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    Clinical Trial Results:
    A phase III, open, multicentre, extension study to assess the immune response following administration of an additional dose of GSK Biologicals’ 10-valent conjugate pneumococcal vaccine or Prevenar™ at approximately 4 years of age in children previously vaccinated with three primary doses of a pneumococcal conjugate vaccine in study 10PN-PD-DIT-003 (105554) and a booster dose of 23-valent pneumococcal plain polysaccharide vaccine in study 10PN-PD-DIT-008 BST: 003 (106623).

    Summary
    EudraCT number
    		 2008-007605-37
    Trial protocol
    		 DE  
    Global end of trial date
    05 Oct 2009

    Results information
    Results version number
    		 v1
    This version publication date
    05 Apr 2016
    First version publication date
    04 Jun 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    112807
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00907777
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, B-1330, Belgium, Belgium,
    Public contact
    GlaxoSmithKline Biologicals, Clinical Trials Call Center, GlaxoSmithKline Biologicals, Clinical Trials Call Center, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, Clinical Trials Call Center, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Mar 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Oct 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Oct 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the immune response following administration of an additional dose of GSK Biologicals’ 10-valent conjugate pneumococcal vaccine (10Pn-PD-DiT) at approximately 4 years of age in children previously vaccinated with 3 doses of 10Pn-PD-DiT vaccine followed by a single dose of 23vPS(Pneumovax 23) vaccine.
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jun 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
    Germany: 52
    Worldwide total number of subjects
    52
    EEA total number of subjects
    52
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    52
    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 Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Prev group
    Arm description
    		 Subjects receiving Prevenar™ vaccine (Pfizer’s 7-valent pneumococcal conjugate vaccine) at approximately 4 years of age in children previously vaccinated with three primary doses of a pneumococcal conjugate vaccine in study 2005-003299-40 (10PN-PD-DIT-003 [105554]) and a booster dose of 23-valent pneumococcal plain polysaccharide vaccine in study 2006-000560-93 (10PN-PD-DIT-008 BST: 003 [106623])
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevenar™
    Investigational medicinal product code
    Other name
    Pfizer’s 7-valent pneumococcal conjugate vaccine, 7Pn
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Vaccine was administered intramuscularly in the deltoid

    Arm title
    		 Pn group
    Arm description
    		 Subjects receiving GSK 1024850A vaccine (10-valent pneumococcal polysaccharide and non typeable Haemophilus influenzae protein D conjugate vaccine) at approximately 4 years of age in children previously vaccinated with three primary doses of a pneumococcal conjugate vaccine in study 2005-003299-40 (10PN-PD-DIT-003 [105554]) and a booster dose of 23-valent pneumococcal plain polysaccharide vaccine in study 2006-000560-93(10PN-PD-DIT-008 BST: 003 [106623])
    Arm type
    		 Experimental

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

    Number of subjects in period 1
    		Prev group Pn group
    Started
    25
    27
    Completed
    25
    26
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Prev group
    Reporting group description
    		 Subjects receiving Prevenar™ vaccine (Pfizer’s 7-valent pneumococcal conjugate vaccine) at approximately 4 years of age in children previously vaccinated with three primary doses of a pneumococcal conjugate vaccine in study 2005-003299-40 (10PN-PD-DIT-003 [105554]) and a booster dose of 23-valent pneumococcal plain polysaccharide vaccine in study 2006-000560-93 (10PN-PD-DIT-008 BST: 003 [106623])

    Reporting group title
    Pn group
    Reporting group description
    		 Subjects receiving GSK 1024850A vaccine (10-valent pneumococcal polysaccharide and non typeable Haemophilus influenzae protein D conjugate vaccine) at approximately 4 years of age in children previously vaccinated with three primary doses of a pneumococcal conjugate vaccine in study 2005-003299-40 (10PN-PD-DIT-003 [105554]) and a booster dose of 23-valent pneumococcal plain polysaccharide vaccine in study 2006-000560-93(10PN-PD-DIT-008 BST: 003 [106623])

