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    Clinical Trial Results:
    An open, phase IV study on the immunogenicity and tolerability of Influsplit SSW® 2005/2006 in children aged 6-13 years.

    Summary
    EudraCT number
    		 2005-004517-14
    Trial protocol
    		 DE  
    Global end of trial date
    28 Mar 2006

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2018
    First version publication date
    13 Dec 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    106252
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00372255
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium,
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    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
    31 Oct 2006
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Mar 2006
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Mar 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Descriptive analysis of the humoral immune response after one or two dose intramuscular administration of a trivalent influenza split vaccine 2005/2006 in children from 6 years to 9 years measured by the geometric mean titers (GMTs) of the haemagglutination-inhibition antibodies against the three influenza virus strains represented in the vaccine and measured by the seroconversion rates
    Protection of trial subjects
    All subjects were supervised for at least 30 min after vaccination/product administration with appropriate medical treatment readily available. Vaccines/products were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines/products. Subjects were followed-up for 30 days after the last vaccination/product administration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Nov 2005
    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: 224
    Worldwide total number of subjects
    224
    EEA total number of subjects
    224
    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)
    110
    Adolescents (12-17 years)
    114
    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
    		 This study was conducted by a principal investigator and 22 investigators in 18 centers in Germany.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 224
    Number of subjects completed
    		 224

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Influsplit SSW 2005/2006 6-9 years Group
    Arm description
    		 Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Influsplit SSW 2005/2006
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Children received 2 doses of Influsplit vaccine in the non-dominant arm

    Arm title
    		 Influsplit SSW 2005/2006 10-13 years Group
    Arm description
    		 Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Influsplit SSW 2005/2006
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Children received 1 dose of Influsplit vaccine in the non-dominant.

    Number of subjects in period 1
    		Influsplit SSW 2005/2006 6-9 years Group Influsplit SSW 2005/2006 10-13 years Group
    Started
    110
    114
    Completed
    108
    113
    Not completed
    2
    1
         Lost to follow-up
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Influsplit SSW 2005/2006 6-9 years Group
    Reporting group description
    		 Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).

    Reporting group title
    Influsplit SSW 2005/2006 10-13 years Group
    Reporting group description
    		 Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.

    Reporting group values
    		 Influsplit SSW 2005/2006 6-9 years Group Influsplit SSW 2005/2006 10-13 years Group Total
    Number of subjects
    		 110 114 224
    Age categorical
    Units: Subjects
        Number of subjects
    		 110 114 224
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 7.4 ( 1.13 ) 11.3 ( 1.07 ) -
    Gender categorical
    Units: Subjects
        Female
    		 62 65 127
        Male
    		 48 49 97
    Race/Ethnicity, Customized
    Units: Subjects
        White/Caucasian
    		 107 111 218
        Not Specified
    		 3 3 6

    End points

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    End points reporting groups
    Reporting group title
    Influsplit SSW 2005/2006 6-9 years Group
    Reporting group description
    		 Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).

    Reporting group title
    Influsplit SSW 2005/2006 10-13 years Group
    Reporting group description
    		 Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.

    Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 3 strains of influenza disease in children aged between 6 and 9 years

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    End point title
    		 Titers for serum Hemagglutination Inhibition (HI) antibodies against 3 strains of influenza disease in children aged between 6 and 9 years [1] [2]
    End point description
    Titers of serum HI antibodies are presented as geometric mean titers (GMTs) against the three influenza strains contained in the trivalent influenza vaccine Influsplit SSW 2005/2006 (GlaxoSmithKline/SSW) after a single versus after two vaccine doses of Influsplit SSW 2005/2006. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
    End point type
    Primary
    End point timeframe
    28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
    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 scope of this endpoint was descriptive analysis. No statistical analyses were 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 analysis was performed only on subjects belonging to the specific age group- 6 to 9 years. Therefore, data are not presented for the other group.
    End point values
    		 Influsplit SSW 2005/2006 6-9 years Group
    Number of subjects analysed
    97
    Units: Titer
    geometric mean (confidence interval 95%)
        A/New Caledonia (H1N1), Dose 1(N-97)
    290.4 (165.6 to 509.3)
        A/New Caledonia (H1N1), Dose 2 (N-95)
    719.2 (503.3 to 1027.7)
        A/New York (H3N2), Dose 1(N-97)
    381.2 (281.3 to 516.6)
        A/New York (H3N2), Dose 2 (N-95)
    393.9 (313.5 to 494.9)
        B/Jiangsu, Dose 1(N-97)
    97.7 (68.6 to 139.2)
        B/Jiangsu, Dose 2 (N-95)
    301.8 (246.3 to 369.9)
    No statistical analyses for this end point

