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    Clinical Trial Results:
    A Phase II, Randomized, Controlled, Open Label, Single-Center Study to Evaluate the Immunogenicity, Safety and Tolerability of Fluad-H5N1 and Seasonal Influenza Vaccine in Adult Subjects.

    Summary
    EudraCT number
    		 2014-004515-37
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 Dec 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 Jul 2016
    First version publication date
    14 Jan 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
    V87P5
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00481065
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics GmbH & Co. KG
    Sponsor organisation address
    Postfach 1630, Marburg, Germany, 35006
    Public contact
    Posting Director, Novartis Vaccines, RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines, 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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Dec 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the magnitude of antibody responses to two or three doses of Fluad-H5N1 (H5N1 adjuvanted) influenza vaccine and seasonal Agrippal.
    Protection of trial subjects
    This trial was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with Good Clinical Practice (GCP), and the applicable regulatory requirement(s) for the country in which the trial was conducted according to International Conference on Harmonization (ICH) guidelines, and applicable Standard Operating Procedures (SOPs).
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    30 Apr 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Colombia: 405
    Worldwide total number of subjects
    405
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    405
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled at 1 site in Columbia.

    Pre-assignment
    Screening details
    		 All subjects enrolled were included in the trial. A total of 405 subjects was enrolled and randomized into 8 groups in this study. The participant flow data are from the all randomized set.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Concomitant Alone
    Arm description
    		 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adjuvanted monovalent H5N1 influenza virus vaccine
    Investigational medicinal product code
    Other name
    Aflunov
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two 0.5mL doses

    Investigational medicinal product name
    Trivalent influenza virus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    one 0.5mL dose

    Arm title
    		 Concomitant+Mixed
    Arm description
    		 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adjuvanted monovalent H5N1 influenza virus vaccine
    Investigational medicinal product code
    Other name
    Aflunov
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two 0.5mL doses one 1mL dose of mixed Adjuvanted monovalent H5N1 influenza virus vaccine and Trivalent influenza virus vaccine

    Investigational medicinal product name
    Trivalent influenza virus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    one 0.5mL dose

    Arm title
    		 Concomitant+MF59-eH5N1
    Arm description
    		 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adjuvanted monovalent H5N1 influenza virus vaccine
    Investigational medicinal product code
    Other name
    Aflunov
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two 0.5mL doses one 1mL dose of mixed Adjuvanted monovalent H5N1 influenza virus vaccine and Trivalent influenza virus vaccine

    Investigational medicinal product name
    Trivalent influenza virus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    one 0.5mL dose

    Arm title
    		 Mixed
    Arm description
    		 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adjuvanted monovalent H5N1 influenza virus vaccine
    Investigational medicinal product code
    Other name
    Aflunov
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    two 1mL doses of mixed Adjuvanted monovalent H5N1 influenza virus vaccine and Trivalent influenza virus vaccine

    Investigational medicinal product name
    Trivalent influenza virus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    two 1mL doses of mixed Adjuvanted monovalent H5N1 influenza virus vaccine and Trivalent influenza virus vaccine

    Arm title
    		 Mixed + Mixed
    Arm description
    		 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trivalent influenza virus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    three 1mL doses of mixed Adjuvanted monovalent H5N1 influenza virus vaccine and Trivalent influenza virus vaccine

    Investigational medicinal product name
    Adjuvanted monovalent H5N1 influenza virus vaccine
    Investigational medicinal product code
    Other name
    Aflunov
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    three 1mL doses of mixed Adjuvanted monovalent H5N1 influenza virus vaccine and Trivalent influenza virus vaccine

    Arm title
    		 Mixed+MF59-eH5N1
    Arm description
    		 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trivalent influenza virus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two 1mL doses of mixed Adjuvanted monovalent H5N1 influenza virus vaccine and Trivalent influenza virus vaccine

    Investigational medicinal product name
    Adjuvanted monovalent H5N1 influenza virus vaccine
    Investigational medicinal product code
    Other name
    Aflunov
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two 1mL doses of mixed Adjuvanted monovalent H5N1 influenza virus vaccine and Trivalent influenza virus vaccine One 0.5mL dose of Adjuvanted monovalent H5N1 influenza virus vaccine

    Arm title
    		 MF59-eH5N1+eTIV_a
    Arm description
    		 1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adjuvanted monovalent H5N1 influenza virus vaccine
    Investigational medicinal product code
    Other name
    Aflunov
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose of Adjuvanted monovalent H5N1 influenza virus vaccine One 1mL dose of mixed Adjuvanted monovalent H5N1 influenza virus vaccine and Trivalent influenza virus vaccine

    Investigational medicinal product name
    Trivalent influenza virus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose of Trivalent influenza virus vaccine One 1mL dose of mixed Adjuvanted monovalent H5N1 influenza virus vaccine and Trivalent influenza virus vaccine

    Arm title
    		 eTIV_a+MF59-eH5N1
    Arm description
    		 1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adjuvanted monovalent H5N1 influenza virus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose of Adjuvanted monovalent H5N1 influenza virus vaccine One 1mL dose of mixed Adjuvanted monovalent H5N1 influenza virus vaccine and Trivalent influenza virus vaccine

    Investigational medicinal product name
    Trivalent influenza virus vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose of Trivalent influenza virus vaccine One 1mL dose of mixed Adjuvanted monovalent H5N1 influenza virus vaccine and Trivalent influenza virus vaccine