    Reporting group values
    		 Prev group Pn group Total
    Number of subjects
    		 25 27 52
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 46.6 ± 0.91 46.7 ± 0.72 -
    Gender categorical
    Units: Subjects
        Female
    		 9 17 26
        Male
    		 16 10 26

    End points

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    End points reporting groups
    Reporting group title
    Prev group
    Reporting group description
    		 Subjects receiving Prevenar™ vaccine (Pfizer’s 7-valent pneumococcal conjugate vaccine) at approximately 4 years of age in children previously vaccinated with three primary doses of a pneumococcal conjugate vaccine in study 2005-003299-40 (10PN-PD-DIT-003 [105554]) and a booster dose of 23-valent pneumococcal plain polysaccharide vaccine in study 2006-000560-93 (10PN-PD-DIT-008 BST: 003 [106623])

    Reporting group title
    Pn group
    Reporting group description
    		 Subjects receiving GSK 1024850A vaccine (10-valent pneumococcal polysaccharide and non typeable Haemophilus influenzae protein D conjugate vaccine) at approximately 4 years of age in children previously vaccinated with three primary doses of a pneumococcal conjugate vaccine in study 2005-003299-40 (10PN-PD-DIT-003 [105554]) and a booster dose of 23-valent pneumococcal plain polysaccharide vaccine in study 2006-000560-93(10PN-PD-DIT-008 BST: 003 [106623])

    Primary: Vaccine pneumococcal serotype antibody concentrations

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    End point title
    		 Vaccine pneumococcal serotype antibody concentrations [1]
    End point description
    Anti-pneumococcal antibody concentration cut-off value assessed >= 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
    End point type
    Primary
    End point timeframe
    Before (Pre) and one month after (Post) the additional administration
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed
    End point values
    		 Prev group Pn group
    Number of subjects analysed
    24
    26
    Units: μg/mL
    geometric mean (confidence interval 95%)
        ANTI-1 Pre (21,24)
    0.14 (0.09 to 0.23)
    0.38 (0.25 to 0.56)
        ANTI-1 Post (24,26)
    0.16 (0.1 to 0.25)
    1.35 (1.05 to 1.73)
        ANTI-4 Pre (21,24)
    0.27 (0.15 to 0.5)
    0.12 (0.08 to 0.19)
        ANTI-4 Post (24,26)
    4.3 (3.38 to 5.48)
    6.76 (4.91 to 9.3)
        ANTI-5 Pre (21,24)
    0.11 (0.08 to 0.16)
    0.5 (0.34 to 0.75)
        ANTI-5 Post (24,26)
    0.15 (0.1 to 0.22)
    1.78 (1.34 to 2.37)
        ANTI-6B Pre (21,23)
    0.65 (0.38 to 1.12)
    0.48 (0.26 to 0.88)
        ANTI-6B Post (24,26)
    7.46 (4.61 to 12.08)
    1.68 (1.1 to 2.56)
        ANTI-7F Pre (21,24)
    0.18 (0.1 to 0.32)
    0.39 (0.26 to 0.59)
        ANTI-7F Post (24,26)
    0.19 (0.11 to 0.32)
    2.53 (1.83 to 3.51)
        ANTI-9V Pre (21,24)
    0.48 (0.27 to 0.86)
    0.44 (0.29 to 0.65)
        ANTI-9V Post (24,26)
    6.88 (4.98 to 9.51)
    2.13 (1.54 to 2.94)
        ANTI-14 Pre (21,24)
    1.5 (0.82 to 2.74)
    1.98 (1.14 to 3.42)
        ANTI-14 Post (24,26)
    25.82 (14.65 to 45.5)
    9.71 (5.61 to 16.82)
        ANTI-18C Pre (21,24)
    0.34 (0.2 to 0.58)
    0.48 (0.26 to 0.9)
        ANTI-18C Post (24,26)
    4.23 (2.94 to 6.08)
    6.4 (4.61 to 8.87)
        ANTI-19F Pre (21,23)
    2.02 (1.29 to 3.16)
    2.37 (1.41 to 3.98)
        ANTI-19F Post (24,26)
    5.68 (3.82 to 8.45)
    15.61 (11.51 to 21.18)
        ANTI-23F Pre (21,24)
    0.33 (0.2 to 0.53)
    0.23 (0.12 to 0.43)
        ANTI-23F Post (24,26)
    5.82 (3.77 to 8.97)
    1.27 (0.9 to 1.8)
    No statistical analyses for this end point

