Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A phase III, open, single centre study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate (10Pn-PD-DiT) vaccine (GSK 1024850A), when either given as a booster dose (at 15-21 months of age) in children previously primed with three doses of the 10Pn-PD-DiT vaccine, or when given as a two-dose catch-up immunization (at 15-21 and 17-23 months of age) in unprimed children, all previously enrolled in the 10PN-PD-DIT-032 primary vaccination study in Mali

    Summary
    EudraCT number
    		 2011-003711-39
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    26 Jul 2010

    Results information
    Results version number
    		 v2(current)
    This version publication date
    19 Apr 2023
    First version publication date
    01 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of full data set and alignment between registries.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    113166
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00985465
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 May 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jun 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jul 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and reactogenicity of the Synflorix vaccine in terms of occurrence of adverse events with intensity grade 3 after booster vaccination.
    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
    12 Nov 2009
    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
    Mali: 218
    Worldwide total number of subjects
    218
    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)
    218
    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

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 218 subjects were enrolled (147 subjects in the Synflorix Primed Group and 71 subjects in the Synflorix Unprimed Group). A total of 210 subjects were vaccinated in the booster vaccination study (141 out of 160 from the Synflorix Primed Group and 69 out of 78 from the Synflorix Unprimed Group).

    Period 1
    Period 1 title
    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
    		 Synflorix Primed Group
    Arm description
    		 Subjects who were previously primed with the Synflorix vaccine in study 10PN-PD-DIT-032, received a booster dose of the Synflorix vaccine, administered intramuscularly in the thigh or deltoid, at 15-21 months of age (Study Month 0).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pneumococcal vaccine GSK1024850A
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT, Synflorix
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered by intramuscular injection in the thigh or deltoid, if the muscle size was adequate.

    Arm title
    		 Synflorix Unprimed Group
    Arm description
    		 Unprimed subjects from the control group of study 10PN-PD-DIT-032, received a two dose catch-up vaccination with the Synflorix vaccine, administered intramuscularly in the thigh or deltoid, during the second year of life (at 15-21 months of age [Study Month 0] and at 17-23 months of age [Study Month 2]).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pneumococcal vaccine GSK1024850A
    Investigational medicinal product code
    Other name
    10Pn-PD-DiT, Synflorix
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses administered by intramuscular injection in the thigh or deltoid, if the muscle size was adequate.

    Number of subjects in period 1 [1]
    		Synflorix Primed Group Synflorix Unprimed Group
    Started
    141
    69
    Completed
    140
    66
    Not completed
    1
    3
         Consent withdrawn by subject
    1
    2
         Considered to be part of the other group
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 218 subjects were enrolled (147 subjects in the Synflorix Primed Group and 71 subjects in the Synflorix Unprimed Group). A total of 210 subjects were vaccinated in the booster vaccination study (141 out of 160 from the Synflorix Primed Group and 69 out of 78 from the Synflorix Unprimed Group).

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Synflorix Primed Group
    Reporting group description
    		 Subjects who were previously primed with the Synflorix vaccine in study 10PN-PD-DIT-032, received a booster dose of the Synflorix vaccine, administered intramuscularly in the thigh or deltoid, at 15-21 months of age (Study Month 0).

    Reporting group title
    Synflorix Unprimed Group
    Reporting group description
    		 Unprimed subjects from the control group of study 10PN-PD-DIT-032, received a two dose catch-up vaccination with the Synflorix vaccine, administered intramuscularly in the thigh or deltoid, during the second year of life (at 15-21 months of age [Study Month 0] and at 17-23 months of age [Study Month 2]).

    Reporting group values
    		 Synflorix Primed Group Synflorix Unprimed Group Total
    Number of subjects
    		 141 69 210
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 141 69 210
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 17 ± 1.11 16.9 ± 1.16 -
    Gender categorical
    Units: Subjects
        Female
    		 75 35 110
        Male
    		 66 34 100

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Synflorix Primed Group
    Reporting group description
    		 Subjects who were previously primed with the Synflorix vaccine in study 10PN-PD-DIT-032, received a booster dose of the Synflorix vaccine, administered intramuscularly in the thigh or deltoid, at 15-21 months of age (Study Month 0).

    Reporting group title
    Synflorix Unprimed Group
    Reporting group description
    		 Unprimed subjects from the control group of study 10PN-PD-DIT-032, received a two dose catch-up vaccination with the Synflorix vaccine, administered intramuscularly in the thigh or deltoid, during the second year of life (at 15-21 months of age [Study Month 0] and at 17-23 months of age [Study Month 2]).