    Number of subjects in period 1
    		Concomitant Alone Concomitant+Mixed Concomitant+MF59-eH5N1 Mixed Mixed + Mixed Mixed+MF59-eH5N1 MF59-eH5N1+eTIV_a eTIV_a+MF59-eH5N1
    Started
    51
    50
    51
    52
    51
    51
    50
    49
    Completed
    29
    33
    32
    37
    28
    27
    34
    30
    Not completed
    22
    17
    19
    15
    23
    24
    16
    19
         Consent withdrawn by subject
    11
    12
    7
    11
    13
    12
    9
    10
         Adverse Event
    1
    1
    3
    -
    1
    -
    1
    1
         Death
    -
    -
    -
    -
    1
    -
    -
    -
         Inappropriate enrolment
    4
    -
    2
    -
    2
    1
    -
    1
         Lost to follow-up
    4
    2
    4
    3
    3
    3
    2
    5
         Unable to Classify
    -
    1
    2
    -
    1
    -
    -
    -
         Protocol deviation
    2
    1
    1
    1
    2
    6
    3
    2
         Administrative reason
    -
    -
    -
    -
    -
    2
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Concomitant Alone
    Reporting group description
    		 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Reporting group title
    Concomitant+Mixed
    Reporting group description
    		 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Reporting group title
    Concomitant+MF59-eH5N1
    Reporting group description
    		 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Reporting group title
    Mixed
    Reporting group description
    		 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Reporting group title
    Mixed + Mixed
    Reporting group description
    		 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382

    Reporting group title
    Mixed+MF59-eH5N1
    Reporting group description
    		 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Reporting group title
    MF59-eH5N1+eTIV_a
    Reporting group description
    		 1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Reporting group title
    eTIV_a+MF59-eH5N1
    Reporting group description
    		 1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Reporting group values
    		 Concomitant Alone Concomitant+Mixed Concomitant+MF59-eH5N1 Mixed Mixed + Mixed Mixed+MF59-eH5N1 MF59-eH5N1+eTIV_a eTIV_a+MF59-eH5N1 Total
    Number of subjects
    		 51 50 51 52 51 51 50 49 405
    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)
    		 29 ( 6.2 ) 29.4 ( 5.8 ) 29.5 ( 6.5 ) 29.8 ( 6.8 ) 29.6 ( 6.1 ) 28.8 ( 6.2 ) 27.9 ( 6.2 ) 30.1 ( 6.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 42 31 36 30 36 39 30 32 276
        Male
    		 9 19 15 22 15 12 20 17 129
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set – Primary Immunogenicity
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects in the enrolled population who actually received at least one dose of study vaccination, provided at least one evaluable serum sample both before and after baseline, provided immunogenicity and safety results for the primary course of vaccination (up to day 43).

    Subject analysis set title
    Full Analysis Set – Persistence Immunogenicity
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects in the enrolled population who actually received at least one dose of study vaccination, provided at least one evaluable serum sample both before and after baseline, provided immunogenicity and safety results for the persistence period (day 43 to day 382).

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

    Subject analysis set title
    All Enrolled Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects enrolled in this study irrespective of whether they have been randomized or not.

    Subject analysis set title
    Full Analysis Set – Booster Immunogenicity
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects in the enrolled population who actually received at least one dose of study vaccination, provided at least one evaluable serum sample both before and after baseline, provided immunogenicity and safety results after booster vaccination (day 382 to day 403).

    Subject analysis sets values
    		 Full Analysis Set – Primary Immunogenicity Full Analysis Set – Persistence Immunogenicity Safety Set All Enrolled Population Full Analysis Set – Booster Immunogenicity
    Number of subjects
    380
    266
    401
    405
    265
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    29.3 ( 6.2 )
    ( )
    Gender categorical
    Units: Subjects
        Female
    276
        Male
    129

    End points

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    End points reporting groups
    Reporting group title
    Concomitant Alone
    Reporting group description
    		 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Reporting group title
    Concomitant+Mixed
    Reporting group description
    		 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Reporting group title
    Concomitant+MF59-eH5N1
    Reporting group description
    		 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Reporting group title
    Mixed
    Reporting group description
    		 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Reporting group title
    Mixed + Mixed
    Reporting group description
    		 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382

    Reporting group title
    Mixed+MF59-eH5N1
    Reporting group description
    		 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Reporting group title
    MF59-eH5N1+eTIV_a
    Reporting group description
    		 1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Reporting group title
    eTIV_a+MF59-eH5N1
    Reporting group description
    		 1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Subject analysis set title
    Full Analysis Set – Primary Immunogenicity
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects in the enrolled population who actually received at least one dose of study vaccination, provided at least one evaluable serum sample both before and after baseline, provided immunogenicity and safety results for the primary course of vaccination (up to day 43).

    Subject analysis set title
    Full Analysis Set – Persistence Immunogenicity
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects in the enrolled population who actually received at least one dose of study vaccination, provided at least one evaluable serum sample both before and after baseline, provided immunogenicity and safety results for the persistence period (day 43 to day 382).

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

    Subject analysis set title
    All Enrolled Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects enrolled in this study irrespective of whether they have been randomized or not.

    Subject analysis set title
    Full Analysis Set – Booster Immunogenicity
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects in the enrolled population who actually received at least one dose of study vaccination, provided at least one evaluable serum sample both before and after baseline, provided immunogenicity and safety results after booster vaccination (day 382 to day 403).

    Primary: 1. Percentages of Subjects Who Responded to Two or Three Doses of MF59-eH5N1 Influenza Vaccine