    Secondary: Opsonophagocytic activity against vaccine pneumococcal serotypes

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    End point title
    		 Opsonophagocytic activity against vaccine pneumococcal serotypes
    End point description
    Opsonophagocytic activity cut-off value assessed >= 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F.
    End point type
    Secondary
    End point timeframe
    Before (pre) and one month after (post) the additional administration
    End point values
    		 Prev group Pn group
    Number of subjects analysed
    24
    26
    Units: titer
    geometric mean (confidence interval 95%)
        OPSONO-1 Pre (22,25)
    4 (4 to 4)
    5.8 (3.6 to 9.4)
        OPSONO-1 Post (24,25)
    5.5 (3.4 to 9.1)
    49.3 (25.5 to 95.2)
        OPSONO-4 Pre (21,23)
    20.7 (6.4 to 67.5)
    12.3 (4.5 to 33.9)
        OPSONO-4 Post (24,26)
    4814 (3380.8 to 6854.6)
    4380.7 (3020.5 to 6353.4)
        OPSONO-5 Pre (23,25)
    4.2 (3.8 to 4.6)
    7.5 (4.5 to 12.5)
        OPSONO-5 Post (24,25)
    4.4 (3.8 to 5.1)
    50.6 (30.8 to 83)
        OPSONO-6B Pre (22,24)
    188.2 (55.5 to 638)
    66.3 (19.7 to 222.7)
        OPSONO-6B Post (24,26)
    6734.3 (3873.2 to 11708.7)
    1424.5 (775 to 2618.4)
        OPSONO-7F Pre (22,24)
    1202.9 (809 to 1788.8)
    1498.9 (1097.8 to 2046.6)
        OPSONO-7F Post (24,26)
    1304.2 (880.7 to 1931.4)
    4657.1 (3321.2 to 6530.3)
        OPSONO-9V Pre (22,23)
    612.9 (458.6 to 819.3)
    442 (224.5 to 870.3)
        OPSONO-9V Post (23,26)
    5829.4 (3909.1 to 8693.2)
    2843.5 (2016 to 4010.6)
        OPSONO-14 Pre (21,25)
    149.7 (65.2 to 343.5)
    330 (186.5 to 584)
        OPSONO-14 Post (24,26)
    5400.8 (3491.3 to 8354.8)
    2812.4 (1734.3 to 4560.7)
        OPSONO-18C Pre (21,24)
    16.1 (5.3 to 49.2)
    23.7 (7.5 to 74.2)
        OPSONO-18C Post (24,25)
    1615.2 (782 to 3336.1)
    2806.6 (1408.8 to 5591.2)
        OPSONO-19F Pre (22,25)
    26.1 (14.8 to 46.1)
    35.8 (18.6 to 68.8)
        OPSONO-19F Post (24,25)
    241.6 (133.6 to 436.7)
    837.3 (559.5 to 1253.2)
        OPSONO-23F Pre (21,25)
    1430.2 (542.5 to 3770.6)
    1383.2 (630.2 to 3036)
        OPSONO-23F Post (24,26)
    23977.2 (14185.3 to 40528.2)
    4865.1 (3977 to 5951.4)
    No statistical analyses for this end point

