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    Clinical Trial Results:
    A phase III, open, controlled study to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10- valent pneumococcal conjugate vaccine administered to children with sickle cell disease between 8 weeks and 2 years of age, as compared to healthy children.

    Summary
    EudraCT number
    		 2012-000254-64
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    23 May 2013

    Results information
    Results version number
    		 v1
    This version publication date
    01 Mar 2016
    First version publication date
    25 Jul 2015
    Other versions
    		 v2 , v3

    Trial information

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    Trial identification
    Sponsor protocol code
    114056
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01175083
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000673-PIP01-09
    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
    01 Jun 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 May 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine when co-administered with DTPw-HBV/Hib and OPV vaccines in children with sickle cell disease, one month after completion of the 3-dose primary vaccination course before 6 months of age
    Protection of trial subjects
    All subjects were supervised after vaccination/product administration with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2011
    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
    Burkina Faso: 300
    Worldwide total number of subjects
    300
    EEA total number of subjects
    0
    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)
    300
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 <6S Group
    Arm description
    		 Children below 6 months of age with sickle cell disease, receiving a 3-dose primary vaccination with 10Pn-PD-DiT vaccine at approximately 8-12-16 weeks of age and booster vaccination at 9-10 months of age. Subjects received DTPw-HBV/Hib + OPV as co-administered vaccines. The allowable intervals between the primary vaccination doses were 28-42 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK1024850A (Synflorix™)
    Investigational medicinal product code
    Other name
    GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae (H. influenzae) protein D conjugate vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 intramuscular vaccine doses were administered intramuscularly into the right thigh.

    Investigational medicinal product name
    Tritanrix-HepB/Hib
    Investigational medicinal product code
    Other name
    DTPw-HBV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 4 doses in the left thigh.

    Investigational medicinal product name
    Polio Sabin
    Investigational medicinal product code
    Other name
    OPV
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    4 doses administered orally.

    Arm title
    		 <6NS Group
    Arm description
    		 Healthy children below 6 months of age, receiving a 3-dose primary vaccination with 10Pn-PD-DiT vaccine at approximately 8-12-16 weeks of age and booster vaccination at 9-10 months of age. Subjects received DTPw-HBV/Hib + OPV as co-administered vaccines. The allowable intervals between the primary vaccination doses were 28-42 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    GSK1024850A (Synflorix™)
    Investigational medicinal product code
    Other name
    GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae (H. influenzae) protein D conjugate vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 intramuscular vaccine doses were administered intramuscularly into the right thigh.

    Investigational medicinal product name
    Tritanrix-HepB/Hib
    Investigational medicinal product code
    Other name
    DTPw-HBV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, 4 doses in the left thigh.

    Investigational medicinal product name
    Polio Sabin
    Investigational medicinal product code
    Other name
    OPV
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    4 doses administered orally.

    Arm title
    		 7-11S Group
    Arm description
    		 Children between 7-11 months of age with sickle cell disease, receiving a 2-dose primary vaccination with 10Pn-PD-DiT vaccine starting at 7-11 months of age with an interval of at least 4 weeks (28-42 days) between primary doses. Subjects received a booster after an interval of 2 to 4 months since the previous dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK1024850A (Synflorix™)
    Investigational medicinal product code
    Other name
    GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae (H. influenzae) protein D conjugate vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 intramuscular vaccine doses were administered intramuscularly into the right thigh.

    Arm title
    		 7-11NS Group
    Arm description
    		 Healthy children between 7-11 months of age, receiving a 2-dose primary vaccination with 10Pn-PD-DiT vaccine starting at 7-11 months of age with an interval of at least 4 weeks (28-42 days) between primary doses. Subjects received a booster after an interval of 2 to 4 months since the previous dose.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    GSK1024850A (Synflorix™)
    Investigational medicinal product code
    Other name
    GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae (H. influenzae) protein D conjugate vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 intramuscular vaccine doses were administered intramuscularly into the right thigh.

    Arm title
    		 12-23S Group
    Arm description
    		 Children between 12-23 months of age with sickle cell disease, receiving a 2-dose vaccination with 10Pn-PD-DiT vaccine starting at 12-23 months of age with an interval of 2 to 4 months between doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK1024850A (Synflorix™)
    Investigational medicinal product code
    Other name
    GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae (H. influenzae) protein D conjugate vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 intramuscular vaccine doses were administered intramuscularly into the right thigh.

