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    Clinical Trial Results:
    A phase III, controlled, single-blind study to assess the reactogenicity, safety and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar™ when co-administered with Hiberix™ at 12-18 months of age in children primed with the same vaccines in study 10PN-PD-DIT-036 (110808).

    Summary
    EudraCT number
    		 2015-001506-34
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    11 Jan 2010

    Results information
    Results version number
    		 v2(current)
    This version publication date
    13 Dec 2020
    First version publication date
    25 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Minor corrections in safety section.

    Trial information

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    Trial identification
    Sponsor protocol code
    112933
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00911144
    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
    17 Jun 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jan 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jan 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety of a booster dose of 10Pn-PD-DiT vaccine in terms of the occurrence of adverse events (AEs) with intensity grade 3, when co-administered with Hib vaccine at 12-18 months of age in children primed with the same vaccines at 2, 4 and 6 months of age in study 10PN-PD-DIT-036 (110808).
    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
    11 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
    Korea, Republic of: 450
    Worldwide total number of subjects
    450
    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)
    450
    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
    		 Two subjects enrolled in the protocol received commercial Prevenar and Hiberix vaccines instead of the clinical vaccines planned to be injected and are as such not included in the number of started subjects below.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    This study was conducted in a single-blind manner meaning that the investigator and/or his staff were aware of the treatment assignment but the subjects’ parent(s)/guardian(s) were not.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Synflorix Group
    Arm description
    		 Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK Biologicals’ Synflorix™ (Pneumococcal vaccine GSK1024850A)
    Investigational medicinal product code
    Other name
    Pneumococcal vaccine GSK1024850A
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, administered as a single dose.

    Investigational medicinal product name
    GSK Biologicals’ Hiberix™
    Investigational medicinal product code
    Other name
    Hib
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, administered as a single dose.

    Arm title
    		 Prevenar Group
    Arm description
    		 Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Wyeth-Lederle’s Prevenar™
    Investigational medicinal product code
    Other name
    7Pn
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, administered as a single dose.

    Investigational medicinal product name
    GSK Biologicals’ Hiberix™
    Investigational medicinal product code
    Other name
    Hib
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, administered as a single dose.

    Number of subjects in period 1 [1]
    		Synflorix Group Prevenar Group
    Started
    335
    113
    Completed
    319
    108
    Not completed
    16
    5
         Consent withdrawn by subject
    16
    5
    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: Out of the total 450 subjects enrolled in the study, 2 subjects received commercial Prevenar and Hiberix vaccines instead of the clinical vaccines planned to be injected and are as such not included in the number of subjects who started the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Synflorix Group
    Reporting group description
    		 Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.

    Reporting group title
    Prevenar Group
    Reporting group description
    		 Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.

    Reporting group values
    		 Synflorix Group Prevenar Group Total
    Number of subjects
    		 335 113 448
    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)
    		 13.6 ( 1.07 ) 13.7 ( 1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 168 59 227
        Male
    		 167 54 221

    End points

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    End points reporting groups
    Reporting group title
    Synflorix Group
    Reporting group description
    		 Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.

    Reporting group title
    Prevenar Group
    Reporting group description
    		 Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.

    Primary: Number of subjects reporting grade 3 adverse events

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    End point title
    		 Number of subjects reporting grade 3 adverse events [1]
    End point description
    Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.
    End point type
    Primary
    End point timeframe
    Within 31 days (Day 0 - 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.
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    332
    113
    Units: Subjects
    42
    13
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited symptoms

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    End point title
    		 Number of subjects reporting solicited symptoms
    End point description
    Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (equal to or above 37.5 degrees Celsius), irritability and loss of appetite.
    End point type
    Secondary
    End point timeframe
    Within 4 days (Days 0 to 3) after booster vaccination
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    332
    113
    Units: Subjects
        Pain
    120
    39
        Redness
    142
    55
        Swelling
    97
    35
        Drowsiness
    75
    21
        Fever
    46
    20
        Irritability
    141
    42
        Loss of appetite
    71
    29
    No statistical analyses for this end point