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    End point title
    		 1. Percentages of Subjects Who Responded to Two or Three Doses of MF59-eH5N1 Influenza Vaccine [1]
    End point description
    Seroconversion (serocon.) is defined as negative pre-vaccination serum (titer <10 for HI [Haemagglutination Inhibition], area ≤4 mm2 for SRH [Single Radial Haemolysis]) / positive post-vaccination titer (titer ≥ 40 for HI, area ≥ 25 mm2 for SRH). Significant increase in antibody titer is defined as at least a fourfold increase for HI or at least 50% increase in the SRH area from non-negative pre-vaccination serum (HI ≥ 10, SRH>4mm2). Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm2. The analysis was done on the full analysis set (FAS).
    End point type
    Primary
    End point timeframe
    21 days after second and third vaccinations (day 43 and day 403)
    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: There were no statistical analysis done.
    End point values
    		 Concomitant Alone Concomitant+Mixed Concomitant+MF59-eH5N1 Mixed Mixed + Mixed Mixed+MF59-eH5N1 MF59-eH5N1+eTIV_a eTIV_a+MF59-eH5N1
    Number of subjects analysed
    46
    48
    47
    50
    49
    48
    48
    44
    Units: Percentages of Subjects
    number (confidence interval 95%)
        HI seroprot. (day1) N=46,48,47,50,49,48,48,44
    0 (0 to 8)
    2 (0.053 to 11)
    0 (0 to 8)
    4 (0 to 14)
    2 (0.052 to 11)
    0 (0 to 7)
    0 (0 to 7)
    0 (0 to 8)
        HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43
    26 (14 to 41)
    69 (54 to 81)
    80 (66 to 91)
    27 (15 to 41)
    65 (49 to 78)
    71 (56 to 83)
    40 (26 to 56)
    51 (35 to 67)
        HI seroprot. (2nd vacc) N=46,48,46,49,48,48,47,43
    26 (14 to 41)
    71 (56 to 83)
    80 (66 to 91)
    29 (17 to 43)
    67 (58 to 80)
    71 (56 to 83)
    40 (26 to 56)
    51 (35 to 67)
        HI serocon. (3rd vacc) N=23,25,28,35,25,20,28,25
    74 (52 to 90)
    60 (39 to 79)
    93 (76 to 99)
    54 (37 to 71)
    64 (43 to 82)
    65 (41 to 85)
    86 (67 to 96)
    64 (43 to 82)
        HI seroprot. (3rd vacc) N=24,25,28,35,25,20,28,25
    75 (53 to 90)
    60 (39 to 79)
    93 (76 to 99)
    57 (39 to 74)
    64 (43 to 82)
    70 (46 to 88)
    86 (37 to 96)
    64 (43 to 82)
        SRH seroprot. (day 1) N=46,48,47,49,47,47,48,43)
    7 (1 to 18)
    13 (5 to 25)
    2 (0.054 to 11)
    8 (2 to 20)
    9 (2 to 20)
    13 (5 to 26)
    8 (2 to 20)
    12 (4 to 25)
        SRH serocon. (2nd vacc) N=46,48,46,49,46,47,47,42
    30 (18 to 46)
    79 (65 to 90)
    93 (82 to 99)
    22 (12 to 37)
    67 (52 to 80)
    81 (67 to 91)
    49 (34 to 64)
    60 (43 to 74)
        SRH seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43
    37 (23 to 52)
    83 (70 to 93)
    93 (82 to 99)
    28 (16 to 42)
    73 (58 to 85)
    88 (75 to 95)
    55 (40 to 70)
    67 (51 to 81)
        SRH serocon. (3rd vacc) N=25,25,28,35,25,20,28,25
    96 (80 to 100)
    80 (59 to 93)
    96 (82 to 100)
    71 (54 to 85)
    48 (28 to 69)
    60 (36 to 81)
    64 (44 to 81)
    64 (43 to 82)
        SRH seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25
    100 (86 to 100)
    84 (64 to 95)
    96 (82 to 100)
    77 (60 to 90)
    44 (24 to 65)
    75 (51 to 91)
    82 (63 to 94)
    76 (55 to 91)
        MN ≥40 (day 1) N=46,48,47,50,49,48,48,44)
    2 (0.055 to 12)
    4 (1 to 14)
    2 (0.054 to 11)
    4 (0 to 14)
    2 (0.052 to 11)
    2 (0.053 to 11)
    2 (0.053 to 11)
    2 (0.058 to 12)
        MN ≥40 (2nd vacc) N=46,48,46,50,48,48,47,43
    30 (18 to 46)
    75 (60 to 86)
    96 (85 to 99)
    32 (20 to 47)
    75 (60 to 86)
    92 (80 to 98)
    51 (36 to 66)
    47 (31 to 62)
        MN ≥40 (3rd vacc) N=25,25,28,35,25,20,28,25
    96 (80 to 100)
    96 (80 to 100)
    100 (88 to 100)
    89 (73 to 97)
    88 (69 to 97)
    100 (83 to 100)
    93 (76 to 99)
    92 (74 to 99)
    No statistical analyses for this end point

    Primary: 2. Geometric Mean Ratio After Two or Three Vaccinations of MF59-eH5N1 Influenza Vaccine

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    End point title
    		 2. Geometric Mean Ratio After Two or Three Vaccinations of MF59-eH5N1 Influenza Vaccine [2]
    End point description
    Geometric mean Ratio (GMR) was calculated for the haemagglutination inhibition (HI), microneutralization (MN) and single-radial haemolysis (SRH) results as well as the associated 95% confidence intervals. GMR was calculated as 21 days after second and third vaccinations over day 1. The analysis was done on the full analysis set (FAS).
    End point type
    Primary
    End point timeframe
    21 days after second and third vaccinations (day 43 and day 403)
    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: There were no statistical analysis done.
    End point values
    		 Concomitant Alone Concomitant+Mixed Concomitant+MF59-eH5N1 Mixed Mixed + Mixed Mixed+MF59-eH5N1 MF59-eH5N1+eTIV_a eTIV_a+MF59-eH5N1
    Number of subjects analysed
    46
    48
    46
    50
    48
    48
    47
    43
    Units: Ratios
    geometric mean (confidence interval 95%)
        HI (2nd vacc) N=46,48,46,49,48,48,47,43
    2.11 (1.29 to 3.46)
    12 (7.09 to 19)
    23 (14 to 37)
    2.16 (1.33 to 3.49)
    9.52 (5.86 to 15)
    14 (8.32 to 22)
    2.96 (1.81 to 4.86)
    5.34 (3.2 to 8.91)
        HI (3rd vacc) N=24,25,28,35,25,20,28,25
    34 (15 to 76)
    17 (7.82 to 37)
    93 (44 to 197)
    10 (5.36 to 20)
    9.89 (4.5 to 22)
    21 (8.56 to 49)
    66 (31 to 139)
    12 (5.53 to 26)
        SRH (2nd vacc) N=46,48,46,49,46,47,47,42
    1.82 (1.35 to 2.44)
    5.32 (3.98 to 7.09)
    9.64 (7.17 to 13)
    1.58 (1.19 to 2.11)
    4.25 (3.16 to 5.71)
    6.04 (4.5 to 8.11)
    2.9 (2.16 to 3.88)
    3.26 (2.39 to 4.44)
        SRH (3rd vacc) N=25,25,28,35,23,19,28,24
    9.92 (6.73 to 15)
    6.22 (4.25 to 9.12)
    11 (7.47 to 16)
    5.13 (3.69 to 7.13)
    3.1 (2.07 to 4.65)
    6.76 (4.33 to 11)
    7.17 (4.95 to 10)
    4.55 (3.08 to 6.74)
        MN (2nd vacc) N=46,48,46,50,48,48,47,43
    2.12 (1.54 to 2.91)
    7.64 (5.61 to 10)
    13 (9.45 to 18)
    2.15 (1.59 to 2.92)
    6.79 (4.98 to 9.26)
    11 (8.04 to 15)
    3.86 (2.82 to 5.29)
    3.49 (2.52 to 4.84)
        MN (3rd vacc) N=25,25,28,35,25,20,28,25
    38 (23 to 64)
    39 (23 to 64)
    66 (40 to 109)
    16 (10 to 25)
    13 (8 to 23)
    23 (13 to 41)
    58 (36 to 95)
    21 (12 to 35)
    No statistical analyses for this end point