    Primary: Seroconversion factor (SCF) for HI antibodies against 3 strains of influenza disease in children aged between 6 and 9 years

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    End point title
    		 Seroconversion factor (SCF) for HI antibodies against 3 strains of influenza disease in children aged between 6 and 9 years [3] [4]
    End point description
    Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
    End point type
    Primary
    End point timeframe
    28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
    Notes
    [3] - 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 scope of this endpoint was descriptive analysis. No statistical analyses were performed.
    [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 analysis was performed only on subjects belonging to the specific age group- 6 to 9 years. Therefore, data are not presented for the other group.
    End point values
    		 Influsplit SSW 2005/2006 6-9 years Group
    Number of subjects analysed
    97
    Units: Fold increase
    geometric mean (confidence interval 95%)
        A/New Caledonia (H1N1), Dose 1(N-97)
    16.7 (11.8 to 23.8)
        A/New Caledonia (H1N1), Dose 2 (N-95)
    40.7 (32.6 to 50.8)
        A/New York (H3N2), Dose 1(N-97)
    14.9 (10.9 to 20.3)
        A/New York (H3N2), Dose 2 (N-95)
    15.4 (11.9 to 20.0)
        B/Jiangsu, Dose 1(N-97)
    8.5 (6.7 to 10.7)
        B/Jiangsu, Dose 2 (N-95)
    26.1 (21.4 to 31.9)
    No statistical analyses for this end point

    Primary: Number of seroconverted subjects against 3 strains of influenza disease in children aged between 6 and 9 years

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    End point title
    		 Number of seroconverted subjects against 3 strains of influenza disease in children aged between 6 and 9 years [5] [6]
    End point description
    A seroconverted subject was defined as a subject who was either seronegative prior to the vaccination and had a protective post-vaccination titer of greater than or equal to (≥) 1:40 or who was seropositive prior to the vaccination and had at least a 4-fold increase in the titer as the outcome of the vaccination. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
    End point type
    Primary
    End point timeframe
    28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
    Notes
    [5] - 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 scope of this endpoint was descriptive analysis. No statistical analyses were performed.
    [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 analysis was performed only on subjects belonging to the specific age group- 6 to 9 years. Therefore, data are not presented for the other group.
    End point values
    		 Influsplit SSW 2005/2006 6-9 years Group
    Number of subjects analysed
    97
    Units: Participants
        A/New Caledonia (H1N1), Dose 1(N-97)
    63
        A/New Caledonia (H1N1), Dose 2 (N-95)
    93
        A/New York (H3N2), Dose 1(N-97)
    79
        A/New York (H3N2), Dose 2 (N-95)
    80
        B/Jiangsu, Dose 1(N-97)
    66
        B/Jiangsu, Dose 2 (N-95)
    92
    No statistical analyses for this end point

    Secondary: Titers for serum HI antibodies against 3 strains of influenza disease in children aged between 10 and 13 years

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    End point title
    		 Titers for serum HI antibodies against 3 strains of influenza disease in children aged between 10 and 13 years [7]
    End point description
    Titers of serum HI antibodies are presented as geometric mean titers (GMTs) against the three influenza strains contained in the trivalent influenza vaccine Influsplit SSW 2005/2006 (GlaxoSmithKline/SSW) after a single versus after two vaccine doses of Influsplit SSW 2005/2006. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
    End point type
    Secondary
    End point timeframe
    21 days post-vaccination (Day 21)
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was performed only on subjects belonging to the specific age group- 10 to 13 years. Therefore, data are not presented for the other group.
    End point values
    		 Influsplit SSW 2005/2006 10-13 years Group
    Number of subjects analysed
    106
    Units: Titers
    geometric mean (confidence interval 95%)
        A/New Caledonia (H1N1), Dose 1 (N-106)
    1326.6 (856.7 to 2054.3)
        A/New York (H3N2), Dose 1(N-106)
    300.6 (241.5 to 374.2)
        B/Jiangsu, Dose 1(N-106)
    218.9 (169.1 to 283.5)
    No statistical analyses for this end point