    Secondary: Cross-reactive pneumococcal serotype antibody concentrations

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    End point title
    		 Cross-reactive pneumococcal serotype antibody concentrations
    End point description
    Anti-pneumococcal antibody concentration cut-off value assessed >= 0.05 microgram per milliliter (μg/mL). The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
    End point type
    Secondary
    End point timeframe
    Before (pre) and one month after (post) the additional administration
    End point values
    		 Prev group Pn group
    Number of subjects analysed
    24
    26
    Units: μg/mL
    geometric mean (confidence interval 95%)
        ANTI-6A Pre (21,24)
    0.22 (0.13 to 0.37)
    0.19 (0.12 to 0.32)
        ANTI-6A Post (24,26)
    1.78 (0.88 to 3.59)
    0.47 (0.29 to 0.75)
        ANTI-19A Pre (21,24)
    0.39 (0.2 to 0.78)
    0.29 (0.17 to 0.5)
        ANTI-19A Post (24,26)
    0.8 (0.44 to 1.44)
    1.24 (0.79 to 1.95)
    No statistical analyses for this end point

    Secondary: Opsonophagocytic activity against cross-reactive pneumococcal serotypes

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    End point title
    		 Opsonophagocytic activity against cross-reactive pneumococcal serotypes
    End point description
    Opsonophagocytic activity cut-off value assessed >= 8. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
    End point type
    Secondary
    End point timeframe
    Before (pre) and one month after (post) the additional administration
    End point values
    		 Prev group Pn group
    Number of subjects analysed
    24
    24
    Units: Titer
    geometric mean (confidence interval 95%)
        OPSONO-6A Pre (20,22)
    106.9 (44.7 to 255.7)
    117.7 (43.6 to 318.3)
        OPSONO-6A Post (24,22)
    2320.4 (1180.2 to 4562.5)
    966.2 (634.8 to 1470.6)
        OPSONO-19A Pre (23,23)
    10.4 (4.9 to 22.1)
    19.6 (6.6 to 58.8)
        OPSONO-19A Post (24,24)
    101.3 (42.7 to 240.7)
    153.9 (67.7 to 349.9)
    No statistical analyses for this end point

    Secondary: Anti-protein D antibody concentrations

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    End point title
    		 Anti-protein D antibody concentrations
    End point description
    Anti-protein D antibody cut-off value (>=100 EL.U/mL) was assessed by Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
    End point type
    Secondary
    End point timeframe
    Before (pre) and one month after (post) the additional administration
    End point values
    		 Prev group Pn group
    Number of subjects analysed
    24
    26
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        ANTI-PD Pre (21,23)
    104.1 (76.8 to 140.9)
    173.1 (113.5 to 263.9)
        ANTI-PD Post (24,26)
    85.9 (64.1 to 115)
    1135.6 (709 to 1819)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and grade 3 solicited local symptoms

