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    Clinical Trial Results:
    A Phase II, Multicentre, Randomised, Observer-blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children Aged >= 6 Months to < 9 Years.

    Summary
    EudraCT number
    		 2014-005183-15
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    26 Oct 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jun 2016
    First version publication date
    30 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CSLCT-CAL-09-60
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00940108
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CSL Limited
    Sponsor organisation address
    45 Poplar Rd, Parkville, Australia, 3052
    Public contact
    Clinical Program Director, bioCSL, bioCSL LTD PTY, biocsl.clinicaltrials@biocsl.com.au
    Scientific contact
    Clinical Program Director, bioCSL, bioCSL LTD PTY, biocsl.clinicaltrials@biocsl.com.au
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Apr 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Oct 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Oct 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the immunogenicity of the 15 μg haemagglutinin (HA) and 30 μg HA antigen doses of 2009 H1N1 vaccine (H1N1 vaccine) in two cohorts of healthy children: Cohort A: participants aged 6 months to less than 3 years ; Cohort B: participants aged 3 years to less than 9 years.
    Protection of trial subjects
    The study protocol, the study protocol amendments, the Participant Information Sheet (PIS) and the Informed Consent Form (ICF) were reviewed and approved by an Independent Ethics Committee (IEC). This study was conducted under an Australian Clinical Trial Notification scheme and documented in accordance with the World Medical Association Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Aug 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 369
    Worldwide total number of subjects
    369
    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)
    101
    Children (2-11 years)
    268
    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
    		 Active Study Initiation Date: 03 August 2009 (First participant, First Visit) Active Study Completion Date: 26 October 2009 (Last participant, Visit 3) The study was conducted at six sites in Australia.

    Pre-assignment
    Screening details
    		 One randomized participant withdrew consent prior to vaccine administration and was not included in the participant flow data or in any analysis population.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort A (6 months to < 3 years)
    Arm description
    		 The H1N1 vaccine, a monovalent, inactivated, split-virus vaccine, contains the HA antigen for the influenza strain A/California/7/2009(H1N1)v-like virus (2009 H1N1). The vaccine was supplied as a thiomersal-free suspension in pre-filled syringes at a concentration of 60 μg HA antigen per mL.
    Arm type
    		 Experimental

    Investigational medicinal product name
    HIN1 vaccine (15 ug HA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The H1N1 vaccine, a monovalent, inactivated, split-virus vaccine, contains the HA antigen for the influenza strain A/California/7/2009(H1N1)v-like virus (2009 H1N1). The dose administered was 15 μg HA antigen per 0.25 mL dose. Participants received two vaccinations of their assigned dose, administered 21 days apart.

    Investigational medicinal product name
    HIN1 vaccine (30 ug HA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The H1N1 vaccine, a monovalent, inactivated, split-virus vaccine, contains the HA antigen for the influenza strain A/California/7/2009(H1N1)v-like virus (2009 H1N1). The dose administered was 30 μg HA antigen per 0.5 mL dose. Participants received two vaccinations of their assigned dose, administered 21 days apart.

    Arm title
    		 Cohort B (3 years to < 9 years)
    Arm description
    		 The H1N1 vaccine, a monovalent, inactivated, split-virus vaccine, contains the HA antigen for the influenza strain A/California/7/2009(H1N1)v-like virus (2009 H1N1). The vaccine was supplied as a thiomersal-free suspension in pre-filled syringes at a concentration of 60 μg HA antigen per mL.
    Arm type
    		 Experimental

    Investigational medicinal product name
    HIN1 vaccine (15 ug HA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The H1N1 vaccine, a monovalent, inactivated, split-virus vaccine, contains the HA antigen for the influenza strain A/California/7/2009(H1N1)v-like virus (2009 H1N1). The dose administered was 15 μg HA antigen per 0.25 mL dose. Participants received two vaccinations of their assigned dose, administered 21 days apart.

    Investigational medicinal product name
    HIN1 vaccine (30 ug HA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The H1N1 vaccine, a monovalent, inactivated, split-virus vaccine, contains the HA antigen for the influenza strain A/California/7/2009(H1N1)v-like virus (2009 H1N1). The dose administered was 30 μg HA antigen per 0.5 mL dose. Participants received two vaccinations of their assigned dose, administered 21 days apart.