    Secondary: SCF for HI antibodies against 3 strains of influenza disease in children aged between 10 and 13 years

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    End point title
    		 SCF for HI antibodies against 3 strains of influenza disease in children aged between 10 and 13 years [8]
    End point description
    Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
    End point type
    Secondary
    End point timeframe
    21 days post-vaccination (Day 21)
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was performed only on subjects belonging to the specific age group- 10 to 13 years. Therefore, data are not presented for the other group.
    End point values
    		 Influsplit SSW 2005/2006 10-13 years Group
    Number of subjects analysed
    106
    Units: Fold increase
    geometric mean (confidence interval 95%)
        A/New Caledonia (H1N1), Dose 1(N-106)
    50.2 (36.2 to 69.8)
        A/New York (H3N2), Dose 1(N-106)
    10.3 (8.2 to 12.8)
        B/Jiangsu, Dose 1(N-106)
    12.6 (10.4 to 15.3)
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects against 3 strains of influenza disease in children aged between 10 and 13 years

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    End point title
    		 Number of seroconverted subjects against 3 strains of influenza disease in children aged between 10 and 13 years [9]
    End point description
    A seroconverted subject was defined as a subject who was either seronegative prior to the vaccination and had a protective post-vaccination titer of greater than or equal to (≥) 1:40 or who was seropositive prior to the vaccination and had at least a 4-fold increase in the titer as the outcome of the vaccination. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
    End point type
    Secondary
    End point timeframe
    21 days post-vaccination (Day 21)
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was performed only on subjects belonging to the specific age group- 10 to 13 years. Therefore, data are not presented for the other group.
    End point values
    		 Influsplit SSW 2005/2006 10-13 years Group
    Number of subjects analysed
    106
    Units: Participants
        A/New Caledonia (H1N1), Dose 1(N-106)
    90
        A/New York (H3N2), Dose 1(N-106)
    83
        B/Jiangsu, Dose 1(N-106)
    90
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects who were unprotected at pre-vaccination against 3 influenza strains in children aged between 10 and 13 years

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    End point title
    		 Number of seroprotected subjects who were unprotected at pre-vaccination against 3 influenza strains in children aged between 10 and 13 years [10]
    End point description
    Seroprotection power (SPP) was defined as the proportion of the subjects unprotected before vaccination (titre < 40) who were protected after vaccination (titer ≥ 40). The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
    End point type
    Secondary
    End point timeframe
    21 days post-vaccination (Day 21)
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was performed only on subjects belonging to the specific age group- 10 to 13 years. Therefore, data are not presented for the other group.
    End point values
    		 Influsplit SSW 2005/2006 10-13 years Group
    Number of subjects analysed
    75
    Units: Participants
        A/New Caledonia (H1N1), Dose 1 (N-48)
    33
        A/New York (H3N2), Dose 1 (N-57)
    52
        B/Jiangsu, Dose 1 (N-75)
    62
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against 3 strains of influenza disease in children aged between 10 and 13 years

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    End point title
    		 Number of seroprotected subjects against 3 strains of influenza disease in children aged between 10 and 13 years [11]
    End point description
    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
    End point type
    Secondary
    End point timeframe
    21 days post-vaccination (Day 21)
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This analysis was performed only on subjects belonging to the specific age group- 10 to 13 years. Therefore, data are not presented for the other group.
    End point values
    		 Influsplit SSW 2005/2006 10-13 years Group
    Number of subjects analysed
    106
    Units: Participants
        A/New Caledonia (H1N1), Dose 1 (N-106)
    91
        A/New York (H3N2), Dose 1 (N-106)
    101
        B/Jiangsu, Dose 1(N-106)
    93
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms

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    End point title
    		 Number of subjects with solicited local symptoms
    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 50 millimeters (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0–3) post-vaccination period following each dose and across doses
    End point values
    		 Influsplit SSW 2005/2006 6-9 years Group Influsplit SSW 2005/2006 10-13 years Group
    Number of subjects analysed
    110
    114
    Units: Participants
        Pain, Any, Dose 1 (N-110,114)
    62
    54
        Pain, Grade 3, Dose 1 (N-110,114)
    0
    1
        Redness, Any, Dose 1 (N-110,114)
    28
    24
        Redness, > 50 mm, Dose 1 (N-110,114)
    0
    0
        Swelling, Any, Dose 1 (N-110,114)
    28
    39
        Swelling, > 50 mm, Dose 1 (N-110,114)
    0
    0
        Pain, Any, Dose 2 (N-108,0)
    68
    0
        Pain, Grade 3, Dose 2 (N-108,0)
    1
    0
        Redness, Any, Dose 2(N-108,0)
    31
    0
        Redness, > 50 mm, Dose 2(N-108,0)
    0
    0
        Swelling, Any, Dose 2(N-108,0)
    35
    0
        Swelling, > 50 mm, Dose 2(N-108,0)
    0
    0
        Pain, Any, Across doses (N-218,114)
    82
    54
        Pain, Grade 3, Across doses(N-218,114)
    1
    1
        Redness, Any, Across doses(N-218,114)
    39
    24
        Redness, > 50 mm, Across doses(N-218,114)
    0
    0
        Swelling, Any, Across doses(N-218,114)
    44
    39
        Swelling, > 50 mm, Across doses(N-218,114)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms

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    End point title
    		 Number of subjects with solicited general symptoms
    End point description
    Assessed solicited general symptoms were Arthralgia, Fatigue, Fever, Headache, Myalgia, Shivering and Sweating. Any= occurrence of the symptom regardless of intensity grade. Grade 3 fever = Grade 3 symptoms greater than (>) 39.0 °C. Related = symptoms considered by the investigator to have a causal relationship to study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0–3) post-vaccination period following each dose and across doses
    End point values
    		 Influsplit SSW 2005/2006 6-9 years Group Influsplit SSW 2005/2006 10-13 years Group
    Number of subjects analysed
    110
    114
    Units: Participants
        Arthralgia, Any, Dose 1 (N-110,114)
    10
    6
        Arthralgia, Grade 3, Dose 1(N-110,114)
    0
    1
        Arthralgia, Related, Dose 1(N-110,114)
    9
    6
        Fatigue, Any, Dose 1(N-110,114)
    22
    22
        Fatigue, Grade 3, Dose 1(N-110,114)
    0
    0
        Fatigue, Related, Dose 1(N-110,114)
    18
    10
        Fever (Axillary), ≥ 37.5ºC,Dose 1(N-110,114)
    3
    3
        Fever (Axillary), > 39.0ºC, Dose 1(N-110,114)
    0
    0
        Fever (Axillary), Related, Dose 1(N-110,114)
    3
    3
        Headache, Any, Dose 1(N-110,114)
    26
    19
        Headache, Grade 3, Dose 1(N-110,114)
    0
    1
        Headache, Related, Dose 1(N-110,114)
    19
    10
        Myalgia, Any, Dose 1(N-110,114)
    22
    13
        Myalgia, Grade 3, Dose 1(N-110,114)
    0
    0
        Myalgia, Related, Dose 1(N-110,114)
    19
    10
        Shivering, Any, Dose 1(N-110,114)
    10
    8
        Shivering, Grade 3, Dose 1(N-110,114)
    0
    1
        Shivering, Related, Dose 1(N-110,114)
    10
    6
        Sweating, Any, Dose 1(N-110,114)
    2
    4
        Sweating, Grade 3, Dose 1(N-110,114)
    0
    0
        Sweating, Related, Dose 1(N-110,114)
    2
    3
        Arthralgia, Any, Dose 2 (N-108, 0)
    3
    0
        Arthralgia, Grade 3, Dose 2 (N-108, 0)
    1
    0
        Arthralgia, Related, Dose 2 (N-108, 0)
    2
    0
        Fatigue, Any, Dose 2 (N-108, 0)
    12
    0
        Fatigue, Grade 3, Dose 2 (N-108, 0)
    1
    0
        Fatigue, Related, Dose 2 (N-108, 0)
    6
    0
        Fever (Axillary), ≥ 37.5ºC, Dose 2(N-108, 0)
    5
    0
        Fever (Axillary), > 39.0ºC, Dose 2(N-108, 0)
    0
    0
        Fever (Axillary), Related, Dose 2(N-108, 0)
    4
    0
        Headache, Any, Dose 2(N-108, 0)
    22
    0
        Headache, Grade 3, Dose 2(N-108, 0)
    2
    0
        Headache, Related, Dose 2(N-108, 0)
    16
    0
        Myalgia, Any, Dose 2(N-108, 0)
    19
    0
        Myalgia, Grade 3, Dose 2(N-108, 0)
    2
    0
        Myalgia, Related, Dose 2(N-108, 0)
    14
    0
        Shivering, Any, Dose 2(N-108, 0)
    8
    0
        Shivering, Grade 3, Dose 2(N-108, 0)
    1
    0
        Shivering, Related, Dose 2(N-108, 0)
    5
    0
        Sweating, Any, Dose 2(N-108, 0)
    3
    0
        Sweating, Grade 3, Dose 2(N-108, 0)
    0
    0
        Sweating, Related, Dose 2(N-108, 0)
    2
    0
        Arthralgia, Any, Across doses(N-110,114)
    13
    6
        Arthralgia, Grade 3, Across doses(N-110,114)
    1
    1
        Arthralgia, Related, Across doses(N-110,114)
    11
    6
        Fatigue, Any, Across doses(N-110,114)
    30
    22
        Fatigue, Grade 3, Across doses(N-110,114)
    1
    0
        Fatigue, Related, Across doses(N-110,114)
    22
    10
        Fever (Axillary),≥ 37.5ºC,Across doses(N-110,114)
    7
    3
        Fever (Axillary),>39.0ºC,Across doses(N-110,114)
    0
    0
        Fever (Axillary), Related, Across doses(N-110,114)
    6
    3
        Headache, Any, Across doses(N-110,114)
    38
    19
        Headache, Grade 3, Across doses(N-110,114)
    2
    1
        Headache, Related, Across doses(N-110,114)
    29
    10
        Myalgia, Any, Across doses(N-110,114)
    28
    13
        Myalgia, Grade 3, Across doses(N-110,114)
    2
    0
        Myalgia, Related, Across doses(N-110,114)
    23
    10
        Shivering, Any, Across doses(N-110,114)
    17
    8
        Shivering, Grade 3, Across doses(N-110,114)
    1
    1
        Shivering, Related, Across doses(N-110,114)
    14
    6
        Sweating, Any, Across doses(N-110,114)
    5
    4
        Sweating, Grade 3, Across doses(N-110,114)
    0
    0
        Sweating, Related, Across doses(N-110,114)
    4
    3
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited adverse events.