    Secondary: Number of subjects reporting unsolicited adverse events

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    End point title
    		 Number of subjects reporting unsolicited adverse events
    End point description
    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
    End point type
    Secondary
    End point timeframe
    Within 31 days (Days 0 to 30) after booster vaccination
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    335
    113
    Units: Subjects
    118
    41
    No statistical analyses for this end point

    Secondary: Number of subjects reporting serious adverse events

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    End point title
    		 Number of subjects reporting serious adverse events
    End point description
    Serious adverse events are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    After booster vaccination up to study end (Month 0 to Month 1)
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    335
    113
    Units: Subjects
    8
    4
    No statistical analyses for this end point

    Secondary: Concentration of antibodies against vaccine pneumococcal serotypes

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    End point title
    		 Concentration of antibodies against vaccine pneumococcal serotypes
    End point description
    Concentrations of antibodies are measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations expressed as microgram per milliliter. Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
    End point type
    Secondary
    End point timeframe
    One month after booster vaccination (Month 1)
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    317
    102
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-1 (n= 317, 100)
    4.03 (3.66 to 4.43)
    0.06 (0.05 to 0.07)
        Anti-4 (n= 317, 102)
    5.77 (5.25 to 6.34)
    12.19 (10.11 to 14.69)
        Anti-5 (n= 317, 102)
    5.51 (5.08 to 5.98)
    0.19 (0.16 to 0.23)
        Anti-6B (n= 317, 102)
    2.78 (2.48 to 3.12)
    7.09 (5.82 to 8.63)
        Anti-7F (n= 317, 102)
    5.39 (4.97 to 5.85)
    0.06 (0.04 to 0.07)
        Anti-9V (n= 317, 102)
    4.99 (4.55 to 5.46)
    12.72 (10.86 to 14.88)
        Anti-14 (n= 316, 102)
    7.73 (7.09 to 8.43)
    22.22 (18.96 to 26.03)
        Anti-18C (n= 317, 102)
    13.14 (11.9 to 14.52)
    14.53 (12.1 to 17.44)
        Anti-19F (n= 317, 101)
    16.89 (14.87 to 19.2)
    4.82 (3.97 to 5.85)
        Anti-23F (n= 317, 102)
    3.75 (3.37 to 4.16)
    14.81 (11.61 to 18.89)
    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
    Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
    End point type
    Secondary
    End point timeframe
    One month after booster vaccination (Month 1)
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    151
    47
    Units: Titer
    geometric mean (confidence interval 95%)
        Opsono-1 (n= 148, 47)
    363.7 (275.3 to 480.5)
    4.7 (3.9 to 5.6)
        Opsono-4 (n= 149, 45)
    1058 (893.9 to 1252.3)
    3717 (2759.3 to 5007)
        Opsono-5 (n= 150, 46)
    233.9 (189.8 to 288.3)
    4 (4 to 4)
        Opsono-6B (n= 150, 46)
    546.5 (415.9 to 718)
    3826.8 (2518 to 5815.9)
        Opsono-7F (n= 145, 46)
    5467.5 (4698.1 to 6363)
    1038.2 (609.9 to 1767.2)
        Opsono-9V (n= 151, 44)
    1707.5 (1497.6 to 1946.8)
    5204 (3842.8 to 7047.4)
        Opsono-14 (n= 150, 46)
    1814.6 (1577.4 to 2087.5)
    3958.4 (2888.1 to 5425.4)
        Opsono-18C (n= 147, 45)
    607.9 (498.2 to 741.6)
    1723.3 (1196.4 to 2482.3)
        Opsono-19F (n= 149, 44)
    1284.5 (1027.2 to 1606.3)
    277.3 (171.6 to 448.2)
        Opsono-23F (n= 149, 44)
    2702.9 (2234.9 to 3268.9)
    29918.6 (17115.7 to 52298.1)
    No statistical analyses for this end point

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

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    End point title
    		 Concentration of antibodies against cross-reactive pneumococcal serotypes 6A and 19A
    End point description
    Concentrations of antibodies are measured by 22F-inhibition ELISA and are presented as geometric mean concentrations expressed as microgram per milliliter.
    End point type
    Secondary
    End point timeframe
    One month after booster vaccination (Month 1)
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    317
    102
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-6A
    0.99 (0.84 to 1.17)
    2.51 (1.79 to 3.51)
        Anti-19A
    1.54 (1.27 to 1.87)
    0.32 (0.24 to 0.43)
    No statistical analyses for this end point