    Primary: 3. Percentages of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)

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    End point title
    		 3. Percentages of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1) [3]
    End point description
    Seroconversion: negative pre-vaccination serum (HI titer <10, SRH area ≤ 4 mm2)/positive post-vaccination titer (HI titer ≥10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm2. The analysis was done on the full analysis set (FAS).
    End point type
    Primary
    End point timeframe
    21 days after second vaccination (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: There were no statistical analysis done.
    End point values
    		 Concomitant Alone Concomitant+Mixed Concomitant+MF59-eH5N1 Mixed Mixed + Mixed Mixed+MF59-eH5N1 MF59-eH5N1+eTIV_a eTIV_a+MF59-eH5N1
    Number of subjects analysed
    46
    48
    47
    50
    49
    48
    48
    44
    Units: Percentages of Subjects
    number (confidence interval 95%)
        HI seroprot. (day1)
    28 (16 to 43)
    38 (24 to 53)
    34 (21 to 49)
    46 (32 to 61)
    31 (18 to 45)
    40 (26 to 55)
    50 (35 to 65)
    45 (30 to 61)
        HI seroconv. (day43) N=46,48,46,50,48,48,47,43
    72 (57 to 84)
    73 (58 to 85)
    78 (64 to 89)
    58 (43 to 72)
    77 (63 to 88)
    77 (63 to 88)
    62 (46 to 75)
    72 (56 to 85)
        HI seroprot. (day43) N=46,48,46,50,48,48,47,43
    80 (66 to 91)
    94 (83 to 99)
    93 (82 to 99)
    78 (64 to 88)
    92 (80 to 98)
    85 (72 to 94)
    91 (80 to 98)
    93 (81 to 99)
    No statistical analyses for this end point

    Primary: 4. Percentages of Subjects Who Responded to Two or Three Vaccinations of seasonal eTIV_a Influenza Vaccine (Strain H3N2)

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    End point title
    		 4. Percentages of Subjects Who Responded to Two or Three Vaccinations of seasonal eTIV_a Influenza Vaccine (Strain H3N2) [4]
    End point description
    Seroconversion: negative pre-vaccination serum (HI titer <10, SRH area ≤4 mm2)/positive post-vaccination titer (HI titer ≥10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm2. The analysis was done on the full analysis set (FAS).
    End point type
    Primary
    End point timeframe
    21 days after second and third vaccinations (day 43 and day 403)
    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: There were no statistical analysis done.
    End point values
    		 Concomitant Alone Concomitant+Mixed Concomitant+MF59-eH5N1 Mixed Mixed + Mixed Mixed+MF59-eH5N1 MF59-eH5N1+eTIV_a eTIV_a+MF59-eH5N1
    Number of subjects analysed
    46
    48
    47
    50
    49
    48
    48
    44
    Units: Percentages of Subjects
    number (confidence interval 95%)
        HI seroprot. (day1)
    43 (29 to 59)
    46 (31 to 61)
    30 (17 to 45)
    46 (32 to 61)
    53 (38 to 67)
    46 (31 to 61)
    25 (14 to 40)
    50 (35 to 65)
        HI seroconv. (2nd vacc) N=46,48,46,49,48,48,47,43
    50 (35 to 65)
    75 (60 to 86)
    76 (61 to 87)
    70 (55 to 82)
    83 (70 to 93)
    83 (70 to 93)
    74 (60 to 86)
    67 (51 to 81)
        HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43
    85 (71 to 94)
    96 (86 to 99)
    96 (85 to 99)
    98 (89 to 100)
    100 (93 to 100)
    100 (93 to 100)
    100 (92 to 100)
    93 (81 to 99)
        HI seroconv. (3rd vacc) N=25,25,28,35,25,20,28,25
    76 (55 to 91)
    80 (59 to 93)
    93 (76 to 99)
    86 (70 to 95)
    72 (51 to 88)
    85 (62 to 97)
    89 (72 to 98)
    84 (64 to 95)
        HI seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25
    100 (86 to 100)
    100 (86 to 100)
    100 (88 to 100)
    100 (90 to 100)
    100 (86 to 100)
    100 (83 to 100)
    100 (88 to 100)
    100 (86 to 100)
    No statistical analyses for this end point

    Primary: 5. Percentages of Subjects Who Responded to Two or Three Vaccinations of seasonal eTIV_a Influenza Vaccine (Strain B)