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    End point title
    		 Number of subjects with unsolicited adverse events.
    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
    During 31 days after the study vaccine dose (Day 0-30)
    End point values
    		 Influsplit SSW 2005/2006 6-9 years Group Influsplit SSW 2005/2006 10-13 years Group
    Number of subjects analysed
    110
    114
    Units: Participants
        Subjects with any AE(s)(N-110,114)
    52
    30
        Subjects with Grade 3 AE(s)(N-110,114)
    3
    1
        Subjects with related AE(s)(N-110,114)
    1
    4
    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
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    During the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group
    End point values
    		 Influsplit SSW 2005/2006 6-9 years Group Influsplit SSW 2005/2006 10-13 years Group
    Number of subjects analysed
    110
    114
    Units: Participants
        Any SAEs(N-110,114)
    3
    0
        Grade 3(N-110,114)
    0
    0
        Related SAEs(N-110,114)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs:During 4-day post-vaccination period after each dose & across doses. Unsolicited AEs:During 31 days after study vaccine dose.SAEs:During entire study period:Day 0-58+5 days for the 6-9 years Group & Day 0-30+5 days for the 10-13 years Group.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    Influsplit SSW 2005/2006 10-13 years Group
    Reporting group description
    		 Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW 2005/2006 vaccine at Day 0.

    Reporting group title
    Influsplit SSW 2005/2006 6-9 years Group
    Reporting group description
    		 Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).