    Number of subjects in period 1
    		Cohort A (6 months to < 3 years) Cohort B (3 years to < 9 years)
    Started
    162
    207
    Completed
    148
    199
    Not completed
    14
    8
         Diagnosed with H1N1
    -
    1
         Consent withdrawn by subject
    3
    1
         Adverse event, non-fatal
    6
    2
         Declined further vaccination
    1
    3
         Refused - pyrexia after Dose 1
    1
    -
         Dose 2 contraindicated
    2
    1
         Viral illness after Dose 1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort A (6 months to < 3 years)
    Reporting group description
    		 The H1N1 vaccine, a monovalent, inactivated, split-virus vaccine, contains the HA antigen for the influenza strain A/California/7/2009(H1N1)v-like virus (2009 H1N1). The vaccine was supplied as a thiomersal-free suspension in pre-filled syringes at a concentration of 60 μg HA antigen per mL.

    Reporting group title
    Cohort B (3 years to < 9 years)
    Reporting group description
    		 The H1N1 vaccine, a monovalent, inactivated, split-virus vaccine, contains the HA antigen for the influenza strain A/California/7/2009(H1N1)v-like virus (2009 H1N1). The vaccine was supplied as a thiomersal-free suspension in pre-filled syringes at a concentration of 60 μg HA antigen per mL.

    Reporting group values
    		 Cohort A (6 months to < 3 years) Cohort B (3 years to < 9 years) Total
    Number of subjects
    		 162 207 369
    Age categorical
    Units: Subjects
        Cohort A: 6 months to <3 years, 15ug dose
    		 82 0 82
        Cohort A: 6 months to <3 years, 30ug dose
    		 80 0 80
        Cohort B: 3 years to <9 years, 15 ug dose
    		 0 103 103
        Cohort B: 3 years to <9 years, 30 ug dose
    		 0 104 104
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 1.71 ( 0.7 ) 5.72 ( 1.71 ) -
    Gender categorical
    Units: Subjects
        Female
    		 82 102 184
        Male
    		 80 105 185
    Subject analysis sets

    Subject analysis set title
    CSL425 (15 mcg) Cohort A
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.

    Subject analysis set title
    CSL425 (30 mcg) Cohort A
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.

    Subject analysis set title
    CSL425 (15 mcg) Cohort B
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.

    Subject analysis set title
    CSL425 (30 mcg) Cohort B
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.

    Subject analysis set title
    Total of all reporting groups
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Total of all reporting groups.

    Subject analysis sets values
    		 CSL425 (15 mcg) Cohort A CSL425 (30 mcg) Cohort A CSL425 (15 mcg) Cohort B CSL425 (30 mcg) Cohort B Total of all reporting groups
    Number of subjects
    82
    80
    103
    104
    369
    Age categorical
    Units: Subjects
        Cohort A: 6 months to <3 years, 15ug dose
    82
    0
    0
    0
    82
        Cohort A: 6 months to <3 years, 30ug dose
    0
    80
    0
    0
    80
        Cohort B: 3 years to <9 years, 15 ug dose
    0
    0
    103
    0
    103
        Cohort B: 3 years to <9 years, 30 ug dose
    0
    0
    0
    104
    104
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    1.68 ( 0.67 )
    1.73 ( 0.74 )
    5.78 ( 1.69 )
    5.66 ( 1.74 )
    3.96 ( 2.42 )
    Gender categorical
    Units: Subjects
        Female
    41
    41
    53
    49
    184
        Male
    41
    39
    50
    55
    185

    End points

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    End points reporting groups
    Reporting group title
    Cohort A (6 months to < 3 years)
    Reporting group description
    		 The H1N1 vaccine, a monovalent, inactivated, split-virus vaccine, contains the HA antigen for the influenza strain A/California/7/2009(H1N1)v-like virus (2009 H1N1). The vaccine was supplied as a thiomersal-free suspension in pre-filled syringes at a concentration of 60 μg HA antigen per mL.