    Primary: Number of subjects with Grade 3 adverse events (solicited and unsolicited)

    		 Close Top of page
    End point title
    		 Number of subjects with Grade 3 adverse events (solicited and unsolicited) [1] [2]
    End point description
    The incidence and nature of Grade 3 symptoms (solicited and unsolicited), reported during the 31-day (Days 0-30) post-vaccination are presented.
    End point type
    Primary
    End point timeframe
    Within 31 days (Day 0 to Day 30) after booster 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [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: This endpoint is only reporting values for the Synflorix Primed Group.
    End point values
    		 Synflorix Primed Group
    Number of subjects analysed
    141
    Units: Subjects
        Any symptom
    3
        General symptoms
    1
        Local symptoms
    2
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with any and Grade 3 solicited local symptoms [3]
    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
    Within 4 days (Day 0-Day 3) after the booster dose
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the Synflorix Primed Group.
    End point values
    		 Synflorix Primed Group
    Number of subjects analysed
    141
    Units: Subjects
        Any Pain
    40
        Grade 3 Pain
    0
        Any Redness
    17
        Grade 3 Redness
    2
        Any Swelling
    67
        Grade 3 Swelling
    0
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with any, Grade 3 and related solicited general symptoms [4]
    End point description
    Assessed solicited general symptoms were drowsiness, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom Drowsiness and Irritability = symptom that prevented normal activity. Grade 3 Loss of appetite = not eating at all. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    Within 4 days (Day 0-Day 3) after the booster dose
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the Synflorix Primed Group.
    End point values
    		 Synflorix Primed Group
    Number of subjects analysed
    141
    Units: Subjects
        Any Drowsiness
    0
        Grade 3 Drowsiness
    0
        Related Drowsiness
    0
        Any Fever
    34
        Grade 3 Fever
    0
        Related Fever
    31
        Any Irritability
    8
        Grade 3 Irritability
    0
        Related Irritability
    8
        Any Loss of appetite
    1
        Grade 3 Loss of appetite
    0
        Related Loss of appetite
    1
    No statistical analyses for this end point

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

    		 Close Top of page
    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
    Within 4 days (Day 0-Day 3) after each vaccine 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: This endpoint is only reporting values for the Synflorix Unprimed Group.
    End point values
    		 Synflorix Unprimed Group
    Number of subjects analysed
    69
    Units: Subjects
        Any Pain, Dose 1 [N=69]
    22
        Grade 3 Pain, Dose 1 [N=69]
    0
        Any Redness, Dose 1 [N=69]
    6
        Grade 3 Redness, Dose 1 [N=69]
    0
        Any Swelling, Dose 1 [N=69]
    46
        Grade 3 Swelling, Dose 1 [N=69]
    1
        Any Pain, Dose 2 [N=67]
    7
        Grade 3 Pain, Dose 2 [N=67]
    0
        Any Redness, Dose 2 [N=67]
    2
        Grade 3 Redness, Dose 2 [N=67]
    0
        Any Swelling, Dose 2 [N=67]
    31
        Grade 3 Swelling, Dose 2 [N=67]
    0
        Any Pain, Across Doses [N=69]
    25
        Grade 3 Pain, Across Doses [N=69]
    0
        Any Redness, Across Doses [N=69]
    8
        Grade 3 Redness, Across Doses [N=69]
    0
        Any Swelling, Across Doses [N=69]
    55
        Grade 3 Swelling, Across Doses [N=69]
    1
    No statistical analyses for this end point

