Pn 7-11M Group
    Reporting group description
    		 This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of 10Pn-PD-DiT (10Pn), one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The 10PN-PD-DiT vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Reporting group title
    10Pn 12-23M Group
    Reporting group description
    		 This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of 10Pn-PD-DiT (10Pn), one first dose at enrolment followed by a second dose 2 months later. The 10PN-PD-DiT vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Reporting group title
    10Pn >=24M Group
    Reporting group description
    		 This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of 10Pn-PD-DiT (10Pn). The 10PN-PD-DiT vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
    Reporting group title
    10Pn <6M Group
    Reporting group description
    		 This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of 10Pn-PD-DiT (or 10Pn) vaccine co-administered with InfanrixTM IPV/Hib (DTPa-IPV/Hib) at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (10Pn-PD-DiT) or the left (DTPa-IPV/Hib) thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Reporting group title
    10Pn 7-11M Group
    Reporting group description
    		 This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of 10Pn-PD-DiT (10Pn), one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The 10PN-PD-DiT vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Primary: Number of subjects with anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 microgram per milliliter (µg/mL).

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    End point title
    		 Number of subjects with anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 microgram per milliliter (µg/mL). [1]
    End point description
    Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition Enzyme-Linked Immuno-Sorbent Assay (ELISA) method. The >=0.20 microgram per milliliter (microg/mL) cut-off corresponded to the seroprotection cut-off as regards anti-pneumococcal serotypes antibody concentrations. Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microg/mL.
    End point type
    Primary
    End point timeframe
    At one month after primary (10Pn <6M & 10Pn 7-11M groups) or after the full (10Pn 12-23M & 10Pn >=24M groups) vaccination course with 10Pn, that is Month (M)3 for 10Pn <6M & 12-23M groups, M2 for 10Pn 711M Group, & M1 for 10Pn >=24M Group,
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 10Pn <6M Group 10Pn 7-11M Group 10Pn 12-23M Group 10Pn >=24M Group
    Number of subjects analysed
    131
    135
    133
    140
    Units: Subjects
        Anti-1 (N=131; 135; 133; 140)
    128
    135
    132
    135
        Anti-4 (N=131; 135; 133; 140)
    128
    135
    133
    140
        Anti-5(N=131; 135; 133; 138)
    130
    134
    131
    135
        Anti-6B (N=131; 135; 133; 140)
    95
    69
    108
    96
        Anti-7F (N=131; 135; 133; 140)
    130
    135
    133
    140
        Anti-9V (N=131; 135; 133; 140)
    128
    129
    130
    132
        Anti-14 (N=131; 135; 133; 139)
    130
    132
    132
    127
        Anti-18C (N=131; 135; 133; 140)
    127
    135
    133
    140
        Anti-19F (N=130; 135; 133; 140)
    122
    129
    131
    140
        Anti-23F (N=131; 135; 133; 139)
    114
    95
    122
    93
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited & Unsolicited AEs: During the 4 & 31 days post PRI/BST vaccination; SAEs: during PRI and BST Phases. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
    Adverse event reporting additional description
    Note that 1) SAEs for PRI Phase for 10Pn <6M & 10Pn 7-11M groups include SAEs reported up to BST dose not included; 2) BST Phase safety follow-up is not applicable to 10Pn 12-23M & 10Pn >=24M groups; to mark this, numbers of subjects for BST events for these groups are marked as equal to 1.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    10Pn <6M Group
    Reporting group description
    		 This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of 10Pn-PD-DiT (or 10Pn) vaccine co-administered with InfanrixTM IPV/Hib (DTPa-IPV/Hib) at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (10Pn-PD-DiT) or the left (DTPa-IPV/Hib) thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Reporting group title
    10Pn 7-11M Group
    Reporting group description
    		 This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of 10Pn-PD-DiT (10Pn), one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The 10PN-PD-DiT vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Reporting group title
    10Pn 12-23M Group
    Reporting group description
    		 This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of 10Pn-PD-DiT (10Pn), one first dose at enrolment followed by a second dose 2 months later. The 10PN-PD-DiT vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Reporting group title
    10Pn >=24M Group
    Reporting group description
    		 This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of 10Pn-PD-DiT (10Pn). The 10PN-PD-DiT vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).

    Serious adverse events
    		 10Pn <6M Group 10Pn 7-11M Group 10Pn 12-23M Group 10Pn >=24M Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 150 (11.33%)
    5 / 150 (3.33%)
    2 / 150 (1.33%)
    0 / 150 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain upper - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (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
    Respiratory, thoracic and mediastinal disorders
    Bronchitis chronic - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 150 (1.33%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychomotor retardation - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (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
    Infections and infestations
    Pneumonia - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 150 (1.33%)
    2 / 150 (1.33%)
    2 / 150 (1.33%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 150 (2.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 150 (0.67%)
    2 / 150 (1.33%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 150 (2.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    2 / 150 (1.33%)
    1 / 150 (0.67%)
    0 / 150 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Exanthema subitum - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (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
    Influenza - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (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
    Respiratory syncytial virus bronchiolitis - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (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
    Respiratory syncytial virus infection - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    0 / 150 (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
    Bacterial infection - BST
    alternative assessment type: Non-systematic
         subjects affected / exposed [1]
    1 / 145 (0.69%)
    0 / 145 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (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
    Gastroenteritis - BST
    alternative assessment type: Non-systematic
         subjects affected / exposed [2]
    0 / 145 (0.00%)
    1 / 145 (0.69%)
    0 / 1 (0.00%)
    0 / 1 (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
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 10Pn <6M Group 10Pn 7-11M Group 10Pn 12-23M Group 10Pn >=24M Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    143 / 150 (95.33%)
    116 / 150 (77.33%)
    113 / 150 (75.33%)
    102 / 150 (68.00%)
    General disorders and administration site conditions
    Pain - PRI
         subjects affected / exposed [3]
    89 / 149 (59.73%)
    63 / 148 (42.57%)
    113 / 149 (75.84%)
    102 / 148 (68.92%)
         occurrences all number
    89
    63
    113
    102
    Redness - PRI
         subjects affected / exposed [4]
    90 / 149 (60.40%)
    95 / 148 (64.19%)
    79 / 149 (53.02%)
    65 / 148 (43.92%)
         occurrences all number
    90
    95
    79
    65
    Swelling - PRI
         subjects affected / exposed [5]
    68 / 149 (45.64%)
    66 / 148 (44.59%)
    59 / 149 (39.60%)
    32 / 148 (21.62%)
         occurrences all number
    68
    66
    59
    32
    Drowsiness – PRI Phase
         subjects affected / exposed [6]
    122 / 149 (81.88%)
    92 / 148 (62.16%)
    90 / 149 (60.40%)
    55 / 148 (37.16%)
         occurrences all number
    122
    92
    90
    55
    Rectal fever >= 38.5°C – PRI Phase
         subjects affected / exposed [7]
    95 / 149 (63.76%)
    55 / 148 (37.16%)
    47 / 149 (31.54%)
    10 / 148 (6.76%)
         occurrences all number
    95
    55
    47
    10
    Irritability – PRI Phase
         subjects affected / exposed [8]
    143 / 149 (95.97%)
    112 / 148 (75.68%)
    107 / 149 (71.81%)
    62 / 148 (41.89%)
         occurrences all number
    143
    112
    107
    62
    Loss of appetite – PRI Phase
         subjects affected / exposed [9]
    70 / 149 (46.98%)
    62 / 148 (41.89%)
    62 / 149 (41.61%)
    41 / 148 (27.70%)
         occurrences all number
    70
    62
    62
    41
    Pain – BST
         subjects affected / exposed [10]
    91 / 144 (63.19%)
    64 / 144 (44.44%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    91
    64
    0
    0
    Redness – BST
         subjects affected / exposed [11]
    80 / 144 (55.56%)
    73 / 144 (50.69%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    80
    73
    0
    0
    Swelling – BST
         subjects affected / exposed [12]
    55 / 144 (38.19%)
    45 / 144 (31.25%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    55
    45
    0
    0
    Drowsiness – BST
         subjects affected / exposed [13]
    73 / 144 (50.69%)
    57 / 144 (39.58%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    73
    57
    0
    0
    Rectal fever >= 38.5°C – BST
         subjects affected / exposed [14]
    63 / 144 (43.75%)
    33 / 144 (22.92%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    63
    33
    0
    0
    Irritability – BST
         subjects affected / exposed [15]
    109 / 144 (75.69%)
    71 / 144 (49.31%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    109
    71
    0
    0
    Loss of appetite – BST
         subjects affected / exposed [16]
    57 / 144 (39.58%)
    35 / 144 (24.31%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    57
    35
    0
    0
    Injection site induration - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    10 / 150 (6.67%)
    10 / 150 (6.67%)
    12 / 150 (8.00%)
    1 / 150 (0.67%)
         occurrences all number
    10
    10
    12
    1
    Pyrexia - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 150 (7.33%)
    21 / 150 (14.00%)
    19 / 150 (12.67%)
    8 / 150 (5.33%)
         occurrences all number
    11
    21
    19
    8
    Pyrexia - BST
    alternative assessment type: Non-systematic
         subjects affected / exposed [17]
    8 / 145 (5.52%)
    12 / 145 (8.28%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    8
    12
    0
    0
    Eye disorders
    Conjunctivitis - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 150 (4.00%)
    12 / 150 (8.00%)
    4 / 150 (2.67%)
    2 / 150 (1.33%)
         occurrences all number
    6
    12
    4
    2
    Gastrointestinal disorders
    Diarrhoea - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 150 (4.00%)
    14 / 150 (9.33%)
    14 / 150 (9.33%)
    5 / 150 (3.33%)
         occurrences all number
    6
    14
    14
    5
    Teething - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    9 / 150 (6.00%)
    17 / 150 (11.33%)
    4 / 150 (2.67%)
    0 / 150 (0.00%)
         occurrences all number
    9
    17
    4
    0
    Respiratory, thoracic and mediastinal disorders
    Cough - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 150 (3.33%)
    15 / 150 (10.00%)
    20 / 150 (13.33%)
    5 / 150 (3.33%)
         occurrences all number
    5
    15
    20
    5
    Infections and infestations
    Nasopharyngitis - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 150 (0.00%)
    11 / 150 (7.33%)
    0 / 150 (0.00%)
         occurrences all number
    0
    0
    11
    0
    Otitis media - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 150 (4.00%)
    24 / 150 (16.00%)
    21 / 150 (14.00%)
    10 / 150 (6.67%)
         occurrences all number
    6
    24
    21
    10
    Rhinitis - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    19 / 150 (12.67%)
    31 / 150 (20.67%)
    18 / 150 (12.00%)
    4 / 150 (2.67%)
         occurrences all number
    19
    31
    18
    4
    Upper respiratory tract infection - PRI
    alternative assessment type: Non-systematic
         subjects affected / exposed
    40 / 150 (26.67%)
    35 / 150 (23.33%)
    21 / 150 (14.00%)
    7 / 150 (4.67%)
         occurrences all number
    40
    35
    21
    7
    Otitis media - BST
    alternative assessment type: Non-systematic
         subjects affected / exposed [18]
    13 / 145 (8.97%)
    8 / 145 (5.52%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    13
    8
    0
    0
    Ear infection - BST
    alternative assessment type: Non-systematic
         subjects affected / exposed [19]
    0 / 145 (0.00%)
    9 / 145 (6.21%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    9
    0
    0
    Rhinitis - BST
    alternative assessment type: Non-systematic
         subjects affected / exposed [20]
    24 / 145 (16.55%)
    8 / 145 (5.52%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    24
    8
    0
    0
    Upper respiratory tract infection - BST
    alternative assessment type: Non-systematic
         subjects affected / exposed [21]
    25 / 145 (17.24%)
    12 / 145 (8.28%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    25
    12
    0
    0
    Notes
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with available results.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Jun 2006
    The protocol was amended to clarify in the study title that the assessment of immunogenicity, safety and reactogenicity would be done in children older than 7 months of age and in children before 6 months of age. Furthermore, because the post-licensure surveillance of Prevenar in the United States had shown a decrease and an increase in invasive pneumococcal disease caused by the cross-reactive pneumococcal serotypes 6A and 19A, respectively, it was of interest to document the immune responses (Enzyme-Linked Immuno-Sorbent Assay [ELISA] and opsonophagocytic activity [OPA]) to these cross-reactive pneumococcal serotypes. Also a higher flexibility of the distribution of replacement vial/syringe for the 10Pn-PD-DiT vaccine at the study centres was allowed as in each group all the children would receive the same vaccine.

    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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