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    End point title
    		 Number of subjects reporting any and grade 3 solicited local symptoms
    End point description
    Solicited general symptoms assessed include pain, redness, and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.
    End point type
    Secondary
    End point timeframe
    During the 8-day (Days 0-7) post-additional dose
    End point values
    		 Prev group Pn group
    Number of subjects analysed
    25
    26
    Units: Subjects
        Pain (Any)
    11
    16
        Pain (Grade 3)
    0
    2
        Redness (Any)
    13
    14
        Redness (Grade 3)
    7
    3
        Swelling (Any)
    7
    9
        Swelling (Grade 3)
    4
    1
    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
    End point description
    Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal everyday activities. Grade 3 loss of appetite was defined as the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination
    End point type
    Secondary
    End point timeframe
    During the 8-day (Days 0-7) post-additional dose
    End point values
    		 Prev group Pn group
    Number of subjects analysed
    25
    26
    Units: Subjects
        Drowsiness (Any)
    4
    12
        Drowsiness (Grade 3)
    0
    1
        Drowsiness (Related)
    0
    8
        Fever (Any)
    1
    8
        Fever (Grade 3)
    0
    0
        Fever (Related)
    0
    6
        Irritability (Any)
    5
    9
        Irritability (Grade 3)
    0
    1
        Irritability (Related)
    2
    7
        Loss of appetite (Any)
    3
    12
        Loss of appetite (Grade 3)
    0
    2
        Loss of appetite (Related)
    1
    7
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs)
    End point description
    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
    End point type
    Secondary
    End point timeframe
    Within 31 days (Day 0-30) post-additional vaccination
    End point values
    		 Prev group Pn group
    Number of subjects analysed
    25
    27
    Units: Subjects
        Any AEs
    8
    6
    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
    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above.
    End point type
    Secondary
    End point timeframe
    Throughout the study
    End point values
    		 Prev group Pn group
    Number of subjects analysed
    25
    27
    Units: Subjects
        Subject(s) with SAEs
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events: entire study period; Solicited local and general symptoms: Within 8 days after the additional vaccination; Unsolicited symptoms: Within 31 days after the additional vaccination
    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
    12.1
    Reporting groups
    Reporting group title
    Pn group
    Reporting group description
    		 Subjects receiving GSK 1024850A vaccine (10-valent pneumococcal polysaccharide and non typeable Haemophilus influenzae protein D conjugate vaccine) at approximately 4 years of age in children previously vaccinated with three primary doses of a pneumococcal conjugate vaccine in study 2005-003299-40 (10PN-PD-DIT-003 [105554]) and a booster dose of 23-valent pneumococcal plain polysaccharide vaccine in study 2006-000560-93 (10PN-PD-DIT-008 BST: 003 [106623])

    Reporting group title
    Prev group
    Reporting group description
    		 Subjects receiving Prevenar™ vaccine (Pfizer’s 7-valent pneumococcal conjugate vaccine) at approximately 4 years of age in children previously vaccinated with three primary doses of a pneumococcal conjugate vaccine in study 2005-003299-40 (10PN-PD-DIT-003 [105554]) and a booster dose of 23-valent pneumococcal plain polysaccharide vaccine in study 2006-000560-93 (10PN-PD-DIT-008 BST: 003 [106623])

    Serious adverse events
    		 Pn group Prev group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pn group Prev group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 27 (59.26%)
    13 / 25 (52.00%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed [1]
    16 / 26 (61.54%)
    11 / 25 (44.00%)
         occurrences all number
    16
    11
    Redness
         subjects affected / exposed [2]
    14 / 26 (53.85%)
    13 / 25 (52.00%)
         occurrences all number
    14
    13
    Swelling
         subjects affected / exposed [3]
    9 / 26 (34.62%)
    7 / 25 (28.00%)
         occurrences all number
    9
    7
    Drowsiness
         subjects affected / exposed [4]
    12 / 26 (46.15%)
    4 / 25 (16.00%)
         occurrences all number
    12
    4
    Fever (>38.0°C)
         subjects affected / exposed [5]
    8 / 26 (30.77%)
    1 / 25 (4.00%)
         occurrences all number
    8
    1
    Irritability
         subjects affected / exposed [6]
    9 / 26 (34.62%)
    5 / 25 (20.00%)
         occurrences all number
    9
    5
    Loss of appetite
         subjects affected / exposed [7]
    12 / 26 (46.15%)
    3 / 25 (12.00%)
         occurrences all number
    12
    3
    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: The analysis of the solicited symptom included only subjects with documented data.
    [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: The analysis of the solicited symptom included only subjects with documented data.
    [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: The analysis of the solicited symptom included only subjects with documented data.
    [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: The analysis of the solicited symptom included only subjects with documented data.
    [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: The analysis of the solicited symptom included only subjects with documented data.
    [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: The analysis of the solicited symptom included only subjects with documented data.
    [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: The analysis of the solicited symptom included only subjects with documented data.

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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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