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

    		 Close Top of page
    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, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom Drowsiness and Irritability = symptom that prevented normal activity. Grade 3 Loss of appetite = not eating at all. Grade 3 fever = fever greater than (>) 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    Within 4 days (Day 0-Day 3) after each vaccine 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: This endpoint is only reporting values for the Synflorix Unprimed Group.
    End point values
    		 Synflorix Unprimed Group
    Number of subjects analysed
    69
    Units: Subjects
        Any Drowsiness, Dose 1 [N=69]
    1
        Grade 3 Drowsiness, Dose 1 [N=69]
    0
        Related Drowsiness, Dose 1 [N=69]
    1
        Any Fever, Dose 1 [N=69]
    21
        Grade 3 Fever, Dose 1 [N=69]
    0
        Related Fever, Dose 1 [N=69]
    19
        Any Irritability, Dose 1 [N=69]
    3
        Grade 3 Irritability, Dose 1 [N=69]
    0
        Related Irritability, Dose 1 [N=69]
    3
        Any Loss of appetite, Dose 1 [N=69]
    1
        Grade 3 Loss of appetite, Dose 1 [N=69]
    0
        Related Loss of appetite, Dose 1 [N=69]
    0
        Any Drowsiness, Dose 2 [N=67]
    0
        Grade 3 Drowsiness, Dose 2 [N=67]
    0
        Related Drowsiness, Dose 2 [N=67]
    0
        Any Fever, Dose 2 [N=67]
    17
        Grade 3 Fever, Dose 2 [N=67]
    1
        Related Fever, Dose 2 [N=67]
    15
        Any Irritability, Dose 2 [N=67]
    3
        Grade 3 Irritability, Dose 2 [N=67]
    0
        Related Irritability, Dose 2 [N=67]
    3
        Any Loss of appetite, Dose 2 [N=67]
    1
        Grade 3 Loss of appetite, Dose 2 [N=67]
    0
        Related Loss of appetite, Dose 2 [N=67]
    1
        Any Drowsiness, Across Doses [N=69]
    1
        Grade 3 Drowsiness, Across Doses [N=69]
    0
        Related Drowsiness, Across Doses [N=69]
    1
        Any Fever, Across Doses [N=69]
    34
        Grade 3 Fever, Across Doses [N=69]
    1
        Related Fever, Across Doses [N=69]
    30
        Any Irritability, Across Doses [N=69]
    6
        Grade 3 Irritability, Across Doses [N=69]
    0
        Related Irritability, Across Doses [N=69]
    6
        Any Loss of appetite, Across Doses [N=69]
    2
        Grade 3 Loss of appetite, Across Doses [N=69]
    0
        Related Loss of appetite, Across Doses [N=69]
    1
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Number of subjects with any unsolicited adverse events (AEs)
    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.
    End point type
    Secondary
    End point timeframe
    Within 31 days (Day 0-Day 30) after each vaccine dose
    End point values
    		 Synflorix Primed Group Synflorix Unprimed Group
    Number of subjects analysed
    141
    69
    Units: Subjects
        Any AEs
    95
    57
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs)

    		 Close Top of page
    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
    From the first vaccination up to one month (31 days) after the last vaccination for each subject
    End point values
    		 Synflorix Primed Group Synflorix Unprimed Group
    Number of subjects analysed
    141
    69
    Units: Subjects
        Any SAEs
    0
    0
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F

    		 Close Top of page
    End point title
    		 Concentrations of antibodies against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
    End point description
    Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (μg/mL). Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was greater than or equal to (≥) 0.05 μg/mL.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
    End point values
    		 Synflorix Primed Group Synflorix Unprimed Group
    Number of subjects analysed
    140
    59
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-1, PRE [N=140,59]
    0.28 (0.23 to 0.35)
    0.04 (0.03 to 0.05)
        Anti-1, POST [N=139,57]
    5.85 (5.07 to 6.76)
    3.2 (2.68 to 3.84)
        Anti-4, PRE [N=140,59]
    0.32 (0.26 to 0.38)
    0.06 (0.04 to 0.09)
        Anti-4, POST [N=139,57]
    10.44 (9.31 to 11.71)
    6.54 (5.47 to 7.82)
        Anti-5, PRE [N=140,59]
    0.37 (0.32 to 0.43)
    0.04 (0.03 to 0.05)
        Anti-5, POST [N=139,57]
    6.07 (5.2 to 7.1)
    3.05 (2.4 to 3.87)
        Anti-6B, PRE [N=140,59]
    0.66 (0.55 to 0.8)
    0.03 (0.03 to 0.04)
        Anti-6B, POST [N=139,57]
    4.44 (3.69 to 5.33)
    0.78 (0.57 to 1.08)
        Anti-7F, PRE [N=140,59]
    0.68 (0.59 to 0.8)
    0.04 (0.03 to 0.06)
        Anti-7F, POST [N=139,57]
    7.82 (6.92 to 8.85)
    4.5 (3.8 to 5.33)
        Anti-9V, PRE [N=140,59]
    0.73 (0.61 to 0.87)
    0.03 (0.03 to 0.04)
        Anti-9V, POST [N=139,57]
    7.99 (6.86 to 9.3)
    1.48 (1.2 to 1.83)
        Anti-14, PRE [N=140,59]
    0.9 (0.73 to 1.09)
    0.11 (0.09 to 0.14)
        Anti-14, POST [N=139,57]
    9.75 (8.02 to 11.85)
    4.51 (3.63 to 5.61)
        Anti-18C, PRE [N=140,59]
    0.92 (0.79 to 1.07)
    0.05 (0.04 to 0.07)
        Anti-18C, POST [N=139,57]
    23.99 (20.29 to 28.37)
    10.95 (8.5 to 14.1)
        Anti-19F, PRE [N=140,59]
    0.82 (0.66 to 1.04)
    0.09 (0.06 to 0.14)
        Anti-19F, POST [N=139,57]
    12.96 (10.96 to 15.34)
    8.52 (5.58 to 13)
        Anti-23F, PRE [N=140,59]
    0.35 (0.28 to 0.45)
    0.03 (0.03 to 0.04)
        Anti-23F, POST [N=139,57]
    4.25 (3.54 to 5.11)
    1.05 (0.74 to 1.49)
    No statistical analyses for this end point