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

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    End point title
    		 Opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A
    End point description
    Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.
    End point type
    Secondary
    End point timeframe
    One month after booster vaccination (Month 1)
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    146
    44
    Units: Titer
    geometric mean (confidence interval 95%)
        Opsono-6A (n= 137, 44)
    196.1 (134.6 to 285.9)
    1415.7 (891.2 to 2248.9)
        Opsono-19A (n= 146, 44)
    64.9 (44.6 to 94.5)
    15.5 (8.1 to 29.9)
    No statistical analyses for this end point

    Secondary: Concentration of antibodies against protein D (PD)

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    End point title
    		 Concentration of antibodies against protein D (PD)
    End point description
    Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per milliliter.
    End point type
    Secondary
    End point timeframe
    One month after booster vaccination (Month 1)
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    316
    101
    Units: EU/mL
        geometric mean (confidence interval 95%)
    1288.9 (1175.6 to 1413.2)
    92 (78.3 to 108.1)
    No statistical analyses for this end point

    Secondary: Concentration of antibodies against polyribosyl-ribitol-phosphate (PRP)

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    End point title
    		 Concentration of antibodies against polyribosyl-ribitol-phosphate (PRP)
    End point description
    Concentrations of antibodies are presented as geometric mean concentrations expressed as microgram per milliliter.
    End point type
    Secondary
    End point timeframe
    One month after booster vaccination (Month 1)
    End point values
    		 Synflorix Group Prevenar Group
    Number of subjects analysed
    163
    54
    Units: µg/mL
        geometric mean (confidence interval 95%)
    152.97 (130.307 to 179.575)
    99.738 (72.964 to 136.335)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious AEs were assessed up to one month following booster vaccination (Month 1). The time frames for Other AEs reporting were 4 days and 31 days following booster vaccination for events collected by systematic and non-systematic methods, respectively.
    Adverse event reporting additional description
    Subjects at risk for systematically assessed other (non-serious) adverse events has been set to the number of subjects that had returned their symptom sheet. 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
    13.0
    Reporting groups
    Reporting group title
    Prevenar Group
    Reporting group description
    		 Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.

    Reporting group title
    Synflorix Group
    Reporting group description
    		 Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.

    Serious adverse events
    		 Prevenar Group Synflorix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 113 (3.54%)
    8 / 335 (2.39%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 335 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 335 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 335 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 335 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 113 (0.00%)
    2 / 335 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 335 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 335 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    H1N1 influenza
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 335 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 335 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 335 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 335 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Prevenar Group Synflorix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    82 / 113 (72.57%)
    243 / 335 (72.54%)
    General disorders and administration site conditions
    Pain at the injection site
    alternative assessment type: Systematic
         subjects affected / exposed
    39 / 113 (34.51%)
    120 / 335 (35.82%)
         occurrences all number
    39
    120
    Redness at the injection site
    alternative assessment type: Systematic
         subjects affected / exposed
    55 / 113 (48.67%)
    142 / 335 (42.39%)
         occurrences all number
    55
    142
    Swelling at the injection site
    alternative assessment type: Systematic
         subjects affected / exposed
    35 / 113 (30.97%)
    97 / 335 (28.96%)
         occurrences all number
    35
    97
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    21 / 113 (18.58%)
    75 / 335 (22.39%)
         occurrences all number
    21
    75
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    20 / 113 (17.70%)
    46 / 335 (13.73%)
         occurrences all number
    20
    46
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    42 / 113 (37.17%)
    141 / 335 (42.09%)
         occurrences all number
    42
    141
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    29 / 113 (25.66%)
    71 / 335 (21.19%)
         occurrences all number
    29
    71
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 113 (10.62%)
    30 / 335 (8.96%)
         occurrences all number
    12
    30
    Nasopharyngitis
         subjects affected / exposed
    10 / 113 (8.85%)
    19 / 335 (5.67%)
         occurrences all number
    10
    19

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Apr 2009
    Comments received from the Korean FDA.

    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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    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.

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