    Arm title
    		 12-23NS Group
    Arm description
    		 Healthy children between 12-23 months of age, receiving a 2-dose vaccination with 10Pn-PD-DiT vaccine starting at 12-23 months of age with an interval of 2 to 4 months between doses.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    GSK1024850A (Synflorix™)
    Investigational medicinal product code
    Other name
    GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae (H. influenzae) protein D conjugate vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 intramuscular vaccine doses were administered intramuscularly into the right thigh.

    Number of subjects in period 1
    		<6S Group <6NS Group 7-11S Group 7-11NS Group 12-23S Group 12-23NS Group
    Started
    50
    50
    50
    50
    50
    50
    Completed
    49
    49
    49
    49
    50
    47
    Not completed
    1
    1
    1
    1
    0
    3
         Adverse event, serious fatal
    -
    -
    1
    -
    -
    -
         Consent withdrawn by subject
    -
    -
    -
    1
    -
    2
         Not coming back for booster vaccination
    1
    1
    -
    -
    -
    -
         Lost to follow-up
    -
    -
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    <6S Group
    Reporting group description
    		 Children below 6 months of age with sickle cell disease, receiving a 3-dose primary vaccination with 10Pn-PD-DiT vaccine at approximately 8-12-16 weeks of age and booster vaccination at 9-10 months of age. Subjects received DTPw-HBV/Hib + OPV as co-administered vaccines. The allowable intervals between the primary vaccination doses were 28-42 days.

    Reporting group title
    <6NS Group
    Reporting group description
    		 Healthy children below 6 months of age, receiving a 3-dose primary vaccination with 10Pn-PD-DiT vaccine at approximately 8-12-16 weeks of age and booster vaccination at 9-10 months of age. Subjects received DTPw-HBV/Hib + OPV as co-administered vaccines. The allowable intervals between the primary vaccination doses were 28-42 days.

    Reporting group title
    7-11S Group
    Reporting group description
    		 Children between 7-11 months of age with sickle cell disease, receiving a 2-dose primary vaccination with 10Pn-PD-DiT vaccine starting at 7-11 months of age with an interval of at least 4 weeks (28-42 days) between primary doses. Subjects received a booster after an interval of 2 to 4 months since the previous dose.

    Reporting group title
    7-11NS Group
    Reporting group description
    		 Healthy children between 7-11 months of age, receiving a 2-dose primary vaccination with 10Pn-PD-DiT vaccine starting at 7-11 months of age with an interval of at least 4 weeks (28-42 days) between primary doses. Subjects received a booster after an interval of 2 to 4 months since the previous dose.

    Reporting group title
    12-23S Group
    Reporting group description
    		 Children between 12-23 months of age with sickle cell disease, receiving a 2-dose vaccination with 10Pn-PD-DiT vaccine starting at 12-23 months of age with an interval of 2 to 4 months between doses.

    Reporting group title
    12-23NS Group
    Reporting group description
    		 Healthy children between 12-23 months of age, receiving a 2-dose vaccination with 10Pn-PD-DiT vaccine starting at 12-23 months of age with an interval of 2 to 4 months between doses.

    Reporting group values
    		 <6S Group <6NS Group 7-11S Group 7-11NS Group 12-23S Group 12-23NS Group Total
    Number of subjects
    		 50 50 50 50 50 50 300
    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: weeks
        arithmetic mean (standard deviation)
    		 8.4 ± 0.95 8.6 ± 0.85 8.6 ± 1.52 8.3 ± 1.21 16.6 ± 3.27 16.7 ± 3.49 -
    Gender categorical
    Units: Subjects
        Female
    		 21 29 26 32 15 24 147
        Male
    		 29 21 24 18 35 26 153

    End points

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    End points reporting groups
    Reporting group title
    <6S Group
    Reporting group description
    		 Children below 6 months of age with sickle cell disease, receiving a 3-dose primary vaccination with 10Pn-PD-DiT vaccine at approximately 8-12-16 weeks of age and booster vaccination at 9-10 months of age. Subjects received DTPw-HBV/Hib + OPV as co-administered vaccines. The allowable intervals between the primary vaccination doses were 28-42 days.

    Reporting group title
    <6NS Group
    Reporting group description
    		 Healthy children below 6 months of age, receiving a 3-dose primary vaccination with 10Pn-PD-DiT vaccine at approximately 8-12-16 weeks of age and booster vaccination at 9-10 months of age. Subjects received DTPw-HBV/Hib + OPV as co-administered vaccines. The allowable intervals between the primary vaccination doses were 28-42 days.