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    End point title
    		 5. Percentages of Subjects Who Responded to Two or Three Vaccinations of seasonal eTIV_a Influenza Vaccine (Strain B) [5]
    End point description
    Seroconversion: negative pre-vaccination serum (HI titer <10, SRH area ≤4 mm2)/positive post-vaccination titer (HI titer ≥10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm2. The analysis was done on the full analysis set (FAS).
    End point type
    Primary
    End point timeframe
    21 days after second and third vaccinations (day 43 and day 403)
    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: There were no statistical analysis done.
    End point values
    		 Concomitant Alone Concomitant+Mixed Concomitant+MF59-eH5N1 Mixed Mixed + Mixed Mixed+MF59-eH5N1 MF59-eH5N1+eTIV_a eTIV_a+MF59-eH5N1
    Number of subjects analysed
    46
    48
    47
    50
    49
    48
    48
    44
    Units: Percentages of subjects
    number (confidence interval 95%)
        HI seroprot. (day1)
    11 (4 to 24)
    8 (2 to 20)
    13 (5 to 26)
    20 (10 to 34)
    4 (0 to 14)
    19 (9 to 33)
    25 (14 to 40)
    11 (4 to 24)
        HI seroconv. (2nd vacc) N=46,48,46,50,48,48,47,43
    80 (66 to 91)
    79 (65 to 90)
    78 (64 to 89)
    82 (69 to 91)
    85 (72 to 94)
    73 (58 to 85)
    77 (62 to 88)
    65 (49 to 79)
        HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43
    87 (74 to 95)
    90 (77 to 97)
    91 (79 to 98)
    92 (81 to 98)
    92 (80 to 98)
    94 (83 to 99)
    94 (82 to 99)
    74 (59 to 86)
        HI seroconv. (3rd vacc) N=25,25,28,35,25,20,28,25
    76 (55 to 91)
    68 (46 to 85)
    68 (48 to 84)
    77 (60 to 90)
    60 (39 to 79)
    65 (41 to 85)
    39 (22 to 59)
    60 (39 to 79)
        HI seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25
    88 (69 to 97)
    84 (64 to 95)
    79 (59 to 92)
    89 (73 to 97)
    72 (51 to 88)
    90 (68 to 99)
    61 (41 to 78)
    80 (59 to 93)
    No statistical analyses for this end point

    Primary: 6. Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)

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    End point title
    		 6. Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1) [6]
    End point description
    For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results as well as the associated 95% confidence intervals. GMR was calculated over day 1. The analysis was done on the full analysis set (FAS).
    End point type
    Primary
    End point timeframe
    21 days after second vaccination (day 43)
    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: There were no statistical analysis done.
    End point values
    		 Concomitant Alone Concomitant+Mixed Concomitant+MF59-eH5N1 Mixed Mixed + Mixed Mixed+MF59-eH5N1 MF59-eH5N1+eTIV_a eTIV_a+MF59-eH5N1
    Number of subjects analysed
    46
    48
    46
    50
    48
    48
    47
    43
    Units: Ratios
    geometric mean (confidence interval 95%)
        GMR (Strain H1N1, Day 43/Day1)
    15 (9.54 to 23)
    13 (8.43 to 20)
    14 (8.82 to 21)
    6.77 (4.46 to 10)
    12 (7.81 to 18)
    10 (6.69 to 16)
    6.23 (4.03 to 9.61)
    11 (6.76 to 17)
    No statistical analyses for this end point

    Primary: 7. Geometric Mean Ratio After Two or Three Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H3N2)

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    End point title
    		 7. Geometric Mean Ratio After Two or Three Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H3N2) [7]
    End point description
    For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results as well as the associated 95% confidence intervals. GMR was calculated over day 1. The analysis was done on the full analysis set (FAS).
    End point type
    Primary
    End point timeframe
    21 days after second and third vaccinations (day 43 and day 403)
    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: There were no statistical analysis done.
    End point values
    		 Concomitant Alone Concomitant+Mixed Concomitant+MF59-eH5N1 Mixed Mixed + Mixed Mixed+MF59-eH5N1 MF59-eH5N1+eTIV_a eTIV_a+MF59-eH5N1
    Number of subjects analysed
    46
    48
    47
    50
    49
    48
    48
    44
    Units: Ratios
    geometric mean (confidence interval 95%)
        HI GMR (2nd vacc) N=46,48,46,50,48,48,47,43
    6.01 (4.01 to 9.01)
    9.72 (6.54 to 14)
    9.34 (6.22 to 14)
    11 (7.54 to 16)
    11 (7.26 to 16)
    10 (6.92 to 15)
    11 (7.25 to 16)
    7.54 (4.96 to 11)
        HI GMR (3rd vacc) N=25,25,28,35,25,20,28,25
    17 (9.56 to 29)
    10 (6.04 to 18)
    17 (9.86 to 28)
    18 (11 to 29)
    8.92 (5.12 to 16)
    11 (5.8 to 20)
    17 (10 to 29)
    13 (7.64 to 23)
    No statistical analyses for this end point

    Primary: 8. Geometric Mean Ratio After Two or Three Doses of the Seasonal eTIV_a Influenza Vaccine (Strain B)

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    End point title
    		 8. Geometric Mean Ratio After Two or Three Doses of the Seasonal eTIV_a Influenza Vaccine (Strain B) [8]
    End point description
    For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results as well as the associated 95% confidence intervals. GMR was calculated over day 1. The analysis was done on the full analysis set (FAS).
    End point type
    Primary
    End point timeframe
    21 days after second and third vaccinations (day 43 and day 403)
    Notes
    [8] - 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: There were no statistical analysis done.
    End point values
    		 Concomitant Alone Concomitant+Mixed Concomitant+MF59-eH5N1 Mixed Mixed + Mixed Mixed+MF59-eH5N1 MF59-eH5N1+eTIV_a eTIV_a+MF59-eH5N1
    Number of subjects analysed
    46
    48
    47
    50
    49
    48
    48
    44
    Units: Ratios
    geometric mean (confidence interval 95%)
        HI GMR (2nd vacc) N=46,48,46,50,48,48,47,43
    11 (7.85 to 17)
    13 (9.01 to 19)
    10 (6.94 to 15)
    10 (7.22 to 15)
    17 (12 to 25)
    8.77 (6.07 to 13)
    10 (6.97 to 15)
    8 (5.44 to 12)
        HI GMR (3rd vacc) N=25,25,28,35,25,20,28,25
    8.85 (5.86 to 13)
    5.47 (3.64 to 8.22)
    7.95 (5.37 to 12)
    7.17 (5.05 to 10)
    5.29 (3.51 to 8)
    5.1 (3.22 to 8.06)
    4.17 (2.82 to 6.18)
    4.26 (2.84 to 6.4)
    No statistical analyses for this end point