    Reporting group title
    Cohort B (3 years to < 9 years)
    Reporting group description
    		 The H1N1 vaccine, a monovalent, inactivated, split-virus vaccine, contains the HA antigen for the influenza strain A/California/7/2009(H1N1)v-like virus (2009 H1N1). The vaccine was supplied as a thiomersal-free suspension in pre-filled syringes at a concentration of 60 μg HA antigen per mL.

    Subject analysis set title
    CSL425 (15 mcg) Cohort A
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.

    Subject analysis set title
    CSL425 (30 mcg) Cohort A
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.

    Subject analysis set title
    CSL425 (15 mcg) Cohort B
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.

    Subject analysis set title
    CSL425 (30 mcg) Cohort B
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.

    Subject analysis set title
    Total of all reporting groups
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Total of all reporting groups.

    Primary: Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination.

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    End point title
    		 Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination. [1]
    End point description
    HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre. The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
    End point type
    Primary
    End point timeframe
    Before and 21 days after the first 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: Data were analysed using descriptive statistics only.
    End point values
    		 CSL425 (15 mcg) Cohort A CSL425 (30 mcg) Cohort A CSL425 (15 mcg) Cohort B CSL425 (30 mcg) Cohort B
    Number of subjects analysed
    76
    73
    98
    99
    Units: percentage of participants
        arithmetic mean (confidence interval 95%)
    88.2 (78.7 to 94.4)
    97.3 (90.5 to 99.7)
    85.7 (77.2 to 92)
    91.9 (84.7 to 96.4)
    No statistical analyses for this end point

    Primary: HI Antibody Titre Seroconversion Rate After the Second Vaccination

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    End point title
    		 HI Antibody Titre Seroconversion Rate After the Second Vaccination [2]
    End point description
    HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre. The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
    End point type
    Primary
    End point timeframe
    Before and 21 days after the second vaccination.
    Notes
    [2] - 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: Data were analysed using descriptive statistics only.
    End point values
    		 CSL425 (15 mcg) Cohort A CSL425 (30 mcg) Cohort A CSL425 (15 mcg) Cohort B CSL425 (30 mcg) Cohort B
    Number of subjects analysed
    64
    69
    95
    96
    Units: percentage of participants
        arithmetic mean (confidence interval 95%)
    96.9 (89.2 to 99.6)
    98.6 (92.2 to 100)
    97.9 (92.6 to 99.7)
    96.9 (91.1 to 99.4)
    No statistical analyses for this end point

    Primary: Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination

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    End point title
    		 Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination [3]
    End point description
    GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre. The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
    End point type
    Primary
    End point timeframe
    Before and 21 days after the first vaccination.
    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: Data were analysed using descriptive statistics only.
    End point values
    		 CSL425 (15 mcg) Cohort A CSL425 (30 mcg) Cohort A CSL425 (15 mcg) Cohort B CSL425 (30 mcg) Cohort B
    Number of subjects analysed
    76
    73
    98
    99
    Units: geometric mean fold increase
        geometric mean (confidence interval 95%)
    13.95 (11.39 to 17.09)
    22.17 (17.87 to 27.49)
    13.25 (10.84 to 16.19)
    15.93 (12.87 to 19.71)
    No statistical analyses for this end point

    Primary: GMFI in the HI Antibody Titre After the Second Vaccination

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    End point title
    		 GMFI in the HI Antibody Titre After the Second Vaccination [4]
    End point description
    GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre. The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
    End point type
    Primary
    End point timeframe
    Before and 21 days after the second vaccination.
    Notes
    [4] - 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: Data were analysed using descriptive statistics only.
    End point values
    		 CSL425 (15 mcg) Cohort A CSL425 (30 mcg) Cohort A CSL425 (15 mcg) Cohort B CSL425 (30 mcg) Cohort B
    Number of subjects analysed
    64
    69
    95
    96
    Units: geometric mean fold increase
        geometric mean (confidence interval 95%)
    57.64 (42.87 to 77.5)
    72.93 (56.1 to 94.8)
    37.48 (28.33 to 49.58)
    37.06 (28.77 to 47.75)
    No statistical analyses for this end point