    Reporting group title
    7-11S Group
    Reporting group description
    		 Children between 7-11 months of age with sickle cell disease, receiving a 2-dose primary vaccination with 10Pn-PD-DiT vaccine starting at 7-11 months of age with an interval of at least 4 weeks (28-42 days) between primary doses. Subjects received a booster after an interval of 2 to 4 months since the previous dose.

    Reporting group title
    7-11NS Group
    Reporting group description
    		 Healthy children between 7-11 months of age, receiving a 2-dose primary vaccination with 10Pn-PD-DiT vaccine starting at 7-11 months of age with an interval of at least 4 weeks (28-42 days) between primary doses. Subjects received a booster after an interval of 2 to 4 months since the previous dose.

    Reporting group title
    12-23S Group
    Reporting group description
    		 Children between 12-23 months of age with sickle cell disease, receiving a 2-dose vaccination with 10Pn-PD-DiT vaccine starting at 12-23 months of age with an interval of 2 to 4 months between doses.

    Reporting group title
    12-23NS Group
    Reporting group description
    		 Healthy children between 12-23 months of age, receiving a 2-dose vaccination with 10Pn-PD-DiT vaccine starting at 12-23 months of age with an interval of 2 to 4 months between doses.

    Primary: Concentrations of antibodies against vaccine pneumococcal serotypes

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    End point title
    		 Concentrations of antibodies against vaccine pneumococcal serotypes [1] [2]
    End point description
    This outcome was measured only in <6S and <6NS Groups. Note that at the time this record was posted, no immunogenicity results were available, so the primary and secondary immunogenicity outcomes remain blank. They will be updated as soon as results become available.
    End point type
    Primary
    End point timeframe
    1 month after primary vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Results were computed separately for sets of groups in this study.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Results were computed separately for sets of groups in this study.
    End point values
    		 <6S Group <6NS Group
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: E.U/mL
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [3] - No results were available at the time of posting this record.
    [4] - No results were available at the time of posting this record.
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any and Grade 3 solicited local symptoms. [5]
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each dose.
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Results were computed separately for sets of groups in this study.
    End point values
    		 <6S Group <6NS Group
    Number of subjects analysed
    50
    50
    Units: Subjects
        Any Pain, Dose 1
    8
    12
        Grade 3 Pain, Dose 1
    0
    0
        Any Redness, Dose 1
    0
    0
        Grade 3 Redness, Dose 1
    0
    0
        Any Swelling, Dose 1
    0
    0
        Grade 3 Swelling, Dose 1
    0
    0
        Any Pain, Dose 2
    7
    7
        Grade 3 Pain, Dose 2
    0
    0
        Any Redness, Dose 2
    0
    0
        Grade 3 Redness, Dose 2
    0
    0
        Any Swelling, Dose 2
    0
    1
        Grade 3 Swelling, Dose 2
    0
    0
        Any Pain, Dose 3
    4
    6
        Grade 3 Pain, Dose 3
    0
    0
        Any Redness, Dose 3
    0
    0
        Grade 3 Redness, Dose 3
    0
    0
        Any Swelling, Dose 3
    0
    0
        Grade 3 Swelling, Dose 3
    0
    0
        Any Pain, Across
    17
    23
        Grade 3 Pain, Across
    0
    0
        Any Redness, Across
    0
    0
        Grade 3 Redness, Across
    0
    0
        Any Swelling, Across
    0
    1
        Grade 3 Swelling, Across
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any, Grade 3 and related solicited general symptoms. [6]
    End point description
    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as rectal temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each dose.
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Results were computed separately for sets of groups in this study.
    End point values
    		 <6S Group <6NS Group
    Number of subjects analysed
    50
    50
    Units: Subjects
        Any Drowsiness, Dose 1
    0
    0
        Grade 3 Drowsiness, Dose 1
    0
    0
        Related Drowsiness, Dose 1
    0
    0
        Any Irritability, Dose 1
    0
    2
        Grade 3 Irritability, Dose 1
    0
    0
        Related Irritability, Dose 1
    0
    0
        Any Loss of appetite, Dose 1
    0
    0
        Grade 3 Loss of appetite, Dose 1
    0
    0
        Related Loss of appetite, Dose 1
    0
    0
        Any Fever, Dose 1
    34
    31
        Grade 3 Fever, Dose 1
    0
    0
        Related Fever, Dose 1
    31
    29
        Any Drowsiness, Dose 2
    0
    0
        Grade 2 Drowsiness, Dose 2
    0
    0
        Related Drowsiness, Dose 2
    0
    0
        Any Irritability, Dose 2
    0
    0
        Grade 3 Irritability, Dose 2
    0
    0
        Related Irritability, Dose 2
    0
    0
        Any Loss of appetite, Dose 2
    0
    0
        Grade 3 Loss of appetite, Dose 2
    0
    0
        Related Loss of appetite, Dose 2
    0
    0
        Any Fever, Dose 2
    40
    30
        Grade 3 Fever, Dose 2
    0
    0
        Related Fever, Dose 2
    38
    28
        Any Drowsiness, Dose 3
    0
    0
        Grade 3 Drowsiness, Dose 3
    0
    0
        Related Drowsiness, Dose 3
    0
    0
        Any Irritability, Dose 3
    3
    4
        Grade 3 Irritability, Dose 3
    0
    0
        Related Irritability, Dose 3
    3
    3
        Any Loss of appetite, Dose 3
    0
    1
        Grade 3 Loss of appetite, Dose 3
    0
    0
        Related Loss of appetite, Dose 3
    0
    0
        Any Fever, Dose 3
    30
    30
        Grade 3 Fever, Dose 3
    0
    0
        Related Fever, Dose 3
    30
    28
        Any Drowsiness, Across Doses
    0
    0
        Grade 3 Drowsiness, Across Doses
    0
    0
        Related Drowsiness, Across Doses
    0
    0
        Any Irritability, Across Doses
    3
    6
        Grade 3 Irritability, Across Doses
    0
    0
        Related Irritability, Across Doses
    3
    3
        Any Loss of appetite, Across Doses
    0
    1
        Grade 3 Loss of appetite, Across Doses
    0
    0
        Related Loss of appetite, Across Doses
    0
    0
        Any Fever, Across Doses
    48
    43
        Grade 3 Fever, Across Doses
    0
    0
        Related Fever, Across Doses
    46
    43
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any unsolicited adverse events (AEs). [7]
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    Within 31 days (Days 0-30) post each vaccination.
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Results were computed separately for sets of groups in this study.
    End point values
    		 <6S Group <6NS Group 7-11S Group 7-11NS Group
    Number of subjects analysed
    50
    50
    50
    50
    Units: Subjects
        Any AEs post primary vaccination [N=50,50,50,50]
    37
    34
    32
    37
        Any AEs post-booster vaccination [N=49,49,50,50]
    8
    17
    18
    12
    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
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    During the entire study period.
    End point values
    		 <6S Group <6NS Group 7-11S Group 7-11NS Group 12-23S Group 12-23NS Group
    Number of subjects analysed
    50
    50
    50
    50
    50
    50
    Units: Subjects
        Any SAEs
    3
    9
    3
    4
    2
    2
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any unsolicited adverse events (AEs). [8]
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    Within the 31-day (Days 0-30) post vaccination period.
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Results were computed separately for sets of groups in this study.
    End point values
    		 12-23S Group 12-23NS Group
    Number of subjects analysed
    50
    50
    Units: Subjects
        Any AE(s)
    23
    25
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any and Grade 3 solicited local symptoms. [9]
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-booster vaccination period.
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Results were computed separately for sets of groups in this study.
    End point values
    		 <6S Group <6NS Group 7-11S Group 7-11NS Group
    Number of subjects analysed
    49
    49
    50
    50
    Units: Subjects
        Any Pain
    11
    6
    3
    0
        Grade 3 Pain
    0
    0
    0
    0
        Any Redness
    0
    0
    0
    0
        Grade 3 Redness
    0
    0
    0
    0
        Any Swelling
    1
    0
    1
    0
        Grade 3 Swelling
    0
    0
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any and Grade 3 solicited local symptoms. [10]
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each dose.
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Results were computed separately for sets of groups in this study.
    End point values
    		 12-23S Group 12-23NS Group
    Number of subjects analysed
    50
    50
    Units: Subjects
        Any Pain, Dose 1 [N=50,50]
    9
    6
        Grade 3 Pain, Dose 1 [N=50,50]
    0
    0
        Any Redness, Dose 1 [N=50,50]
    0
    0
        Grade 3 Redness, Dose 1 [N=50,50]
    0
    0
        Any Swelling, Dose 1 [N=50,50]
    1
    1
        Grade 3 Swelling, Dose 1 [N=50,50]
    0
    0
        Any Pain, Dose 2 [N=50,48]
    5
    3
        Grade 3 Pain, Dose 2 [N=50,48]
    0
    0
        Any Redness, Dose 2 [N=50,48]
    0
    0
        Grade 3 Redness, Dose 2 [N=50,48]
    0
    0
        Any Swelling, Dose 2 [N=50,48]
    0
    0
        Grade 3 Swelling, Dose 2 [N=50,48]
    0
    0
        Any Pain, Across Doses [N=50,50]
    13
    9
        Grade 3 Pain, Across Doses [N=50,50]
    0
    0
        Any Redness, Across Doses [N=50,50]
    0
    0
        Grade 3 Redness, Across Doses [N=50,50]
    0
    0
        Any Swelling, Across Doses [N=50,50]
    1
    1
        Grade 3 Swelling, Across Doses [N=50,50]
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any, Grade 3 and related solicited general symptoms. [11]
    End point description
    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as rectal temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each dose.
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Results were computed separately for sets of groups in this study.
    End point values
    		 7-11S Group 7-11NS Group
    Number of subjects analysed
    50
    50
    Units: Subjects
        Any Drowsiness, Dose 1
    0
    1
        Grade 3 Drowsiness, Dose 1
    0
    0
        Related Drowsiness, Dose 1
    0
    1
        Any Irritability, Dose 1
    0
    0
        Grade 3 Irritability, Dose 1
    0
    0
        Related Irritability, Dose 1
    0
    0
        Any Loss of appetite, Dose 1
    0
    0
        Grade 3 Loss of appetite, Dose 1
    0
    0
        Related Loss of appetite, Dose 1
    0
    0
        Any Fever, Dose 1
    22
    26
        Grade 3 Fever, Dose 1
    0
    0
        Related Fever, Dose 1
    19
    22
        Any Drowsiness, Dose 2
    0
    0
        Grade 3 Drowsiness, Dose 2
    0
    0
        Related Drowsiness, Dose 2
    0
    0
        Any Irritability, Dose 2
    0
    0
        Grade 3 Irritability, Dose 2
    0
    0
        Related Irritability, Dose 2
    0
    0
        Any Loss of appetite, Dose 2
    0
    0
        Grade 3 Loss of appetite, Dose 2
    0
    0
        Related Loss of appetite, Dose 2
    0
    0
        Any Fever, Dose 2
    22
    11
        Grade 3 Fever, Dose 2
    0
    0
        Related Fever, Dose 2
    20
    9
        Any Drowsiness, Across Doses
    0
    1
        Grade 3 Drowsiness, Across Doses
    0
    0
        Related Drowsiness, Across Doses
    0
    1
        Any Irritability, Across Doses
    0
    0
        Grade 3 Irritability, Across Doses
    0
    0
        Related Irritability, Across Doses
    0
    0
        Any Loss of appetite, Across Doses
    0
    0
        Grade 3 Loss of appetite, Across Doses
    0
    0
        Related Loss of appetite, Across Doses
    0
    0
        Any Fever, Across Doses
    31
    29
        Grade 3 Fever, Across Doses
    0
    0
        Related Fever, Across Doses
    29
    25
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any, Grade 3 and related solicited general symptoms. [12]
    End point description
    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as rectal temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-booster vaccination period.
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Results were computed separately for sets of groups in this study.
    End point values
    		 <6S Group <6NS Group 7-11S Group 7-11NS Group
    Number of subjects analysed
    49
    49
    50
    50
    Units: Subjects
        Any Drowsiness
    0
    0
    0
    0
        Grade 3 Drowsiness
    0
    0
    0
    0
        Related Drowsiness
    0
    0
    0
    0
        Any Irritability
    6
    0
    0
    0
        Grade 3 Irritability
    0
    0
    0
    0
        Related Irritability
    5
    0
    0
    0
        Any Loss of appetite
    0
    0
    0
    0
        Grade 3 Loss of appetite
    0
    0
    0
    0
        Related Loss of appetite
    0
    0
    0
    0
        Any Fever
    38
    31
    14
    13
        Grade 3 Fever
    0
    0
    0
    0
        Related Fever
    35
    28
    13
    13
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any and Grade 3 solicited local symptoms. [13]
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each dose.
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Results were computed separately for sets of groups in this study.
    End point values
    		 7-11S Group 7-11NS Group
    Number of subjects analysed
    50
    50
    Units: Subjects
        Any Pain, Dose 1
    7
    10
        Grade 3 Pain, Dose 1
    0
    0
        Any Redness, Dose 1
    0
    0
        Grade 3 Redness, Dose 1
    0
    0
        Any Swelling, Dose 1
    0
    0
        Grade 3 Swelling, Dose 1
    0
    0
        Any Pain, Dose 2
    5
    7
        Grade 3 Pain, Dose 2
    0
    0
        Any Redness, Dose 2
    0
    0
        Grade 3 Redness, Dose 2
    0
    0
        Any Swelling, Dose 2
    0
    1
        Grade 3 Swelling, Dose 2
    0
    0
        Any Pain, Across Doses
    12
    15
        Grade 3 Pain, Across Doses
    0
    0
        Any Redness, Across Doses
    0
    0
        Grade 3 Redness, Across Doses
    0
    0
        Any Swelling, Across Doses
    0
    1
        Grade 3 Swelling, Across Doses
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any, Grade 3 and related solicited general symptoms. [14]
    End point description
    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as rectal temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each dose.
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Results were computed separately for sets of groups in this study.
    End point values
    		 12-23S Group 12-23NS Group
    Number of subjects analysed
    50
    50
    Units: Subjects
        Any Drowsiness, Dose 1 [N=50,50]
    0
    0
        Grade 3 Drowsiness, Dose 1 [N=50,50]
    0
    0
        Related Drowsiness, Dose 1 [N=50,50]
    0
    0
        Any Irritability, Dose 1 [N=50,50]
    1
    0
        Grade 3 Irritability, Dose 1 [N=50,50]
    0
    0
        Related Irritability, Dose 1 [N=50,50]
    1
    0
        Any Loss of appetite, Dose 1 [N=50,50]
    0
    1
        Grade 3 Loss of appetite, Dose 1 [N=50,50]
    0
    0
        Related Loss of appetite, Dose 1 [N=50,50]
    0
    1
        Any Fever, Dose 1 [N=50,50]
    21
    15
        Grade 3 Fever, Dose 1 [N=50,50]
    0
    0
        Related Fever, Dose 1 [N=50,50]
    21
    13
        Any Drowsiness, Dose 2 [N=50,48]
    0
    0
        Grade 3 Drowsiness, Dose 2 [N=50,48]
    0
    0
        Related Drowsiness, Dose 2 [N=50,48]
    0
    0
        Any Irritability, Dose 2 [N=50,48]
    1
    0
        Grade 3 Irritability, Dose 2 [N=50,48]
    0
    0
        Related Irritability, Dose 2 [N=50,48]
    1
    0
        Any Loss of appetite, Dose 2 [N=50,48]
    0
    0
        Grade 3 Loss of appetite, Dose 2 [N=50,48]
    0
    0
        Related Loss of appetite, Dose 2 [N=50,48]
    0
    0
        Any Fever, Dose 2 [N=50,48]
    12
    12
        Grade 3 Fever, Dose 2 [N=50,48]
    0
    0
        Related Fever, Dose 2 [N=50,48]
    10
    9
        Any Drowsiness, Across Doses [N=50,50]
    0
    0
        Grade 3 Drowsiness, Across Doses [N=50,50]
    0
    0
        Related Drowsiness, Across Doses [N=50,50]
    0
    0
        Any Irritability, Across Doses [N=50,50]
    2
    0
        Grade 3 Irritability, Across Doses [N=50,50]
    0
    0
        Related Irritability, Across Doses [N=50,50]
    2
    0
        Any Loss of appetite, Across Doses [N=50,50]
    0
    1
        Grade 3 Loss of appetite, Across Doses [N=50,50]
    0
    0
        Related Loss of appetite, Across Doses [N=50,50]
    0
    1
        Any Fever, Across Doses [N=50,50]
    29
    20
        Grade 3 Fever, Across Doses [N=50,50]
    0
    0
        Related Fever, Across Doses [N=50,50]
    28
    17
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms: within 4 days after each vaccination dose. Unsolicited symptoms: within 31 days after each vaccination. SAEs: during the whole study period.
    Adverse event reporting additional description
    The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    <6S Group
    Reporting group description
    		 Children below 6 months of age with sickle cell disease, receiving a 3-dose primary vaccination with 10Pn-PD-DiT vaccine at approximately 8-12-16 weeks of age and booster vaccination at 9-10 months of age. Subjects received DTPw-HBV/Hib + OPV as co-administered vaccines. The allowable intervals between the primary vaccination doses were 28-42 days.