    Secondary: 9. Number of Subjects Reporting Local and Systemic Reactions by Vaccination

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    End point title
    		 9. Number of Subjects Reporting Local and Systemic Reactions by Vaccination
    End point description
    To evaluate the safety of the administration of two or three vaccinations of MF59-eH5N1(H5N1 adjuvanted) influenza vaccine, either given sequentially, concomitantly or mixed extemporaneously with seasonal eTIV_a influenza vaccine. The analysis was done on the safety set.
    End point type
    Secondary
    End point timeframe
    for 21 days after 2nd and 3rd vaccinations (from day 22 to day43 and from day 382 to day 403)
    End point values
    		 Concomitant Alone Concomitant+Mixed Concomitant+MF59-eH5N1 Mixed Mixed + Mixed Mixed+MF59-eH5N1 MF59-eH5N1+eTIV_a eTIV_a+MF59-eH5N1
    Number of subjects analysed
    50
    50
    50
    51
    51
    50
    49
    49
    Units: Subjects
        Erythema (N=0,48,47,0,48,47,47,43) 2nd vacc
    0
    8
    8
    0
    8
    8
    7
    5
        Induration(N=0,48,47,0,48,47,47,43) 2nd vacc
    0
    2
    3
    0
    3
    2
    1
    3
        Swelling(N=0,47,47,0,48,47,47,43) 2nd vacc
    0
    2
    5
    0
    4
    1
    1
    1
        Ecchymosis(N=0,48,47,0,48,47,47,43) 2nd vacc
    0
    0
    0
    0
    1
    1
    1
    0
        Pain(N=0,48,47,0,48,47,47,43) 2nd vacc
    0
    21
    16
    0
    20
    18
    12
    16
        Erythema(N=31,33,36,39,31,29,34,31) 3rd vacc
    8
    4
    9
    9
    12
    7
    6
    11
        Induration(N=31,33,36,39,31,28,34,31) 3rd vacc
    6
    6
    14
    9
    9
    9
    7
    8
        Swelling(N=31,33,36,39,31,29,34,31) 3rd vacc
    5
    3
    9
    2
    7
    8
    6
    5
        Ecchymosis(N=31,33,36,39,31,29,34,31) 3rd vacc
    2
    1
    1
    1
    1
    1
    2
    3
        Pain(N=31,33,36,39,31,29,34,31) 3rd vacc
    20
    16
    21
    23
    20
    17
    17
    15
        Chills(N=0,48,47,0,48,45,47,42) 2nd vacc
    0
    0
    1
    0
    2
    4
    2
    2
        Chills(31,33,36,39,31,29,34,32) 3rd vacc
    3
    0
    6
    3
    4
    0
    3
    0
        Malaise(N=0,48,47,0,48,45,47,42) 2nd vacc
    0
    2
    4
    0
    7
    6
    2
    6
        Malaise(N=31,33,36,39,31,29,34,32) 3rd vacc
    6
    5
    9
    10
    8
    7
    9
    7
        Myalgia(N=0,48,47,0,48,45,47,42) 2nd vacc
    0
    8
    7
    0
    9
    6
    3
    5
        Myalgia(N=30,33,36,39,31,29,34,32) 3rd vacc
    12
    11
    17
    13
    12
    10
    8
    13
        Arthralgia(N=0,48,47,0,48,45,47,42) 2nd vacc
    0
    0
    3
    0
    1
    4
    2
    2
        Arthralgia(N=31,33,36,39,31,29,34,32) 3rd vacc
    2
    3
    5
    4
    4
    3
    4
    4
        Headache(N=0,48,47,0,48,45,47,42) 2nd vacc
    0
    2
    5
    0
    6
    5
    3
    4
        Headache (N=31,32,36,39,31,29,34,32) 3rd vacc
    8
    7
    11
    7
    10
    8
    5
    7
        Sweating(N=0,48,47,0,48,45,47,42) 2nd vacc
    0
    0
    1
    0
    0
    2
    1
    1
        Sweating(N=31,33,36,39,31,29,34,32) 3rd vacc
    2
    0
    2
    2
    0
    1
    0
    3
        Fatigue(N=0,48,47,0,48,45,47,42) 2nd vacc
    0
    1
    0
    0
    1
    1
    2
    2
        Fatigue(N=31,33,36,39,31,29,34,32) 3rd vacc
    2
    1
    3
    1
    2
    2
    1
    1
        Nausea(N=0,48,47,0,48,45,47,42) 2nd vacc
    0
    0
    1
    0
    1
    1
    2
    2
        Nausea(N=31,33,36,39,31,29,34,32) 3rd vacc
    1
    1
    3
    2
    3
    0
    2
    2
        Fever ≥38C(N=0,47,47,0,48,45,46,42) 2nd vacc
    0
    0
    0
    0
    1
    3
    0
    2
        Fever ≥38C (N=31,33,36,39,31,29,34,32) 3rd vacc
    2
    0
    0
    0
    0
    1
    1
    2
    No statistical analyses for this end point

    Secondary: 10. Percentages of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 (H5N1 Adjuvanted) Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine

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    End point title
    		 10. Percentages of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 (H5N1 Adjuvanted) Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine [9]
    End point description
    Booster was given on day 382; seroconversion: negative pre-vaccination serum (HI titer <10, SRH area ≤ 4 mm2)/positive post- vaccination titer (HI titer ≥10) or at least 50% increase in SRH area; seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm2. The number of subjects achieving seroconversion or significant increase and seroprotection were taken on day 403 and ratios calculated as Day403/day382 at day 382. The analysis was done on the full analysis set (FAS).
    End point type
    Secondary
    End point timeframe
    21 days after booster vaccination (day 403)
    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: There were no statistical analysis done.
    End point values
    		 Mixed Mixed + Mixed
    Number of subjects analysed
    39
    31
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Seroprotection (HI) - MF59-eH5N1 (N=35,25)
    74 (57 to 88)
    64 (43 to 82)
        Seroconversion (HI) - MF59-eH5N1 (N=35,25)
    71 (54 to 85)
    60 (39 to 79)
        Seroprotection (SRH) - MF59-eH5N1 (N=35,25)
    57 (39 to 74)
    28 (12 to 49)
        Seroconversion (SRH) - MF59-eH5N1 (N=35,25)
    60 (42 to 76)
    40 (21 to 61)
        Seroprotection (HI) - eTIV_a (H1N1) N=35,25
    94 (81 to 99)
    96 (80 to 100)
        Seroconversion (HI) - eTIV_a (H1N1) N=35,25
    49 (31 to 66)
    40 (21 to 61)
        Seroprotection (HI) - eTIV_a (H3N2) N=35,25
    100 (90 to 100)
    100 (86 to 100)
        Seroconversion (HI) - eTIV_a (H3N2) N=35,25
    34 (19 to 52)
    20 (7 to 41)
        Seroprotection (HI) - eTIV_a (B) N=35,25
    89 (73 to 97)
    72 (51 to 88)
        Seroconversion (HI) - eTIV_a (B) N=35,25
    17 (7 to 34)
    16 (5 to 36)
    No statistical analyses for this end point

    Secondary: 11. Geometric Mean Ratios After the Booster Vaccination Against the MF59-eH5N1 (H5N1 Adjuvanted) Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine

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    End point title
    		 11. Geometric Mean Ratios After the Booster Vaccination Against the MF59-eH5N1 (H5N1 Adjuvanted) Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine [10]
    End point description
    For each vaccine group, the least squares GMRs were calculated for the HI and SRH results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 382 for all time points for the booster dose. The analysis was done on the full analysis set (FAS).
    End point type
    Secondary
    End point timeframe
    21 days after booster vaccination (day 403)
    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: There were no statistical analysis done.
    End point values
    		 Mixed Mixed + Mixed
    Number of subjects analysed
    39
    31
    Units: Ratios
    geometric mean (confidence interval 95%)
        HI (MF59-eH5N1) N=35,25
    13 (6.99 to 25)
    7.14 (3.4 to 15)
        SRH (MF59-eH5N1) N=35,25
    4.88 (3.59 to 6.63)
    2.77 (1.93 to 3.98)
        HI (eTIV_a, H1N1) N=35,25
    4.85 (3.05 to 7.73)
    2.61 (1.51 to 4.51)
        HI (eTIV_a, H3N2) N=35,25
    2.62 (1.83 to 3.76)
    2.21 (1.44 to 3.39)
        HI (eTIV_a l, B) N=35,25
    1.96 (1.55 to 2.48)
    1.94 (1.47 to 2.55)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events and serious adverse events were collected for 20 months (the duration of the study).
    Adverse event reporting additional description
    The number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Concomitant Alone
    Reporting group description
    		 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Reporting group title
    Concomitant+Mixed
    Reporting group description
    		 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Reporting group title
    Concomitant+MF59-eH5N1
    Reporting group description
    		 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Reporting group title
    Mixed
    Reporting group description
    		 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Reporting group title
    Mixed + Mixed
    Reporting group description
    		 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382

    Reporting group title
    Mixed+MF59-eH5N1
    Reporting group description
    		 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Reporting group title
    MF59-eH5N1+eTIV_a
    Reporting group description
    		 1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Reporting group title
    eTIV_a+MF59-eH5N1
    Reporting group description
    		 1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