    Primary: Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination

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    End point title
    		 Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination [5]
    End point description
    The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
    End point type
    Primary
    End point timeframe
    21 days after the first vaccination
    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: Data were analysed using descriptive statistics only.
    End point values
    		 CSL425 (15 mcg) Cohort A CSL425 (30 mcg) Cohort A CSL425 (15 mcg) Cohort B CSL425 (30 mcg) Cohort B
    Number of subjects analysed
    76
    73
    98
    99
    Units: percentage of participants
        number (confidence interval 95%)
    92.1 (83.6 to 97)
    100 (95.1 to 100)
    92.9 (85.8 to 97.1)
    96 (90 to 98.9)
    No statistical analyses for this end point

    Primary: Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination

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    End point title
    		 Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination [6]
    End point description
    The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
    End point type
    Primary
    End point timeframe
    21 days after the second vaccination
    Notes
    [6] - 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: Data were analysed using descriptive statistics only.
    End point values
    		 CSL425 (15 mcg) Cohort A CSL425 (30 mcg) Cohort A CSL425 (15 mcg) Cohort B CSL425 (30 mcg) Cohort B
    Number of subjects analysed
    64
    69
    95
    96
    Units: percentage of participants
        number (confidence interval 95%)
    100 (94.4 to 100)
    100 (94.8 to 100)
    100 (96.2 to 100)
    100 (96.2 to 100)
    No statistical analyses for this end point

    Secondary: Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination - PART A

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    End point title
    		 Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination - PART A
    End point description
    Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Cried when limb was moved/spontaneously painful (Cohort A) or prevented normal daily activities (Cohort B) for injection site pain; Size > 100 mm for injection site redness and induration/swelling; Temperature > 103.1°F (39.5°C) for fevers; Prevented normal daily activities or required medical intervention for all other systemic AEs. The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. Headache, muscle ache and malaise not solicited for Cohort A. Appetite and irritability not solicited for Cohort B.
    End point type
    Secondary
    End point timeframe
    During the 7 days after each vaccination.
    End point values
    		 CSL425 (15 mcg) Cohort A CSL425 (30 mcg) Cohort A
    Number of subjects analysed
    82
    80
    Units: percentage of participants
    number (not applicable)
        Any solicited local AE
    69.5
    63.8
        Any pain at injection site
    48.8
    43.8
        Grade 3 pain at injection site
    1.2
    1.3
        Any redness at injection site
    53.7
    38.8
        Grade 3 redness at injection site
    0
    1.3
        Any swelling/induration at injection site
    30.5
    32.5
        Grade 3 swelling/induration at injection site
    0
    2.5
        Any solicited systemic AE
    79.3
    93.8
        Any nausea/vomiting
    13.4
    30
        Grade 3 nausea/vomiting
    1.2
    1.3
        Any diarrhoea
    26.8
    32.5
        Grade 3 diarrhoea
    1.2
    0
        Any loss of appetite
    40.2
    50
        Grade 3 loss of appetite
    1.2
    0
        Any irritability
    63.4
    72.5
        Grade 3 irritability
    2.4
    1.3
        Any fever
    50
    71.3
        Grade 3 fever
    1.2
    8.8
    No statistical analyses for this end point

    Secondary: Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination - PART B

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    End point title
    		 Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination - PART B
    End point description
    Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Cried when limb was moved/spontaneously painful (Cohort A) or prevented normal daily activities (Cohort B) for injection site pain; Size > 100 mm for injection site redness and induration/swelling; Temperature > 103.1°F (39.5°C) for fevers; Prevented normal daily activities or required medical intervention for all other systemic AEs. The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. Appetite and irritability not solicited for in Cohort B. Headache, muscle ache and malaise not solicited for in Cohort A.
    End point type
    Secondary
    End point timeframe
    During the 7 days after each vaccination.
    End point values
    		 CSL425 (15 mcg) Cohort B CSL425 (30 mcg) Cohort B
    Number of subjects analysed
    103
    104
    Units: percentage of participants
    number (not applicable)
        Any solicited local AE
    68
    71.2
        Any pain at injection site
    59.2
    64.4
        Grade 3 pain at injection site
    0
    1
        Any redness at injection site
    37.9
    37.5
        Grade 3 redness at injection site
    2.9
    2.9
        Any swelling/induration at injection site
    25.2
    26.9
        Grade 3 swelling/induration at injection site
    0
    4.8
        Any solicited systemic AE
    54.4
    61.5
        Any nausea/vomiting
    15.5
    20.2
        Grade 3 nausea/vomiting
    0
    1
        Any diarrhoea
    12.6
    12.5
        Grade 3 diarrhoea
    0
    0
        Any fever
    20.4
    29.8
        Grade 3 fever
    0
    2.9
        Any headache
    27.2
    23.1
        Grade 3 headache
    0
    1
        Any muscle ache
    15.5
    22.1
        Grade 3 muscle ache
    0
    1
        Any malaise
    19.4
    26.9
        Grade 3 malaise
    0
    1.9
    No statistical analyses for this end point

    Secondary: Duration of Solicited AEs After the First Vaccination - PART A

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    End point title
    		 Duration of Solicited AEs After the First Vaccination - PART A
    End point description
    Solicited AEs included AEs that were specifically sought for. The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. Headache, muscle ache and malaise not solicited for in Cohort A.
    End point type
    Secondary
    End point timeframe
    During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7.
    End point values
    		 CSL425 (15 mcg) Cohort A CSL425 (30 mcg) Cohort A
    Number of subjects analysed
    82
    80
    Units: days
    arithmetic mean (standard deviation)
        Pain at injection site
    1.48 ( 0.677 )
    1.52 ( 0.823 )
        Redness at injection site
    2.08 ( 1.382 )
    2.23 ( 1.602 )
        Swelling/induration at injection site
    1.88 ( 0.957 )
    1.64 ( 0.745 )
        Nausea/vomiting
    1.33 ( 0.5 )
    1.05 ( 0.213 )
        Diarrhoea
    1.67 ( 1.328 )
    1.55 ( 0.945 )
        Loss of appetite
    2.32 ( 1.906 )
    1.97 ( 1.447 )
        Irritability
    1.78 ( 1.56 )
    1.73 ( 1.574 )
        Fever
    1.77 ( 1.547 )
    1.52 ( 1.079 )
    No statistical analyses for this end point

    Secondary: Duration of Solicited AEs After the First Vaccination - PART B

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    End point title
    		 Duration of Solicited AEs After the First Vaccination - PART B
    End point description
    Solicited AEs included AEs that were specifically sought for. The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. Loss of appetite and irritability not solicited for in Cohort B.
    End point type
    Secondary
    End point timeframe
    During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7.
    End point values
    		 CSL425 (15 mcg) Cohort B CSL425 (30 mcg) Cohort B
    Number of subjects analysed
    103
    104
    Units: days
    arithmetic mean (standard deviation)
        Pain at injection site
    1.91 ( 1.221 )
    1.8 ( 1.016 )
        Redness at injection site
    2.26 ( 1.347 )
    2 ( 1.134 )
        Swelling/induration at injection site
    1.6 ( 0.737 )
    2.04 ( 1.136 )
        Nausea/vomiting
    1.18 ( 0.405 )
    1.53 ( 1.837 )
        Diarrhoea
    1.11 ( 0.333 )
    1.17 ( 0.577 )
        Fever
    1.4 ( 0.737 )
    1.54 ( 1.319 )
        Headache
    2.04 ( 2.911 )
    1.63 ( 1.149 )
        Muscle ache
    1.45 ( 0.6888 )
    1.86 ( 2.175 )
        Malaise
    1.6 ( 0.91 )
    1.69 ( 1.966 )
    No statistical analyses for this end point

    Secondary: Duration of Solicited AEs After the Second Vaccination - PART A

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    End point title
    		 Duration of Solicited AEs After the Second Vaccination - PART A
    End point description
    Solicited AEs included AEs that were specifically sought for. The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. Headache, muscle ache and malaise not solicited for in Cohort A.
    End point type
    Secondary
    End point timeframe
    During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.
    End point values
    		 CSL425 (15 mcg) Cohort A CSL425 (30 mcg) Cohort A
    Number of subjects analysed
    77
    71
    Units: days
    arithmetic mean (standard deviation)
        Pain at injection site
    1.67 ( 0.966 )
    1.64 ( 1.002 )
        Redness at injection site
    1.69 ( 1.004 )
    2.14 ( 1.037 )
        Swelling/induration at injection site
    1.74 ( 0.872 )
    2.32 ( 1.108 )
        Nausea/vomiting
    5 ( 8.832 )
    1 ( 0 )
        Diarrhoea
    3.4 ( 3.777 )
    1.25 ( 0.452 )
        Loss of appetite
    3.15 ( 4.475 )
    1.73 ( 0.883 )
        Irritability
    2.57 ( 2.41 )
    2.1 ( 1.533 )
        Fever
    2.14 ( 3.005 )
    1.63 ( 1.165 )
    No statistical analyses for this end point

    Secondary: Duration of Solicited AEs After the Second Vaccination - PART B

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    End point title
    		 Duration of Solicited AEs After the Second Vaccination - PART B
    End point description
    Solicited AEs included AEs that were specifically sought for. The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. Loss of appetite and irritability not solicited for in Cohort B.
    End point type
    Secondary
    End point timeframe
    During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.
    End point values
    		 CSL425 (15 mcg) Cohort B CSL425 (30 mcg) Cohort B
    Number of subjects analysed
    100
    99
    Units: days
    arithmetic mean (standard deviation)
        Pain at injection site
    1.9 ( 1.179 )
    1.8 ( 1.04 )
        Redness at injection site
    1.92 ( 1.055 )
    1.7 ( 0.822 )
        Swelling/induration at injection site
    2.24 ( 1.348 )
    2.27 ( 1.751 )
        Nausea/vomiting
    1.43 ( 0.787 )
    1.11 ( 0.333 )
        Diarrhoea
    1.4 ( 0.894 )
    2 ( 1 )
        Fever
    1.54 ( 0.877 )
    1.67 ( 1.414 )
        Headache
    1.33 ( 0.686 )
    1.73 ( 2.412 )
        Muscle ache
    1.6 ( 0.516 )
    1.29 ( 0.756 )
        Malaise
    1.2 ( 0.422 )
    2 ( 1.826 )
    No statistical analyses for this end point

    Secondary: Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)

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    End point title
    		 Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)
    End point description
    An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma). The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.
    End point type
    Secondary
    End point timeframe
    Up to 180 days after the last vaccination.
    End point values
    		 CSL425 (15 mcg) Cohort A CSL425 (30 mcg) Cohort A CSL425 (15 mcg) Cohort B CSL425 (30 mcg) Cohort B
    Number of subjects analysed
    82
    80
    103
    104
    Units: percentage of participants
    number (not applicable)
        At least one SAE
    4.9
    1.3
    1
    1
        Related SAE
    0
    0
    0
    1
        At least one AESI
    2.4
    1.3
    0
    0
        Related AESI
    0
    0
    0
    0
        At least one NOCI
    1.2
    3.8
    1.9
    0
        Related NOCI
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination

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    End point title
    		 Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination
    End point description
    Unsolicited AEs included AEs other than those specifically sought for. Grade 1 unsolicited AE definition: Easily tolerated and did not interfere with normal daily activities. Grade 2 unsolicited AE definition: Some interference with normal daily activities. Grade 3 unsolicited AE definition: Prevented normal daily activities. The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.
    End point type
    Secondary
    End point timeframe
    During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs.
    End point values
    		 CSL425 (15 mcg) Cohort A CSL425 (30 mcg) Cohort A CSL425 (15 mcg) Cohort B CSL425 (30 mcg) Cohort B
    Number of subjects analysed
    82
    80
    103
    104
    Units: percentage of subjects
    number (not applicable)
        At least one unsolicited AE
    78
    82.5
    67
    76
        Grade 1 unsolicited AE
    26.8
    33.8
    27.2
    37.5
        Grade 2 unsolicited AE
    41.5
    41.3
    37.9
    26.9
        Grade 3 unsolicited AE
    9.8
    7.5
    1.9
    11.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
    Adverse event reporting additional description
    Loss of appetite and irritability were not solicited for in Cohort B. Headache, muscle ache and malaise were not solicted for in Cohort A.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13
    Reporting groups
    Reporting group title
    CSL425 (15 mcg) Cohort A
    Reporting group description
    		 Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.

    Reporting group title
    CSL425 (30 mcg) Cohort A
    Reporting group description
    		 Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.

    Reporting group title
    CSL425 (15 mcg) Cohort B
    Reporting group description
    		 Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.

    Reporting group title
    CSL425 (30 mcg) Cohort B
    Reporting group description
    		 Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.

    Serious adverse events
    		 CSL425 (15 mcg) Cohort A CSL425 (30 mcg) Cohort A CSL425 (15 mcg) Cohort B CSL425 (30 mcg) Cohort B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 82 (4.88%)
    1 / 80 (1.25%)
    1 / 103 (0.97%)
    1 / 104 (0.96%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    Kawasaki's disease
         subjects affected / exposed
    0 / 82 (0.00%)
    1 / 80 (1.25%)
    0 / 103 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion in childhood
         subjects affected / exposed
    2 / 82 (2.44%)
    0 / 80 (0.00%)
    0 / 103 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 80 (0.00%)
    0 / 103 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
    Additional description: defined as a NOCI.
         subjects affected / exposed
    1 / 82 (1.22%)
    1 / 80 (1.25%)
    0 / 103 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    1 / 82 (1.22%)
    0 / 80 (0.00%)
    0 / 103 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 80 (0.00%)
    1 / 103 (0.97%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CSL425 (15 mcg) Cohort A CSL425 (30 mcg) Cohort A CSL425 (15 mcg) Cohort B CSL425 (30 mcg) Cohort B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    81 / 82 (98.78%)
    78 / 80 (97.50%)
    91 / 103 (88.35%)
    96 / 104 (92.31%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    3 / 82 (3.66%)
    6 / 80 (7.50%)
    4 / 103 (3.88%)
    7 / 104 (6.73%)
         occurrences all number
    3
    6
    5
    7
    Excoriation
         subjects affected / exposed
    2 / 82 (2.44%)
    1 / 80 (1.25%)
    3 / 103 (2.91%)
    6 / 104 (5.77%)
         occurrences all number
    2
    1
    3
    8
    Contusion
         subjects affected / exposed
    1 / 82 (1.22%)
    1 / 80 (1.25%)
    0 / 103 (0.00%)
    6 / 104 (5.77%)
         occurrences all number
    1
    1
    0
    6
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    12 / 82 (14.63%)
    10 / 80 (12.50%)
    7 / 103 (6.80%)
    9 / 104 (8.65%)
         occurrences all number
    14
    10
    8
    9
    Pyrexia
         subjects affected / exposed
    10 / 82 (12.20%)
    4 / 80 (5.00%)
    3 / 103 (2.91%)
    2 / 104 (1.92%)
         occurrences all number
    10
    4
    4
    2
    Pain at Injection Site
         subjects affected / exposed
    40 / 82 (48.78%)
    35 / 80 (43.75%)
    61 / 103 (59.22%)
    67 / 104 (64.42%)
         occurrences all number
    52
    47
    96
    105
    Redness at Injection Site
         subjects affected / exposed
    44 / 82 (53.66%)
    31 / 80 (38.75%)
    39 / 103 (37.86%)
    39 / 104 (37.50%)
         occurrences all number
    66
    44
    53
    52
    Swelling/Induration at Injection Site
         subjects affected / exposed
    25 / 82 (30.49%)
    26 / 80 (32.50%)
    26 / 103 (25.24%)
    28 / 104 (26.92%)
         occurrences all number
    35
    33
    32
    40
    Nausea/Vomiting
         subjects affected / exposed
    11 / 82 (13.41%)
    24 / 80 (30.00%)
    16 / 103 (15.53%)
    21 / 104 (20.19%)
         occurrences all number
    15
    26
    18
    28
    Diarrhoea
         subjects affected / exposed
    22 / 82 (26.83%)
    26 / 80 (32.50%)
    13 / 103 (12.62%)
    13 / 104 (12.50%)
         occurrences all number
    28
    32
    14
    15
    Loss of appetite
         subjects affected / exposed
    33 / 82 (40.24%)
    40 / 80 (50.00%)
    0 / 103 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    48
    55
    0
    0
    Irritability
         subjects affected / exposed
    52 / 82 (63.41%)
    58 / 80 (72.50%)
    0 / 103 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    92
    99
    0
    0
    Fever
         subjects affected / exposed
    41 / 82 (50.00%)
    57 / 80 (71.25%)
    21 / 103 (20.39%)
    31 / 104 (29.81%)
         occurrences all number
    51
    75
    28
    37
    Headache
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 80 (0.00%)
    28 / 103 (27.18%)
    24 / 104 (23.08%)
         occurrences all number
    0
    0
    42
    38
    Muscle ache (Myalgia)
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 80 (0.00%)
    16 / 103 (15.53%)
    23 / 104 (22.12%)
         occurrences all number
    0
    0
    21
    28
    Malaise
         subjects affected / exposed
    0 / 82 (0.00%)
    0 / 80 (0.00%)
    20 / 103 (19.42%)
    28 / 104 (26.92%)
         occurrences all number
    0
    0
    25
    39
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 82 (0.00%)
    2 / 80 (2.50%)
    8 / 103 (7.77%)
    4 / 104 (3.85%)
         occurrences all number
    0
    2
    8
    5
    Gastrointestinal disorders
    Teething
         subjects affected / exposed
    14 / 82 (17.07%)
    12 / 80 (15.00%)
    0 / 103 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    18
    19
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 82 (0.00%)
    4 / 80 (5.00%)
    2 / 103 (1.94%)
    2 / 104 (1.92%)
         occurrences all number
    0
    4
    2
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 82 (7.32%)
    11 / 80 (13.75%)
    13 / 103 (12.62%)
    11 / 104 (10.58%)
         occurrences all number
    6
    12
    13
    12
    Rhinorrhoea
         subjects affected / exposed
    8 / 82 (9.76%)
    17 / 80 (21.25%)
    4 / 103 (3.88%)
    8 / 104 (7.69%)
         occurrences all number
    8
    17
    4
    10
    Asthma
         subjects affected / exposed
    2 / 82 (2.44%)
    4 / 80 (5.00%)
    3 / 103 (2.91%)
    3 / 104 (2.88%)
         occurrences all number
    2
    4
    4
    4
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    7 / 82 (8.54%)
    3 / 80 (3.75%)
    0 / 103 (0.00%)
    2 / 104 (1.92%)
         occurrences all number
    7
    3
    0
    2
    Dermatitis diaper
         subjects affected / exposed
    7 / 82 (8.54%)
    1 / 80 (1.25%)
    0 / 103 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    7
    1
    0
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    22 / 82 (26.83%)
    28 / 80 (35.00%)
    22 / 103 (21.36%)
    24 / 104 (23.08%)
         occurrences all number
    28
    31
    26
    26
    Viral infection
         subjects affected / exposed
    4 / 82 (4.88%)
    0 / 80 (0.00%)
    3 / 103 (2.91%)
    9 / 104 (8.65%)
         occurrences all number
    4
    0
    4
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jun 2009
    The purpose of the first protocol amendment was to make the following revisions to the protocol: To incorporate changes to the exclusion criteria. Exclusion criteria were updated to exclude - Participants with a laboratory-confirmed infection with untyped influenza A since May 2009. - Participants who were receiving immunosuppressive or immunomodulative therapy, or have received such therapy within the 3 months preceding study entry. - To update the list of prohibited medications to include immunosuppressive or immunomodulative therapy.
    01 Oct 2009
    The purpose of the second protocol amendment was to make the following revisions to the protocol: - In order to aid public health decision-making regarding a potential 2009 H1N1 influenza vaccine immunisation program, the randomisation code will be unblinded after all enrolled participants complete the Active Study Period and the data collected during the Active Study Period are entered into the database. This modification altered the study design from a randomised, observer-blind, parallel group study to a randomised, observer-blind parallel group study with an open-label follow-up study period. - To clarify the tertiary analyses.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    31 Aug 2009
    Halting rules were triggered once because of a suspected unexpected serious adverse reaction (SUSAR) of pyrexia reported in an 8-year old participant in the 30 μg group. After medical review, the DSMB recommenced the study.
    01 Sep 2009

    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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