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    Clinical Trial Results:
    A Multi-center, Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Doses of Adjuvanted Cell-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Japanese Pediatric Subjects.

    Summary
    EudraCT number
    		 2014-005075-88
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    10 Dec 2009

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 Jul 2016
    First version publication date
    03 May 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Required for the re-QC project because of the EudraCT system glitch and possible updates to results may be required. Moreover, a change in system user for this study is necessary.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V110_08
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01000207
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma K.K
    Sponsor organisation address
    Minato-ku, Tokyo, Japan, 106-8618
    Public contact
    Posting Director, Novartis Vaccines and Diagnostics S.r.l, RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines and Diagnostics S.r.l, RegistryContactVaccinesUS@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Mar 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Dec 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To identify the preferred vaccine dose (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine (FCC101) in healthy children/adolescents based on EMEA/CHMP criteria, and safety & tolerability.
    Protection of trial subjects
    This trial was performed with the ethical principles that have their origin in the Declaration of Helsinki, that are consistent with Good Clinical Practice (GCP) according to International Conference on Harmonisation (ICH) guidelines, the applicable regulatory requirements (s) for the country in which the study is conducted, and applicable standard operating procedures (SOPs).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Oct 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
    Japan: 123
    Worldwide total number of subjects
    123
    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)
    14
    Children (2-11 years)
    76
    Adolescents (12-17 years)
    30
    Adults (18-64 years)
    3
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 5 sites in Japan.

    Pre-assignment
    Screening details
    		 All enrolled subjects were included in the trial.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 3.75_halfMF59
    Arm description
    		 Subjects received two doses of cell-derived H1N1sw vaccine containing 3.75µg + half MF59.
    Arm type
    		 Experimental

    Investigational medicinal product name
    H1N1 Vaccine
    Investigational medicinal product code
    V110
    Other name
    FCC 101
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Vaccination consisted of two 0.25mL doses of H1N1 vaccine (3.75mcg of H1N1 and half MF59) administered three weeks apart. All vaccinations were administered IM in the deltoid muscle or alternative area, preferably of the non-dominant arm at the first vaccination and of the opposite arm to the first vaccination, as a rule, at the second vaccination. For children less than 12 months of age, investigator administered the vaccine into the anterolateral aspect of the thigh (or alternative area).

    Arm title
    		 7.5_fullMF59
    Arm description
    		 Subjects received two doses of cell-derived H1N1sw vaccine containing 7.5µg + full MF59.
    Arm type
    		 Experimental

    Investigational medicinal product name
    H1N1 Vaccine
    Investigational medicinal product code
    V110
    Other name
    FCC 101
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Vaccination consisted of two 0.5mL doses of H1N1 vaccine (7.5mcg of H1N1 and full MF59) administered three weeks apart. All vaccinations were administered IM in the deltoid muscle or alternative area, preferably of the non-dominant arm at the first vaccination and of the opposite arm to the first vaccination, as a rule, at the second vaccination. For children less than 12 months of age, investigator administered the vaccine into the anterolateral aspect of the thigh (or alternative area).

    Number of subjects in period 1
    		3.75_halfMF59 7.5_fullMF59
    Started
    61
    62
    Completed
    59
    59
    Not completed
    2
    3
         Consent withdrawn by subject
    1
    -
         unable to clasify
    1
    -
         Adverse event, non-fatal
    -
    2
         uable to clasify
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    3.75_halfMF59
    Reporting group description
    		 Subjects received two doses of cell-derived H1N1sw vaccine containing 3.75µg + half MF59.

    Reporting group title
    7.5_fullMF59
    Reporting group description
    		 Subjects received two doses of cell-derived H1N1sw vaccine containing 7.5µg + full MF59.