    Serious adverse events
    		 Influsplit SSW 2005/2006 10-13 years Group Influsplit SSW 2005/2006 6-9 years Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 114 (0.00%)
    3 / 110 (2.73%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Congenital, familial and genetic disorders
    Hereditary fructose intolerance
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enteritis
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Tonsillitis
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         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: 0%
    Non-serious adverse events
    		 Influsplit SSW 2005/2006 10-13 years Group Influsplit SSW 2005/2006 6-9 years Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    90 / 114 (78.95%)
    100 / 110 (90.91%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Muscle strain
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Radius fracture
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Skin injury
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    19 / 114 (16.67%)
    38 / 110 (34.55%)
         occurrences all number
    20
    50
    General disorders and administration site conditions
    Axillary pain
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Chills
         subjects affected / exposed
    8 / 114 (7.02%)
    17 / 110 (15.45%)
         occurrences all number
    8
    18
    Fatigue
         subjects affected / exposed
    22 / 114 (19.30%)
    30 / 110 (27.27%)
         occurrences all number
    22
    34
    Injection site pruritus
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    54 / 114 (47.37%)
    82 / 110 (74.55%)
         occurrences all number
    54
    130
    Pyrexia
         subjects affected / exposed
    4 / 114 (3.51%)
    11 / 110 (10.00%)
         occurrences all number
    4
    12
    Swelling
         subjects affected / exposed
    39 / 114 (34.21%)
    44 / 110 (40.00%)
         occurrences all number
    39
    63
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Otosalpingitis
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Vertigo
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Eye pruritus
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Ocular hyperaemia
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 114 (2.63%)
    4 / 110 (3.64%)
         occurrences all number
    3
    4
    Aphthous stomatitis
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 114 (0.88%)
    4 / 110 (3.64%)
         occurrences all number
    1
    6
    Dysphagia
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Enteritis
         subjects affected / exposed
    0 / 114 (0.00%)
    4 / 110 (3.64%)
         occurrences all number
    0
    5
    Flatulence
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    0 / 114 (0.00%)
    3 / 110 (2.73%)
         occurrences all number
    0
    3
    Vomiting
         subjects affected / exposed
    2 / 114 (1.75%)
    5 / 110 (4.55%)
         occurrences all number
    2
    5
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Cough
         subjects affected / exposed
    5 / 114 (4.39%)
    5 / 110 (4.55%)
         occurrences all number
    6
    6
    Dyspnoea
         subjects affected / exposed
    0 / 114 (0.00%)
    3 / 110 (2.73%)
         occurrences all number
    0
    3
    Pharyngeal erythema
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Pharyngolaryngeal pain
         subjects affected / exposed
    2 / 114 (1.75%)
    3 / 110 (2.73%)
         occurrences all number
    2
    3
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Eczema
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Erythema
         subjects affected / exposed
    24 / 114 (21.05%)
    39 / 110 (35.45%)
         occurrences all number
    24
    59
    Hyperhidrosis
         subjects affected / exposed
    4 / 114 (3.51%)
    5 / 110 (4.55%)
         occurrences all number
    4
    5
    Petechiae
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 110 (0.00%)
         occurrences all number
    2
    0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 114 (5.26%)
    13 / 110 (11.82%)
         occurrences all number
    7
    13
    Back pain
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    13 / 114 (11.40%)
    28 / 110 (25.45%)
         occurrences all number
    13
    41
    Torticollis
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 110 (1.82%)
         occurrences all number
    0
    2
    Infections and infestations
    Acute tonsillitis
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 110 (1.82%)
         occurrences all number
    1
    2
    Ear infection
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 110 (1.82%)
         occurrences all number
    0
    2
    Fungal infection
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 114 (1.75%)
    1 / 110 (0.91%)
         occurrences all number
    2
    2
    Lice infestation
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 110 (1.82%)
         occurrences all number
    1
    2
    Nasopharyngitis
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 110 (1.82%)
         occurrences all number
    1
    2
    Otitis media
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    1 / 114 (0.88%)
    7 / 110 (6.36%)
         occurrences all number
    1
    8
    Sinusitis
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 110 (0.00%)
         occurrences all number
    1
    0
    Streptococcal infection
         subjects affected / exposed
    0 / 114 (0.00%)
    3 / 110 (2.73%)
         occurrences all number
    0
    3
    Tonsillitis
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Tracheitis
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 114 (4.39%)
    13 / 110 (11.82%)
         occurrences all number
    5
    14
    Viral infection
         subjects affected / exposed
    0 / 114 (0.00%)
    3 / 110 (2.73%)
         occurrences all number
    0
    3
    Vulvitis
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 110 (0.91%)
         occurrences all number
    0
    1

    More information

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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
    For support, Contact us.
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