    Serious adverse events
    		 Concomitant Alone Concomitant+Mixed Concomitant+MF59-eH5N1 Mixed Mixed + Mixed Mixed+MF59-eH5N1 MF59-eH5N1+eTIV_a eTIV_a+MF59-eH5N1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 50 (8.00%)
    1 / 50 (2.00%)
    2 / 51 (3.92%)
    3 / 51 (5.88%)
    3 / 51 (5.88%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         number of deaths (all causes)
    0
    0
    0
    0
    1
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Investigations
    Aspiration Bronchial
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-cell small lymphocytic lymphoma
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ependymoma
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion spontaneous incomplete
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Concomitant Alone Concomitant+Mixed Concomitant+MF59-eH5N1 Mixed Mixed + Mixed Mixed+MF59-eH5N1 MF59-eH5N1+eTIV_a eTIV_a+MF59-eH5N1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 50 (76.00%)
    43 / 50 (86.00%)
    41 / 51 (80.39%)
    39 / 51 (76.47%)
    42 / 51 (82.35%)
    43 / 50 (86.00%)
    37 / 49 (75.51%)
    38 / 49 (77.55%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    18 / 50 (36.00%)
    17 / 50 (34.00%)
    22 / 51 (43.14%)
    14 / 51 (27.45%)
    25 / 51 (49.02%)
    19 / 50 (38.00%)
    13 / 49 (26.53%)
    15 / 49 (30.61%)
         occurrences all number
    27
    31
    35
    17
    41
    31
    20
    19
    Migraine
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    3
    1
    0
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    5 / 50 (10.00%)
    5 / 50 (10.00%)
    10 / 51 (19.61%)
    8 / 51 (15.69%)
    8 / 51 (15.69%)
    8 / 50 (16.00%)
    5 / 49 (10.20%)
    3 / 49 (6.12%)
         occurrences all number
    7
    6
    10
    9
    11
    9
    10
    3
    Fatigue
         subjects affected / exposed
    3 / 50 (6.00%)
    4 / 50 (8.00%)
    5 / 51 (9.80%)
    3 / 51 (5.88%)
    5 / 51 (9.80%)
    4 / 50 (8.00%)
    4 / 49 (8.16%)
    4 / 49 (8.16%)
         occurrences all number
    4
    5
    6
    3
    6
    4
    9
    5
    Injection site erythema
         subjects affected / exposed
    12 / 50 (24.00%)
    17 / 50 (34.00%)
    17 / 51 (33.33%)
    16 / 51 (31.37%)
    21 / 51 (41.18%)
    16 / 50 (32.00%)
    16 / 49 (32.65%)
    21 / 49 (42.86%)
         occurrences all number
    16
    24
    24
    18
    29
    19
    20
    23
    Injection Site Haemorrhage
         subjects affected / exposed
    3 / 50 (6.00%)
    5 / 50 (10.00%)
    2 / 51 (3.92%)
    5 / 51 (9.80%)
    5 / 51 (9.80%)
    3 / 50 (6.00%)
    3 / 49 (6.12%)
    3 / 49 (6.12%)
         occurrences all number
    3
    6
    2
    5
    6
    3
    4
    3
    Injection Site Induration
         subjects affected / exposed
    11 / 50 (22.00%)
    15 / 50 (30.00%)
    21 / 51 (41.18%)
    16 / 51 (31.37%)
    15 / 51 (29.41%)
    15 / 50 (30.00%)
    10 / 49 (20.41%)
    15 / 49 (30.61%)
         occurrences all number
    13
    24
    36
    18
    18
    16
    15
    19
    Injection site pain
         subjects affected / exposed
    29 / 50 (58.00%)
    34 / 50 (68.00%)
    33 / 51 (64.71%)
    32 / 51 (62.75%)
    34 / 51 (66.67%)
    32 / 50 (64.00%)
    33 / 49 (67.35%)
    29 / 49 (59.18%)
         occurrences all number
    47
    80
    75
    48
    68
    54
    53
    38
    Injection site swelling
         subjects affected / exposed
    8 / 50 (16.00%)
    9 / 50 (18.00%)
    15 / 51 (29.41%)
    10 / 51 (19.61%)
    10 / 51 (19.61%)
    10 / 50 (20.00%)
    9 / 49 (18.37%)
    11 / 49 (22.45%)
         occurrences all number
    9
    14
    26
    10
    15
    13
    12
    12
    Malaise
         subjects affected / exposed
    15 / 50 (30.00%)
    18 / 50 (36.00%)
    22 / 51 (43.14%)
    19 / 51 (37.25%)
    21 / 51 (41.18%)
    21 / 50 (42.00%)
    17 / 49 (34.69%)
    14 / 49 (28.57%)
         occurrences all number
    25
    23
    27
    24
    34
    35
    27
    21
    Pyrexia
         subjects affected / exposed
    5 / 50 (10.00%)
    1 / 50 (2.00%)
    2 / 51 (3.92%)
    4 / 51 (7.84%)
    4 / 51 (7.84%)
    8 / 50 (16.00%)
    2 / 49 (4.08%)
    7 / 49 (14.29%)
         occurrences all number
    6
    1
    2
    4
    4
    11
    2
    7
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 50 (2.00%)
    3 / 50 (6.00%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    2 / 51 (3.92%)
    1 / 50 (2.00%)
    4 / 49 (8.16%)
    1 / 49 (2.04%)
         occurrences all number
    1
    4
    0
    2
    2
    1
    6
    1
    Nausea
         subjects affected / exposed
    4 / 50 (8.00%)
    5 / 50 (10.00%)
    6 / 51 (11.76%)
    2 / 51 (3.92%)
    6 / 51 (11.76%)
    4 / 50 (8.00%)
    4 / 49 (8.16%)
    7 / 49 (14.29%)
         occurrences all number
    4
    5
    7
    2
    9
    4
    9
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    2 / 51 (3.92%)
    2 / 51 (3.92%)
    4 / 50 (8.00%)
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    1
    2
    2
    4
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
    3 / 51 (5.88%)
    2 / 51 (3.92%)
    1 / 50 (2.00%)
    0 / 49 (0.00%)
    0 / 49 (0.00%)
         occurrences all number
    0
    0
    2
    3
    2
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    3 / 50 (6.00%)
    2 / 50 (4.00%)
    8 / 51 (15.69%)
    4 / 51 (7.84%)
    3 / 51 (5.88%)
    4 / 50 (8.00%)
    2 / 49 (4.08%)
    4 / 49 (8.16%)
         occurrences all number
    4
    2
    9
    4
    5
    5
    4
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 50 (6.00%)
    4 / 50 (8.00%)
    11 / 51 (21.57%)
    6 / 51 (11.76%)
    8 / 51 (15.69%)
    9 / 50 (18.00%)
    7 / 49 (14.29%)
    6 / 49 (12.24%)
         occurrences all number
    3
    4
    13
    7
    11
    10
    13
    6
    Myalgia
         subjects affected / exposed
    16 / 50 (32.00%)
    24 / 50 (48.00%)
    25 / 51 (49.02%)
    23 / 51 (45.10%)
    24 / 51 (47.06%)
    17 / 50 (34.00%)
    18 / 49 (36.73%)
    17 / 49 (34.69%)
         occurrences all number
    22
    38
    36
    35
    41
    30
    30
    21
    Infections and infestations
    Influenza
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    1 / 49 (2.04%)
    1 / 49 (2.04%)
         occurrences all number
    3
    1
    0
    1
    1
    1
    1
    1
    Sinusitis
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 49 (0.00%)
    3 / 49 (6.12%)
         occurrences all number
    1
    1
    0
    0
    1
    0
    0
    3
    Tonsillitis
         subjects affected / exposed
    2 / 50 (4.00%)
    2 / 50 (4.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    3 / 50 (6.00%)
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences all number
    2
    2
    0
    0
    2
    3
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jan 2008
    Change of study design: to do the booster also with a tetravalent vaccine (MF59-EH5N1 mixed extemporaneously with Agrippal® 2007/2008).

    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/23536690
    http://www.ncbi.nlm.nih.gov/pubmed/21606530
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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