    Reporting group title
    <6NS Group
    Reporting group description
    		 Healthy children below 6 months of age, receiving a 3-dose primary vaccination with 10Pn-PD-DiT vaccine at approximately 8-12-16 weeks of age and booster vaccination at 9-10 months of age. Subjects received DTPw-HBV/Hib + OPV as co-administered vaccines. The allowable intervals between the primary vaccination doses were 28-42 days.

    Reporting group title
    7-11S Group
    Reporting group description
    		 Children between 7-11 months of age with sickle cell disease, receiving a 2-dose primary vaccination with 10Pn-PD-DiT vaccine starting at 7-11 months of age with an interval of at least 4 weeks (28-42 days) between primary doses. Subjects received a booster after an interval of 2 to 4 months since the previous dose.

    Reporting group title
    7-11NS Group
    Reporting group description
    		 Healthy children between 7-11 months of age, receiving a 2-dose primary vaccination with 10Pn-PD-DiT vaccine starting at 7-11 months of age with an interval of at least 4 weeks (28-42 days) between primary doses. Subjects received a booster after an interval of 2 to 4 months since the previous dose.

    Reporting group title
    12-23S Group
    Reporting group description
    		 Children between 12-23 months of age with sickle cell disease, receiving a 2-dose vaccination with 10Pn-PD-DiT vaccine starting at 12-23 months of age with an interval of 2 to 4 months between doses.

    Reporting group title
    12-23NS Group
    Reporting group description
    		 Healthy children between 12-23 months of age, receiving a 2-dose vaccination with 10Pn-PD-DiT vaccine starting at 12-23 months of age with an interval of 2 to 4 months between doses.

    Serious adverse events
    		 <6S Group <6NS Group 7-11S Group 7-11NS Group 12-23S Group 12-23NS Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 50 (6.00%)
    9 / 50 (18.00%)
    3 / 50 (6.00%)
    4 / 50 (8.00%)
    2 / 50 (4.00%)
    2 / 50 (4.00%)
         number of deaths (all causes)
    1
    1
    1
    0
    0
    0
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Malnutrition
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteomyelitis acute
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 50 (2.00%)
    6 / 50 (12.00%)
    1 / 50 (2.00%)
    2 / 50 (4.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    3 / 50 (6.00%)
    3 / 50 (6.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    1 / 50 (2.00%)
    2 / 50 (4.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis Salmonella
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 <6S Group <6NS Group 7-11S Group 7-11NS Group 12-23S Group 12-23NS Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    48 / 50 (96.00%)
    43 / 50 (86.00%)
    31 / 50 (62.00%)
    29 / 50 (58.00%)
    29 / 50 (58.00%)
    20 / 50 (40.00%)
    General disorders and administration site conditions
    Pain (Primary vaccination, Across Doses)
    alternative assessment type: Systematic
         subjects affected / exposed
    17 / 50 (34.00%)
    23 / 50 (46.00%)
    12 / 50 (24.00%)
    15 / 50 (30.00%)
    13 / 50 (26.00%)
    9 / 50 (18.00%)
         occurrences all number
    17
    23
    12
    15
    13
    9
    Pain (Booster vaccination, Across Doses)
    Additional description: Groups 12-23S and 12-23NS were not included in the analysis since they received no booster dose, so the numbers presented for them are placeholder values.
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    11 / 49 (22.45%)
    6 / 49 (12.24%)
    3 / 50 (6.00%)
    0 / 50 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    11
    6
    3
    0
    0
    0
    Swelling (Primary vaccination, Across Doses)
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    1 / 50 (2.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    0
    1
    1
    1
    Swelling (Booster vaccination, Across Doses)
    Additional description: Groups 12-23S and 12-23NS were not included in the analysis since they received no booster dose, so the numbers presented for them are placeholder values.
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    1 / 49 (2.04%)
    0 / 49 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Drowsiness (Primary vaccination, Across Doses)
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Irritability (Primary vaccination, Across Doses)
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 50 (6.00%)
    6 / 50 (12.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    2 / 50 (4.00%)
    0 / 50 (0.00%)
         occurrences all number
    3
    6
    0
    0
    2
    0
    Irritability (Booster vaccination, Across Doses)
    Additional description: Groups 12-23S and 12-23NS were not included in the analysis since they received no booster dose, so the numbers presented for them are placeholder values.
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    6 / 49 (12.24%)
    0 / 49 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    6
    0
    0
    0
    0
    0
    Loss of Appetite (Primary vaccination, Across Doses)
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Fever (Primary vaccination, Across Doses)
    Additional description: Fever was assessed rectally.
    alternative assessment type: Systematic
         subjects affected / exposed
    48 / 50 (96.00%)
    43 / 50 (86.00%)
    31 / 50 (62.00%)
    29 / 50 (58.00%)
    29 / 50 (58.00%)
    20 / 50 (40.00%)
         occurrences all number
    48
    43
    31
    39
    29
    20
    Fever (Booster vaccination, Across Doses)
    Additional description: Fever was assessed rectally. Groups 12-23S and 12-23NS were not included in the analysis since they received no booster dose, so the numbers presented for them are placeholder values.
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    38 / 49 (77.55%)
    31 / 49 (63.27%)
    14 / 50 (28.00%)
    13 / 50 (26.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    38
    31
    14
    13
    0
    0
    Pyrexia (Primary)
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    3 / 50 (6.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    3
    0
    0
    1
    Blood and lymphatic system disorders
    Sickle cell anaemia with crisis (Primary)
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    3 / 50 (6.00%)
    0 / 50 (0.00%)
    10 / 50 (20.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    3
    0
    10
    0
    Gastrointestinal disorders
    Diarrhoea (Primary)
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    3 / 50 (6.00%)
    1 / 50 (2.00%)
    1 / 50 (2.00%)
    7 / 50 (14.00%)
         occurrences all number
    0
    0
    3
    1
    1
    7
    Diarrhoea (Booster)
         subjects affected / exposed [5]
    1 / 50 (2.00%)
    2 / 50 (4.00%)
    3 / 50 (6.00%)
    1 / 50 (2.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    2
    3
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough (Primary)
         subjects affected / exposed
    0 / 50 (0.00%)
    5 / 50 (10.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    5
    0
    0
    1
    0
    Infections and infestations
    Malaria (Primary)
         subjects affected / exposed
    10 / 50 (20.00%)
    7 / 50 (14.00%)
    9 / 50 (18.00%)
    13 / 50 (26.00%)
    10 / 50 (20.00%)
    10 / 50 (20.00%)
         occurrences all number
    10
    7
    9
    13
    10
    10
    Malaria (Booster)
    Additional description: Groups 12-23S and 12-23NS were not included in the analysis since they received no booster dose, so the numbers presented for them are placeholder values.
         subjects affected / exposed [6]
    0 / 49 (0.00%)
    8 / 49 (16.33%)
    8 / 50 (16.00%)
    4 / 50 (8.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    8
    8
    4
    0
    0
    Bronchitis (Primary)
         subjects affected / exposed
    9 / 50 (18.00%)
    10 / 50 (20.00%)
    3 / 50 (6.00%)
    8 / 50 (16.00%)
    1 / 50 (2.00%)
    4 / 50 (8.00%)
         occurrences all number
    9
    10
    3
    8
    1
    4
    Gastroenteritis (Primary)
         subjects affected / exposed
    6 / 50 (12.00%)
    5 / 50 (10.00%)
    3 / 50 (6.00%)
    9 / 50 (18.00%)
    1 / 50 (2.00%)
    6 / 50 (12.00%)
         occurrences all number
    6
    5
    3
    9
    1
    6
    Rhinitis (Primary)
         subjects affected / exposed
    0 / 50 (0.00%)
    7 / 50 (14.00%)
    4 / 50 (8.00%)
    3 / 50 (6.00%)
    3 / 50 (6.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    7
    4
    3
    3
    4
    Nasopharyngitis (Primary)
         subjects affected / exposed
    6 / 50 (12.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    7 / 50 (14.00%)
    3 / 50 (6.00%)
    6 / 50 (12.00%)
         occurrences all number
    6
    0
    0
    7
    3
    6
    Gastrointestinal fungal infection (Primary)
         subjects affected / exposed
    0 / 50 (0.00%)
    5 / 50 (10.00%)
    3 / 50 (6.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    5
    3
    0
    0
    0
    Enteritis (Primary)
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    6 / 50 (12.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    6
    0
    0
    1
    Enteritis (Booster)
    Additional description: Groups 12-23S and 12-23NS were not included in the analysis since they received no booster dose, so the numbers presented for them are placeholder values.
         subjects affected / exposed [7]
    0 / 49 (0.00%)
    2 / 49 (4.08%)
    0 / 50 (0.00%)
    3 / 50 (6.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    3
    0
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local and general symptoms have been tabulated only for subjects with a symptom sheet completed and who received all vaccine doses.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local and general symptoms have been tabulated only for subjects with a symptom sheet completed and who received all vaccine doses.
    [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: Solicited local and general symptoms have been tabulated only for subjects with a symptom sheet completed and who received all vaccine doses.
    [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: Solicited local and general symptoms have been tabulated only for subjects with a symptom sheet completed and who received all vaccine doses.
    [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: Less subjects received the booster dose than the primary vaccination.
    [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: Less subjects received the booster dose than the primary vaccination.
    [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: Less subjects received the booster dose than the primary vaccination.

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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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