    Secondary: Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F

    		 Close Top of page
    End point title
    		 Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
    End point description
    OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
    End point values
    		 Synflorix Primed Group Synflorix Unprimed Group
    Number of subjects analysed
    139
    58
    Units: Titers
    geometric mean (confidence interval 95%)
        Opsono-1, PRE [N=139,58]
    9.3 (7.3 to 11.8)
    5.8 (4.3 to 7.8)
        Opsono-1, POST [N=139,57]
    661.7 (513.5 to 852.6)
    108.7 (79.5 to 148.6)
        Opsono-4, PRE [N=139,57]
    24 (16.7 to 34.6)
    11.8 (6.3 to 22.1)
        Opsono-4, POST [N=139,55]
    6541.7 (5468.5 to 7825.6)
    2716.7 (2149 to 3434.2)
        Opsono-5, PRE [N=133,58]
    9 (7.4 to 10.9)
    4.3 (3.7 to 5)
        Opsono-5, POST [N=139,57]
    340.5 (272.2 to 426)
    71.9 (51.8 to 99.7)
        Opsono-6B, PRE [N=116,46]
    82.6 (50.5 to 135.1)
    38.7 (16.2 to 92)
        Opsono-6B, POST [N=134,50]
    1729 (1361.9 to 2194.9)
    1202.9 (701.3 to 2063)
        Opsono-7F, PRE [N=133,51]]
    3230.6 (2588.4 to 4032.1)
    2454.4 (1587.3 to 3795.1)
        Opsono-7F, POST [N=136,57]
    9116.9 (7679.8 to 10822.9)
    9161.1 (7254.1 to 11569.4)
        Opsono-9V, PRE [N=100,44]
    407.9 (265.3 to 627)
    138.2 (63.2 to 302.6)
        Opsono-9V, POST [N=111,43]
    3640.4 (2859 to 4635.3)
    4596.5 (3519.4 to 6003.3)
        Opsono-14, PRE [N=112,36]]
    84.3 (53.4 to 132.9)
    18.8 (8.4 to 42.3)
        Opsono-14, POST [N=109,41]
    3281.8 (2488.4 to 4328.2)
    2246.1 (1621.5 to 3111.1)
        Opsono-18C, PRE [N=95,33]
    6 (4.8 to 7.5)
    6.4 (4 to 10.3)
        Opsono-18C, POST [N=106,38]
    2413.2 (1925.5 to 3024.6)
    2045.3 (1161.5 to 3601.8)
        Opsono-19F, PRE [N=124,57]
    12.8 (9.3 to 17.7)
    4.8 (3.7 to 6.3)
        Opsono-19F, POST [N=127,47]
    1084.2 (828.9 to 1418.1)
    693.7 (350.8 to 1371.6)
        Opsono-23F, PRE [N=132,49]
    90.7 (52.7 to 156.2)
    30.4 (12.9 to 71.4)
        Opsono-23F, POST [N=137,57]
    3476.4 (2706.8 to 4464.7)
    3571 (2793.4 to 4565.1)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A

    		 Close Top of page
    End point title
    		 Concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A
    End point description
    Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (μg/mL). The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22Finhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was ≥0.05 μg/mL.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
    End point values
    		 Synflorix Primed Group Synflorix Unprimed Group
    Number of subjects analysed
    140
    59
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Anti-6A, PRE [N=140,59]
    0.13 (0.11 to 0.17)
    0.04 (0.03 to 0.05)
        Anti-6A, POST [N=139,57]
    0.55 (0.42 to 0.73)
    0.1 (0.07 to 0.14)
        Anti-19A, PRE [N=140,58]
    0.16 (0.13 to 0.22)
    0.06 (0.04 to 0.09)
        Anti-19A, POST [N=130,57]
    1.13 (0.83 to 1.53)
    1.36 (0.91 to 2.03)
    No statistical analyses for this end point