    Reporting group values
    		 3.75_halfMF59 7.5_fullMF59 Total
    Number of subjects
    		 61 62 123
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8 ( 4.6 ) 8.6 ( 5.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 32 28 60
        Male
    		 29 34 63

    End points

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    End points reporting groups
    Reporting group title
    3.75_halfMF59
    Reporting group description
    		 Subjects received two doses of cell-derived H1N1sw vaccine containing 3.75µg + half MF59.

    Reporting group title
    7.5_fullMF59
    Reporting group description
    		 Subjects received two doses of cell-derived H1N1sw vaccine containing 7.5µg + full MF59.

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects in the All Randomized Set who actually received a study vaccination, and provided at least one evaluable serum sample both before and after baseline. In case of vaccination not done according to randomization, subjects were analyzed as randomized in the FAS.

    Subject analysis set title
    Per protocol population- Immunogenicity
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the FAS who receive all the relevant doses of vaccine correctly, and provide evaluable serum samples at the relevant time points, and have no major protocol violation as pre-specified in the Analysis Plan. A major deviation is defined as a protocol deviation that is considered to have a significant impact on the immunogenicity result of the subject. The PPS was defined for the entire study and not limited to one visit.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who actually received a study vaccination who provided post-baseline safety data.

    Primary: Percentage of subjects achieving seroconversion or a significant increase on day 22 and day 43 as measured by Hemagglutination Inhibition assay (HI).

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    End point title
    		 Percentage of subjects achieving seroconversion or a significant increase on day 22 and day 43 as measured by Hemagglutination Inhibition assay (HI). [1]
    End point description
    Percentage of subjects achieving seroconversion or a significant increase (defined as: HI ≥1:40 for subjects negative at baseline [<1:10]; a minimum 4-fold increase in HI titre for subjects positive at baseline [HI≥1:10]) on day 22 and day 43. Seroconversion is defined as negative pre-vaccination serum (<10 for HI) / positive postvaccination titer (≥40 for HI). Significant increase in antibody titer/area is defined as at least a fourfold increase in HI from non-negative pre-vaccination serum (≥10 for HI).
    End point type
    Primary
    End point timeframe
    Measured at day 22 and day 43.
    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: No statistical analyses for this end point
    End point values
    		 3.75_halfMF59 7.5_fullMF59
    Number of subjects analysed
    57
    59
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Day 22
    56.1 (42.4 to 69.3)
    76.4 (63 to 86.8)
        Day 43
    100 (93.7 to 100)
    100 (93.5 to 100)
    No statistical analyses for this end point

    Primary: Percentage of subjects achieving seroprotection (i.e., HI titer ≥1:40).

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    End point title
    		 Percentage of subjects achieving seroprotection (i.e., HI titer ≥1:40). [2]
    End point description
    Percentage of subjects achieving seroprotection (i.e., HI titer ≥1:40) on Day 1, Day 22 and Day 43.
    End point type
    Primary
    End point timeframe
    At Day 1, Day 22 and Day 43.
    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: No statistical analyses for this end point
    End point values
    		 3.75_halfMF59 7.5_fullMF59
    Number of subjects analysed
    57
    59
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Day 1
    0 (0 to 6.3)
    6.8 (1.9 to 16.5)
        Day 22
    56.1 (42.4 to 69.3)
    78 (65.3 to 87.7)
        Day 43
    100 (93.7 to 100)
    100 (93.9 to 100)
    No statistical analyses for this end point

    Primary: To evaluate the geometric mean titers on day 1, day 22 and day 43 as measured by HI assay and Microneutralisation (MN) assay.

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    End point title
    		 To evaluate the geometric mean titers on day 1, day 22 and day 43 as measured by HI assay and Microneutralisation (MN) assay. [3]
    End point description
    The immunogenicity was assessed in terms of Geometric Mean Titer (GMT) on Day 1, Day 22 and Day 43 was evaluated by HI and MN assay.
    End point type
    Primary
    End point timeframe
    At Day 1, Day 22 and Day 43
    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: No statistical analyses for this end point
    End point values
    		 3.75_halfMF59 7.5_fullMF59
    Number of subjects analysed
    57
    59
    Units: Titers
    geometric mean (confidence interval 95%)
        GMTs (HI) on day 1 (N=57,59)
    5.24 (4.58 to 5.99)
    6.23 (5.47 to 7.09)
        GMTs (HI) on day 22 (N=57,59)
    34 (21 to 54)
    84 (53 to 131)
        GMTs (HI) on day 43 (N=57,59)
    355 (278 to 453)
    596 (471 to 754)
        GMTs (MN) day 1 (N=57,59)
    5.2 (4.64 to 5.84)
    6.03 (5.4 to 6.74)
        GMTs (MN) day 22 (N=55,58)
    31 (20 to 47)
    57 (38 to 84)
        GMTs (MN) day 43 (N=57, 58)
    288 (226 to 368)
    445 (351 to 564)
    No statistical analyses for this end point

    Primary: To evaluate the geometric mean ratios as measured by HI assay and MN assay.

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    End point title
    		 To evaluate the geometric mean ratios as measured by HI assay and MN assay. [4]
    End point description
    The antibody responses were evaluated in terms of Geometric Mean Ratios (GMR) of post vaccination GMTs versus pre vaccination GMTs by HI and MN assay.
    End point type
    Primary
    End point timeframe
    At day 1, day 22 and day 43.
    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: No statistical analyses for this end point
    End point values
    		 3.75_halfMF59 7.5_fullMF59
    Number of subjects analysed
    57
    59
    Units: Ratio
    number (confidence interval 95%)
        GMR (HI) - Day 22 to day 1 (N=57,59)
    6.45 (4.14 to 10)
    13 (8.75 to 21)
        GMR (HI) - Day 43 to day 1 (N=57,59)
    68 (52 to 88)
    96 (75 to 123)
        GMR (MN) - Day 22 to day 1 (N=55,58)
    6.04 (4.08 to 8.93)
    9.85 (6.75 to 14)
        GMR (MN) - day 43 to day 1 (N=57,58)
    55 (43 to 71)
    74 (58 to 94)
    No statistical analyses for this end point

    Primary: Percentage of subjects with a MN titer ≥1:40, 1:80, and 1:160 and achieving at least 4-fold increase in MN titer.

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    End point title
    		 Percentage of subjects with a MN titer ≥1:40, 1:80, and 1:160 and achieving at least 4-fold increase in MN titer. [5]
    End point description
    Immunogenicity was assessed in terms of percentage of subjects with a MN titer ≥1:40, 1:80, and 1:160 on day 1 and day 43 and percentage of subjects achieving at least a 4-fold increase in MN titer on day 22 and day 43.
    End point type
    Primary
    End point timeframe
    At day 1, day 22 and day 43.
    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: No statistical analyses for this end point
    End point values
    		 3.75_halfMF59 7.5_fullMF59
    Number of subjects analysed
    57
    59
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Day 1 (≥1:40) (N=57,59)
    0 (0 to 6.3)
    6.8 (1.9 to 16.5)
        Day 22 (≥1:40) (N=55,58)
    45.5 (32 to 59.4)
    58.6 (44.9 to 71.4)
        Day 43 (≥1:40) (N=57,58)
    98.2 (90.6 to 100)
    100 (93.8 to 100)
        Day 1 (≥1:80) (N=57,59)
    0 (0 to 6.3)
    0 (0 to 6.1)
        Day 22 (≥1:80) (N=55,58)
    27.3 (16.1 to 41)
    43.1 (30.2 to 56.8)
        Day 43 (≥1:80) (N=57,58)
    91.2 (80.7 to 97.1)
    98.3 (90.8 to 100)
        Day 1 (≥1:160) (N57,59)
    0 (0 to 6.3)
    0 (0 to 6.1)
        Day 22 (≥1:160) (N=55,58)
    16.4 (7.8 to 28.8)
    22.4 (12.5 to 35.3)
        Day 43 (≥1:160) (N=57,58)
    70.2 (56.6 to 81.6)
    82.8 (70.6 to 91.4)
        Day 22 to day 1 (4-fold increase) (N=55,58)
    60 (45.9 to 73)
    74.1 (61 to 84.7)
        Day 43 to day 1 (4-fold increase) (N=57,58)
    100 (93.7 to 100)
    100 (93.8 to 100)
    No statistical analyses for this end point

    Primary: Number of subjects reporting solicited local and systemic reactions after first and second vaccination of subjects aged 6 to 35 months

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    End point title
    		 Number of subjects reporting solicited local and systemic reactions after first and second vaccination of subjects aged 6 to 35 months [6]
    End point description
    Safety was assessed as the number of subjects who reported solicited local and systemic reactions 1 week after first and second vaccination of subjects aged 6 to 35 months.
    End point type
    Primary
    End point timeframe
    From day 1 through day 7 after first and 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: No statistical analyses for this end point
    End point values
    		 3.75_halfMF59 7.5_fullMF59
    Number of subjects analysed
    10
    11
    Units: number of Subjects
        Any Local (vacc 1)
    4
    4
        Ecchymosis Any (vacc 1)
    2
    1
        Ecchymosis 1-10mm (vacc 1)
    1
    1
        Ecchymosis 11-25mm (vacc 1)
    1
    0
        Ecchymosis 26-50mm (vacc 1)
    0
    0
        Ecchymosis 51-100mm (vacc 1)
    0
    0
        Ecchymosis >100mm (vacc 1)
    0
    0
        Erythema Any (Vacc 1)
    3
    3
        Erythema 1-10mm (Vacc 1)
    1
    1
        Erythema 11-25mm (Vacc 1)
    2
    1
        Erythema 26-50mm (Vacc 1)
    0
    0
        Erythema 51-100mm (Vacc 1)
    0
    1
        Erythema >100 (Vacc 1)
    0
    0
        Induration Any (Vacc 1)
    2
    0
        Induration 1-10mm (Vacc 1)
    1
    0
        Induration 11-25mm (Vacc 1)
    1
    0
        Induration 26-50mm (Vacc 1)
    0
    0
        Induration 51-100mm (Vacc 1)
    0
    0
        Induration >100 (Vacc 1)
    0
    0
        Swelling Any (Vacc 1)
    1
    0
        Swelling 1-10mm (Vacc 1)
    0
    0
        Swelling 11-25mm (vacc 1)
    1
    0
        Swelling 26-50mm (Vacc 1)
    0
    0
        Swelling 51-100mm (Vacc 1)
    0
    0
        Swelling >100mm (Vacc 1)
    0
    0
        Tenderness (vacc 1)
    0
    2
        Cried when Injected limb was moved (Vacc 1)
    0
    0
        Systemic (Vacc 1)
    3
    4
        Sleepiness (Vacc 1)
    3
    1
        Diarrhea (Vacc 1)
    0
    1
        Vomiting (Vacc 1)
    1
    1
        Irritability (Vacc 1)
    1
    0
        Change in eating habits (Vacc 1)
    2
    0
        Shivering (Vacc 1)
    0
    0
        Unusual Crying (Vacc 1)
    1
    0
        Other (Vacc 1)
    2
    0
        Fever Temp (Axillary) (vacc 1)
    1
    2
        Temp 37.5-37.9 C (Vacc 1)
    2
    0
        Temp 38.0-38.9 C (Vacc 1)
    0
    2
        Temp 39.0-39.9 C (Vacc 1)
    1
    0
        Temp ≥ 40.0 C (Vacc 1)
    0
    0
        Any Local (vacc 2)
    3
    3
        Ecchymosis Any (Vacc 2)
    1
    0
        Ecchymosis 1-10mm (Vacc 2)
    1
    0
        Ecchymosis 11-25mm (Vacc 2)
    0
    0
        Ecchymosis 26-50mm (Vacc 2)
    0
    0
        Ecchymosis 51-100mm (Vacc 2)
    0
    0
        Ecchymosis >100mm(Vacc 2)
    0
    0
        Erythema Any (Vacc 2)
    3
    3
        Erythema 1-10mm (Vacc 2)
    0
    1
        Erythema 11-25mm (Vacc 2)
    1
    0
        Erythema 26-50mm (Vacc 2)
    1
    0
        Erythema 51-100mm (Vacc 2)
    1
    1
        Erythema >100mm (Vacc 2)
    0
    1
        Induration Any (Vacc 2)
    1
    1
        Induration 1-10mm (Vacc 2)
    0
    0
        Induration 11-25mm (Vacc 2)
    0
    0
        Induration 26-50mm (Vacc 2)
    0
    0
        Induration 51-100mm (Vacc 2)
    1
    1
        Induration >100mm (Vacc 2)
    0
    0
        Swelling Any (Vacc 2)
    2
    2
        Swelling 1-10mm (vacc 2)
    0
    0
        Swelling 11-25mm (Vacc 2)
    1
    0
        Swelling 26-50mm (Vacc 2)
    0
    0
        Swelling 51-100mm (Vacc 2)
    1
    1
        Swelling >100mm (Vacc 2)
    0
    1
        Tenderness (Vacc 2)
    2
    2
        Cried when injected limb was moved (Vacc 2)
    0
    0
        Systemic (Vacc 2)
    4
    2
        Sleepiness (Vacc 2)
    1
    0
        Diarrhea (Vacc 2)
    1
    1
        Vomiting (Vacc 2)
    0
    0
        Irritability (Vacc 2)
    0
    0
        Change in eating habits (Vacc 2)
    0
    0
        Shivering (Vacc 2)
    0
    0
        Unusual Crying (Vacc 2)
    0
    0
        Other (Vacc 2)
    2
    0
        Fever Temp (Axillary) (Vacc 2)
    3
    2
        Temp 37.5-37.9 C (Vacc 2)
    2
    2
        Temp 38.0-38.9 C (Vacc 2)
    0
    2
        Temp 39.0-39.9 C (Vacc 2)
    3
    0
        Temp ≥ 40.0 C (Vacc 2)
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects reporting Solicited local and systemic reactions after first and second vaccination of 3 to 19 years of age

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    End point title
    		 Number of subjects reporting Solicited local and systemic reactions after first and second vaccination of 3 to 19 years of age [7]
    End point description
    Safety was assessed as the number of subjects who reported solicited local and systemic reactions 1 week after first and second vaccination of subjects age 3 to 19 years.
    End point type
    Primary
    End point timeframe
    From day 1 through day 7 after first and second vaccination .
    Notes
    [7] - 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: No statistical analyses for this end point
    End point values
    		 3.75_halfMF59 7.5_fullMF59
    Number of subjects analysed
    50
    51
    Units: Number of subjects
        Any Local (Vacc 1)
    39
    44
        Ecchymosis Any (Vacc 1)
    3
    4
        Ecchymosis 1-10mm (Vacc 1)
    2
    2
        Ecchymosis 11-25mm (Vacc 1)
    1
    1
        Ecchymosis 26-50mm (Vacc 1)
    0
    0
        Ecchymosis 51-100mm (Vacc 1)
    0
    1
        Ecchymosis >100mm (Vacc 1)
    0
    0
        Erythema Any (Vacc 1)
    16
    21
        Erythema 1-10mm (Vacc 1)
    3
    5
        Erythema 11-25mm (Vacc1)
    3
    1
        Erythema 26-50mm (Vacc 1)
    4
    9
        Erythema 51-100mm (Vacc 1)
    6
    6
        Erythema >100mm (Vacc 1)
    0
    0
        Induration Any (Vacc 1)
    9
    12
        Induration 1-10mm (Vacc 1)
    4
    6
        Induration 11-25mm (Vacc 1)
    1
    3
        Induration 26-50mm (Vacc 1)
    2
    2
        Induration 51-100mm (Vacc 1)
    2
    1
        Induration >100mm (Vacc 1)
    0
    0
        Swelling Any (Vacc 1)
    14
    18
        Swelling 1-10mm (Vacc 1)
    2
    5
        Swelling 11-25mm (Vacc 1)
    1
    1
        Swelling 26-50mm (Vacc 1)
    8
    9
        Swelling 51-100mm (Vacc 1)
    3
    3
        Swelling >100mm (Vacc 1)
    0
    0
        Pain (Vacc 1)
    32
    42
        Systemic (Vacc 1)
    21
    22
        Chills (Vacc 1)
    2
    4
        Malaise (Vacc 1)
    7
    8
        Myalgia (Vacc 1)
    4
    9
        Arthralgia (Vacc 1)
    1
    4
        Headache (Vacc 1)
    11
    11
        Sweating (Vacc 1)
    1
    1
        Fatigue (Vacc 1)
    8
    11
        Nausea (Vacc 1)
    1
    4
        Other (Vacc 1)
    5
    5
        Fever Temp (Axilliary) (Vacc 1)
    4
    5
        Temp 37.5-37.9 C (Vacc 1)
    0
    3
        Temp 38.0-38.9 C (Vacc 1)
    3
    2
        Temp 39.0-39.9 C (Vacc 1)
    1
    3
        Temp ≥ 40.0 C (Vacc 1)
    0
    0
        Any Local (Vacc 2)
    39
    37
        Ecchymosis (vacc 2)
    2
    6
        Ecchymosis 1-10mm (Vacc 2)
    1
    2
        Ecchymosis 11-25mm (Vacc 2)
    0
    0
        Ecchymosis 26-50mm (Vacc 2)
    0
    2
        Eccymosis 51-100mm (Vacc 2)
    1
    2
        Eccymosis >100mm (Vacc 2)
    0
    0
        Erythema Any (Vacc 2)
    12
    12
        Erythema 1-10mm (Vacc 2)
    2
    0
        Erythema 11-25mm (Vacc 2)
    3
    0
        Erythema 26-50mm (Vacc 2)
    4
    6
        Erythema 51-100mm (Vacc 2)
    3
    6
        Erythema >100mm (Vacc 2)
    0
    0
        Induration Any (Vacc 2)
    7
    8
        Induration 1-10mm (Vacc 2)
    3
    2
        Induration 11-25mm (Vacc 2)
    3
    1
        Induration 26-50mm (Vacc 2)
    0
    2
        Induration 51-100mm (Vacc 2)
    1
    3
        Induration >100mm (Vacc 2)
    0
    0
        Swelling Any (Vacc 2)
    13
    16
        Swelling 1-10mm (Vacc 2)
    1
    0
        Swelling 11-25mm (Vacc 2)
    0
    1
        Swelling 26-50mm (Vacc 2)
    7
    9
        Swelling 51-100mm (Vacc 2)
    4
    6
        Swelling >100mm (Vacc 2)
    1
    0
        Pain (Vacc 2)
    32
    30
        Systemic (Vacc 2)
    12
    16
        Chills (Vacc 2)
    1
    3
        Malaise (Vacc 2)
    5
    10
        Myalgia (Vacc 2)
    3
    6
        Arthalgia (Vacc 2)
    0
    1
        Headache (Vacc 2)
    3
    8
        Sweating (Vacc 2)
    1
    0
        Fatigue (Vacc 2)
    5
    6
        Nausea (Vacc 2)
    3
    1
        Other (Vacc 2)
    1
    5
        Fever Temp (Axillary) (Vacc 2)
    1
    3
        Temp 37.5-37.9 C (Vacc 2)
    0
    1
        Temp 38.0-38.9 C (Vacc 2)
    1
    3
        Temp 39.0-39.9 C (Vacc 2)
    0
    0
        Temp ≥ 40.0 C (Vacc 2)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to Day 43.
    Adverse event reporting additional description
    Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    3.75_halfMF59
    Reporting group description
    		 Subjects received two doses of cell-derived H1N1sw vaccine containing 3.75µg + half MF59.

    Reporting group title
    7.5_fullMF59
    Reporting group description
    		 Subjects received two doses of cell-derived H1N1sw vaccine containing 7.5µg + full MF59.

    Serious adverse events
    		 3.75_halfMF59 7.5_fullMF59
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 60 (3.33%)
    3 / 62 (4.84%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Humerus Fracture
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Influenza
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    2 / 60 (3.33%)
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 3.75_halfMF59 7.5_fullMF59
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    57 / 60 (95.00%)
    57 / 62 (91.94%)
    Nervous system disorders
    Headache
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    13 / 60 (21.67%)
    15 / 62 (24.19%)
         occurrences all number
    19
    22
    Somnolence
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    4 / 60 (6.67%)
    1 / 62 (1.61%)
         occurrences all number
    5
    1
    General disorders and administration site conditions
    Chills
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    3 / 60 (5.00%)
    7 / 62 (11.29%)
         occurrences all number
    3
    8
    Fatigue
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    9 / 60 (15.00%)
    17 / 62 (27.42%)
         occurrences all number
    13
    24
    Injection Site Erythema
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    27 / 60 (45.00%)
    27 / 62 (43.55%)
         occurrences all number
    35
    40
    Injection Site Haemorrhage
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    7 / 60 (11.67%)
    10 / 62 (16.13%)
         occurrences all number
    8
    12
    Injection Site Induration
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    12 / 60 (20.00%)
    18 / 62 (29.03%)
         occurrences all number
    19
    21
    Injection Site Pain
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    41 / 60 (68.33%)
    46 / 62 (74.19%)
         occurrences all number
    66
    79
    Injection Site Pruritus
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    5 / 60 (8.33%)
    7 / 62 (11.29%)
         occurrences all number
    6
    8
    Injection Site Swelling
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    22 / 60 (36.67%)
    26 / 62 (41.94%)
         occurrences all number
    30
    36
    Malaise
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    12 / 60 (20.00%)
    16 / 62 (25.81%)
         occurrences all number
    14
    18
    Pyrexia
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    11 / 60 (18.33%)
    12 / 62 (19.35%)
         occurrences all number
    14
    13
    Gastrointestinal disorders
    Nausea
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    4 / 60 (6.67%)
    5 / 62 (8.06%)
         occurrences all number
    4
    7
    Respiratory, thoracic and mediastinal disorders
    Upper Respiratory Tract Inflammation
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    3 / 60 (5.00%)
    6 / 62 (9.68%)
         occurrences all number
    3
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    1 / 60 (1.67%)
    6 / 62 (9.68%)
         occurrences all number
    1
    6
    Myalgia
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    5 / 60 (8.33%)
    12 / 62 (19.35%)
         occurrences all number
    7
    19
    Infections and infestations
    Bronchitis
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    1 / 60 (1.67%)
    6 / 62 (9.68%)
         occurrences all number
    1
    6
    Nasopharyngitis
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    3 / 60 (5.00%)
    7 / 62 (11.29%)
         occurrences all number
    3
    8
    Pharyngitis
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    4 / 60 (6.67%)
    1 / 62 (1.61%)
         occurrences all number
    5
    1
    Upper Respiratory Tract Infection
    Additional description: Occurrences table was generated by using MedDRA version 17.1.
         subjects affected / exposed
    4 / 60 (6.67%)
    1 / 62 (1.61%)
         occurrences all number
    4
    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/20586002
    http://www.ncbi.nlm.nih.gov/pubmed/22472791
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