    Secondary: Opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A

    		 Close Top of page
    End point title
    		 Opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A
    End point description
    OPA titers against pneumococcal serotypes 6A and 19A (Opsono-6A and Opsono-19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥8.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
    End point values
    		 Synflorix Primed Group Synflorix Unprimed Group
    Number of subjects analysed
    138
    58
    Units: Titers
    geometric mean (confidence interval 95%)
        Opsono-6A, PRE [N=127,54]
    18.7 (12.2 to 28.6)
    24 (12.5 to 46.3)
        Opsono-6A, POST [N=126,48]
    100.7 (60.4 to 168)
    106.3 (46.3 to 244)
        Opsono-19A, PRE [N=138,58]
    6.2 (5.1 to 7.6)
    5.9 (4.2 to 8.3)
        Opsono-19A [N=134,54]
    91.5 (60.4 to 138.5)
    171.2 (94.2 to 311.3)
    No statistical analyses for this end point

    Secondary: Concentrations of antibodies against protein D (PD)

    		 Close Top of page
    End point title
    		 Concentrations of antibodies against protein D (PD)
    End point description
    Concentrations of antibodies against protein D (PD) were determined by ELISA assay. Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EL.U/mL). Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is ≥100 ELISA units per milliliter (EL.U/mL).
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
    End point values
    		 Synflorix Primed Group Synflorix Unprimed Group
    Number of subjects analysed
    139
    59
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PD, PRE (N=139, 59)
    301.1 (257.7 to 351.8)
    62.1 (54.9 to 70.3)
        Anti-PD, POST (N =139, 56)
    3710.1 (3109 to 4427.4)
    839.3 (643.5 to 1094.6)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Solicited adverse events: within 4 days (Day 0-Day 3) after each vaccine dose. Unsolicited AEs:within 31 days (Day 0-Day 30) after each vaccine dose. SAEs: from the first vaccination up to one month (31 days) after the last vaccination for each subject.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Synflorix Primed Group
    Reporting group description
    		 Subjects who were previously primed with the Synflorix vaccine in study 10PN-PD-DIT-032, received a booster dose of the Synflorix vaccine, administered intramuscularly in the thigh or deltoid, at 15-21 months of age (Study Month 0).

    Reporting group title
    Synflorix Unprimed Group
    Reporting group description
    		 Unprimed subjects from the control group of study 10PN-PD-DIT-032, received a two dose catch-up vaccination with the Synflorix vaccine, administered intramuscularly in the thigh or deltoid, during the second year of life (at 15-21 months of age [Study Month 0] and at 17-23 months of age [Study Month 2]).

    Serious adverse events
    		 Synflorix Primed Group Synflorix Unprimed Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 141 (0.00%)
    0 / 69 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Synflorix Primed Group Synflorix Unprimed Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    125 / 141 (88.65%)
    64 / 69 (92.75%)
    Injury, poisoning and procedural complications
    Wound
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 141 (0.71%)
    6 / 69 (8.70%)
         occurrences all number
    1
    6
    Surgical and medical procedures
    Circumcision
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 141 (0.71%)
    4 / 69 (5.80%)
         occurrences all number
    1
    4
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    40 / 141 (28.37%)
    25 / 69 (36.23%)
         occurrences all number
    40
    29
    Redness
         subjects affected / exposed
    17 / 141 (12.06%)
    8 / 69 (11.59%)
         occurrences all number
    17
    8
    Swelling
         subjects affected / exposed
    67 / 141 (47.52%)
    55 / 69 (79.71%)
         occurrences all number
    67
    77
    Fever (Axillary)
         subjects affected / exposed
    34 / 141 (24.11%)
    34 / 69 (49.28%)
         occurrences all number
    35
    38
    Irritability
         subjects affected / exposed
    8 / 141 (5.67%)
    6 / 69 (8.70%)
         occurrences all number
    8
    6
    Injection site induration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 141 (3.55%)
    10 / 69 (14.49%)
         occurrences all number
    5
    10
    Gastrointestinal disorders
    Enteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 141 (4.26%)
    8 / 69 (11.59%)
         occurrences all number
    6
    10
    Respiratory, thoracic and mediastinal disorders
    Allergic bronchitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    38 / 141 (26.95%)
    22 / 69 (31.88%)
         occurrences all number
    38
    22
    Infections and infestations
    Rhinitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    26 / 141 (18.44%)
    14 / 69 (20.29%)
         occurrences all number
    27
    15
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    12 / 141 (8.51%)
    15 / 69 (21.74%)
         occurrences all number
    12
    16
    Skin infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    9 / 141 (6.38%)
    3 / 69 (4.35%)
         occurrences all number
    9
    3

    More information

    		 Close Top of page

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

    European Medicines Agency © 1995-Thu Apr 25 17:09:54 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA